Quality

The following comments represent a consolidated set of comments from organizations that have decided to form an Industry Coalition for Rational Implementation of USP <467> to express industry’s concerns with FDA’s implementation of <467>.

The Structured Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".

The members of the Consumer Healthcare Products Association appreciate the opportunity to provide comments on the interim final rule on the petition to request an exemption from 100 percent identity testing for dietary ingredients.

Letter to Dr. Williams regarding "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

The Industry Coalition on 21 CFR Part 11 is pleased to submit the attached Citizen Petition to FDA for consideration. The Coalition comprises 13 trade associations representing manufacturers of products including foods, drugs, cosmetics, veterinary drugs, and medical devices.

We would like to add our voice to the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutrition Foods Association in supporting the joint industry submission.

CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.

The Coalition is pleased that FDA has issued guidance that takes a risk-based approach to compliance. We strongly support this approach as a more realistic and effective way to protect public health.

Oral testimony of the Consumer Healthcare Products Association to the White House Commission on Complementary and Alternative Medicine Policy.