claims about scientific studies might imply FDA approval

BioGaia USA, LLC v. Probiotiv Naturals LLC, 2025 WL 2946910, No. CV 25-3592 PA (MBKx) (C.D. Cal. Sept. 5, 2025)

BioGaia sued Probiotiv – a competitor in the sale of priobiotic dietary supplements for oral health, for false advertising; Probiotiv counterclaimed for false advertising and the court declines to dismiss the counterclaim.

Probiotiv allged that BioGaia made unlawful health claims that BioGaia products “[d]efend against common dental issues,” provide “that good bacteria that your body needs to stay healthy every day,” and “promote healthy gums and teeth” that violate the Lanham Act. Priobiotiv further alleged that BioGaia’s claims that probiotics are backed by research and are clinically studied mislead consumers to believe that BioGaia products are effective like drugs, convey a false sense of scientific consensus and regulatory compliance, and mislead consumers to believe that the products provide the therapeutic benefits mentioned on the labels. Statements that its products are subject to clinical trials and longstanding research and trusted worldwide were allegedly likely to cause confusion and deceive consumers as to the scientific approval or endorsement of the products. [New category of endorsement confusion found!]

BioGaia argued FDCA preemption/preclusion. Although “the Fourth Circuit has held that false advertising claims based on allegations of implied governmental approval are not allowed absent an allegation that there was an explicit representation of government approval,” Mylan Lab’ys, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993), and many courts have followed it, courts have also recognized a false advertising claim based on a theory of implied government approval where it is adequately alleged that “the message ‘our product is FDA-approved’ was actually conveyed to consumers.” That just requires the court to be convinced of the plausibility of the plaintiff’s theory of deception, usually because of statements that are drug- or FDA-adjacent (e.g., references to “off-label” use or use of formularies/systems that are usually reserved for FDA-approved products).

Here, BioGaia’s use of phrases such as “clinically proven,” “most clinically studied,” and “backed by 30+ years probiotic research” allegedly conveyed a false sense of scientific consensus and regulatory compliance. That was more than implied governmental approval [from silence]. [That is, this court seems to read the preemption line as rejecting any theory that people assume that products are legally on the market, thus making their mere presence an implicit representation about legality. But people probably do assume this. I’m not sure why even that wouldn’t be enough if you proved the elements required for a Lanham Act violation (communication of a false/misleading message, materiality, harm) along with a clear enough FDCA violation. I understand the problems with predicting how the FDA would come out where it has discretion; that’s a decent reason for declining to find determinable falsity, but there are some pretty clear scenarios out there where a Lanham Act claim doesn’t require agency interpretation to determine falsity, or where the interpretation is statutory and thus the agency has no special expertise.]

Anyway, this also allowed a state-law false advertising claim to survive.