Saturday, July 21, 2007

07/21/07 - FDA Warning; current issues bulletpoints


1. Health Freedom Blog Update
2. Recent FDA Warning Letter
3. Bulletin Points: Current Regulatory Issues

1. Vitamin Lawyer Health Freedom Blog New Posting

New posting on newest FDA draft guidance on Health Claims:

Dr. Laibow remarks that the guidance is “apparently in direct response to Dr. Ron Paul's Health Freedom Protection Act, HR 2117…” and offers a link to protest this to the FDA:


2. Here are excerpts from a warning letter FDA issued a couple weeks ago

It shows us current thinking on “drug” claims for Dietary Supplements and gives a “text book” example of what claims not to make:

“This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at … and has determined that the products … are promoted for conditions that cause the products to be drugs under … the Federal Food, Drug, and Cosmetic Act (the Act) ... The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. … Examples [X} “…Cancer Prevention and Treatment” … "The scientific community has recently had very positive results on the effect of … on certain types of cancers. In tests on a variety of tumor types, the treatment with … led to improvement of overall health status, prolongation of life span, and a decrease in tumor size. Also, in local applications of … to skin cancer, it reduced tumor formation and growth." … "For prevention … As part of Cancer therapy"

*** [Y] The Hangover Preventive" … "When you drink alcohol, the body tries to break down the toxins.... These toxins are not fully broken down and cause damage to your organs. The side effects of this damage, we call a `hangover' such as headache and nausea, as well as other ill effects that we can't see (liver damage)…. absorbs the toxins from the alcohol before they are processed into your organs."

The above claims about individual products are supplemented by claims on your homepage about your products in general and by metatags you use to bring consumers to your website. Examples of the metatags include "cancer prevention," "toxin removal," and "Natural supplements that... are proven to inhibit cancerous tumor growth, and will even prevent hangovers.... Effective … cure." ***

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs"… New drugs may not be legally marketed in the U.S. without prior approval from FDA …. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

In addition, we note that your website states the following: "This form of [Y] is approved by the FDA as completely safe...." We have cited several examples in this letter to demonstrate that you are not in compliance with FDA requirements. Further, FDA has not reviewed the safety of [Y], nor its interactions with other substances. Therefore, the use of this statement to promote your products is false or misleading in that it implies FDA approval or sanction of your product and its purported uses. The false and misleading information misbrands your[Y] products ... ***

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. …Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.”

Students of the Vitamin Lawyer Red Flags Review School will readily see all the mistakes the marketer made… all the dangerous claims and over the line statements. A word to the wise…


3. Some Bullet Points regarding current regulatory issues

* Since the last days of 2006 there have been a series of challenges to Health Freedom
o Adverse Event Reporting Act [December 2006]
o FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]
o USDA & Codex: Organic Standards Diminished
o Codex: Raising Toxic Levels, Mandating Irradiation
o Codex: GM (Genetically Modified) Labeling Failures
o FDA GMPs (Good Manufacturing Practices for Dietary Supplements)
o Senate & House adoption of FDA enabling bills [S.1082 & HR.2900]
[Only S.1082 contains DSHEA protection language]
o Failure of US House to consider Health Freedom Protection Act – HR.2117
[Although over 100,000 messages to Congress demanded protection]
* Now the FDA has directly challenged HR.2117 with a new draft guidance
“Evidence-Based Review System for the Scientific Evaluation of Health Claims”
o Citation:
o Draft guidance document represents the agency's current thinking on
+ 1) the process for evaluating the scientific evidence for a health claim,
+ 2) the meaning of the significant scientific agreement (SSA) standard
+ 3) credible scientific evidence to support a qualified health claim.
* Ron Paul’s Health Freedom Protection Act (HR.2117)
o Health Claims must be allowed unless the FDA determines that –
+ (i) there is no scientific evidence that supports the claim;
+ (ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer

The opportunity should be clear: resubmit HR.2117 as the Health Freedom Restoration and Protection Act with language addressing each of the pending challenges noted above.

“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07

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