CRN Challenges FDA’s Take on Synthetic Ingredients in NDI Evaluations

June 30, 2011

CRN expressed concern over instances in which the agency has rejected NDI notifications, stating that synthetic ingredients cannot qualify as dietary ingredients.

In a letter to FDA yesterday, the Council for Responsible Nutrition (CRN; Washington, DC) expressed concern over instances in which the agency has rejected new dietary ingredient (NDI) notifications based on the stance that synthetic ingredients cannot qualify as dietary ingredients.

Specifically, the association argues that this “narrow interpretation” of synthetic ingredients may adversely affect product innovation as well as resulting consumer access to beneficial ingredients.

Earlier this year, FDA rejected an NDI notification from Ovos Natural Health for a synthetic homotaurine ingredient, stating that synthetic ingredients cannot be dietary ingredients if they have not been historically marketed as dietary ingredients prior to the enactment of the Dietary Supplement Health and Education Act of 1994 (DHSEA). In its letter, CRN points out this case as well as a similar situation with an NDI response FDA sent regarding conjugated linoleic acid (CLA).

However, the letter’s author, Douglas MacKay, vice president of scientific and regulatory affairs for CRN, argues that no regulations in 201(ff)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FDCA) bars synthetic ingredients. MacKay also calls FDA’s responses in the CLA and homotaurine cases “erroneous.” He states that FDA wrongly applied the historical-use limitation that synthetic ingredients not historically proven to be part of the diet prior to 1994 cannot qualify as dietary ingredients-a position that CRN says the current laws do not support.

“The cases above illustrate that FDA has taken an incorrect and unduly restrictive approach to determining what constitutes a dietary supplement,” MacKay wrote.

“Imagine that future research shows that a minor constituent of a particular fruit, e.g., a banana, has demonstrable beneficial effects on the structure or function of the body, but it is impractical, infeasible, or worse-environmentally detrimental or unsustainable-to extract this component from its natural source on a commercial scale,” MacKay continued. “Under the analysis FDA applied regarding synthetic CLA and homotaurine, the agency would not accept a nature-identical synthetic version of this newly identified component as a dietary ingredient absent evidence that the synthetic version was a historical component in the human diet. The end result would be either denying consumers access to an ingredient shown to be beneficial to human health or forcing the production of such an ingredient in an environmentally irresponsible manner. Neither of these results makes for product policy, and neither is what Congress intended.”