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

Massachusetts District Dourt Judge George O’Toole rendered a summary judgement in favor of Vitamin Shoppe, Inc. The putative class action had alleged that the supplement retailer had oversold the benefits of a creatine-glutamine sports nutrition product.

Plaintiffs alleged dosage couldn’t provide claimed benefits

The original case was filed on March 21, 2017, and the demand, according to court documents, was $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 regulating 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 claims to FDA 30 days before putting a product on the market. The claims must conform to federal regulation 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 had no standing to challenge the claims as DHSEA, a portion fo the federal Food Drug & Cosmetic Act, takes precedence.  The plaintiffs had further alleged that the Vitamin Shoppe product did not contain enough glutamine in it to have the claimed effects, but O’Toole ruled that the structure/function claims regulation pertains to the function of an ingredient, not the makeup of specific products.

Attorney: Firms don’t have to prove 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 great decision for the industry and follows last year’s dismissal by the Ninth Circuit of the class action against hair, skin and nails dietary supplements containing biotin.  If the claim is a structure/function claim, is narrowly tailored to that specific nutrient, and the company has substantiation on the role the nutrient plays in that bodily structure or function, these courts are saying the claim is allowed for supplements under the FFDCA without having to prove the health benefits of taking the supplement,”​ Jennifer Adams, a partner at the law firm Amin Talati Wasserman, told NutraIngredients-USA.​

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

“​While companies should rejoice that that this may discourage some new class action filings, they should not take this as meaning they do not need to have substantiation for all express and implied structure/function and other 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 actions in other circuits.  Even the FDA, which has a not-often-used authority to challenge any false or misleading claims on product labels, could get into the act,”​ she added.

Daniel Fabricant, PhD, president and CEO of the Natural Products Association, also welcomed the news. NPA has focused recently on forestalling legal threats to the supplement industry arising out of state jurisdictions.

“We are always happy to see the precedence of federal law upheld. We want one competent authority regulating the industry —FDA,” ​he said.

CRN: Private state enforcement harms consumers

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

“​CRN is pleased the court recognized the importance of federal preemption to ensure a national uniform standard in supplement labeling and substantiation. While we are concerned about the court’s critical position on supplement substantiation, Congress’ carefully crafted federal standard for structure function claims does adequately protect consumers by expanding the scope of truthful information provided to consumers about a nutrient,”​ she said. 

“The key here is that claims about a nutrient must be truthful — a standard that is met when a company possess a reasonable scientific basis for the claimed role of a nutrient.  Here the defendant and court both agreed that the scientific evidence shows that glutamine helps support muscle growth.  Where a company truthfully apprises a consumer of the role of a nutrient and provides a source of that nutrient, the company has met the well-reasoned requirements of federal substantiation law. This standard was correctly recognized by the Ninth Circuit in ​Greenberg v. Target Corp, a case that the Massachusetts court has relied on here and a case in which CRN participated through an amicus brief apprising that court of the importance and purpose of Congress’ federal substantiation regime,”​ she added.

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