09/28/07 - Vitamin Label Warnings; Functional Beverages

VLUeM – 09.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. How to Avoid Alienating Search Engines
3. Vitamin Label Warnings
4. Functional Beverages… the future of supplementation?
5. Are your papers in order?
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1. Vitamin Lawyer Health Freedom Blog - New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Does the FDA really want public comments?
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2. SE Tactics: How to Avoid Alienating the Major Search Engines
http://www.entireweb.com/newsletter/archive/2007/ISSUE373.html

Some more good advice from EntireWeb.com:

Each of the major search engines… have quality webmaster guidelines … prevent … manipulation of search engine rankings …. These webmaster guidelines change frequently … and those websites found engaging in these illicit practices are consequently dropped from the search engine rankings....

Being banned or dropped from the search engine rankings can have dire effects on your website traffic, online sales generation and site popularity…

If you wish to avoid alienating the major search engines then do not engage in the following SE tactics:

1. 'Cloaking' or sneaky redirects - displaying different content to the search engines than shown to your normal website visitors including hidden text and hidden links. …
2. 'Doorway' pages created specifically for the search engines that are aimed at spamming the index of a search engine…
3. Don't create pages that install viruses, Trojans or badware. 'Badware' is spyware, malware or deceptive adware…
4. Avoid using software that sends automatic programming queries to the search engines to submit pages or check rankings... you will be penalized for using it.
5. Don't load web pages with irrelevant words.
6. Don't link to 'bad neighborhood' sites who have: Free for all links pages, Link farms - automated linking schemes with lots of unrelated links, Known web spammers or the site has been dropped or banned by the search engines.
7. Avoid 'broken links' or '404 errors,' your site will be penalized for them.
8. Don't display pages with minimal content that is of little value to your site visitors.
9. Do not duplicate content unnecessarily.
10. Do not use pop-ups, pop-unders or exit consoles.
11. Do not use pages that rely significantly on links to content created for another website.
12. Do not use 'cross linking' to artificially inflate a site's popularity... multiple sites cross linking … together, if all sites are hosted on the same servers the search engines will pick this up and the sites will be penalized.
13. Do not misuse a competitors name or brand names in site content.
14. Sites with numerous, unnecessary virtual host names will be penalized.
15. Do not use techniques that artificially increase the number of links to your web pages ie. Link farms.
16. Display web pages with deceptive, fraudulent content or pages that provide users with irrelevant page content.
17. Using content, domain titles, meta tags and descriptions that violate any laws, regulations, infringe on copyrights & trademarks, trade secrets or intellectual property rights of an individual or entity….

About the Author: Rosemary Donald is an SEO Consultant with www.rank1websitemarketing.com - & author of the SEO ebook 'Insider Secrets of Rank 1 Websites'
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3. Vitamin Label Warnings…

In addition to the statutory FDA “…not evaluated…not intended…” disclaimer, here are some warnings for you to consider for your labels; please note that the AER warning may have to be modified when the final AER regulations are issued in the next couple weeks.

Product Warnings:

- Keep out of reach of children.
- Do not exceed recommended dose.
- Do not use if outer or inner seal is broken or damaged.
- If you have a serious adverse reaction to product, discontinue use
immediately, seek medical attention if necessary, and contact us.
- If you are undergoing treatment for a medical condition or if you are pregnant
or lactating, consult your physician when taking this product.

In addition to the above, you may need a Food Allergy Warning:

“The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.”

That warning should read: ALLERGY WARNING: contains [list allergens].

Finally, there is a special warning for iron containing pills or capsules: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
http://www.cfsan.fda.gov/~dms/secgiro2.html
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4. Functional Beverages… the future of supplementation?

Nutraingredients.com reports: “As part of its newsletter on equity research - Healthy Living Monthly … highlighted an increased consumer focus on health and wellness as a key driver of new trends… growth and innovation will stem from more alternative segments. There will as such be opportunities for functional beverage and ingredients manufacturers alike as these categories grow. But it depends on how they align their resources and efforts.

"The beverage industry has become a leading delivery vehicle for functional nutritional ingredients, is a major beneficiary of the convenience movement in the US, and is desperate, in our opinion, for any new ideas to offset the stagnant market for carbonated soft drinks," write the report's authors.

