FDA Update

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 5 • November-December 2003

FDA Update
FDA "Clarifies" Its Position on Health Claims: It Is Illegal to Say that Vitamin C Can Treat Scurvy

In our (Dr. Julian Whitaker, American Longevity, Durk Pearson & Sandy Shaw, and Pure Encapsulations, Inc.) latest suit against the FDA (Whitaker v. Thompson), we seek a health claim that saw palmetto can reduce the symptoms of mild benign prostatic hypertrophy. The claim is truthful and nonmisleading. The FDA, however, has refused to evaluate the evidence for the claim, saying that this is a drug claim, since saw palmetto (a dietary supplement) is said to be able to treat or cure disease. The FDA claims that health claims are allowed only for prevention of disease, not treatment.

Our two most important arguments against the FDA are that the congressional statute (DSHEA) allowing for health claims specified that they could apply to the relationship between a nutrient and any health-related condition, the clear language of which includes treatment claims. Second, even if the statute did not allow for treatment claims, the FDA cannot prohibit truthful, nonmisleading speech on dietary supplement labels (First Amendment, U.S. Constitution; Pearson v. Shalala, Court of Appeals for the District of Columbia, Jan. 19, 1999).

As we have noted before, the outcome of this suit will be of immense importance. If we win, there will be a parallel system of medicine in which less regulated and usually inexpensive dietary supplements can compete directly with prescription drugs. On Nov. 10, 2003, oral arguments took place before the U.S. Court of Appeals for the District of Columbia Circuit in the case of Whitaker v. Thompson (No. 03-5020). After the oral arguments had taken place and in violation of court rules, the FDA sent a letter to the court, attempting to "clarify" something they’d said at oral argument. (This shows that the FDA is seriously concerned about the outcome of the oral arguments.) In the letter, the FDA said, "Consistent with the position in our brief, under Section 321(g)(1)(B) and the penultimate sentence in section 343(r)(6), a claim regarding the treatment, mitigation, or cure of a nutrient deficiency disease, like any other disease, remains a drug claim."

What the FDA is saying here is that it would be illegal (and would require a New Drug Application) for a manufacturer or distributor of supplemental vitamin C to say that vitamin C can treat or cure scurvy! They did this, we believe, because they felt they had to be consistent in their drive to reserve all treatment and cure claims to prescription drugs. They couldn’t allow an exception without weakening their restriction. The requirement for consistency led them to make the unbelievably incredible statement to the court, namely, that one could not say that a vitamin C dietary supplement can treat or cure scurvy.

We do not believe that FDA could find a single scientist who would not agree that vitamin C effectively treats and cures scurvy. This is clearly a truthful and nonmisleading statement. The FDA’s other strategy is to claim that they are not stopping you from saying vitamin C cures scurvy, but that in order to say it, you have to file a New Drug Application and get it approved. The response to that is that you are denied your First Amendment rights if you cannot come up with the $250,000 needed to make such an application and the $50,000,000 or so needed to get it approved. Moreover, the vitamin C is the same whether you call it a drug or a dietary supplement—only the speech used with it is different—thus, the FDA is regulating speech and this case is a pure First Amendment issue.

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