These comments are submitted on behalf of CRN and CHPA in response to the FDA Notice and Request for Comments on the implementation of section 301(ll) of the Federal Food, Drug, and Cosmetic Act.
The Structured Product Labeling OTC sub-team appreciates the opportunity to comment on the collection of information pertaining to the July 2008 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing.
The undersigned trade associations are writing to request that the Commission exercise enforcement discretion with respect to the new general conformity certification requirement imposed by the Consumer Product Safety Improvement Act of 2008 (CSPIA).
The Consumer Healthcare Products Association, Council for Responsible Nutrition, and Natural Products Association submit this response to the request for relevant information on the developmental and reproductive toxicity of caffeine.
Comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of ten drug substances.
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Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".
On May 7, 2008, CHPA received correspondence from the United States Food and Drug Administration (FDA) requesting safety data for over-the-counter (OTC) mouth rinse products containing cetylpyridinium chloride (CPC).
