This contain too much bad stuffA tweet last week from Project Nosh set my food-labeling-lawyer-head buzzing: “Consumers are looking for snacks that aren’t just empty calories. Brands are providing everything from protein to anti-nausea properties.” An anti-nausea claim on a food label – can they say that?

As consumers more fully embrace the idea of food as medicine, and food companies jump to respond, food companies will find themselves asking that question, often stumbling through the fog of the Food and Drug Administration’s (FDA) labeling-claims regulations in their efforts to market their products. Food companies that want to tout the health benefits of their products should take care to ensure that their claims do not get them into hot water, legally speaking.

One category of labeling claims causes the most confusion—called structure/function claims—and is where that anti-nausea claim may fall.[1] The FDA explains that structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims.”

Basically, the FDA is saying “you can talk about ways your food supports health, but don’t make claims that would make your product a drug.” But, of course, what constitutes a drug claim isn’t always clear either. The FDA has provided ten criteria in a guidance document to help food companies determine whether a particular statement is a structure/function claim or a drug claim.

Basically, the FDA is saying “you can talk about ways your food supports health, but don’t make claims that would make your product a drug.”

Some criteria are more obvious—e.g., a statement that mentions a specific disease or class of diseases (e.g., “protective against the development of cancer”). On the other hand, some are less clear—e.g., a statement that “claims an effect on a condition associated with a natural state or process” (e.g., “helps with mild mood changes and cramps associated with the menstrual cycle” versus “helps with severe depression associated with the menstrual cycle”). Additionally, a claim doesn’t have to mention a disease explicitly; pictures, vignettes, and other implications can cause a statement to be characterized as a drug claim.

Further complicating things is the application of different requirements based on whether the product is a conventional food or a dietary supplement. Structure/function claims on conventional foods are limited to statements about the product’s “nutritive value,” while structure/function claims on dietary supplements can additionally focus on a product’s non-nutritive benefits.

Dietary supplements carrying structure/function claims must add a disclaimer that the claims have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease, while structure/function claims on conventional food are not required to bear the disclaimer. Structure/function claims on dietary supplements must be submitted to the FDA 30-days after first marketing the product, whereas conventional foods can use structure/function claims without notifying the FDA. Finally, of course, all structure/function claims require substantiation – that is, both food and supplement companies must be able to show the FDA that the claims made on the label are true based on “competent and reliable scientific evidence.”

Dietary supplements carrying structure/function claims must add a disclaimer that the claims have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease, while structure/function claims on conventional food are not required to bear the disclaimer.

Back to Project Nosh’s tweet: most of the claims food companies want to make about the health benefits of their products will fall into the structure/function category. It behooves food companies to carefully consider any claims they’d like to make on their product labels that might fall into the structure/function category of claims. The “anti-nausea properties” mentioned in Project Nosh’s tweet, if on a label, might make the FDA characterize the food product a drug. However, without more information about the product and the claim, it is difficult to know for sure. After all this thinking about structure/function claims, my head is spinning. Do they have a food for that?

[1] The other two categories are nutrient content claims and health claims. “Nutrient content claims” are claims that expressly or impliedly characterize the level of a particular nutrient in the food product (think “low fat,” “high in fiber,” “sugar-free,” and “healthy”). Note that the characterization of the term “healthy” can be a bit more nuanced. “Health claims” are claims that are pre-approved by the FDA that link a nutrient to a disease or health-related condition (for example, “adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis”).