0. Blog & News - Self-Shielding is going viral…
1. Confusion reigns in cosmeceutical name game
2. New Webinar - July 9, 2009 – The Ministry and Alt Practices
3. Webinar Archives
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0. Blog & News –
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
Gen Bert on Freedom for Independence Day
vitaminlawyerhealthfreedom.blogspot. com/2009/07/gen-stubblebine-on-freedom-for.html
[Please
note: all URLs in this memo are "broken" with spaces inserted after the
www. to avoid the memo being treated as "spam" by certain email service
providers.]
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1. Confusion reigns in cosmeceutical name game
The
article below highlights some of the changes facing the natural
products industry, as more creative products "cross the lines" created
by bureaucracy.
In
a normally functioning market, the market would set product categories
based on consumer desires, and thereby greater social utility would
evolve, as independent actors in the market competed for consumer
loyalty.
However,
in a bureaucratized market, the "soft fascism" that Dr. Ron Paul so
eloquently warns us against, whether, for example, your product is
"ingested" or taken into the body some other way (sublingually,
transdermally...) will determine whether it is a dietary supplement,
even though in reality, the nutrient benefits the normal structure and
function of the body no matter how it is delivered. Similarly, whether a
substance is a nutrient, a cosmetic or a drug, will depend on how you
sell it and what your "intent" is, not what the market wants. Such
interventions tend to reduce consumer satisfaction and reduce overall
social utility, thereby reducing all our prosperity.
So what do you sell?
www.
nutraingredients.
com/Industry/Confusion-reigns-in-cosmeceutical-name-game/?c=gbrnO2ewSG1xi7WszuqLDQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
29-Jun-2009
– “The term cosmeceutical has always been controversial, but the
blurring boundaries between the worlds of nutrition and cosmetics are
highlighting divisions that neither industry can ignore. Ingestible
products with cosmetic benefits are an emerging product category for
both the nutritional and the cosmetics industries.
“Beauty
yoghurts, anti-wrinkle drinks, and skin care supplements are all part
of a market expected to be worth $2.5bn by 2012, according to market
research company Kline.
“However,
the industries don’t seem to agree on what to call this emerging
product category. For the healthy foods and supplements industry these
products fall under the term cosmeceuticals, which for the cosmetics
industry means something quite different.
“As
these industries begin to work together to take advantage of this
growing market, there is a dire need for some clear definitions.
“Click
here to read full comment from our sister publications for the
cosmetics industry, www. cosmeticsdesign. com/ and
http://www.cosmeticsdesign-europe.com/ .”
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2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
New Webinar: Thursday July 9, 2009 - 6 PM MT (4 PM EDT): Your Ministry, the Law and Alternative Practices -
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. Includes eBook
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past and the new webinar as well.
3. Webinar Archives [follow instructions above to reach these]
A. CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
C. Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources). The new webinar system will also
include Vital Connection forums specific to the participants in the
webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. News - Self-Quarantine / Self-Shielding
1. Majority Willing to Spend More on Nutrition
2. Multivitamins linked to 25 percent of supplement AERs
3. FDA Goes After Bayer…
4. FDA: “H1N1: No Natural Remedy Claims!”
5. Webinar Series Archives
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0. Blog News –
Insider Information: Google Search gives special attention to web pages that have videos embedded in the page; it is easy to embed YouTube videos in web pages (see the example in the HFUSA link in item 5 below).
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Quarantine / Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
[Please note: all URLs in this memo are "broken" with spaces inserted after the www. to avoid the memo being treated as "spam" by certain email service providers.]
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1. Majority Willing to Spend More on Nutrition
www. nutraingredients-usa.com/Consumer-Trends/Nutrition-vs-Cost-Survey-outlines-consumer-priorities/?c=gbrnO2ewSG2cMQI1pLFtsQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
By Lorraine Heller, 17-Jun-2009
Over half of Americans are willing to spend more on healthier versions of food, but price remains a barrier for some, according to a new online survey.
