Alliance for Natural Health Scores First Amendment Victory on Qualified Health ClaimsJune 1, 2010
By Ricardo Carvajal & Diane B. McColl –
The Alliance for Natural Health (“ANH”) has prevailed on summary judgment in its court challenge to FDA’s denials of, and restrictions on, certain qualified health claims regarding selenium and cancer. The decision marks the latest chapter in a long-running battle between industry and FDA over the agency’s attempts to implement the FDC Act’s restrictions on the use of health claims in the labeling of foods, including dietary supplements.
ANH submitted a qualified health claim ("QHC") petition to FDA which proposed numerous claims that consumption of selenium reduces the risk of some cancers. The court’s conclusions with respect to FDA’s handling of those claims are summarized below.
- FDA denied as “misleading on their face” claims that selenium “may reduce the risk of certain cancers” and “may produce anticarcinogenic effects.” FDA argued that the former claim is misleading because it fails to specify the cancers on which selenium has an effect, and that the latter claim falsely implies that selenium has an effect on all cancers. Citing the principles established in Pearson I (Pearson v. Shalala, 164 F.3d 650, 652 (D.C. Cir. 1999)), the court found FDA’s action unconstitutional in the absence of “empirical evidence that any disclaimer would fail to correct the claims’ purported misleadingness.” If FDA cannot produce that evidence, then FDA must draft “one or more” disclaimers for those claims.
- FDA denied a claim regarding lung/respiratory tract cancers and a claim regarding colon/digestive tract cancers on the ground that the claims were unsupported by any credible evidence. The court conducted its own review of the underlying studies and found that FDA’s basis for discounting one or more of the studies was erroneous and not in keeping with its guidance on the evaluation of health claims. For the lung/respiratory tract cancer claim, FDA must now draft a disclaimer that accounts for the one study deemed by the court to be supportive. For the colon/digestive tract claim, FDA must reconsider that claim and draft a disclaimer as needed.
- FDA entirely redrafted a claim regarding prostate cancer because the agency found the language proposed by plaintiff to be false and misleading. The court concluded that FDA erred when it “completely eviscerated plaintiff’s claim” instead of taking the less restrictive approach of drafting one or more “short, succinct, and accurate” disclaimers. Further, based on its review of the underlying studies, the court found FDA’s proposed claim to be contradictory and inaccurate.
Barring a successful appeal, this decision could cement in place a regime for FDA’s review of qualified health claims that is very favorable to health claim petitioners. As a practical matter, the burden that FDA would have to meet before it can deny a qualified health claim petition would be unachievable in all but the most extreme cases – an outcome that should cheer advocates of unfettered commercial speech.
Although qualified health claims and structure/function claims are governed by different standards, this decision could raise questions with regard to whether the government’s current approach to substantiation of structure/function claims can withstand a First Amendment challenge. FDA and FTC guidance documents maintain that there is no fixed substantiation standard for such claims; however, both agencies have suggested that a minimum of two high quality clinical studies are needed. Query whether either agency could lawfully suppress an appropriately qualified structure/function claim that is based on a single study – or any other credible scientific evidence, for that matter.
Although individual firms should certainly profit from a less restrictive approach to the use of health and structure/function claims, there is a risk to industry writ large. If the end result is an explosion in the use of claims based on very limited scientific support, and if those claims prove to have no merit in the long run, then consumers’ skepticism of all health-related claims can be expected to increase. This would be an “unhappy meal” indeed.