Vitamin Lawyer Update Memo: April 15, 2008
This issue:
1. FDA Food Labeling Guide
2. FDA – FTC Health Claims Crackdown
3. Allowed Product Claims
4. Are Your SOPs in Order? AER SOP Available
------------------------------------------------------
Blog Update: My Blog has been unblocked
FTC Receives Truthful Vaccine Advertising Petition
http:// vitaminlawyerhealthfreedom .blogspot .com
Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. New FDA Food Labeling Guide issued April 3rd
Says FDA regarding its new food labeling guide, “The most frequently raised questions have been addressed using a ‘question and answer’ format. We believe the vast majority of food labeling questions are answered.” I’ve looked it over and find it cogent. www .cfsan.fda .gov/~dms/2lg-toc .html
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2. FDA – FTC Health Claims Crackdown
www .nutraingredients-usa .com/news/
Good advise from a “Beltway” industry lawyer, from NutraIngredients .com -
“Just because others do it, doesn't mean it's OK… FDA regulates product labels, whereas FTC regulates product marketing. However, both agencies have limited resources… they cannot stay on top of every new product launch…. Nevertheless - budgets allowing - the agencies will clamp down when misleading health claim use is brought to their attention. When this happens, companies are held responsible for their marketing, regardless of competitor activity…
“FDA and FTC both use science as a golden standard, and this is what any safety claims for a product or ingredient need to be based on…
“If a manufacturer highlights the fact that a product contains a particular ingredient, this is considered to be an implied claim that the ingredient will have some effect…
“Keep apprised of FDA/FTC enforcement actions… "Especially in some of the grayer areas, knowing the opinions expressed by the agencies in the context of enforcement actions will give you valuable information that you can use when deciding whether to launch a new product or tweak an existing one."
“…FDA and FTC have both stressed that they are particularly wary of 'miracle cures' or 'all-in-one' cures… High on the agencies' radars are claims to cure serious diseases, products targeting children, and weight loss. They also look out for 'patches', as dietary supplements cannot be topical - they must be ingested…
“Double Blind Placebo Controlled studies with Statistically Significant Results are key to substantiating claims… However, despite the need for caution, companies should not be scared to make claims that can be substantiated… Animal studies can be important for support, but they cannot stand alone as sufficient evidence to support the efficacy of a product. Human clinical studies are what hold the real weight, and any support from animal studies is an added benefit.
“Keep your customers happy… Customer complaints can also serve to alert regulatory agencies to the need for action. In addition, companies should be sure to keep their promises…if products make money back guarantees, then companies should be prepared to honor the promise...
“‘Getting the advice of a qualified lawyer or consultant before launching a product or an advertising campaign may not be cheap, but it can be money well spent, and end up saving you a lot in the long run.’”
Ivan Wasserman, Esq. who specializes on advertising and labeling issues in the food and dietary supplement sectors, was addressing industry members at Expo West in Anaheim, California this March.
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3. Allowed Product Claims
www .nutraingredients-usa .com/news/
Please note: a “health claim” as discussed below is one step up from the typical “structure and function” claim most marketers make. S&F claims can be made without prior FDA approval, not so with health claims. Here is what
“As defined by [FDA] health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
“The use - and regulation - of health claims on products varies depending on which category these fall under: medical, or non-medical. The golden rule to using claims on foods, beverages and dietary supplements is to steer clear of implying in any way that these can prevent or treat a health condition, as they would then be classified as drugs.
Foods and supplements can carry two major types of health claims: Authorized health claims or qualified health claims… Examples of [authorized] claims would include:
* Calcium and the risk of osteoporosis
* Plant sterol/stanol esters and the risk of coronary heart disease
* Folic acid and the risk of neural tube defects
Authorized health claims can also be based on an authoritative statement from a scientific body of the US government or National Academy of Sciences… Examples include:
* Whole grain foods and risk of heart disease and certain cancers
* Potassium and the risk of high blood pressure and stroke…
Qualified health claims are those based on emerging evidence for the relationship between a food or supplement and a reduced risk of disease… this type of claim must include qualifying language to indicate that the evidence supporting the claim is limited… Examples include:
* Selenium and risk of certain cancers
* Walnuts and risk of coronary heart disease…
[Other types of claims include:] Structure/function claims on foods focus on the effects derived from the nutritive value of a food… Nutrient content claims characterize the level of a nutrient in the food, either directly or by implication.”
-----------------------------------------------
4. Are your Papers in order? AER SOPs
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
-----------------------------------------------
It’s been several weeks since my last VL Update Memo… we’ve been very busy, but I do expect to get back to one update every ten days or so. Thank you for your patience.
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Tuesday, April 15, 2008
Saturday, March 8, 2008
03/08/08 - Substantiation Resource
This issue:
1. Substantiation Resource
2. Has the DS Industry Reached “Maturity”?
3. AER SOP
------------------------------------------------------
Blog Update: Healthcare vs the Illness Industry
http:// vitaminlawyerhealthfreedom.blogspot .com
Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. Substantiation Resource: Natural Standard Research
I’ve recently taken a look at a good source of substantiation information. If you think this may help your company, please contact Jason (contact info below) and tell him The Vitamin Lawyer sent you. He is knowledgeable and very helpful. I think this service may be quite useful for both substantiation and with Adverse Event Reporting.
“About The Natural Standard Research Collaboration
”The Natural Standard Research Collaboration provides high quality, evidence-based information on dietary supplements (including herbs, vitamins, and minerals), and functional foods to manufacturers. Natural Standard is the trusted professional reference of the National Institutes of Health and provides patient information to MD Anderson Cancer Center, Susan Komen Breast Cancer Foundation, The Mayo Clinic and Harvard Medical School.
”The Natural Standard Electronic Database
”The Natural Standard Database is an evidence based clinical database that will expedite and consolidate the literature retrieval process, assist researchers in new product development, promote safety and efficacy when labeling and marketing products, and assists in registering products or making structure function claims.
”Relevant Database Features:
”All available human studies provided with the level of evidence for each one are included (RCT, meta-analyses, systematic review, case reports, etc). Each clinical trial is rated for methodological quality with limitations discussed.
”Recommendations are made for future high quality studies. An ID program that allows users to search for related terms, substances, synonyms, foreign language terms, constituents, Latin terms and common names.
”Standardized grading criteria for effectiveness that is completely reproducible and based on the US Preventative Services Taskforce Sections that include anecdotal evidence, traditional uses, manufacturer reports, potentially biased publications, internet hearsay, popular opinion, and those that report controversy between secondary and primary data Brief safety summaries that includes maximum dose and duration as well as interactions with conditions Adverse, Effects/Precautions/Contraindications Interactions
Pregnancy/Lactation Data.
”Dosing/Toxicology section that provides brand names of products, dosing, frequency, duration, level of evidence, standardization and toxicology Mechanism of Action, Pharmacodynamics/Kinetics Evidence table and discussion of individual studies.
