CapsCanada
Wakunaga

Nature’s Bounty Wins in False Advertising Suit

by Nicholas Saraceno | January 28, 2019

According to JD Supra, the U.S. Court of Appeals for the Ninth Circuit recently affirmed a California district court’s grant of summary judgment for defendants NBTY, Inc. and Nature’s Bounty, Inc., based in New York. Plaintiff Paul Dachauer alleged that defendants’ vitamin E supplements violated California’s Unfair Competition Law, Cal. Bus. & Prof. Code § 17200 and Consumers Legal Remedies Act, Cal. Civ. Code § 1770 in that they claim to “support cardiovascular health” and “promote [] immune function,” “immune health,” and “circulatory health.”

The Food and Drug Administration (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 (65 Fed. Reg. at 1012). The Federal Food, Drug, and Cosmetic Act (FDCA) distinguishes between “disease claims” and “structure/function” claims that manufacturers make about their products. A structure/function claim describes “the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function” ((21 U.S.C. § 343(R)(6)). Conversely, a disease claim “claims to diagnose, mitigate, treat, cure, or prevent disease,” either explicitly or implicitly (21 C.F.R. § 101.93(G)(2)(II)).

The Ninth Circuit held that § 343-1(a)(5) of the FDCA preempts plaintiff’s state law claim that defendants’ advertising claims are false or misleading because their supplements do not prevent cardiovascular disease. Defendants did not claim that their supplements treat or prevent cardiovascular disease. The court also noted that by definition, defendants’ structure/function claims “do not” and “may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases” (21 U.S.C. § 343(r)(6)). Nevertheless, the plaintiff sought to require proof that the vitamin E supplements treat or prevent cardiovascular disease. The court found, however, that such a requirement is not identical to the requirement of § 343(r) and is therefore preempted under § 343(1)(a)(5) of the FDCA.

The Court also held that the FDCA preempted plaintiff’s state law claim that defendants’ labels stating that their supplements promote immune health, were false and misleading because the supplements failed to reduce all-cause mortality. The court found that plaintiff’s claim was preempted because manufacturers are not required to substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality (21 U.S.C. § 343(r)(6)).

Finally, the court also considered whether defendants’ claim that their supplements promoted immune health was false and misleading because the supplements allegedly increased the risk of all-cause mortality. The Court noted that this part of plaintiff’s claim was not preempted because the FDCA and California law both require disclosure of an increased risk of death. However, because plaintiff failed to offer evidence that vitamin E supplements were “actually harmful,” as opposed to “simply useless,” in promoting immune health, plaintiff failed to create a genuine issue of material fact as to whether the immune-health claim was misleading. As a result, the Ninth Circuit affirmed defendants’ summary judgment.

According to Matthew I. Kaplan, partner, Ohio-based Tucker Ellis LLP, this decision is of importance to both retailers and manufacturers.

“For retailers and manufacturers, the Dachauer case provides a clear defense to claims seeking to hold them to a different standard than the FDA for claims they make about their dietary supplements and improves the chances of getting out of a case at the early stages,” he noted. “The decision also reinforces the importance of having high-quality substantiation for supplement claims before they are made to both insure that they qualify as structure/function claims and to defeat cases in which a plaintiff tries to prove the structure/function claim is false.”

Robert M. Andalman, a lawyer with A&G Law LLC (Illinois) representing the defendants, stated that “Nature’s Bounty is very pleased with this important decision. In it, the Ninth Circuit confirms that companies like Nature’s Bounty, which sell great products that comply with all of the federal labeling requirements, should not and cannot be subjected to meritless state-law cases like this one.”

So what does this mean for similar cases moving forward?

“For future cases,” Kaplan explained, “dietary supplement manufacturers and retailers will have a much better chance of ending the lawsuits quickly. The broad preemption ruling coupled with the rule prohibiting private plaintiffs from suing on the grounds that a manufacturer lack [s] substantiation for claims made about a supplement means more cases will be resolved early, on a motion to dismiss. Even pending cases face the prospect of dismissal where the plaintiff tries to impose standards for advertising claims that are not identical to those of the FDA. As long as a supplement manufacturer is not making a disease claim about their products, makes only truthful and non-misleading statements and has substantiation for those statements, they should be protected from liability in false advertising cases.”

Stewart M. Weltman (Siprut PC in Illinois) representing Dachauer, refused to comment on pending litigation.

Don't Miss Out!

Sign up for Vitamin Retailer Digital Newsletter
Digital Newsletter
Subscribe to Vitamin Retailer Magazine
Vitamin Retailer Magazine

Industry Professionals
Stay Informed!

Stay informed about the latest health, nutrition, and wellness developments by signing up for a FREE subscription to Vitamin Retailer magazine and digital newsletter.

Once subscribed, you will receive industry insights, product trends, and important news directly to your doorstep and inbox.

Subscribe To Our Newsletter

Stay Informed! Breaking news, industry trends featured topics, and more.

Subscribe to our newsletter today!