District court ruling reaffirms precedence of federal law over structure/function claims

Dourt District of Massachusetts Judge George O’Toole granted summary judgment in favor of Vitamin Shoppe, Inc. The alleged class action lawsuit alleged that the supplement retailer oversold the benefits of a sports nutrition product to creatine-glutamine base.

Claimants’ alleged dosage could not provide claimed benefits

The original case was filed on March 21, 2017, and the claim, according to court documents, was for $5 million. It was filed by two plaintiffs named Richard Ferrari and William Bohr.

The plaintiffs had linked their challenge to three claims on the Vitamin Shoppe product related to the ingredient glutamine, an amino acid. They were that glutamine “has been shown to possess anti-catabolic properties to help preserve muscle”, “helps support muscle growth and recovery as well as immune health”, and that it “is involved in the regulation of protein synthesis”.

By law, a structure/function claim must relate to the action of an ingredient to affect a structure in the body or to affect a bodily function. Companies are required to submit such complaints to the FDA 30 days before bringing a product to market. Claims must comply with federal regulations in terms of not making a disease treatment claim, and companies are required to have scientific substantiation for making the claim.

O’Toole ruled that the plaintiffs lacked standing to contest the claims because DHSEA, part of the federal drug and cosmetic law, takes precedence. The plaintiffs had further alleged that the Vitamin Shoppe product did not contain enough glutamine to have the claimed effects, but O’Toole ruled that the structure/function claim settlement related to an ingredient’s function, and not to the composition of specific products.

Avocado: companies don’t have to prove the benefit of taking a specific product

Industry stakeholders were quick to cite the welcome precedent offered by O’Toole’s ruling.

“This is clearly another big move for the industry and follows last year’s dismissal by the Ninth Circuit of the Hair, Skin and Nails Class Action Lawsuit of dietary supplements containing biotin. If the claim is a structure/function claim, is closely tailored to that specific nutrient, and the company has evidence of the role the nutrient plays in that body structure or function, these courts say the claim is allowed. for supplements under the FFDCA without having to prove the health benefits of taking the supplement,”Jennifer Adams, partner at law firm Amin Talati Wasserman, said NutraIngredients-USA.

But Adams warned that the decision was narrow in nature and does not provide a blank check so to speak for companies putting claims on the labels.

While companies should welcome that this may discourage some new class action filings, they should not take this to mean that they do not need to have justification for all express and implied structures/functions and the like. claims for their products – which is required if challenged by the Federal Trade Commission, by a State Attorney General, by the NAD, or even perhaps by class action lawsuits in other circuits. Even the FDA, which has little-used authority to challenge any false or misleading claims on product labels, could get in on the act,”she added.

Daniel Fabricator, PhD, president and CEO of the Natural Products Association, also welcomed the news. The NPA has recently focused on preventing legal threats against the supplement industry arising from state jurisdictions.

“We are always happy to see the precedence of federal law confirmed. We want a competent authority regulating the industry – the FDA”, he said.

CRN: Private State Enforcement Harms Consumers

Megan Olsen, senior vice president and general counsel for the Council for Responsible Nutrition, said the case was a significant win for the industry. But that comes with a small caveat in that O’Toole’s decision seemed to imply criticism of a regulatory regime that doesn’t ensure effective doses of ingredients are used in products.

CRN is pleased that the court recognized the importance of federal preemption in ensuring a uniform national standard in supplement labeling and justification. While we are concerned about the court’s critical stance on supplement justification, Congress’s carefully crafted Federal Standard for Structure Function Claims adequately protects consumers by expanding the scope of truthful information provided to consumers about a nutrient,”she says.

“The key here is that claims about a nutrient must be truthful – a standard that is met when a company has a reasonable scientific basis for a nutrient’s claimed role. Here, the defendant and the court both agreed that scientific evidence shows that glutamine helps support muscle growth.When a company honestly informs a consumer of the role of a nutrient and provides a source of that nutrient, the company has met the well-reasoned requirements of the federal law on This standard has been properly recognized by the Ninth Circuit in ​Greenberg v Target Corpa case relied upon by the Massachusetts court here and a case in which CRN participated through an amicus brief informing this court of the importance and purpose of the federal Congressional justification regime »,she added.

“CRN has long advocated that fact-specific nutrient substantiation issues be considered under the single federal regulatory regime, and state law standards that allow private plaintiffs to usurp this federal standard harm consumers by limiting access to important nutritional information”, Olsen concluded.

Ida M. Morgan