Commissioned by the United Soybean Board and conducted by an independent research firm, the survey found that most people who do not opt for healthier food are still interested in nutrition but cannot deal with the heftier price tag.
Consumer Attitudes about Nutrition 2009 has a strong focus on the nutritional benefits of soy – presented as a “budget-friendly” health food – but it also reveals some useful general statistics about consumer shopping behavior.
The latest study, which is the 16th annual report of its kind, includes 1,009 random online surveys conducted in January 2009, selected to provide a sample representative of the US population…
The survey findings, released yesterday, reveal that 54 percent of Americans will spend more on healthier products. Of those that do not opt for the healthier versions, the majority (52 percent) say the obstacle is financial, suggesting that a lack of interest in nutrition is not always the case.
Some 87 percent of respondents said they were concerned about the nutritional content of the food they eat. In addition, 88 percent said they consider nutrition important when purchasing foods at the grocery store.
--------------------------------
2. Multivitamins linked to 25 percent of supplement AERs
www. nutraingredients-usa.com/Regulation/Multivitamins-linked-to-25-percent-of-supplement-AERs/?c=gbrnO2ewSG31nsFv6bi6DQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
By Lorraine Heller, 16-Jun-2009
“Multivitamins and minerals were the subject of one quarter of Adverse Event Reports (AERs) filed with FDA in the first six months of last year, but this does not mean that this product category is problematic, says the American Herbal Products Association (AHPA).
The trade group analyzed 598 AERs received by the US Food and Drug Administration (FDA) between January 1 and June 30 2008, which highlighted potential adverse health effects of dietary supplement products.
However, although 25 per cent of these were for mainstream multivitamins and minerals, the findings must not be misinterpreted as identifying this as the most dangerous class of products, said Michael McGuffin, director AHPA.
‘This is not a cause and effect reporting system, it’s an association system. So although a large part of the AERs are linked to multivitamins, this does not mean that they are dangerous. It simply reflects usage patterns, and the most used dietary supplements are multivitamins,’ McGuffin told NutraIngredients-USA.com.
The AER reports were obtained by AHPA via Freedom of Information (FOI) requests with FDA. AHPA revealed its analysis of these reports at the recent SupplySide East trade show in Secaucus, New Jersey.
A number of supplement brands or products were repeatedly flagged up in the AERs. The most common single product reports were for:
· Total Body Formula (93 reports)
· Bayer One a Day (all formulas) (81 reports)
· Centrum (all formulas) (25 reports)
· Flintstones Vitamins (all formulas) (24 reports)
· Mainstream calcium products (25 reports)
However, McGuffin again cautioned that this does not implicate these brands or products as being dangerous. It reflects the frequency of reporting by a select number of companies, which have put systematic reporting systems in place, he explained.
Out of the 600 AERs reviewed by AHPA, 44 percent were for combination products, 25 percent were for vitamins and minerals, 10 percent were for ‘other primary ingredients’ products, and 5 percent were for herbals.
The majority (almost 60 percent) of reports had been submitted by companies, while just under a third (30 percent) were submitted by consumers. Around 10 percent were sent in by health professionals.
The majority of cases (73 percent) were female consumers, and 54 percent of reports were for people aged between 50 and 79. Again, this reflects supplement usage, said McGuffin.”
-------------------------------
3. FDA Goes After Bayer…
www. nutraingredients-usa.com/Regulation/Bayer-faces-lawsuit-for-selenium-cancer-prevention-ads/?c=gbrnO2ewSG1kWGM7CmFI8w%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
Bayer faces lawsuit for selenium cancer prevention ads
By Lorraine Heller, 18-Jun-2009
“Bayer Healthcare could face a lawsuit in the United States for advertising that its One A Day vitamins could reduce prostate cancer due to their selenium content.
Consumer advocacy Center for Science in the Public Interest (CSPI) today notified Bayer that it will sue the company unless it ceases the ad claims.
