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 www.globalhealthfreedom.org


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 Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com

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

No comments: