Sometimes it really is as easy as A, B, C or as simple as 1, 2, 3. Where the FDA has set specific rules for the type of labeling claims a manufacturer can make and the manufacturer abides by those rules, claims by plaintiffs seeking to require something different are preempted. Just like do, re, mi. In Greenberg v. Target Corporation, — F.3d–, 2021 WL 116537 (9th Cir. Jan. 13, 2021), the Ninth Circuit kept it simple.
Plaintiff purchased a dietary supplement containing the vitamin biotin. The label said:
- Biotin “helps” support healthy hair and skin;”
- “This statement has not been evaluated by the Food and Drug Administration;” and
- “This product is not intended to diagnose, treat, cure, or prevent any disease.”
Id. at *1-2. That is a called a structure/function claim – a claim that addresses “only the nutrient’s role in the human body, not the product’s health impact on the general population.” Id. at *1 (emphasis added). Once you start talking about health impact, you are making a disease claim. Disease claims and structure/function claims are governed by different FDA requirements. To make a structure/function claim:
A. The statement must be substantiated so that is truthful and not misleading;
B. The manufacture must include a disclaimer that the statement has not been evaluated by the FDA and that the product is not intended to “diagnose, treat, cure, or prevent” any disease; and
C. The statement itself cannot claim to diagnose, treat, cure, or prevent any disease.
Id. at *3 (citing 21 U.S.C. §343(r)(6)(B)-(C)). Sound familiar?
Those requirements are found in the Nutrition and Labeling Education Act (NLEA) which is a 1990 amendment to the FDCA. The NLEA also contains an express preemption provision preventing states from imposing “any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement of section 343(r).” Id. This is even more straightforward than the “i before e, except after c” rule. Weird, seize, glacier – exceptions always muck things up.
There really was no dispute that the manufacturers met requirements 2 and 3. The label included the necessary disclaimer and the statement did not say it would treat any disease. Id. at *5. It was really requirement 1 where plaintiff put all his eggs. But here too, there were undisputed facts. Such as, the manufacturer had substantiation for the claim that the vitamin supports healthy hair and skin. The scientific evidence backs that up. Id. at *4. Plaintiff argued that the statement was false and misleading because most people are not biotin deficient and therefore taking an extra dose of biotin does not provide a benefit to the general population. Id.
But that’s not the standard for structure/function claims. As noted above, the FDCA establishes two classes of claims: structure/function and disease. Plaintiff
cannot implicitly import a disease claim requirement — evidence showing the product’s impact on the consumer’s health or disease — into the structure/function claim, given the differences in the statutory requirements for each.
Id. Like trying to fit a square peg into a round hole. Mucks things up.
Moreover, plaintiff cannot use generalized “false and misleading” allegations to defeat what Congress specifically allowed for this type of label claim. We see this all the time in drug and device cases too. Plaintiffs try to tether their claims to the FDCA’s general prohibition on false or misleading statements without regard for the manufacturer’s adherence to the specific labeling requirements. Here, plaintiff argued that only a handful of people actually derive a benefit from the vitamin supplement. But as the court pointed out that is likely true of almost all dietary supplements. For example, a vitamin C supplement might include a claim that it “boosts immunity.” By plaintiff’s logic that would be a misleading statement “because most people are not vitamin C deficient.” Id. at *5. “Such reasoning conflicts with the FDCA’s statutory language and the FDA’s stated purpose for allowing structure/function claims.” Id. Plaintiff is attempting to impose an additional requirement on structure/function claims – a likely benefit to the majority of consumers – that the FDA has not mandated. Just like 2+2=4; adding requirements beyond the FDCA equals preemption.