Brand names with ingredients Interactions cover herb/supplement, food, lab, name brand products, generic products, name brand drug and generic drug interactions Condition databases that allow user to compare effectiveness and include both conventional and integrative therapy treatment options News for product recalls, contaminants, and industry news RSS feeds,
”For more information please contact:
Jason Petralia
JPetralia@NaturalStandard.com
Director of Business Development
Natural Standard
www. naturalstandard .com”
-------------------------------------------------------
2. “Supplement Market Nears Maturity, Nutraceuticals Report
By Lorraine Heller
February 29, 2008 - The US, Europe and Japan will continue to drive the global nutraceuticals market, although growth in dietary supplements is expected to slow, according to a new report. Published by Global Industry Analysts, Nutraceuticals: A Global Strategic Business Report examines the leading markets for functional foods and dietary supplements, and the factors driving growth.
The report, which analyzes the past, current and future market dynamics over the period 2000-2010, projects "healthy growth" for the nutraceuticals market over the next few years, with global sales expected to reach $187bn by 2010.
Leading markets
According to GIA, the United States, Europe and Japan dominate the global market, with a combined share estimated at 86 percent last year... Primary reasons for the strength of these markets are the high-income levels of consumers, greater awareness and widespread preferences for specialty nutritional and herbal products, and trends promoting preventive medicine and self-treatment.
The US alone accounted for 37 percent of 2007 nutraceutical sales, but Asia Pacific is expected to emerge as the fastest growing market, boosted by the "robust" Chinese and Indian markets, and increasing economic prosperity, said the report.
Growth drivers
According to the report, rising consumer desire for leading a healthy life continues to drive sales of nutraceutical products… Other factors include an expanding elderly population, as well as escalating costs associated with healthcare, which is pushing the demand for self-medication and healthy foods.
Functional Foods
According to the report, functional foods constitute a fast moving segment in the nutraceuticals market, driven by the rising health awareness among consumers…
Supplements
Growth in the dietary supplements segment is expected to slow, as the category fast approaches maturity levels, said the report. This is particularly the case in developed regions…
Competition
As the global nutraceuticals industry continues to grow, competition will also increase. This will be driven by factors such as price, safety, efficacy, packaging and brand loyalty, said the report… nutraingredients-usa .com/news/printNewsBis.asp?id=83651”
My view is that the natural products / natural remedies / nutrition market will continue to experience significant growth as Baby Boomers seek to maintain and regain youthfulness.
-----------------------------------------------
3. AER SOP
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
-----------------------------------------------
Ralph Fucetola JD
www. vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
Wednesday, February 27, 2008
02/27/08 - 2008 Supplement Tends
Vitamin Lawyer Update Memo: February 27, 2008
This issue:
“Quackwatch” Exposed
Supplement Trends for 2008
Metabolic Syndrome
C&D Letters
FDA Gets Tough on Health Claims
Natural Solutions Panama ARC Project
------------------------------------------------------
Tim Bolen has exposed the “quackwatch” methodology used to attack CAM practitioners, nutrient and natural remedy purveyors. Please read my blog on this important issue.
vitaminlawyerhealthfreedom .blogspot.com/2008/02/tim-bolen-exposes-quack-anti-health.html
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
Hartman outlines supplement trends for 2008 - By Lorraine Heller
nutraingredients-usa .com/news/ng.asp?n=83162&m=1NIU211&c=jegwylrviswtnqa
Feb-11-2008 - Healthy aging, balanced energy and inflammation are the three core health concerns that consumers try to address with dietary supplements,
according to a new report. The Hartman Group's Tinderbox on Trends 2008 draws its conclusions through ethnographic research, which includes consumer
interviews and observation in the home and in retail outlets. According to the research group, when a health concern presents itself, most consumers will first examine their diet. When food does not remedy the situation, they look to supplements, preferably from whole foods, to correct and balance their condition.
Supplements most popular with "leading-edge" or "core" consumers were those that addressed aging, energy and inflammation, said Hartman.
Although most supplement users are diligent when it comes to taking multi-vitamins, Hartman said that they tend to vary in their choice of supplements addressing
these three issues, either as they learn of new products, or as they shift focus from the one issue to another.
The group said consumers are "constantly searching for the latest supplement that may ease their condition or outperform a current supplement which is filling
nutritional holes missing from their diet".
Supplement use
Hartman divides supplement usage into three main categories: frequent, occasional and sporadic.
Frequent usage refers to those supplements that are taken on a daily basis in order to complement nutritional needs that are lacking from the diet. Ideally, consumers prefer 'daily' supplements to be sourced from whole foods sources.
These supplements are considered mainstays are taken daily and year-round as a preventative, said the group. Occasionally used supplements are those that are used to boost or alleviate a chronic condition or as a substitute for a prescription drug.
"Typically these supplements are taken from a few days to a week or until the bottle is finished. This demonstrates the core consumer's proactive approach to their
health," said Hartman.
Supplements that are sporadically used are those taken to alleviate an immediate health condition, or those that are tried for the first time. They are typically not taken in the long-term because consumers are unsure about their long-term use or possible side-effects.
Healthy mind and body
According to the report, consumers place a lot of emphasis on the balance between a healthy mind and body. Linked into this is the increasing search for natural methods to reduce low energy, sleep disturbances and anxiety. "Getting enough sleep, having sustained energy throughout the day and managing emotional ups and downs requires being present and truly paying attention to what their body and soul needs from day to day. When one element is out of balance, such as sleep or feeling blue, the whole person eventually needs tuning," said the report. "The core consumer looks to whole foods and the latest vitamin, mineral and herbal supplements in their quest for balancing mood, energy and sleep."
---------------------------------------------------------------
nytimes .com/2008/02/05/health/nutrition/05symp.html?_r=1&oref=slogin
"Researchers have found a correlation between drinking diet soda and metabolic syndrome — the collection of risk factors for cardiovascular disease and diabetes
that include abdominal obesity, high cholesterol and blood glucose levels, and elevated blood pressure... But the one-third who ate the most fried food increased their
risk by 25 percent compared with the one-third who ate the least, and surprisingly, the risk of developing metabolic syndrome was 34 percent higher among those
who drank one can of diet soda a day compared with those who drank none."
-------------------------------------------------------------
nutraingredients-usa .com/news/ng.asp?n=83202&m=1NIU212&c=jegwylrviswtnqa
How to respond to a Cease & Desist Letter
By James F. Ewing, Michelle A. Flores, and Michel Morency
Feb - 12 -2008 - Legal experts form Foley & Lardner suggest a strategy to help nutraceuticals companies respond to an accusation of infringing patent rights.
The nutraceuticals market is dynamic and competitive. As such, your nutraceuticals company may be subject to enforcement of another's patent rights. Receiving a
Cease & Desist letter ('the Letter') accusing you of infringing the patent rights of another is an unwelcome notice that can create a sense of urgency akin to having
been just set ablaze.
