Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.
CHPA recognizes the need for modernization of USP monographs. CHPA member companies are dedicated to fulfilling their commitment outlined in the letter to this Planning Committee on February 2, 2011.
CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.
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.
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.