Advertisements and labels for Bayer’s One A Day Men’s 50+ Advantage and One A Day Men’s Health Formula multivitamins claim that “emerging research” suggests selenium may reduce the risk of prostate cancer.
However, according to CSPI, such claims are deceptive and are not backed by sufficient science.
The group also filed a complaint today with the Federal Trade Commission (FTC) today, urging them to put a stop to the claims and to require Bayer to run a corrective advertising campaign since its ads have “for so long reinforced the false notion that selenium prevents prostate cancer”.
Selenium is the only mineral that can carry an FDA-approved qualified health claim for general cancer reduction incidence.
The claim reads: ‘Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.’”
---------------------------------------
4. FDA: “H1N1: No Natural Remedy Claims!”
www. naturalnews.com/026473_the_FDA_H1N1_natural_products.html
Natural News: Mike Adams
June 18, 2009
“ In an effort to censor any online text that might inform consumers of the ability of natural products to protect consumers from H1N1 influenza A, the FDA is now sending out a round of warning letters, threatening to "take enforcement action... such as seizure or injunction for violations of the FFDC Act without further notice."
"Firms that fail to take correction action," the FDA warns, "may also be referred to the FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws."
The message is crystal clear: No product may be described as protecting against or preventing H1N1 infections unless it is approved by the FDA. And which products has the FDA approved? Tamiflu (the anti-viral drug that most people will never have access to), and soon the new H1N1 vaccine that's being manufactured at a cost of one billion dollars (paid to Big Pharma by the taxpayers). This vaccine, of course, will be utterly useless because H1N1 will undoubtedly mutate between now and the time the vaccine is ready, rendering the vaccine useless.”
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5. Natural Solutions Vital Connection Archived Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past, including these:
A. CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
C. Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested). With eBook.
Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. News - “PANDEMIC” LEVEL 6
1. Webinar – Sustainable IRAs – June 13, 2009 – Noon EDT
2. Webinar Series Archives
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0. Blog News –
Yesterday: “Pandemic” Level 6 Declared! Are you prepared?
http:// www. healthfreedomusa. org/?p=2830
Follow me on Twitter - www.twitter.com/healthfreedomus
http:// vitaminlawyerhealthfreedom.blogspot .com/2009/06/nj-adopts-fake-hemp-reform-no-gain-for.html
[Please
note: all URLs in this memo are "broken" with spaces inserted before
the .com or .org to avoid the memo being treated as "spam" by AOL and
other service providers.]
-----------------------------------------------
1. Sustainable IRA
Saturday June 13, 2009 - 10 AM MT (NOON - EDT): Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees will lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). Sunday Webinar, Noon Eastern
Time.
Remember:
Webinars are lectures you can either participate in when they are given
live OR you can “audit the class” at a later time on-line.
-----------------------------------------------
2. Natural Solutions Vital Connection Archived Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past, including these:
A. CAM Advanced Healthcare Practitioner SOPs
Date: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Date: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources). The new webinar system will also
include Vital Connection forums specific to the participants in the
webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. News - Vitamin Lawyer on Twitter!
1. Guest Message on GMPs
2. Webinar Series Archives
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0. Blog News –
Follow me on Twitter - www.twitter.com/healthfreedomus
http://vitaminlawyerhealthfreedom.blogspot.com/2009/05/health-freedom-and-torture.html
[Please
note: all URLs in this memo are "broken" with spaces inserted before
the .com or .org to avoid the memo being treated as "spam" by AOL and
other service providers.]
-----------------------------------------------
1. GMPs coming to you…
By: Jeffrey S. Bliss
jsb@tampabay.rr.com
“The GMP Final Rule for Dietary Supplements is in full force. The next upcoming compliance dates are June 10th thru the 25th, 2009. Is your company ready to meet the obligations of the rule?
Can you show the FDA that every product you carry is made according to GMP requirements?