Canaccord Adams valued the US nonalcoholic beverage market at $100bn in 2005. Carbonated soft drinks (CSDs) take up the majority of this market, with a reported $64.7bn in sales. However, the analyst says growth in the nonalcoholic segment is coming from categories other than soft drinks as consumers move towards healthier options or, at least, options that are perceived as healthier.

The firm conjectures this interest in healthier beverages is in part due to the fact US consumers are increasingly overweight. An estimated 66 percent of adults in the US are either overweight or obese, based on results from the 2003-2004 National Health and Nutrition Examination Survey (NHANES). The rate of obesity more than doubled from the previous NHANES survey - increasing from 15.0 percent (1976-1980) to 32.9 percent (2003-2004).

In terms of recommending how manufacturers large and small ought to innovate in this market, the report repeatedly highlights the example of the rise of energy drink.

"The history of the energy drink category in the United States illustrates both the opportunities and the risks that exist as change occurs within the beverage industry," write the analysts.

While Canaccord Adams has identified emerging trends in the beverage market as being fortification, functionality, and a shift towards premium, "green" and organic products… For instance, instead of water, beverage manufacturers should now look out for 'enhanced' water.

"Don't buy commodity bottled water today, despite its enormous profitability," states the report. "It is late in the trend, and the early adopters are telling us that."

Waters fortified with healthy ingredients hold the biggest potential and are being cashed in on by the beverage giants. Coca-Cola this year forked out $4.1bn to acquire vitamin water company Energy Brands for the manufacture and marketing of new nutritionally enhanced vitamin water lines.

These fortified categories are the way of the future, according to Canaccord Adams… The analyst states that though dairy was once the bastion for beverage fortification, it has given way to alternative drink sources that come with perhaps less calories or fat.

http://www.nutraingredients-usa.com/news/ng.asp?n=80162&m=1NIU927&c=jegwylrviswtnqa
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5. Are your papers in order?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

09/19/07 - Eco Friendly Packaging; SOPs up to date?

VLUeM – 09.19.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. More EU machinations
3. Eco-friendly packaging
4. Boomers and Dietary Supplements…
5. Are your SOPs up to date?
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SEPTEMBER 19: Fairfield, New Jersey, 7pm. Dr. Laibow, Gen. Stubblebine III, Ralph Fucetola (the Vitamin Lawyer), Prof. Murray Sabrin (spokesperson for Presidential candidate and US Congressman Ron Paul) and a spokesperson for Presidential candidate Dennis Kucinich are guest speakers at the Health Freedom vs. Health Tyranny Rally.

VFW Post 7925, 45 Plymouth Road, Fairfield, NJ. 937-227-9600.
Your Rights to Natural Health Care are in Jeopardy!

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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Asking Congress to demand FDA reporting on AERs
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2. Does the situation in Europe portend developments here?

The FDA’s public policy of “harmonizing” with international regulations suggests so. Here is a report on what is happening in Europe, a potential market for many US dietary supplements and model for US regulators.

“…the harmonization process for EU food laws, including maximum mineral and vitamin levels, has "a long way to go" before completion. European Advisory Services (EAS) said the "vastly different national approaches" currently in place will continue to impact on companies launching onto the European marketplace. Manager of scientific and regulatory affairs Efi Leontopoulou also stressed the strategic importance of the evolving regulatory climate in non-EU countries such as Russia and Turkey, which she described as being "two complex but very promising markets for the food industry." She added that: "Bulgaria and Romania have recently joined the EU and this creates new market opportunities but also more challenges in terms of the harmonization process."

A lengthy wait is predicted due to the number or rules and complexity of the current situation, but EAS was unable to say how long this might take prior to publication. The warning means that uncertainty about what may or may not be imposed for minerals and vitamins will continue to spread through the industry. Some countries could suffer a blow if EU legislation were to proscribe the sale of high dose products or vice versa. In the UK, for example, high dose products account for 12 to 15 per cent of the £220m vitamin and mineral market and could experience trouble... Member states at the moment vary dramatically on maximum and minimum levels, which would come to an end once Europe-wide unification is imposed.

Yesterday NutraIngredients.com reported how lobbyists from Consumers for Health Choice have pleaded with the commission president José Manuel Barroso to not stay away from a heavy-handed approach to maximum levels. The setting of maximum levels forms part of the 2002 Food Supplements Directive, and the new with fortified foods regulation...

