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To: hawkeye who wrote (5682)9/16/1998 11:46:00 PM
From: Arcane Lore  Read Replies (1) | Respond to of 26163
 
Hawkeye:

I enjoyed your 'shorts' posts earlier in the thread. Here's one in a more or less similar vein to add to your collection: #reply-3563109.

Turning to more substantive matters, I believe you are interpreting 'labeling' in too narrow a sense, namely as referring simply to the the text on the container or the package insert, if any. Here is what one attorney has to say on FDA's policy on this health claims in 'labeling' for dietary supplements:

Legal Update Column from FDA Hotline (June 1997) by Jonathan W. Emord:

With few exceptions, the FDA prohibits health claims unless pre-approved by the agency. A health claim is a statement on the label or in the labeling of a dietary supplement that characterizes the realtionship of any substance to a disease or health-related condition. Labeling includes any statement, whether given orally or in writing, that concerns a product and is part of an integrated distribution plan for that product. While the FTC has jurisdiction over advertising, when advertising also constitutes labeling, both the FTC and the FDA have jurisidiction over it.

The FDA regards an unapproved health claim as transforming a product into a drug.

The claim usually causes the product to satisfy the drug definition: any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. If noticed by FDA, the claim will cause the agency to issue a warning letter. The claim causes the supplement to be misbranded and subject to seizure and injunction against sale. The company's owners may be prosecuted. ...

emord.com