CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.
FDA issued a proposed rule on labeling requirements for OTC human drugs. The announcement proposed a definition for “convenience-size” OTC drug packages as well as the option of alternative labeling requirements for these products. CHPA welcomes the opportunity to comment on the proposed rule changes.
CHPA Dietary Supplements Committee members fully support the proposed changes to the labeling requirements for health claims regarding calcium and osteoporosis. These proposed changes amend the regulation authorizing health claims on the relationship between calcium and a reduced risk of osteoporosis.
The PCPC and CHPA are pleased to provide these comments in response to FDA's proposed amendment to the final monograph for OTC sunscreen drug products for human use.
Request for extension of comment period regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs.
The Consumer Healthcare Products Association welcomes the opportunity to present its recommendations for CFSAN’s top priorities for the upcoming fiscal year and congratulates FDA on its achievements of the previous year.