United States: Ninth Circuit Sets Vitamin E Free

Appeals court halts marketing suit, citing FDCA-pre-emption and structural claims

Intent to Prevent

When Paul Dachauer filed suit against Nature's Bounty Inc. in January 2016, he was coming after the vitamin and supplement manufacturer under California's Unfair Competition Law and Consumers Legal Remedies Act. His argument seemed straightforward enough: Nature's Bounty was making spurious claims about the vitamin E supplements he purchased.

Before we proceed, it's probably a good idea to get a feel for the language used on Nature's Bounty's supplement packaging. According to the complaint, Nature's Bounty "uniformly represent on the front of every label of their products that their Vitamin E supplements will promote immune, heart and circulatory health ... each and every bottle of their Vitamin E supplements ... represent[s] that the Product 'Promotes' Immune Health, Heart Health and, Circulatory Health."

Note the words "will promote," please.

So what, specifically, was Dachauer's beef? The California resident claimed that the product violated California law because it did not prevent cardiovascular disease. More seriously, he claimed use of the product might lead to higher rates of mortality among users.

Distinction With a Difference

At the heart of the case is a distinction that Dachauer probably wishes he had not introduced to his suit: disease claims vs. structure claims (we'll try to make this painless for you).

When it comes to diet supplements, federal law draws a distinction between "structure/function" claims (an assertion that describes the role of a nutrient or dietary ingredient in a bodily function in humans) and a "disease claim"(a statement that the product or ingredient prevents, treats or cures a specific disease).

The Northern District of California, where the case was filed, agreed with Nature's Bounty's motion for summary judgment, noting that Dachauer had chosen to build his case the hard way.

"Common sense suggests that the claims on the vitamin E labels – claims that refer not just to heart, circulatory, and immune function, but to heart, circulatory, and immune health – imply a connection to disease. ..." The court also noted that Nature's Bounty's own evidence seemed to indicate that the specifics of the facts at hand meant that a "health" claim implied some sort of "disease outcome."

"Had Dachauer built a case around this theory, things might have gotten interesting," the court wrote. If the claims could be shown to be disease claims, California law might have been on Dachauer's side. "Instead, Dachauer is suing on the theory that the defendants' labels are false, or misleading based on their representations about structure or function," the court continued. "This makes for a more difficult burden ... a burden Dachauer can't meet."

The Takeaway

The Ninth Circuit upheld the district court's order on appeal. First, the appeals court ruled that the Federal Food, Drug, and Cosmetic Act (FDCA) pre-empted the California statutes under which Dachauer pursued his claim because both the FDCA and California law "have the same labeling requirements with respect to failing to disclose an increased risk of death."

Next, the appeals court held that, under the FDCA, Nature's Bounty's structure/function claims about vitamin E's promotion of cardiovascular health were not challenged by Dauchauer's evidence that the product did not prevent cardiovascular disease altogether.

"The FDA allows manufacturers of supplements to make general claims – such as 'promotes heart health' – and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body," the Ninth Circuit panel wrote. "Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease. ... Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it."

Finally, the court found that Dachauer lacked evidence that vitamin E caused actual harm to consumers, therefore failing to create "a genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading."

The lesson for advertisers here is not in the successful defense, based on the narrowness of the pleadings, but is in the court's dicta that there might have been actionable claims made in the advertising. As always, claims need to be carefully constructed, substantiated and checked for regulatory compliance.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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