Friday, September 7, 2007

Health Freedom Allowed by DSHEA

I was asked to explain what Dietary Supplement regulation was like before the FDA's iniatives this year.

I think the best way to answer this is to note, first, such regulation is not primarily about the ingredients; it is about claims. Any dietary ingredient on the market before mid June, 1994 is allowed on the market; as is any new dietary ingredient approved by the FDA.

Prior to 1994, when the Dietary Supplement Health and Education Act (DSHEA) was adopted, no claims could be made regarding dietary supplements.

DSHEA allowed certain types of claims; limited or forbid others.

1. Allowed: General Wellness Claims ("take vitamin C and feel good") and claims about Classical Deficiency Diseases ("take 60 mg vitamin C daily and avoid scurvy").

2. Allowed: Normal Structure and Function Claims (which characterize the relationship between a nutrient and the normal function or structure of the body). A 30 day post-marketing notice of claims is required. This type of claim is the typical DS product claim.

3. Allowed only after FDA approval: Health Claims (which characterize the relationship between a nutrient and a health condition). The FDA approved so few health claims that Durk Pearson and Sandy Shaw sued the FDA. In 2000 they won (Pearson v Shalala) thereby forcing the FDA to consider "conditional" or "qualified" health claims where there was not necessarily "Significant Scientific Agreement." The SSA standard, which is mentioned in DSHEA for health claims, is high than the standard commercial substantiation standard of 'Competent and Reliable Scientific Evidence.' The Court basically held that the CRSE standard would apply for such conditional or qualified claims. This is similar to Traditional Use Claims that have to disclose the limits on CRSE for such uses.

In 2004 FDA had stated, "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'."

4. Not Allowed: Medical claims (prevent, mitigate, treat, cure) are never allowed for dietary ingredients... as such claims would make the ingredients "drugs" -- even where there is SSA about the claim. This is contrary to the 2002 Supreme Court case of Thompson v Western States that held, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort... We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information... Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning that the [product] had not undergone FDA testing and that its risks were unknown."

That's where we were by the mid 2000's.

Then, this year, FDA came out with a series of regulatory initiatives: the anti-CAM draft guidance and the Health Claims draft guidance (as well as the Good Manufacturing Process regulations and, shortly, the regulations for the new Adverse Events Reporting law).

The draft guidances, especially, would change the playing field by creating a new category of "CAM Products" (without Congressional approval) and by reimposing the SSA standard on all health related claims, contrary to the FDA's 2004 statement and the intent of Congress in adopting DSHEA that Dietary Supplements should be regulated as foods, not drugs.

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