"Working with all of these different national legislations in Europe can be quite a minefield for companies, from issues such as the addition of nutrients to foods and the types of ingredients permitted in countries, to details on new product notification requirements and national approaches towards derogations for vitamins and minerals."

…A working party of Member States is expected to sit down and discuss maximum health claims next week, and the Commission is expected to propose a directive with actual figures in 2009.”

www.nutraingredients.com/news/ng.asp?n=79835&m=1NIE918&c=jegwylrviswtnqa
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3. Eco-friendly packaging

A recent issue of a nutrition industry magazine carried an interesting article on eco-friendly packaging. The two newest offerings are Polyactide (PLA) plastic bottles (made from corn and readily biodegradable) and Tetra Paks. The PLA is colorful, costs less than petroleum-based plastic and uses less energy to produce. The Tetra Paks, vaguely rectangular in shape, are mostly recyclable paper, but with a special aseptic process that allows liquids long shelf life without degrading the ingredients high temperatures, irradiation, etc.

Tetra Pak is at: www.tetrapak.com and you can Google “Polyactide bottles” for a number of links.

From “Design of the Times” September 2007 Nutrition Industry Executive – www.niemagazine.com

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4. Vitamins, minerals and boomers…

“Men and women over the age of 51 who regularly take dietary supplements are more likely to get adequate amounts of several vitamins and minerals than those who do not, a study suggests. Researchers writing in the Journal of the American Dietetic Association also found that a substantial portion of people in this age range do not get enough vitamins and minerals from their diet alone and the use of supplements is necessary. Not only do these results give the supplements industry a boost, but they could also help supplement providers in deciding which age group to target with marketing, as well as giving a clear indicator of what nutrients should be included… They concluded that a large "proportion of older adults do not consume sufficient amounts of many nutrients from foods alone. Supplements compensate to some extent, but only an estimated half of this population uses them daily…”

www.nutraingredients.com/news/ng.asp?n=79836&m=1NIE918&c=jegwylrviswtnqa

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5. Are your SOPs up to date?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

09/12/07 - FDA focus on saftety?

VLUeM – 09.12.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at: http://tinyurl.com/rkneb
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1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/

Divesting the FDA and A Little History of Regulations

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From an FDA warning letter issued last week: "...FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions."
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2. News Bits…

From New Hope Media: Dietary ingredient shortage!

“Retailers may have to start charging their customers more for dietary supplements containing vitamin C by the end of the year as manufacturers are forced to pass on higher prices from suppliers. Prices for vitamin C are ballooning because of supply shortages out of China, the world's primary supplier, and the use of corn, a source of vitamin C for mass production, as a biofuel, said Ed Keenan, vice president of marketing at New York-based supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim they are shutting down plants to remodel them to meet Western standards of production. China supplies about three quarters of the global vitamin C market. "What they've done is squeeze production. They're holding back in their production," Kennan said of the Chinese production companies. "The whole industry is going to be hit by a severe shortage."
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1436&strSite=FFNSite

AHPA Speaks Out:

The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition.

 "The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter drugs be submitted to the FDA, which goes into effect this December," AHPA stated.

NAC & Gambling:

“A common amino acid sold as a dietary supplement could help diminish pathological gambling addictions, according to a new study. Researchers at the University of Minnesota uncovered the link following an eight-week trial involving 27 people who were given increasing doses of N-acetyl cysteine. By the end of the pilot study, published in the September 15th issue of Biological Psychiatry, 60 percent of the participants reported having less urges to gamble. The potential significance of these findings is huge - given the widespread damage caused by addictive gambling.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79705&m=1NIU912&c=jegwylrviswtnqa

Symbols of Harmonization?

“The US government yesterday concluded a hearing examining the implementation of a nation-wide food labeling system to provide consistent nutrition information on product labels. .. FDA this week held a two-day meeting to gather comments from industry, health groups, advocacy organizations and medical experts on the use of a labeling program similar to the UK's traffic light system. Indeed, a number of countries around the world have already instituted voluntary labeling systems for government-designed nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful, with further information available elsewhere, such as in booklets and web sites. In the US, the food and beverage industry has identified the need to spell things out simply for consumers..”

http://www.nutraingredients-usa.com/news/ng.asp?n=79708&m=1NIU912&c=jegwylrviswtnqa
And this, from Nutrition 21, indicating that the middlemen are moving into marketing as the new GMPs become effective.