Being subject to enforcement of another's patent rights, however, is not an uncommon occurrence for successful businesses in competitive markets such as the
nutraceuticals market. Such letters usually identify the granted Patent(s) by its number(s), assert ownership to the Intellectual Property, and detail your alleged infringing activities as well as conditions and deadlines that are to be met.
To avoid being burned in such circumstances, you may consider implementing a STOP, DROP and ROLL approach. STOP and objectively consider the claims.
Implementing the STOP, DROP and ROLL approach does not mean that you need to immediately stop your business activities upon receiving a Cease & Desist
letter. However, whether the Letter demands that you cease making, using, or selling a particular product or service, or merely suggests that you might be interested in licensing certain patent(s), you should stop to carefully consider the allegation, and refer it to knowledgeable Counsel.
Being placed "on notice" of another's patent rights, is a legally significant event where you have a duty to act. Proactively addressing the concerns or demands of a
patent owner serves to protect your company and mitigate exposure to possible damages and fees for alleged willful conduct.
'DROP a Line' to experienced patent counsel Your response to the Letter should be timely, well-considered, and strategic.
Before responding you need to engage the services of knowledgeable patent counsel. This may involve one or more individuals with expertise in patent prosecution
and enforcement matters who can render an opinion regarding whether your commercial product or activities may infringe the patent claims asserted against you
and/or assess the validity of these claims, and develop an appropriate response strategy.
Enforcement issues can be highly complex and a skilled patent counsel will provide essential guidance to address the issues and assess the risks and potential
commercial impact against your company. Be prepared to 'ROLL with the Punches'...
Simply ignoring a Cease & Desist letter will not make the issue go away and may result in increased costs and liability for the accused patent infringer. The STOP,
DROP and ROLL approach provides a strategy to minimize potential adverse impacts in these situations.
James F. Ewing, Michelle A. Flores, and Michel Morency are attorneys with Foley & Lardner LLP.
[Yes, The Vitamin Lawyer does have C&D formats for your use....]
-------------------------
FDA gets tough on rogue health claims
By Alex McNally
nutraingredients-usa.com/news/ng.asp?n=83501&m=1NIU225&c=jegwylrviswtnqa
25-Feb-2008 -
Two companies have signed an agreement that prohibits them from claiming any of their products can cure, treat, mitigate or prevent diseases after making
unauthorized health claims. The Food and Drug Administration said both Cherry Capital Services and Brownwood Acres Foods have a history of promoting unapproved claims, such as "chemicals found in cherries may help fight diabetes." The terms of the consent decree mean the firms have to remove drug and unauthorized health claims from their labels, brochures and websites....
Margaret Glavin, associate commissioner for regulatory affairs, said: "The FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."
...The US version of health claims was introduced a few years ago. Initially the legislation was beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the FDA has exceeded this timeframe on a number of occasions. In one case the FDA was more than 300 days over an original
deadline for approval.
--------------------------------------
If you've been trying to reach me, you know I just got back from a quick trip to Panama. Awesome! Read on...
Natural Solutions Foundation in Panama was set up to research, educate and demonstrate natural solutions. Our shared vision is of an intentional community that links home sites (on a wonderful hillside with great views) with a natural wellness center/spa and organic+ farm and school, all on a 300 hectare (700+ acre) site that has never been farmed with chemicals. Currently, about ten acres are planted with organic coffee.
Our Panamanian legal entity is very flexible, combining the best aspects of a non-profit and a “private interest” entity that is allowed to form its own commercial enterprises. In keeping with the Songhai Principals, we see three “profit centers” for the project: the Wellness Center, the Organic+ Farm and School and what I call the Infrastructure Company, which provides transportation, communications, off-grid power, etc. to the center and farm school as well as the home sites. The Foundation will hold majority interest in the commercial entities, but there will be private investment opportunities.
The area is in the far north, by the Costa Rica border, against the 17,000 acre Amistad National Forest. Elevations vary from 3,000 to 5,000 feet above sea level. It is in the township of Santa Clara (Sacred Light) and is reached by modern road about an hour from the Vulcan eco-tourist area. The climate is year-round temperate (the woods look much like the woods of the US Northeast: similar evergreen, birch and other deciduous trees, deer and rabbits, but with coffee, banyan trees, plantains and howler monkeys too).
Gen. Stubblebine and Dr. Laibow have explored the area in recent months and I went there last week with a Natural Solutions supporter, guided by Kenneth Taylor, our Panamanian builder with experience in the area.
I am most impressed by Panama as a country where people have great hopes for the future... Panama City and the Canal area, where half of the 3 million population resides, is a very modern, thriving area with a huge building boom, very well developed banking and commercial sectors (the Singapore of the New World).
The Santa Clara area, to the far north, is pristine, flower filled and well connected to civilized amenities (international cuisine, locovore restaurants). It is becoming an eco-tourist center mostly because of the Vulcan Baru. The area is filled with ExPats from the US and Europe (20% of one town is American).
Land values are quite reasonable right now, but will not stay that way for long, as Americans and Europeans looking for more freedom than they can find at home, join the Panamanians in appreciating this land. Two hours away, in Boquete, land is bumping $100,000 per hectare (2.45 acres) – about 8 times our cost. Land taxes are very low and there is a 20 year tax holiday for new construction.
Because the land owners, who farm organically themselves, appreciate our vision, they are giving us a highly favorable financial arrangement and going far out of their way to work with us in a positive and helpful way. One of their sons, who lives on the land, would be ideal as a land manager for us. He is most amenable to that idea.
We are currently making arrangements to have the land surveyed, the soil and water tested and will be setting up preliminary meetings with architects to determine the number of building lots and areas. A generous donor has made that possible with a first gift for Panama.
We are now open for donations which, while fully tax deductible in the US, will allow the Natural Solutions Foundation to proceed with the development of our better than organic, advanced farming technology project complete with farm school for farmers from around the world -- teaching how to farm and feed communities while resisting the pressures of Big Agribiz is a central commitment of the Panama Project.
So is providing a free, beautiful, healthful and sustainable community for visionaries like ...YOU! Leasehold and ownership interests will be available.
If you are interested, just send an email to Ralph Fucetola - ralph.fucetola@usa.net - with "Panama" in the subject line or call 973-300-4594 to learn more about your place in the Panama Project! Before I became “The Vitamin Lawyer” I grew up on family construction projects and practiced construction law for fifteen years, being involved in housing, hotel, mall and commercial developments (including historical renovations) in northeast NJ.
I believe this site is ideal to develop and demonstrate natural solutions. It is the right country (friendly to Americans, natural health and organics) and the right natural area. We've looked for years for the best place to demonstrate natural solutions. In my humble opinion, this is the place!
You are invited to join our Panama Yahoo!Group forum where you will find many photos, copies of the organizing documents, skills database and much more:
http://tech.groups.yahoo.com/group/NSF-Panama/join
Natural Solutions Foundation is more than just talk: we are willing to walk our talk… and a beautiful walk up the mountain it will be!
