Claims & Labeling: 5 Key Takeaways from the Dietary Supplements Regulatory Summit

The Dietary Supplements Regulatory Summit hosted briefings from FDA and industry experts. Here, a legal update on labeling and claims.

Courtesy of CHPA
Courtesy of CHPA

Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and Drug Administration (FDA), toxicologists in the field, legal professionals, and more. Speakers dissected trends in the nutritional supplements market and educated on pressing issues for industry members, including FDA news, legal cases, and resources.

Key areas of focus at the Dietary Supplements Regulatory Summit included:

  • FDA Priorities
  • Remote Regulatory Assessments
  • Drug Preclusion Provision
  • FDA’s Process Used to Make a Section 201(ff)(3)(B) Ingredient Determination
  • Hot Topics in Dietary Supplements Class Action Activity
  • 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, including Greenberg 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.”

3) “Natural” Claims

Another trend to be aware of: Legal suits over “natural” claims. Use of the claim “natural” in marketing and advertising has been deemed false, deceptive, and misleading because products allegedly contained non-natural, synthetic ingredients (Orrico v. Nordic Naturals (E.D. N.Y. 2022). Other undefined terms can be a target such as “clean” and “pure.”

4) “Green” Claims

There also has been an increase in environmental claims in recent years. These lawsuits have typically been filed by consumers and non-profits. For example, Greenpeace, Inc. v. Walmart Inc. (N.D. Cal. Jan. 2021). According to FTC Green Guides, marketers should avoid unqualified general environmental benefit claims. Avoid broad claims with a range of meanings. This messaging may convey that the product has no negative environmental impact, and such claims should be avoide. Al-Mondhiry noted that the general thinking is that it is highly unlikely that marketers can substantiate all reasonable interpretations of these claims.

5) DSHEA Disclaimer Placement

There have been attacks on the placement of DSHEA disclaimer (for example in Barnes v. Iovate Health Sciences U.S.A. Inc. (N.D. Cal. June 2021). This described an allegation that products were misbranded, unlawful supplements, and/or unapproved drugs. There has been an increase in citing noncompliance with 21 CFR 101:93 (d): “the disclaimer shall appear on each panel or page where there such is a statement.”

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