Dietary Supplements

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 The Draft Guidance would undo nearly two decades of agency practice and policy.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.

In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.

CHPA appreciates the opportunity to nominate candidates to serve as the nonvoting industry representative for the FDA Center for Food Safety and Applied Nutrition (CFSAN) Food Advisory Committee.

As noted in our prior comments, CHPA does not believe that the Beneficial Nutrients Regulatory Concept is necessary or supportive of the intent of the Safe Drinking Water and Toxic Enforcement Act of 1986.