“Nutrition 21, the developer of chromium-based Chromax, announced it has entered into definitive agreements to privately place shares and warrants to fund $17.75mn for marketing and retailing of its condition-specific products. The New York state-based company previously used its science portfolio to support branded ingredient Chromax's use in supplements. However, the company has opted for a change in direction and invested heavily in promoting Chromax directly as a finished supplement product through food, drug and mass retail outlets. The company is going to attempt to take the market by storm, because it says its products have the potential to be attractive to a wide variety of consumers.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79678&m=1NIU912&c=jegwylrviswtnqa

3. Reminder: Update Archives at: http://tinyurl.com/rkneb

Here are some of the topics of recent Updates.

08.31.07 - More on cGMPs impact
08.17.07 - Web Site Mistakes - Speaking in NJ 09/19
08.17.07 - Superfooods Market to Double by 2011
08.03.07 - AER Regulations about to be issued.
07.21.07 - FDA Warning; current issues bulletpoints
07.17.07 - Another FDA guidance and a DC Road Trip
07.10.07 - cGMPs, TX AG, Codex degrades standards
06.28.07 - Randomized Clinical Trials; cGMPs posted
06.23.07 - cGMP Rule issued; ingredient testing...
06.07.07 - Summer of Decisions; Define your Market
05.31.07 - Ron Paul's Bill is the Answer to FDA Failings
05.16.07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05.11.07 - OMB approves cGMPs- S.1082 amend confirmed
05.03.07 - Responding to Net Attacks; Victory in Congress!
04.26.07 - SUS Page Updates

08/31/07 - More on cGMPs impact

VLUeM – 08.31.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. More on the GMPs
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

More News on Lobbying Congress to Divest FDA of Food Authority.
http://www.globalhealthfreedom.org
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2. More on GMPs

I’ve been reading the GMPs that were issued in June. You can read my initial blog on them at:
http://vitaminlawyerhealthfreedom.blogspot.com/2007_06_01_archive.html .

Meanwhile, a number of organizations have also been reviewing the new Rules and I’ve been reviewing what they are saying. AHPA (American herbal Products Association) has been part of the process from the start. Here are excerpts from a report they’ve prepared (my headings in ALL CAPS).

BACKGROUND: "…compared to the existing cGMP for conventional foods, which is expressed … in just under six thousand words, the final rule on dietary supplement cGMP will be codified in 21 CFR 111 in over sixteen thousand words."

"Publication of this final rule is the culmination of a process that was begun in 1995 with the submission to FDA of an “industry draft” by AHPA, CRN, NDMA (now CHPA), NNFA (now NPA), and UNPA. This draft was published as an advance notice of proposed rulemaking on February 6, 1997, and followed by publication of a proposed rule on March 13, 2003" The final rule was published June 22, 2007 and can be seen at: http://www.cfsan.fda.gov/~dms/dscgmps6.html

APPLIES TO: “The rule applies to all firms that manufacture, package, label or hold dietary supplements for sale in the U.S. and Puerto Rico, with the exception of retailers who hold dietary supplements “for the sole purpose of direct retail sale to individual consumers.” The final rule notes, however, that this retailer exception does not extend to “a warehouse or other storage facility for a retailer,” or to “a warehouse or other storage facility that sells directly to individual consumers.”

STRUCTURE OF RULE: The Rule is divided into 16 parts:

“Subpart A General Provisions (*)
Subpart B Personnel
Subpart C Physical Plant and Grounds (* as Buildings and Facilities)
Subpart D Equipment and Utensils (* as Equipment)
Subpart E Requirement to Establish a Production and Process Control System (*as Production and Process Controls)
Subpart F Production and Process Control System – Requirements for Quality Control
Subpart G Production and Process Control System **
Subpart H Production and Process Control System – Requirements for the Master Manufacturing Record
Subpart I Production and Process Control System – Requirements for the Batch Production Record
Subpart J Production and Process Control System – Requirements for Laboratory Operations
Subpart K Production and Process Control System – Requirements for Manufacturing Operations
Subpart L Production and Process Control System – Requirements for Packaging and Labeling Operations
Subpart M Holding and Distributing
Subpart N Returned Dietary Supplements
Subpart O Product Complaints
Subpart P Records and Recordkeeping”

