Multivitamin and dietary supplement makers are under fire. A December 17 editorial in the journal Annals of Internal Medicine takes direct aim at the multi-billion dollar nutritional supplements industry. After summarizing the results of three studies of the impact of supplements on chronic diseases, the editorial delivers this verdict: "Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided."
That conclusion is difficult to square with how dietary supplements are marketed. Claims on packaging like "cellular age defying formula," "boosts your immune system," and "improves digestive health" are commonplace. While those claims are a far cry from the "fair balance" required in prescription drug marketing, statements on the label of a dietary supplement that describe the "general well-being from consumption of a nutrient or dietary ingredient" are acceptable under the Federal Food, Drug, and Cosmetic Act ("FDCA") so long as the supplement manufacturer "has substantiation that the statement is truthful and not misleading" and the claim is accompanied by a disclaimer. 21 U.S.C. § 343(r)(6); 21 C.F.R. § 101.93.
None of this is lost on false advertising plaintiffs. In the past, suits have been brought against supplement manufacturers alleging false advertising and related state law claims. See,e.g., Stanley v. Bayer Healthcare,LLC, No. 11cv862-IEG(BLM), 2012 WL 1132920 (S.D. Cal. 2012) (asserting false advertising claim against probiotic supplement). The studies published in the Annals of Internal Medicine will embolden these plaintiffs.
One defense supplement makers have raised in these cases is the primary jurisdiction doctrine. Since supplement labeling is addressed by the FDCA and pursuing violations of that statute is committed to the discretion of the FDA, supplement manufacturers argue that federal and state false advertising claims are essentially pre-empted. Defendants thus urge courts to have consumers and competitors direct their complaints to the FDA.
At its January 10 conference, the Supreme Court will consider whether to take a case in which it could shed light on the viability of this defense. The case, Pom Wonderful LLC v. Coca-Cola Co., involves Coca-Cola's Minute Maid Pomegranate Blueberry Juice. Coca-Cola's juice contains less than 1% pomegranate and blueberry juice. The other 99% is apple and grape juice. Pom sells a competing juice that is a blend of only pomegranate and blueberry juice. Asserting it was losing sales to Coca-Cola, Pom sued Coca-Cola for false advertising under the federal Lanham Act.
As I explained last year, the Ninth Circuit Court of Appeals rejected Pom's Lanham Act claim. The Ninth Circuit found that "Congress and the FDA have thus considered and spoken to what content a label must bear, and the relative sizes in which the label must bear it, so as not to deceive." Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170, 1177 (9th Cir. 2012). The court dismissed Pom's Lanham Act claim and told it to take its complaint to the FDA. Id. at 1178.
Pom is asking the Supreme Court to reverse the Ninth Circuit's decision. The Supreme Court has been considering the petition for more than a year. Earlier this year, the Court asked the Solicitor General for the views of the United States. While the United States criticized aspects of the Ninth Circuit's ruling, it ultimately recommended that Pom's petition for discretionary review be denied. If history is any indicator, the Court will follow the Solicitor General's recommendation. Those who serve clients in industries regulated under the FDCA will want to keep close tabs on what the Court does with Pom's petition.