As
a distributor and holder of dietary supplements, you are fully
responsible for what you do in-house as well as for anything that is
done on your behalf by manufacturers, packagers and labelers. Given that
you have the ultimate responsibility for showing your products comply
with GMP rules, what are the steps you need to take to ensure you're
ready for an FDA inspection?
Think about the below.
The need to establish written specifications for each product
How to demonstrate your products comply with those specifications
The functions of quality control personnel
Requirements for ID testing of dietary ingredients and finished products
And Much More!
The
bigger the company you are, the quicker the FDA will notice you. Much
of what will transpire from all this is that those who are operating in
an un-ethical manner will find it very hard to continue to do business.
It is highly recommended that you have the right people on your side in
your efforts to establish, grow, and continue your business.”
Vitamin
Lawyer Comment: Jeff Bliss has a good point there. The Vitamin Lawyer
SOP (Standard Operating Procedures) focuses on your company’s marketing
and claims. Jeff’s focuses on the GMPs… you need both!
-----------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.
A. CAM Advanced Healthcare Practitioner SOPs
Date: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Date: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources). The new webinar system will also
include Vital Connection forums specific to the participants in the
webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. News - “Pandemic” Panic…1. Supplement Shelf Life2. FDA Plans to Review Pre-’76 Devices3. Webinar Series Archives and Plans – May 6th and 9th------------------------------------------------------0. Blog News – Weaponized Virus; Weaponized VaccinesPandemic Alert: Proactive Protection Stepswww .healthfreedomusa.org/?p=2581[Please
note: all URLs in this memo are "broken" with spaces inserted before
the .com or .org to avoid the memo being treated as "spam" by AOL and
other service providers.]-----------------------------------------------1. Supplement Shelf LifeRecently
several clients asked me about dietary supplement product shelf-life
(and ''best used by'') requirements. The general rule regarding dietary
supplements (unlike drugs) is that you do not have to specify a
shelf-life unless clinical studies have been done that show a limit on
the shelf-life. If
you do state a shelf-life, however, you have to be able to substantiate
the claimed shelf-life. Some lawyers advise that having a specific
shelf-life limits exposure to consumer claims for use beyond the
specified period. I'm not aware of any cases in which that actually
became an issue.The
CGMPs "Requires records associated with the manufacture, packaging,
labeling, or holding of a dietary supplement to be kept for 1 year
beyond the shelf life dating (when such dating is used, such as
expiration dating, shelf life dating, or ''best if used by'' dating), or
if shelf life dating is not used, for 2 years beyond the date of
distribution of the last batch of dietary supplements associated with
those records." Final Sec. 111.605And
this comment: "Because the final rule does not require that you
establish an expiration date, we decline to offer guidance on the type
of data that are acceptable to support an expiration date, other than to
repeat that any expiration date that you place on a product label
(including a ''best if used by'' date) should be supported by data."http://www.cfsan.fda.gov/~lrd/fr07625a.htmlExcerpts from the FDA comments on “shelf-life” are reproduced below.-----------------“In
the preamble to the 2003 CGMP Proposal (68 FR 12157 at 12203), we
stated that we had considered whether to propose requirements for
expiration dating, shelf life dating, or ''best if used by'' dating
(referred to in this preamble as shelf life or expiration dating). We
recognized that there are current and generally available methods to
determine the expiration date of some dietary ingredients, such as
vitamin C. However, we were uncertain whether there are current and
generally available methods to determine the expiration dating of other
dietary ingredients, especially botanical dietary ingredients…The
preamble to the 2003 CGMP Proposal emphasized that, if you use an
expiration date on a product, you should have data to support that date
(68 FR 12157 at 12204). We recommended that you have a written testing
program designed to assess the stability characteristics of the dietary
supplement, and that you use the results of the stability testing to
determine appropriate storage conditions and expiration dates…(Comment
200) Several comments agree with our decision not to require expiration
dating on labels for dietary supplements at this time, because of the
wide range of products and the need for additional data. Most of these
comments state, however, that manufacturers should be allowed to include
a ''best if used by'' date. One comment suggests addressing the issue
in a separate rulemaking. Other comments support an expiration date
because consumers and retailers expect one, and some markets require
one. Some comments state that the expiration date orstatement of product shelf life will help ensure that the product meets its label claims and potency…(Response)
These comments do not provide data or information that would reduce the
uncertainty about the feasibility of conducting tests to support an
expiration date and, thus, do not persuade us to alter our position not
to require that you establish an expiration date for your product.