* From the Food GMPs
** “Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement”

APPLIES TO SOME CAM PRACTITIONERS: "FDA also noted in the preamble to the final rule that it “would be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis, to determine whether to apply the requirements of this final rule” to health care practitioners, such as acupuncturists, herbalists, and naturopaths who are “adequately trained in their profession” and who provide supplements that they prepare in “one-on-one consultation[s].” The agency stated, however, that it is “not considering exercising our enforcement discretion with respect to practitioners who prepare batches of herbs and sell them to individual consumers without determining whether the dietary supplement is appropriate for each consumer’s needs in a one-on-one personal consultation, or those that prepare batches of a dietary supplement for which there is a known or suspected safety concern.”"

Since that’s written in bureaucratic “bass-ackwards” let’s make that clearer: IF you do individualized one-on-one counseling, the FDA does NOT expect you to meet GMPs; if you repackage ingredients without one-on-one consultations, you will be treated as a distributor and be required to meet GMPs.

I’ve also read the United Natural Products Alliance report on the GMPs. In general their analysis is similar to AHPA. Some points they note (quotes are from the FDA Rule comments):

PRODUCT COMPLAINTS: “The final rule defines product complaint…examples of product complaints are foul odor, off-taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a DS container, improper packaging, mislabeling or DS that are super potent, sub-potent or contain the wrong ingredient or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)…”

QUALITY: “Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminates and has been manufactured, packaged, labeled and held under conditions to prevent adulteration…”

GMP TRAINING: While FDA will not provide GMP training materials, “…paragraph, § 111.14(b)(2) requires you to make and keep documentation of training, including the date of training, the type of training and the persons trained.”

BATCH TESTING: “We are persuaded that as an alternative to testing each finished batch of product, we can allow for the use of a statistically sound sampling and testing program for finished batches of DS unless a manufacturer chooses to test every batch. Such a sampling and testing program is feasible when controls are implemented earlier than the final product stage in the manufacturing process. Controls include the use of a C of A from a qualified supplier for specifications other than the identity of a DI and the establishment and monitoring of in-process manufacturing controls.”

“We agree with the comments that if we reduce the requirements for testing at the finished batch stage, then it is critical that you determine whether components meet specifications. We address this issue in the following two ways: (1) Each manufacturer must confirm the identity of each component prior to use (you must test or examine DIs to verify the identity but may rely on a C of A to confirm the identity of components other than DS) and (2) Each company must confirm other required specifications for components prior to use, either by relying upon a C of A or by testing or examining the components.”

“Because of the critical importance of insuring the proper identity of DIs – they are the central defining ingredient of a DS – we are requiring each firm that uses a DI to perform its own testing or examination for identity of each DI prior to use. Firms may not rely upon a C of A provided by suppliers to determine the identity of a DI before use. … We believe that the minimum criteria that we are establishing for a C of A, together with the requirement that a firm relying on a C of A must qualify a supplier and periodically repeat that qualification process can prevent the problems that have occurred with faulty certificates in the past.”

“Under final § 111.75(a), a firm may rely upon a C of A from its supplier of a component provided that certain criteria are met which include the following: (1) The firm first qualifies the supplier by establishing the reliability of the supplier’s C of A through confirmation of the results of the supplier’s tests or examinations; (2) The C of A includes a description of the tests or examination method(s) used, limits of the tests or examinations, and actual results of the tests or examinations; (3) The firm maintains documentation of how it qualified the supplier; (4) The firm periodically reconfirms the supplier’s C of A; (5) The firm’s quality control personnel review and approve the documentation setting for the basis for qualification (and re-qualification) of any supplier.”

PRODUCT SPECIFICATIONS: “The requirement to establish specifications is not limited to when a manufacturer purports that its product possesses attributes of strength and composition on the label. One comment asks for guidance as to what constitutes an official or scientifically valid standard for specifications. We are not aware of any officially recognized standard for specifications… the manufacturer establishes the set of criteria to which a product should conform to be considered acceptable for its intended use. In general, a specification may include a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described.”

