Qualified Health Claims - Set Them Free!!

In the several years after DSHEA's passage in 1994, FDA steadfastly refused to approve any type of health claim on a dietary supplement that was truthful and non-misleading. FDA's intransigence resulted in a round of First Amendment freedom of commercial speech lawsuits that the agency consistently lost - and not just lost but lost big. FDA was usually not only excoriated by a federal judge for unconstitutionally restricting commercial speech, the courts also often took matters into their own hands by requiring FDA to rely on court-proposed disclaimers as a less restrictive alternative to FDA's propensity for outright suppression.

FDA finally ended its federal-court losing streak by proposing to allow what are now called Qualified Health Claims. For example, one of the first Qualified Health Claims the FDA approved was for folic acid supplementation: "FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects." Incredibly, even this Qualified Health Claim did not receive FDA's imprimatur until April 2001, at least several years after the medical, scientific, and nutritional communities knew such a nutrient-disease claim was totally meritorious.

In July 2004, FDA published guidelines that permitted dietary supplement manufacturers to submit a Qualified Health Claim Petition - thus formalizing a regulatory process for having FDA approve a Qualified Health Claim, rather than the agency being forced to accept claims written by the federal courts.

The dietary supplement industry was satisfied with the Qualified Health Claim Petition process and industry petitions began rolling in to FDA for approval. As might have been expected, however, given FDA's long-held determination to suppress health claims altogether, the FDA's next best strategy has become to delay and postpone, delay and postpone, for as long as possible approving a Qualified Health Claim Petition.

Even for a time-worn litigant such as the dietary supplement industry, justice delayed is still justice denied. However, rather than going back to federal court to force the agency's hand to comply with its own regulations, this time the dietary supplement industry has jumped headlong into the court of public opinion. And perhaps the strategy appears to be working - at least for now.

This past July, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) sent a letter to FDA blasting the agency for delaying decisions and missing their own regulatory deadlines on approving Qualified Health Claims. The Senators requested a summary of the number of petitions FDA had received, the length of time FDA was taking to approve each petition, and the number of FDA staffers assigned to the process. A not-so-veiled implication of the Hatch-Harkin letter was that federal legislation might be necessary to unplug the FDA logjam.

Then this past September, a coalition of 28 dietary supplement companies, public interest groups, and supplement distributors announced the start-up of a national grassroots campaign to bring pressure on FDA to honestly open the marketplace to truthful and non-misleading nutrient-disease information. The campaign's goal is to seek signatures on a nationwide petition to Congress, to be submitted in January 2006, demanding legislative reform of FDA's foot dragging and undermining of the First Amendment. The campaign is working off of multiple combined membership lists comprising 15-million American consumers.

Perhaps the strategy is working. In the last few months, a handful of Qualified Health Claims have been approved by FDA, including Qualified Health Claims for: (1) calcium and colon/rectal cancer and calcium and colon/rectal polyps; (2) chromium picolinate and reduced risk of insulin resistance and Type 2 diabetes; and (3) calcium and hypertension, pregnancy-induced hypertension, and preeclampsia. During the same time, however, FDA rejected a number of Qualified Health Claims related to lycopene and various cancers. A complete list of Qualified Health Claims - both approved and disapproved by FDA - can be found at www.cfsan.fda.gov/~dms/lab-qhc.html.

Of course, FDA's approval of just three Qualified Health Claims between August and November is hardly throwing open the floodgates. Maybe it's a show of good faith, then again maybe it's just another FDA tactic to throw its opponents off track. Regardless, the aforementioned grassroots campaign and their supporters in Congress should keep up the pressure on FDA. Many more Qualified Health Claims are waiting to be - and should be - approved.