Ralph Fucetola JD
vitaminlawyer .com
vitaminlawyerarchives .blogspot.com/
This issue:
“Quackwatch” Exposed
Supplement Trends for 2008
Metabolic Syndrome
C&D Letters
FDA Gets Tough on Health Claims
Natural Solutions Panama ARC Project
------------------------------------------------------
Tim Bolen has exposed the “quackwatch” methodology used to attack CAM practitioners, nutrient and natural remedy purveyors. Please read my blog on this important issue.
vitaminlawyerhealthfreedom .blogspot.com/2008/02/tim-bolen-exposes-quack-anti-health.html
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
Hartman outlines supplement trends for 2008 - By Lorraine Heller
nutraingredients-usa .com/news/ng.asp?n=83162&m=1NIU211&c=jegwylrviswtnqa
Feb-11-2008 - Healthy aging, balanced energy and inflammation are the three core health concerns that consumers try to address with dietary supplements,
according to a new report. The Hartman Group's Tinderbox on Trends 2008 draws its conclusions through ethnographic research, which includes consumer
interviews and observation in the home and in retail outlets. According to the research group, when a health concern presents itself, most consumers will first examine their diet. When food does not remedy the situation, they look to supplements, preferably from whole foods, to correct and balance their condition.
Supplements most popular with "leading-edge" or "core" consumers were those that addressed aging, energy and inflammation, said Hartman.
Although most supplement users are diligent when it comes to taking multi-vitamins, Hartman said that they tend to vary in their choice of supplements addressing
these three issues, either as they learn of new products, or as they shift focus from the one issue to another.
The group said consumers are "constantly searching for the latest supplement that may ease their condition or outperform a current supplement which is filling
nutritional holes missing from their diet".
Supplement use
Hartman divides supplement usage into three main categories: frequent, occasional and sporadic.
Frequent usage refers to those supplements that are taken on a daily basis in order to complement nutritional needs that are lacking from the diet. Ideally, consumers prefer 'daily' supplements to be sourced from whole foods sources.
These supplements are considered mainstays are taken daily and year-round as a preventative, said the group. Occasionally used supplements are those that are used to boost or alleviate a chronic condition or as a substitute for a prescription drug.
"Typically these supplements are taken from a few days to a week or until the bottle is finished. This demonstrates the core consumer's proactive approach to their
health," said Hartman.
Supplements that are sporadically used are those taken to alleviate an immediate health condition, or those that are tried for the first time. They are typically not taken in the long-term because consumers are unsure about their long-term use or possible side-effects.
Healthy mind and body
According to the report, consumers place a lot of emphasis on the balance between a healthy mind and body. Linked into this is the increasing search for natural methods to reduce low energy, sleep disturbances and anxiety. "Getting enough sleep, having sustained energy throughout the day and managing emotional ups and downs requires being present and truly paying attention to what their body and soul needs from day to day. When one element is out of balance, such as sleep or feeling blue, the whole person eventually needs tuning," said the report. "The core consumer looks to whole foods and the latest vitamin, mineral and herbal supplements in their quest for balancing mood, energy and sleep."
---------------------------------------------------------------
nytimes .com/2008/02/05/health/nutrition/05symp.html?_r=1&oref=slogin
"Researchers have found a correlation between drinking diet soda and metabolic syndrome — the collection of risk factors for cardiovascular disease and diabetes
that include abdominal obesity, high cholesterol and blood glucose levels, and elevated blood pressure... But the one-third who ate the most fried food increased their
risk by 25 percent compared with the one-third who ate the least, and surprisingly, the risk of developing metabolic syndrome was 34 percent higher among those
who drank one can of diet soda a day compared with those who drank none."
-------------------------------------------------------------
nutraingredients-usa .com/news/ng.asp?n=83202&m=1NIU212&c=jegwylrviswtnqa
How to respond to a Cease & Desist Letter
By James F. Ewing, Michelle A. Flores, and Michel Morency
Feb - 12 -2008 - Legal experts form Foley & Lardner suggest a strategy to help nutraceuticals companies respond to an accusation of infringing patent rights.
The nutraceuticals market is dynamic and competitive. As such, your nutraceuticals company may be subject to enforcement of another's patent rights. Receiving a
Cease & Desist letter ('the Letter') accusing you of infringing the patent rights of another is an unwelcome notice that can create a sense of urgency akin to having
been just set ablaze.
Being subject to enforcement of another's patent rights, however, is not an uncommon occurrence for successful businesses in competitive markets such as the
nutraceuticals market. Such letters usually identify the granted Patent(s) by its number(s), assert ownership to the Intellectual Property, and detail your alleged infringing activities as well as conditions and deadlines that are to be met.
To avoid being burned in such circumstances, you may consider implementing a STOP, DROP and ROLL approach. STOP and objectively consider the claims.
Implementing the STOP, DROP and ROLL approach does not mean that you need to immediately stop your business activities upon receiving a Cease & Desist
letter. However, whether the Letter demands that you cease making, using, or selling a particular product or service, or merely suggests that you might be interested in licensing certain patent(s), you should stop to carefully consider the allegation, and refer it to knowledgeable Counsel.
Being placed "on notice" of another's patent rights, is a legally significant event where you have a duty to act. Proactively addressing the concerns or demands of a
patent owner serves to protect your company and mitigate exposure to possible damages and fees for alleged willful conduct.
'DROP a Line' to experienced patent counsel Your response to the Letter should be timely, well-considered, and strategic.
Before responding you need to engage the services of knowledgeable patent counsel. This may involve one or more individuals with expertise in patent prosecution
and enforcement matters who can render an opinion regarding whether your commercial product or activities may infringe the patent claims asserted against you
and/or assess the validity of these claims, and develop an appropriate response strategy.
Enforcement issues can be highly complex and a skilled patent counsel will provide essential guidance to address the issues and assess the risks and potential
commercial impact against your company. Be prepared to 'ROLL with the Punches'...
Simply ignoring a Cease & Desist letter will not make the issue go away and may result in increased costs and liability for the accused patent infringer. The STOP,
DROP and ROLL approach provides a strategy to minimize potential adverse impacts in these situations.
James F. Ewing, Michelle A. Flores, and Michel Morency are attorneys with Foley & Lardner LLP.
[Yes, The Vitamin Lawyer does have C&D formats for your use....]
-------------------------
FDA gets tough on rogue health claims
By Alex McNally
nutraingredients-usa.com/news/ng.asp?n=83501&m=1NIU225&c=jegwylrviswtnqa
25-Feb-2008 -
Two companies have signed an agreement that prohibits them from claiming any of their products can cure, treat, mitigate or prevent diseases after making
unauthorized health claims. The Food and Drug Administration said both Cherry Capital Services and Brownwood Acres Foods have a history of promoting unapproved claims, such as "chemicals found in cherries may help fight diabetes." The terms of the consent decree mean the firms have to remove drug and unauthorized health claims from their labels, brochures and websites....
