National Program Uniformity

Preempt state and local laws that would duplicate new authorities in the FDA regulation of cosmetics; preempt state and local laws for all cosmetic ingredients based on human health concerns if the FDA has reviewed the ingredient’s safety or has been presented with a safety review of the ingredient by the Expert Panel for Cosmetic Ingredient Safety and, after a period for the FDA review, has not rejected the Expert Panel’s safety finding.

Mandatory Registration

Establish mandatory foreign and domestic manufacturing establishment registration and ingredient reporting by manufacturers for all cosmetic products sold in the United States

Adverse Event Reporting

Require mandatory reporting by manufacturers to the FDA of serious and unexpected adverse health events experienced by a consumer from a cosmetic product marketed and used in the U.S.

Good Manufacturing Practices

Authorize the FDA to issue Good Manufacturing Practices for cosmetics products

Mandatory Recall

Provide the FDA authority to order a mandatory recall of a product if a manufacturer refuses to comply with a FDA request for a voluntary recall in which the FDA has a reasonable belief that the product is adulterated or otherwise is likely to cause serious adverse health consequences

FDA Cosmetic Ingredient Review

Create a FDA program authorized to review the safety of individual cosmetic ingredients and nonfunctional constituents found in cosmetics in a timely manner and utilizing widely accepted scientific principles such as those reflected in the scientific reviews by the Expert Panel and other scientifically based organizations

Cosmetic Records Inspection: Allow the FDA to inspect a manufacturer’s records if the FDA has a reasonable belief that a cosmetic product presents a threat of serious adverse health consequences to humans

Safety Substantiation

Require manufacturers to substantiate the safety of cosmetic products and ingredients, utilizing widely accepted scientific principles and established scientific ingredient reviews such as the Expert Panel’s Cosmetic Ingredient Review. Manufacturers may choose which FDA-accepted data to use.

Special Provisions for Small Businesses

Allow flexibility for small businesses, as defined by the Small Business Administration, to comply with certain requirements, including additional time to submit ingredient statements to the FDA, simplified ingredient statements, additional FDA guidance on safety substantiation, and extended effective date for GMP compliance. Very small cosmetic manufacturers (those making less than $2 million in gross receipts annually in the U.S.) would be entirely exempted from any new requirements.

OTC and Cosmetic Regulation

Clarify that when a product falls under the FDA’s cosmetic and over-the-counter (OTC) drug authorities and the requirements conflict, the OTC drug requirements will apply. Members can click here to access the OTC Reform Webinar Recording.

Alternatives to Animal Testing

Encourage FDA approval of alternatives to animal testing

Importation

Bar importation of cosmetics produced outside the U.S. where the manufacturing facility or ingredient statement has not been registered with the FDA