“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

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
feeling”: a reasonable consumer could understand this statement as promising
protection from the COVID virus or other transmissible diseases. 

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