Margaret Glavin, associate commissioner for regulatory affairs, said: "The FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."
...The US version of health claims was introduced a few years ago. Initially the legislation was beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the FDA has exceeded this timeframe on a number of occasions. In one case the FDA was more than 300 days over an original
deadline for approval.
--------------------------------------
If you've been trying to reach me, you know I just got back from a quick trip to Panama. Awesome! Read on...
Natural Solutions Foundation in Panama was set up to research, educate and demonstrate natural solutions. Our shared vision is of an intentional community that links home sites (on a wonderful hillside with great views) with a natural wellness center/spa and organic+ farm and school, all on a 300 hectare (700+ acre) site that has never been farmed with chemicals. Currently, about ten acres are planted with organic coffee.
Our Panamanian legal entity is very flexible, combining the best aspects of a non-profit and a “private interest” entity that is allowed to form its own commercial enterprises. In keeping with the Songhai Principals, we see three “profit centers” for the project: the Wellness Center, the Organic+ Farm and School and what I call the Infrastructure Company, which provides transportation, communications, off-grid power, etc. to the center and farm school as well as the home sites. The Foundation will hold majority interest in the commercial entities, but there will be private investment opportunities.
The area is in the far north, by the Costa Rica border, against the 17,000 acre Amistad National Forest. Elevations vary from 3,000 to 5,000 feet above sea level. It is in the township of Santa Clara (Sacred Light) and is reached by modern road about an hour from the Vulcan eco-tourist area. The climate is year-round temperate (the woods look much like the woods of the US Northeast: similar evergreen, birch and other deciduous trees, deer and rabbits, but with coffee, banyan trees, plantains and howler monkeys too).
Gen. Stubblebine and Dr. Laibow have explored the area in recent months and I went there last week with a Natural Solutions supporter, guided by Kenneth Taylor, our Panamanian builder with experience in the area.
I am most impressed by Panama as a country where people have great hopes for the future... Panama City and the Canal area, where half of the 3 million population resides, is a very modern, thriving area with a huge building boom, very well developed banking and commercial sectors (the Singapore of the New World).
The Santa Clara area, to the far north, is pristine, flower filled and well connected to civilized amenities (international cuisine, locovore restaurants). It is becoming an eco-tourist center mostly because of the Vulcan Baru. The area is filled with ExPats from the US and Europe (20% of one town is American).
Land values are quite reasonable right now, but will not stay that way for long, as Americans and Europeans looking for more freedom than they can find at home, join the Panamanians in appreciating this land. Two hours away, in Boquete, land is bumping $100,000 per hectare (2.45 acres) – about 8 times our cost. Land taxes are very low and there is a 20 year tax holiday for new construction.
Because the land owners, who farm organically themselves, appreciate our vision, they are giving us a highly favorable financial arrangement and going far out of their way to work with us in a positive and helpful way. One of their sons, who lives on the land, would be ideal as a land manager for us. He is most amenable to that idea.
We are currently making arrangements to have the land surveyed, the soil and water tested and will be setting up preliminary meetings with architects to determine the number of building lots and areas. A generous donor has made that possible with a first gift for Panama.
We are now open for donations which, while fully tax deductible in the US, will allow the Natural Solutions Foundation to proceed with the development of our better than organic, advanced farming technology project complete with farm school for farmers from around the world -- teaching how to farm and feed communities while resisting the pressures of Big Agribiz is a central commitment of the Panama Project.
So is providing a free, beautiful, healthful and sustainable community for visionaries like ...YOU! Leasehold and ownership interests will be available.
If you are interested, just send an email to Ralph Fucetola - ralph.fucetola@usa.net - with "Panama" in the subject line or call 973-300-4594 to learn more about your place in the Panama Project! Before I became “The Vitamin Lawyer” I grew up on family construction projects and practiced construction law for fifteen years, being involved in housing, hotel, mall and commercial developments (including historical renovations) in northeast NJ.
I believe this site is ideal to develop and demonstrate natural solutions. It is the right country (friendly to Americans, natural health and organics) and the right natural area. We've looked for years for the best place to demonstrate natural solutions. In my humble opinion, this is the place!
You are invited to join our Panama Yahoo!Group forum where you will find many photos, copies of the organizing documents, skills database and much more:
http://tech.groups.yahoo.com/group/NSF-Panama/join
Natural Solutions Foundation is more than just talk: we are willing to walk our talk… and a beautiful walk up the mountain it will be!
Ralph Fucetola JD
vitaminlawyer .com
vitaminlawyerarchives .blogspot.com/
Tuesday, February 5, 2008
02/05/08 - SEO Strategies, Berries and Weight Management
… VLUeM – 02.05.08 - VITAMIN LAWYER UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: Privacy and Search Engine Optimization
_______________________________________________
1. Vitamin Lawyer Blogs and Factoid
2. Deep red and blue berry elements in weight management
3. Bio-Identical Hormones at Risk!
4. Important Yahoo!Groups Privacy Information
5. Top 10 Search Engine Optimization Strategies For Your Website!
6. VL Update eMemo Archive Blog
______________________________________________
1. Vitamin Lawyer Blogs & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: "01/02/2008 - The deadline for health claims to be submitted by member states to the European Commission passed yesterday, and among those passed on was the UK's 4,000 page dossier. The country's 3,931 page-long booklet, submitted by the Food Standards Agency (FSA), shows the scale of the task before the Commission and the European Food Safety Authority" As usual, relying on bureaucracy to rationalize the market is a near impossible task. Maybe they shoud have left it to market forces? nutraingredients.com/news/ng.asp?n=82966&m=1NIE201&c=jegwylrviswtnqa
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Deep red and blue berry elements in weight management
From a study being published in Journal of Agricultural and Food Chemistry
http://www.nutraingredients.com/news/ng.asp?n=82855&m=1NIE129&c=jegwylrviswtnqa
"Purified forms of extracted anthocyanins from berries may decrease obesity, but the whole fruit doesn't produce the same benefits, suggests a new study with mice.
If the results can be translated to humans, anthocyanins extracted from blueberries and strawberries could find a role in the burgeoning weight loss and management market, estimated to already be worth $7bn (€5.2bn) globally.
"The recent findings that anthocyanins could possibly affect the development of obesity, at least in animal models, have generated considerable interest," explained the researchers, from USDA Arkansas Children's Nutrition Center and the University of Arkansas. "
______________________________________________
3. Bio-Identical Hormones at Risk!
From P2C2 - Patients and Professionals for Customized Care
http://iacprx.convio.net/site/PageServer?pagename=P2C2001secBHRTatRisk
"The FDA and Wyeth, a big drug maker, are trying to stop bio-identical hormone replacement therapy! Get involved and fight back!
Last week FDA decided to support a Wyeth campaign against compounded treatments and announced that it will "halt" compounding of hormone treatments that contain estriol. Estriol is a common and critical component of many bioidentical hormone therapies (including Bi-Est and Tri-Est) that meets standards that were established by Congress. If you are not sure if you are taking estriol, ask your doctor or pharmacist. Even if you don't take a medication with estriol, is your hormone or other compounded treatment next?
