We venture a bit outside our normal drug/medical device arena today for a case involving dietary supplements, but you know we cannot resist a case shot down as an attempt to pursue a private FDCA cause of action. It’s a bit like the refrain to The Christmas Song – “although it’s been said many times, many ways” – the FDCA does not create a private cause of action. It may not be as melodious as “Merry Christmas to you,” but we’ve said it about as often on this blog. And in as many different ways as we can think to say it. More importantly, courts have said it. Over and over and over, to plaintiffs from one to 92. Still, plaintiffs continue to file suits based solely on violations of the FDCA. If everybody knows turkey and mistletoe are the keys to a bright season, shouldn’t plaintiffs know they can’t privately enforce the FDCA. It’s as obvious as the nose on your face, the one Jack Frost is nipping at.
In Womack v. Evol Nutrition Assocs., 2021 U.S. Dist. LEXIS 238347 (N.D.N.Y. Dec. 14, 2021), plaintiff filed a purported class action alleging defendant, the manufacturer of dietary supplements that raise energy and enhance mood, violated the Unfair and Deceptive Trade Practices Act, New York General Business Law (“NYGBL”) by omitting information about the risks of one of the active ingredients in the supplements. Id. at *1-2. That ingredient is known as Phenibut. In 2019, the FDA sent defendant a warning letter stating that because Phenibut is not recognized under the FDCA as a dietary ingredient, including it as such on product labeling caused the product to be misbranded. The ingredient would also require premarket approval before it could be sold in the United States. Id. at *4.
Plaintiff tried to turn that into an action for consumer fraud under the NYGBL. But “The FDCA does not provide a private cause of action, and that gap is not filled by the NYGBL.” Id. at *23. Under the NYGBL, plaintiff must plead that the product is “inherently deceptive.” However, plaintiff’s only allegations of deceptiveness relied on the warning letter and allegations of violations of the FDCA. Id. The deceptive act cannot be based on the fact that the act violates a different statute for which there is no private enforcement. Id. So, any claim based on alleged FDCA violations was dismissed.
Plaintiff argued that that they also alleged that Phenibut had side effects and addictive properties that defendant did not disclose and that by omission, defendant’s labeling was deceptive and misleading. For an omission-based claim under the NYGBL, plaintiff must allege that the defendant “alone possesses material information that is relevant to the consumer and fails to provide the information.” Id. at *26. While the complaint alleged side effects, it failed to allege that information was “exclusively in [d]efendant’s possession, or even that [d]efendant had knowledge that the [p]roduct was causing health problems.” Id. at *27. There is nothing in the FDA warning letter about the risk of side effects and no allegation that any consumer had made reports to defendant of any side effects. So, all allegations concerning defendants’ knowledge were “vague and conclusory.” Id. at *29.
Without a deceptive act outside of the FDCA or an omission of information exclusively within defendant’s knowledge, plaintiff failed to state a claim warranting dismissal of the action. So, you can roast your chestnuts, sing your carols, or look for flying reindeer until your heart’s content. It won’t change this simple phrase – no private enforcement of the FDCA.. . . And to all a good night.