"virologist developed" etc. plausibly implies disease prevention

Corbett v. PharmaCare U.S., Inc., 2021 WL 4866124, No. 21cv137-GPC(AGS) (S.D. Cal. Oct. 19, 2021)

This is a putative class action for violations of consumer fraud statutes in the sale of Sambucol, a dietary supplement that contains a “proprietary extract” of black elderberry. Plaintiffs brought the usual California claims; warranty claims; and Massachusetts and Missouri consumer protection claims.

“In March 2020, sales of the elderberry supplements increased by 415% over prior years as consumers sought to buy products that would offer ‘immune support’ from the coronavirus.” Plaintiffs had two theories: (1) the products were illegal to sell under the FDCA/DSHEA and California’s Sherman Law; and (2) false advertising by affirmative statements and omissions:

Under the DSHEA, a “new” dietary ingredient (those not used in the United States before 1994), may be used in dietary supplements but must first be submitted to the FDA prior to sale unless the ingredient has been “present in the food supply as an article used for food without being chemically altered.” … Dietary supplements that contain undisclosed NDIs are “adulterated” for purposes of the FDCA. Because the elderberry extract was not marketed as a dietary ingredient in the U.S. before 1994, and is an NDI, the FAC maintains that Defendant did not notify the FDA with the required NDI notification for its elderberry extract. As such, Plaintiffs allege that Defendant’s Products are illegal to sell because the elderberry extract is adulterated and misbranded under the FDCA and California’s Sherman.

In addition, defendant allegedly made prohibited implied disease claims, not merely structure/function claims, by marketing the products as “scientifically tested”, “virologist developed”, “developed by a world renowned virologist”, along with advertising that the products “support[ ] immunity” or claim “immunity support.” “Scientifically tested” was allegedly misleading because no published studies of the products exist, and the existing studies test a different elderberry extract, and because it improperly suggested that the products were effective against disease. And the products were allegedly misbranded because the labeling fails to include adequate directions for use and because they claimed “high antioxidant levels” in violation of regulations.

The named plaintiffs allegedly saw and relied on the misleading representations, and believed that the products were legally sold supplements.

PharmaCare argued that plaintiffs lacked California statutory standing because the alleged fact that the products were illegal didn’t establish standing. However, plaintiffs alleged material misrepresentations and reliance. The Ninth Circuit has explained that the “misrepresentation of prescription pet food as medicine or FDA-controlled can be a material fact for a reasonable consumer—particularly for a pet owner who is dealing with possibly a sick or unhealthy pet,” and so too for humans. “They do not merely allege a regulatory violation but base their claims on misrepresentations arising from regulatory violations.”  The same analysis applied to Missouri’s consumer protection law, which requires “a causal connection between the ascertainable loss and the unfair or deceptive merchandising practice” but not reliance. And to Massachusetts law, which does require reliance.

NLEA preemption:  The NLEA expressly preempts any state law that establishes “any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title.”  PharmaCare argued that its use of the phrase “supports the immune system” was an acceptable structure/function claim and thus allegations of an implied disease claim were preempted.

 As FDA regulations state, “[i]mplied disease claims do not mention the name of a specific disease, but refer to identifiable characteristics of a disease from which the disease itself may be inferred.” Courts may consider extra-label materials when determining whether certain advertising is an implied disease claim. The FDA warned that its general rule wasn’t “intended to establish whether any particular structure/function claim is appropriate for any specific product,” and that “an otherwise acceptable structure/function claim might nevertheless be false or misleading for other reasons.” But, as an example, “supports the body’s antiviral capabilities” or “supports the body’s ability to resist infection” would be a disease claim, in contrast to “supports the immune system,” “[a] more general reference to an effect on a body system that did not imply prevention or treatment of a disease state...” Id. The FDA explained that the distinction “is one of specificity.”

PharmCare argued that “supports the immune system” “helps you...stay healthy” and “arms you with the best protection nature has to offer” were acceptable structure/function claims. By themselves, that would be true, but plaintiffs also alleged label and extra-label statements and alleged that, “viewed in their totality, they are either explicitly or implicitly claiming to mitigate or prevent disease.” In particular, “scientifically tested”, “[v]irologist [d]eveloped”, contain “the most extensively researched” extract “in the world” and “[d]eveloped by a world renowned Virologist,” allegedly necessarily implied disease prevention “because a virologist is an expert that deals with viruses and the disease they cause.” So to with other claims like “stay healthy through the toughest season” which allegedly implied cold/flu protection, and a FAQ entry answering  “What are the traditional uses of black elderberry?” with the statement that it is “used in traditional remedies for colds, coughs, and upper respiratory infections.” PharmaCare’s homepage website states, “Get that NOT WORRIED ABOUT A 5 HOUR FLIGHT IN THE MIDDLE SEAT kinda feeling”: a reasonable consumer could understand this statement as promising protection from the COVID virus or other transmissible diseases.