In draft guidance published this month, the agency outlines substantiation requirements for infant formula structure/function claims, such as supports immunity and digestion.
While the draft guidance is tailored specifically for claims about infant formula, the main take-away points have broader implications for all conventional food, Ricardo Carvajal, a food and drug lawyer with Hyman, Phelps & McNamara notes on his firm’s blog.
Indeed, before digging into the specific requirements for infant formula claims, FDA first explains how marketers can use structure/function claims for all conventional foods and how they differ from those made about dietary supplements.
The primary difference between the types of structure/function claims allowed for food versus dietary supplements is that for food the claims must relate primarily to the product’s taste, aroma and nutritive value. This is much narrower than the use of the claims for dietary supplements, which may also relate to non-nutritive effects on the structure or function of the body, as well as to nutritive effects, according to the draft guidance.
FDA explains in the draft guidance that the broader application to dietary supplements is due to a carve out under the Dietary Supplement Health and Education Act.
Structure/function claims for conventional food that veer away from “the product’s character as a food,” could be interpreted by the agency as a drug claim, causing the food to be misbranded, FDA notes in the draft guidance.
While the application of structure/function claims to food and supplements may be different, the recommendation to provide “competent and reliable scientific evidence,” is the same, according to the draft guidance.
“Although there is no general rule for how many studies or what combination of study types are sufficient to substantiate a structure/function claim, the replication of research results in independent, well-conducted studies make it more likely that the totality of the scientific evidence will substantiate the claim,” FDA notes.
In the context of infant formulas, the agency explains this means “evidence that includes findings from well-designed and controlled intervention studies in an appropriate population of US infants … using an appropriate formula matrix with and without the constituent of interest.”
As in other cases, FDA also prefers randomized, controlled, double-blind intervention studies that can show cause-and-effect. However, the agency acknowledges that observational studies and research synthesis studies can be useful, even if they cannot determine a causal relationship.
That said the agency urges companies not to rely on studies that examine a different target population, do not have recognized and appropriate endpoints, lack statistical power, do not adequately protect subjects or do not have an appropriate intervention or control group, according to the draft guidance.
Manufacturers and marketers also must examine all the applicable research, and not just cherry pick studies that support the claims they want to make, FDA says in the guidance.
The agency will accept comments on the draft guidance and recommendations through Nov. 8.