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New posting on newest FDA draft guidance on Health Claims: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

Tuesday, July 17, 2007

07/17/07 - Another FDA guidance and a DC Road Trip


1. Health Freedom Blog Update
2. Another FDA Guidance: Health Claims Substantiation

1. Vitamin Lawyer Health Freedom Blog New Posting

The House passed the FDA enabling act last week and we visited Washington…

Things are about to get very exciting as Dr. Ron Paul leads the way in countering recent attacks on Health Freedom by the FDA, Congress and Codex!


2. New FDA Draft Guidance: “Evidence-Based Review System for the Scientific
Evaluation of Health Claims” -

Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August.

Says the introduction: “This 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 in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act … and 3) credible scientific evidence to support a qualified health claim. … This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners … The specific topics addressed in this guidance document are: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

This guidance attempts to impose a high standard on Health Claims. Dr. Ron Paul’s pending bill, the Health Freedom Protection Act, HR.2117 addresses this further FDA power grab by imposing the standard commercial substantiation requirement. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' The text of the bill, reintroduced on May 7, 2007, can be found at:

This latest FDA Guidance needs further analysis and comments will be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency.

Tuesday, July 10, 2007

07/10/07 - cGMPs, TX AG, Codex degrades standards


1. Aspartame, etc. now Dietary Supplements?
2. Texas AG and Testimonial Claims
3. More on the new cGMPs
4. Health Freedom Blog Update

1. Codex, the World Food Code, continues to degrade food standards…

Rome 07.06.07 – “…the Codex General Standard for Food Additives (GSFA), which sets down the conditions for permitted food additives for all supplements, has now agreed the higher levels for castor oil, polysorbates, polyvinyl alcohol, acesulfame potassium, aspartame, cyclamates, neotame, saccharin, and sucralose. A US-led working group had been charged with drawing up a list of allowed additives and with setting levels based on technical justification and safety. The group had previously drafted lower than expected guidelines….”

You can keep up with the Byzantine world of the Codex Mandarins at


2. “The Texas Attorney General last week charged supplement manufacturer Mannatech for illegally marketing using dubious claims and testimonials about the health benefits of its products.

”Mannatech, its owner and related entities were found in violation of the Texas Deceptive Trade Practices Act, which can result in civil penalties of $20,000 per violation, as well as going against the Texas Food, Drug, and Cosmetic Act, which can result in up to $25,000 per day, per violation.

”State judgments such as these can pick-up where the Federal Trade Commission - which is increasingly on the look-out for misuse of consumer testimonials - has not reached, or not yet reached.

”Mannatech has in particular been charged with encouraging salespeople to make use of misleading testimonials. … "With today's enforcement action, the Office of the Attorney General seeks to shut down an elaborate scheme to defraud innocent consumers across the nation," Texas Attorney General Greg Abbott said in a written statement.

”According to the Office of the Attorney General, exaggerated claims relating to the therapeutic benefits of Mannatech's dietary supplements and products were used to unlawfully mislead consumers with cancer, Down's syndrome, cystic fibrosis and other serious illnesses.”

A word to the wise should be sufficient: Testimonials are not substantiation. Says the FTC in its Testimonial Guide,

“Endorsements must always reflect the honest opinions, findings, beliefs, or experience of the endorser. Furthermore, they may not contain any representations which would be deceptive, or could not be substantiated if made directly by the advertiser.”


3. More on the new cGMPs

As I continue to read the 467 page Good Manufacturing Practices document recently issued by the FDA I will continue to send off “tidbits” that exemplify the spirit of the new regulations.

For example, from the Economic Impact section:

“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.”


4. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at The address is:

I just posted more information on the House and the pending FDA “revitalization” bill, based on contact from the office of a friendly Congressman.