If FDA and Wyeth have their way, you will lose this access to vital treatment options. This action affects hundreds of thousands of women!"
______________________________________________
4. Important Yahoo!Groups Privacy Information Received from a Friend
If you belong to any Yahoo Groups read this notice - it is important!
Yahoo is now using something called "Web Beacons" to track Yahoo Group users around the net and see what you're doing and where you are going (similar to Cookies.)
Yahoo is recording every website and every group you visit.
Take a look at their updated privacy statement
1. http://info.yahoo.com/privacy/us/yahoo/details.html
2. About half-way down the page, in the section on Cookies, you will see a link that says "Web Beacons".
Click on the phrase "WebBeacons".
3. That will bring you to a paragraph entitled "Outside the Yahoo Network".
In this section you'll see a little "click here to opt out" link which will let you "opt-out" of their new method of snooping.
4. Once you have clicked that link, you are exempted.
Notice the "Success" message on the top of the next page.
Note: Be careful because on that page there is also a "Cancel Opt-out" button which, if clicked, will *undo* the opt-out. It appears after you have hit the opt-out button so is very confusing.
______________________________________________
5. Top 10 Search Engine Optimization Strategies For Your Website!
entireweb.com/newsletter/archive/2008/PRINT409.html
Entireweb Newsletter * January 29, 2008 * ISSUE #409
“Although the concept of search engine optimization can be somewhat complex, there are a number of basic search engine optimization techniques you can use to improve your organic search results…
1. Meta Tags. Meta tags are simple lines of code at the top of your web page programming that tell search engines about your page. Include the title tag, keyword stag, description tag, and robots tag on each page.
2. Create and update your sitemap. Developing a site map is a simple way of giving search engines the information they need to crawl your entire website. There are plenty of free software packages on the web that can help…
3. Ensure that all navigation is in HTML. All too often, navigational items are in the form of java script. Even though navigation technically still works in this format, it's not optimized. Create your navigation in HTML…
4. Check that all images include ALT text. Your image's alt text is spidered by search engines. If you're not including your keywords in alt text, you're missing out on a huge opportunity for improved search engine result placements…
5. Use Flash content sparingly. Content generated through java script or flash is a big no-no…
6. Make sure that your website code is clean. Keep in mind when optimizing a web page crawlers are basically only looking at your source code…
7. Place keywords in your page content. Search engines scan your website and web pages for keywords. Shoot for a keyword density of between two and eight percent…
8. Submit your website to search engine directories. It's always a good idea to let large search engine directories know that you're out there. Submit your website URL to directories like Google, Yahoo, and DMOZ.
9. Build links to your website. Consider building a link exchange program or create one-way links to your site using articles or forum posts…
10. Learn the basics. Learning to optimize your website for search engines takes time and patience…
Author: Michael Fleischner is a Marketing Expert and Search Engine Optimization Specialist - MarketingScoop.com
______________________________________________
6. VL Update eMemo Archive Blog
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
Attorney at Law in NJ, 1971 – 2006 / All Rights Reserved © 2008 . . .
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: Privacy and Search Engine Optimization
_______________________________________________
1. Vitamin Lawyer Blogs and Factoid
2. Deep red and blue berry elements in weight management
3. Bio-Identical Hormones at Risk!
4. Important Yahoo!Groups Privacy Information
5. Top 10 Search Engine Optimization Strategies For Your Website!
6. VL Update eMemo Archive Blog
______________________________________________
1. Vitamin Lawyer Blogs & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: "01/02/2008 - The deadline for health claims to be submitted by member states to the European Commission passed yesterday, and among those passed on was the UK's 4,000 page dossier. The country's 3,931 page-long booklet, submitted by the Food Standards Agency (FSA), shows the scale of the task before the Commission and the European Food Safety Authority" As usual, relying on bureaucracy to rationalize the market is a near impossible task. Maybe they shoud have left it to market forces? nutraingredients.com/news/ng.asp?n=82966&m=1NIE201&c=jegwylrviswtnqa
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Deep red and blue berry elements in weight management
From a study being published in Journal of Agricultural and Food Chemistry
http://www.nutraingredients.com/news/ng.asp?n=82855&m=1NIE129&c=jegwylrviswtnqa
"Purified forms of extracted anthocyanins from berries may decrease obesity, but the whole fruit doesn't produce the same benefits, suggests a new study with mice.
If the results can be translated to humans, anthocyanins extracted from blueberries and strawberries could find a role in the burgeoning weight loss and management market, estimated to already be worth $7bn (€5.2bn) globally.
"The recent findings that anthocyanins could possibly affect the development of obesity, at least in animal models, have generated considerable interest," explained the researchers, from USDA Arkansas Children's Nutrition Center and the University of Arkansas. "
______________________________________________
3. Bio-Identical Hormones at Risk!
From P2C2 - Patients and Professionals for Customized Care
http://iacprx.convio.net/site/PageServer?pagename=P2C2001secBHRTatRisk
"The FDA and Wyeth, a big drug maker, are trying to stop bio-identical hormone replacement therapy! Get involved and fight back!
Last week FDA decided to support a Wyeth campaign against compounded treatments and announced that it will "halt" compounding of hormone treatments that contain estriol. Estriol is a common and critical component of many bioidentical hormone therapies (including Bi-Est and Tri-Est) that meets standards that were established by Congress. If you are not sure if you are taking estriol, ask your doctor or pharmacist. Even if you don't take a medication with estriol, is your hormone or other compounded treatment next?
If FDA and Wyeth have their way, you will lose this access to vital treatment options. This action affects hundreds of thousands of women!"
______________________________________________
4. Important Yahoo!Groups Privacy Information Received from a Friend
If you belong to any Yahoo Groups read this notice - it is important!
Yahoo is now using something called "Web Beacons" to track Yahoo Group users around the net and see what you're doing and where you are going (similar to Cookies.)
Yahoo is recording every website and every group you visit.
Take a look at their updated privacy statement
1. http://info.yahoo.com/privacy/us/yahoo/details.html
2. About half-way down the page, in the section on Cookies, you will see a link that says "Web Beacons".
Click on the phrase "WebBeacons".
3. That will bring you to a paragraph entitled "Outside the Yahoo Network".
In this section you'll see a little "click here to opt out" link which will let you "opt-out" of their new method of snooping.
4. Once you have clicked that link, you are exempted.
Notice the "Success" message on the top of the next page.
Note: Be careful because on that page there is also a "Cancel Opt-out" button which, if clicked, will *undo* the opt-out. It appears after you have hit the opt-out button so is very confusing.
______________________________________________
5. Top 10 Search Engine Optimization Strategies For Your Website!
entireweb.com/newsletter/archive/2008/PRINT409.html
Entireweb Newsletter * January 29, 2008 * ISSUE #409
“Although the concept of search engine optimization can be somewhat complex, there are a number of basic search engine optimization techniques you can use to improve your organic search results…
1. Meta Tags. Meta tags are simple lines of code at the top of your web page programming that tell search engines about your page. Include the title tag, keyword stag, description tag, and robots tag on each page.