COMPLIANCE NOTIFICATION: “…an unqualified statement such as ‘produced in compliance with dietary supplement current good manufacturing requirements,’ without more, could suggest the product may be safe and effective or somehow superior to other DS products that are subject to the same CGMP requirements (id.) [and] would likely be considered misleading …, but that including language clarifying to consumers that all DS must be manufactured in compliance with CGMP requirements, and that such compliance does not mean that the DS is safe or effective, may be a way to cure that unqualified statement … Thus, we are not prohibiting voluntary statements on the DS label, provided that such statements are truthful and non-misleading…”

GMP & AER: And, despite the new AER law, “We continue to strongly recommend that firms that receive product complaints, that are not ‘serious adverse events’ notify us about any illness or injury, because, for example, we may have additional expertise or data that may be helpful in investigating the complaint or determining whether the problem applies to more than one product…We encourage you to include our recommendations in the written procedures that you develop for handling product complaints.”

CONCLUSION: Your bottom line: over the next three years, as GMPs become effective first for large firms, then in 2 years for medium firms (under 500 employees) and finally in three years for small (under 20 employees) individual firms will have to manage their compliance with the requirements. The Vitamin Lawyer Consultancy will be available to help.

STANDARD SOP: Expect my revised Standard Operating Procedures (for Dietary Supplement companies and for CAM practitioners) providing for phasing in the GMP requirements, to be available in the next month or so. I’ll let you know as soon as they are ready. You can see outlines of my pre-final rule SOPs at http://tinyurl.com/2eu6yj - these will be re-organized to fit the 16 GMP categories noted above. I estimate it will take 2 – 3 hours to customize the revised formats for each operating company responsible for GMPs.

08/17/07 - Web Site Mistakes - Speaking in NJ 09/19

VLUeM – 08.17.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. Web Site Mistakes
3. Wiki Biased Editing Exposed
4. I’ll be speaking in NJ on September 19th
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

New link established to allow Health Claims comments to FDA! Comments end: 08/31/08.
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2. Entireweb Newsletter * August 14, 2007 * ISSUE #361 * entireweb.com

Excerpts from: Do You Make These Mistakes With Your Web Site?

“… no web site is absolutely perfect… But there are some basic web site mistakes …
- Not enough content. - …minimal information along with their contact information on their web sites … today's web visitors are looking for … lots of good quality content … build credibility for your business.
- Old or outdated content. - If you want visitors and search engines to pay attention to your web site, you need to keep adding new content and updating the existing information....
- Not being search engine friendly. - … in order to be included in the search engine databases.
- Not monitoring your site in the search engines. - … Monitoring your web site means that you can react to changes and take appropriate steps to make sure your site shows up in the search results and that web traffic keeps flowing.
- The site is built using Frames or Flash. - Not too many web sites still make this mistake…
Making your web site the best it can be is a very effective and affordable marketing option for most small businesses. Of all the other types of advertising and marketing that you do each year, your web site has the potential to be seen by more customers, can continue to promote your company perpetually through links, is always accessible to customers, and can instantly reflect changes and provide fresh information to draw people in….”
About the Author: Lauren Hobson is the Editor of Biz Talk Newsletter and the Five Sparrows Marketing Blog from Five Sparrows, LLC at www.fivesparrows.com/biztalk.
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3. Wiki Biased Editing Exposed

http://www.prisonplanet.com/articles/august2007/140807_wikipedia_credibility.htm

Has your company been the victim of derogatory Wikipedia postings?

Says PrisonPlanet.com: “The credibility of the online encyclopedia Wikipedia has taken another dive after a newly developed software program exposed how the CIA, corporations like Diebold and others routinely edit entries to bury criticism and manipulate the truth . . . Now a CalTech graduate student has developed a software tool that threatens to slam the final nail in the coffin of any credibility Wikipedia had left… Wikipedia Scanner -- the brainchild of CalTech computation and neural-systems graduate student Virgil Griffith -- offers users a searchable database that ties millions of anonymous Wikipedia edits to organizations where those edits apparently originated, by cross-referencing the edits with data on who owns the associated block of internet IP addresses," reports Wired News.”

"The Wikipedia Scanner (http://wikiscanner.virgil.gr/) also allows users to type in an IP range and find out which organizations are editing what pages on Wikipedia."

