Protein Claims: Where FDA Compliance Meets Class Action Risk

Walk down any grocery aisle, and you’ll see it: protein is everywhere. Consumers are looking to up their protein intake, and food and beverage manufacturers are looking to supply products that fulfill that demand. But as high protein products gain popularity, so too have protein claims drawn the attention of plaintiffs’ attorneys. Thus, when manufacturers are looking to advertise their products by reference to their protein content, they must first carefully evaluate both their compliance with FDA regulations and the likelihood that consumers might find protein claims to be misleading. 

Under the Food, Drug and Cosmetic Act (FDCA), food and beverage manufacturers are required to state the number of grams of protein per serving in each product’s Nutrition Facts Panel (“NFP”). See 21 C.F.R. § 101.9(c)(7). Manufacturers are expressly permitted to use a method of calculating a product’s protein content that is based on nitrogen content. Nitrogen may be present due to factors other than protein, leading to a rise in lawsuits regarding alleged “protein spiking” or “nitrogen spiking”—artificially inflating protein calculations by incorporating other high nitrogen ingredients. However, because a nitrogen-based calculation is expressly allowed by the FDA, courts have dismissed putative class actions for state law claims based on such allegations as preempted by federal law. 

But where a product features a “protein claim”—which could be something as simple as stating the number of grams of protein per serving on the product’s front label—the FDCA requires something further: manufacturers must include a quality-adjusted percent daily value figure in the product’s NFP, measured using a “protein digestibility-corrected amino acid score.” See 21 C.F.R. § 101.9(c)(7)(i)-(iii). This measure is considered to better reflect the quantity of protein in a product that is actually usable by the human body. 

Thus, manufacturers that advertise the protein content of their products but fail to include a quality-adjusted percent daily value leave themselves open to not just regulatory scrutiny, but also litigation risk. Courts have consistently held that front-label protein claims on products without a quality-adjusted value in the NFP could plausibly be false or misleading, and that state law causes of action based on such claims are not preempted by federal law. On the other hand, manufacturers who face false advertising claims for representations about the amount of protein in products that do have a quality-adjusted percent daily value are likely to be able to assert a strong preemption defense. 

But even where manufacturers include a quality-adjusted percent daily value on the NFP, they must also be cautious about the types of protein claims made on a product’s packaging. For example, front-label claims about the source of protein are less likely to be preempted. For example, courts have allowed cases to move forward where labels implied that all the product’s protein came from “whey” or a “premium” blend of protein sources, when the product allegedly relied partly on cheaper free-form amino acids. 

On the other hand, courts have generally tossed challenges to phrases like “protein-packed” or “a powerful nutrition boost” as puffery or as unlikely to mislead, especially where the actual grams of protein were clearly disclosed. Just remember that regulated terms like “high”, “rich” or “excellent source” carry specific FDA requirements.

As demand for protein-rich products continues to grow, so will scrutiny of how protein is marketed. Manufacturers that pair accurate, FDA-compliant labeling with careful review of front-label claims will be best positioned to capitalize on the protein trend while minimizing litigation risk.