Indeed, the comments generally concur with that position. Because the
final rule does not require that you establish an expiration date, we
decline to offer guidance on the type of data that are acceptable to
support an expiration date, other than to repeat that any expiration
date that you place on a product label (including a ''best if used by''
date) should be supported by data.”------------------------------------------------2. FDA Plans to Review Pre-’76 Devices“FDA to Review Medical Devices Marketed Prior to 1976 “The
FDA today announced that manufacturers of 25 types of medical devices
marketed prior to 1976 must submit safety and effectiveness information
to the agency so that it may evaluate the risk level for each device
type. Devices found by the FDA to be of high risk to consumers will be
required to undergo the agency’s most stringent premarket review
process.“These
25 device types… were marketed in the U.S. prior to the Medical Device
Amendments to the Food, Drug, and Cosmetic Act of 1976... The FDA
classifies medical devices into three categories according to their
level of risk. Class III devices represent the highest level of risk and
generally require a showing of safety and effectiveness before they may
be marketed. Class III devices include heart valves and intraocular
lenses. Class I and Class II devices pose lower risks and include
devices such as adhesive bandages and wheelchairs. Most Class II devices
and some Class I devices are marketed after submission of premarket
notifications establishing their substantial equivalence to legally
marketed devices that do not require premarket approval…
“’We are taking the necessary steps to complete this very complex
process while continuing to protect public health by thoroughly
reviewing and evaluating all medical device submissions presented to the
agency,’ said Daniel G. Schultz, M.D., director of the FDA’s Center for
Devices and Radiological Health. ‘New premarket notification
submissions for devices of these 25 types will continue to receive an
appropriate level of scrutiny to ensure safety and effectiveness.’“…
The FDA will review the submitted data and, based on the risk level,
issue regulations for each device type that either will require
manufacturers to submit premarket approval applications or will
re-classify the devices into Class I or Class II.”From: www .fda.gov/bbs/topics/NEWS/2009/NEW01990.htmlPlease
note that none of the 25 devices listed at www
.fda.gov/OHRMS/DOCKETS/98fr/E9-8022.htm include any of the popular
Advanced Healthcare (CAM) electro-energetic devices.-----------------------------------------------3. Natural Solutions Vital Connection Webinars with The Vitamin LawyerVital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system: Go to www. VitalConnectionUniversity .comAt the top right you will find the Student Login. Once you’re on that screen, take the steps to create a New Student Account. Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.A. CAM Advanced Healthcare Practitioner SOPsDate: May 6, 2009 [This Webinar is being re-taught for the new webinar platform.]Time: 8:00 PM EDT (approximately 2 hours)You can see my short introductory YouTube video at:vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.htmlB. Bringing New Natural Products to MarketDate: May 10, 2009Time: 8:00 PM EDT (approximately 2 hours)What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook and a private forum for additional communications.Sign up through link at: www. healthfreedomusa. org/?page_id=2002"Your papers must be in order."Are your ingredients "grandfathered" under DSHEA?Have you filed your Structure and Function Claims Notices?Do you have your SOPs (Standard Operating Procedures)Is your web site Site Use Statement up-to-date? Is your Substantiation Notebook ready?Your papers need to be in order before the FDA inspection!Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources). The new webinar system will also
include Vital Connection forums specific to the participants in the
webinar.. ----------------------------------------------Ralph Fucetola JDwww .vitaminlawyer .comhttp:// vitaminlawyerarchives .blogspot .com