2. Create and update your sitemap. Developing a site map is a simple way of giving search engines the information they need to crawl your entire website. There are plenty of free software packages on the web that can help…
3. Ensure that all navigation is in HTML. All too often, navigational items are in the form of java script. Even though navigation technically still works in this format, it's not optimized. Create your navigation in HTML…
4. Check that all images include ALT text. Your image's alt text is spidered by search engines. If you're not including your keywords in alt text, you're missing out on a huge opportunity for improved search engine result placements…
5. Use Flash content sparingly. Content generated through java script or flash is a big no-no…
6. Make sure that your website code is clean. Keep in mind when optimizing a web page crawlers are basically only looking at your source code…
7. Place keywords in your page content. Search engines scan your website and web pages for keywords. Shoot for a keyword density of between two and eight percent…
8. Submit your website to search engine directories. It's always a good idea to let large search engine directories know that you're out there. Submit your website URL to directories like Google, Yahoo, and DMOZ.
9. Build links to your website. Consider building a link exchange program or create one-way links to your site using articles or forum posts…
10. Learn the basics. Learning to optimize your website for search engines takes time and patience…
Author: Michael Fleischner is a Marketing Expert and Search Engine Optimization Specialist - MarketingScoop.com
______________________________________________
6. VL Update eMemo Archive Blog
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
Attorney at Law in NJ, 1971 – 2006 / All Rights Reserved © 2008 . . .
Friday, January 25, 2008
01/25/08 - Web site cross promotion
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company from costly new FDA regulations…
_______________________________________________
1. Health Freedom Blog update
2. Cross-promotion of web sites
3. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Entire Web on Cross-promotion of Web Sites
Entireweb Newsletter * January 22, 2008 * ISSUE #407
Easy Cross-Promotion Tactics
Cross-promotion is an easy, inexpensive method for generating more traffic and more revenue for your business and for the business of your promotional partners.
What could be better than a real win-win situation? With cross-promotion not only can you generate more customers and profit, usually for free, but you can help another entrepreneur do the same!
One simple example of good cross-promotion is swapping business cards with another business in your area. The idea is to find a related, yet non-competing operation, give them a stack of your cards to hand out and take a stack of their cards in exchange.
For example when I ran a local Web design company I swapped stacks of business cards with a nearby computer repair service. It made sense because both of us targeted small businesses, and nearly all small businesses today have computers in their office and a Website to promote their products and services. So often my customers would have an interest in a good computer repair service, and the repair shop's clients might be interested in somebody to build or re-design their Website.
It's easy to see how both parties stand to benefit in this arrangement. And the customers of both businesses also benefit!
Putting together a win-win cross-promotion on the Web is even easier, and here are a few examples of how you might do this:
Exchange Thank You Page Ads
Thank you or confirmation pages that prospects see after they make a purchase or register for a free mailing list are great places to post promotions. The people who see these pages are action takers, making them the ultimate target for a good advertisement.
You could place an ad for your cross-promotion partner on one or more of your thank you pages and have them do the same for you.
Unannounced Member Bonus
If you and your promotional partner run membership programs, you could place unannounced bonuses within one another's secure member areas. For instance, when members login to your site they could find a "free gift" from your partner, and be required to register at your partner's Website to receive access to their free gift; of course you would place a similar promotion in your promotion partner's member area.
Swap Autoresponder Messages
You could include an email in your automated message series promoting your partner's product or service, and they could reciprocate with an email for you. You could even promote as affiliates for one another so you both earn commissions in the process.
Cover Page Promotions
If you and your partner both produce digital information products such as e-books and special reports, you could swap promotions on the first page of your PDF products. This would provide both of you with quality exposure as your ads would be seen by the people who purchase and actually open digital products; so prospects generated by this measure are both buyers and action takers.
These four examples are just the tip of the iceberg. Once you sit down and really brainstorm about innovative ways to cross promote you might be amazed with what you come up with.
Both you and your promotional partner(s) stand to benefit, and neither of you will need to pay any advertising expense to generate new traffic and sales.
About the Author: Tim Whiston is a professional Internet marketer who enjoys his work. He has owned numerous Websites and ezines and has created hundreds of thousands of dollars in profits for his clients. Be sure to check out his free Information Marketing Course and Internet Marketing Tools.
http://www.entireweb.com/newsletter/archive/2008/PRINT407.html
______________________________________________
3. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
Friday, January 18, 2008
01/18/08 - SOPs and FDA Regulations
… VLUeM – 01.18.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company from costly new FDA regulations…
_______________________________________________
1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at ralph.fucetola@usa.net and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
______________________________________________
3. Food niche with potential
Report pinpoints functional food niche with most potential - By Lorraine Heller
January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.
TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.
"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.
Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health
[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]
…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function
…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."
…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.
For more –
http://www.nutraingredients-usa.com/news/ng.asp?n=82599&m=1NIU116&c=jegwylrviswtnqa
______________________________________________
4. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company from costly new FDA regulations…
_______________________________________________
1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at ralph.fucetola@usa.net and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
______________________________________________
3. Food niche with potential
Report pinpoints functional food niche with most potential - By Lorraine Heller
January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.
TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.
"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.
Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health
[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]
…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function
…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."
…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.
For more –
http://www.nutraingredients-usa.com/news/ng.asp?n=82599&m=1NIU116&c=jegwylrviswtnqa
______________________________________________
4. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
Friday, January 4, 2008
01/04/08 - FDA on AER Labeling
… VLUeM – 01.04.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company money…
_______________________________________________
1. Health Freedom Blog update
2. Web site titles and descriptions
3. The Electric Tree – savings and more
4. Guidance from FDA on AER labeling
5. Cost of foods… calorie
6. Coming next year: improved format for the VL Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: Nutrition Business Journal (nutritionbusiness.com) announced recently that the global nutrition industry has reached $226-billion annually. Other sources suggest the US share is about 50% -- so what portion of that $113 billion a year does your company earn?
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL seems to be blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Web site advice from Entireweb Newsletter * January 1, 2008 * ISSUE #401 – entireweb.com
“How to Create Compelling Site Titles and Descriptions - There are many places in your HTML you can include keywords, but the Titles and descriptions are arguably the most important elements of your Web site… These places are …most important in terms of their ability to compel someone to visit your Web site. That is, after all, the ultimate goal of search engine positioning, isn't it? Not a lot of point in attaining a top ranking in a search engine if you are just going to call you site "Shop Here." …the Title tag has special relevance, because so many search engines use the title exactly as it appears on your page. …the title of the site is more important than the site description.
