Key areas of focus at the Dietary Supplements Regulatory Summit included:
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FDA Priorities
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Remote Regulatory Assessments
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Drug Preclusion Provision
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FDA’s Process Used to Make a Section 201(ff)(3)(B) Ingredient Determination
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Hot Topics in Dietary Supplements Class Action Activity
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A Standardized Approach to Adverse Event Data
Labeling & Claims Lawsuit Trends
Product labeling and claims were at hot topic at the summit. Rend Al-Mondhiry, Partner, Amin Talati Wasserman LLP, spoke OF legal actions. “Our firm is either helping clients in the food and supplement space try to avoid this risk, or we’re helping them respond to threatened or filed suits regarding allegedly misleading claims,” Al-Mondhiry told attendees. “It’s become the cost of doing business for these industries, and one of the main reasons our firm opened up an office in California…which is where most of these suits originate. Most of what we see in the class action realm, whether it’s a filed or threatened suit, are actions where consumers alleged they were deceived by false or misleading claims."Al-Mondhiry discussed common themes in cases that are increasing across the supplement space. And while the courts have typically sided with the defendant or supplement company, she said, she urged caution, and advised attendees to be increasingly aware of current trends and case precedents in the space.
1) False & Deceptive Labeling
There has been a rise in cases related FD&C Act compliance. Allegations are primarily tied to state law and regulation. Even where labeling or the product is compliant, Al-Mondhiry said, claims may still be misleading. Due to this, noncompliance doesn’t mean the case will succeed. It is fact- and context-specific, she explained.2) Structure/Function Claims
Al-Mondhiry presented case examples, includingGreenberg v. Target Corp., (9th Cir. 2021)targeting a biotin supplement with the claim “helps support healthy hair and skin.” Greenberg filed a putative class action under California’s Unfair Competition Law, alleging that most people do not benefit from biotin supplementation, making the labels deceptive. The panel affirmed summary judgment in favor of the manufacturer and distributors. There is substantiation that biotin “helps support healthy hair and skin," so that statement was truthful, not misleading, and is a permissible structure/function claim.Al-Mondhiry summed up the outcome: “Simply put, manufacturers may make structure/function claims about a nutrient’s general role on the human body without disclosing whether the product will provide a health benefit to each consumer."
