Dietary Supplements

Echoing earlier comments submitted to the agency, CHPA and its member companies marketing dietary supplement products support the presumption of safety for dietary ingredients outlined in the 1994 passage of DSHEA.

We take this opportunity to voice our support of comments submitted by the Council for Responsible Nutrition (CRN) regarding the appropriate interpretation of the term “chemically altered” under Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act.

We take this opportunity to voice our support of comments submitted by the American Herbal Products Association regarding proposed revisions to the agency's Draft Guidance on New Dietary Ingredient Notification.

CHPA welcomes the opportunity to comment on the above captioned request published in the January 18, 2013 Federal Register.

The industry favors and supports the development of reasonable guidance. However, the agency’s attempt to redefine the NDI notification process contradicts the letter and spirit of DSHEA. The Draft Guidance would undo nearly two decades of agency practice and policy.

We encourage the FDA to continue to abide by its current guidance statement which indicates that there is no causal link between the intake of synthetic food colors and childhood hyperactivity.

CHPA comments in response to the notice announcing the proposed rule entitled “Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease.” These remarks specifically address our concern regarding Section VI. of the notice regarding enforcement discretion.