“Longer Titles are More Effective - Longer titles build a more compelling reason to visit a Web site. Because it takes a certain number of words to persuade someone to take action, logic dictates that longer sentences have more opportunity to create that compelling argument… People often scan headlines in brochures and magazines, even when they don't read all the information…
“People Don't Read Text, They Recognize Words - …Educators know that people glance at words and recognize the words by the shapes defined by the tops of the letters. …Since people recognize words because the tops of words vary in height and appearance, then sentences that start with just one capital letter and then lowercase letters are easier to recognize and get read faster… Words in all caps are hard to read…
Every little advantage helps you.” - Pamela Upshur - upshurcreative.com
______________________________________________
3. The Electric Tree = savings and corporate responsibility
Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.
______________________________________________
4. FDA Guidance & AER Labeling
You can find a listing of FDA guidance documents for the vitamin industry at: http://www.cfsan.fda.gov/guidance.html
Among the new guidances published is a draft labeling guidance for the AER (adverse event reporting) system, with frequently asked questions. This document was finalized on January 2, 2008, as “Guidance for Industry: Questions and Answers Regarding, the Labeling of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act” - Docket No. 2007D-0491. It can be found at: http://www.cfsan.fda.gov/~dms/dsaergu2.html
Here is the summary of the label requirement: “the act requires the label of a dietary supplement being marketed in the United States to include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or telephone number, the dietary supplement is misbranded.” FDA also “recommends that the label bear a clear, prominent statement informing consumers that the domestic address or telephone number is for reporting serious adverse events associated with use of the product.”
http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/07-6266.htm
Please note the distinction between “the act requires…” and FDA “recommends.” If a company voluntarily chooses to add language that the phone number or address on the label is there to report AERs, FDA does say “dual purpose” language such as “"To report a serious adverse event or obtain product information, contact..." would be acceptable.
And the FDA’s overall FAQs for AERs cam be found at: http://www.cfsan.fda.gov/~dms/dsaergui.html
That document also states: “Your submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported. Any serious adverse event report submitted to FDA, including any new medical information submitted as a follow-up to the initial report, is considered a safety report under section 756 of the FD&C Act (21 U.S.C. 379v) and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the serious adverse event.”
If you have any occasion to report an adverse event, you ought to have the report reviewed by The Vitamin Lawyer before submitting it.
______________________________________________
5. Cost of food, per calorie
Reuters reported on 01/02/08, “the average price of the lowest-calorie foods -- including green vegetables, tomatoes and berries -- increased by almost 20 percent over 2 years. In contrast, in the same time period there was a 2-percent dip in the cost of the most calorie-laden fare, such as butter, potato chips, cookies and candy bars… findings, published in the Journal of the American Dietetic Association, highlight a key obstacle to healthy eating. … They found that snack foods, sweets and fatty foods offered the most bang for a shopper's buck. Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories.”
______________________________________________
6. Upgrading the VL Update eMemo!
Coming early this year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider making an end-of-the-year donation to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Wishing you and yours a joyous, prosperous, peaceful and free new year!
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company money…
_______________________________________________
1. Health Freedom Blog update
2. Web site titles and descriptions
3. The Electric Tree – savings and more
4. Guidance from FDA on AER labeling
5. Cost of foods… calorie
6. Coming next year: improved format for the VL Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: Nutrition Business Journal (nutritionbusiness.com) announced recently that the global nutrition industry has reached $226-billion annually. Other sources suggest the US share is about 50% -- so what portion of that $113 billion a year does your company earn?
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL seems to be blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Web site advice from Entireweb Newsletter * January 1, 2008 * ISSUE #401 – entireweb.com
“How to Create Compelling Site Titles and Descriptions - There are many places in your HTML you can include keywords, but the Titles and descriptions are arguably the most important elements of your Web site… These places are …most important in terms of their ability to compel someone to visit your Web site. That is, after all, the ultimate goal of search engine positioning, isn't it? Not a lot of point in attaining a top ranking in a search engine if you are just going to call you site "Shop Here." …the Title tag has special relevance, because so many search engines use the title exactly as it appears on your page. …the title of the site is more important than the site description.
“Longer Titles are More Effective - Longer titles build a more compelling reason to visit a Web site. Because it takes a certain number of words to persuade someone to take action, logic dictates that longer sentences have more opportunity to create that compelling argument… People often scan headlines in brochures and magazines, even when they don't read all the information…
“People Don't Read Text, They Recognize Words - …Educators know that people glance at words and recognize the words by the shapes defined by the tops of the letters. …Since people recognize words because the tops of words vary in height and appearance, then sentences that start with just one capital letter and then lowercase letters are easier to recognize and get read faster… Words in all caps are hard to read…
Every little advantage helps you.” - Pamela Upshur - upshurcreative.com
______________________________________________
3. The Electric Tree = savings and corporate responsibility
Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.
______________________________________________
4. FDA Guidance & AER Labeling
You can find a listing of FDA guidance documents for the vitamin industry at: http://www.cfsan.fda.gov/guidance.html
Among the new guidances published is a draft labeling guidance for the AER (adverse event reporting) system, with frequently asked questions. This document was finalized on January 2, 2008, as “Guidance for Industry: Questions and Answers Regarding, the Labeling of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act” - Docket No. 2007D-0491. It can be found at: http://www.cfsan.fda.gov/~dms/dsaergu2.html
Here is the summary of the label requirement: “the act requires the label of a dietary supplement being marketed in the United States to include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or telephone number, the dietary supplement is misbranded.” FDA also “recommends that the label bear a clear, prominent statement informing consumers that the domestic address or telephone number is for reporting serious adverse events associated with use of the product.”
http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/07-6266.htm
Please note the distinction between “the act requires…” and FDA “recommends.” If a company voluntarily chooses to add language that the phone number or address on the label is there to report AERs, FDA does say “dual purpose” language such as “"To report a serious adverse event or obtain product information, contact..." would be acceptable.
And the FDA’s overall FAQs for AERs cam be found at: http://www.cfsan.fda.gov/~dms/dsaergui.html
That document also states: “Your submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported. Any serious adverse event report submitted to FDA, including any new medical information submitted as a follow-up to the initial report, is considered a safety report under section 756 of the FD&C Act (21 U.S.C. 379v) and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the serious adverse event.”
If you have any occasion to report an adverse event, you ought to have the report reviewed by The Vitamin Lawyer before submitting it.
______________________________________________
5. Cost of food, per calorie
Reuters reported on 01/02/08, “the average price of the lowest-calorie foods -- including green vegetables, tomatoes and berries -- increased by almost 20 percent over 2 years. In contrast, in the same time period there was a 2-percent dip in the cost of the most calorie-laden fare, such as butter, potato chips, cookies and candy bars… findings, published in the Journal of the American Dietetic Association, highlight a key obstacle to healthy eating. … They found that snack foods, sweets and fatty foods offered the most bang for a shopper's buck. Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories.”
______________________________________________
6. Upgrading the VL Update eMemo!
Coming early this year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider making an end-of-the-year donation to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Wishing you and yours a joyous, prosperous, peaceful and free new year!
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
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