Adds PrisonPlanet: "Though Wikipedia's raison d'etre is obviously based around allowing users to edit the content, the checks to prevent abuse and organized partisan attack campaigns against certain subjects or ideas are non-existent and the absence of any kind of reasonable moderation is destroying Wiki's reputation. ... Wikipedia is fast becoming a complete anathema to reliable research and will see its wavering reputation as a trustworthy source for information quickly evaporate if it continues to allow itself to be abused by intelligence agencies, corporations and dedicated trolls."

Over the past two years we've noted that attempts to put positive postings on Wikipedia about alternative healthcare and natural nutrients has been met with attacks by "Quackwatch" types, even as the "official" Quackwatch sites and founders have been found by courts to be untrustworthy of belief. Will see over the next few months if Wikipedia is capable of reforming itself to regain its credibility.
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4. I’ll be speaking in NJ on September 19th - Here’s the flyer from NJNHP:

New Jersey Natural Health Professionals & Natural Solutions Foundation
Health Freedom vs. Health Tyranny: Your Voice Matters

September 19, 2007 7:00 p.m. - 10:00 p.m.
VFW Post 7925 - 45 Plymouth Road - Fairfield, New Jersey
973-227-9600

Guest Speakers:
Rima E. Laibow, MD
Founder Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army Ret.)
President Natural Solutions Foundation
Ralph Fucetola, JD
Best known as “The Vitamin Lawyer”
Professor Murray Sabrin
Spokesperson for Presidential Candidate & U.S.Congressman Ron Paul

For more information/reservations, please contact:
Sharan Woods, President
New Jersey Natural Health Professionals
Fairfield, New Jersey
973-882-0181

08/11/07 - Superfooods Market to Double by 2011

VLUeM – 08.11.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Updates
2. Superfoods market to double by 2011
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1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/

AER Regulations Immanent… EU Backs off banning natural vitamins!!
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2. Superfoods market set to double by 2011 - Alex McNally

“Aug. 10, 2007 - The superfood and drink market is expected to almost double in the ten year period up to 2011, says a report published today, with soy products and exotic fruits leading the charge.

…Michael Hughes, market analyst and author of the report Super Food and Drinks: Consumer Attitudes To Nutrient Rich Products, said shoppers are actively seeking nutrient rich fresh, organic and functional food and drinks and turning their backs on foods high in fats, sugars and salts… Hughes said: "The trend towards 'positive nutrition' is well reflected by the recent popularization of superfoods, especially in the UK and US."

As a result, superfoods and drinks, like acai and goji berries, are seeing a surge in demand. Datamonitor defined superfoods for the purpose of the report as foods rich in "specific nutrients and phyto-chemicals (i.e. anti-oxidants) and are promoted as being able to improve health condition and/or disease prevention." A spokesperson told NutraIngredients.com that the definition includes both foods which are naturally high in nutritional value and those with added nutrition. This means it can include much of the functional food market. Many food and drinks associated with superfood status have also enjoyed healthy growth in the last five years and this - in part - can be attributed to this status, he added. Hughes said: "The popularization of superfoods means that many food and drinks now have a 'healthy-halo' which significantly influences consumer preferences."

Exotic, highly fashionable fruits such as acai berries, goji berries and pomegranates have all risen in popularity, with pomegranate currently one of the most fashionable superfood ingredients, the analyst said. In the period January 2005 to May 2007, there had already been a 500 per cent increase in the number of products using pomegranate as an ingredient compared to the period 1999 to 2004.

Hughes added: "Right now, pomegranate is the hot ingredient, but this is likely to be superseded given that new ingredients are being continuously touted. "Monitoring these developments will be vital if industry players are going to fully capitalize on the superfoods movement." … Green tea sales have grown substantially in the US. The market grew from €18m ($119m) in 2001 to €116m ($160m) in 2006… Datamonitor also identified an opportunity for manufacturers to respond to growing time constraints which are leading to people in Europe missing around 100 meals a years because they do not have time. The report suggests companies can take advantage of this by offering nutritionally enhanced snacks as a substitution for missed meals.

http://www.nutraingredients.com/news/ng.asp?n=78969&m=1NIE810&c=jegwylrviswtnqa

08/03/07 - AER Regulations about to be issued.

VLUeM – 08.03.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. AER Regulations Immanent
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
FDA enabling act delayed! Hope abounds…
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2. AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

www.nutraingredients-usa.com/news/ng.asp?n=78773&m=1NIU803&c=jegwylrviswtnqa

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…"