Cosmetic Safety Amendments

(Measure passed Senate, amended)

Cosmetic Safety Amendments - =Title I: Cosmetic Safety= - Sets forth procedures for the safety substantiation of cosmetics and cosmetic ingredients. Places the burden on manufacturers of throughly testing their products for safety prior to offering them to the public. Authorizes the Food and Drug Administration to require premarket submission of safety test data when it believes such submission would better protect the safety of consumers.

Empowers the Administration to require specific safety testing which it believes is necessary to set screening levels for toxicity and sensitization of cosmetics, and to designate ingredients or classes of cosmetics which it finds present a significant risk of injury.

Permits the Administration to prohibit ingredients, prescribe limits of tolerance, require additional labeling, or ban a cosmetic, if it finds that a product or ingredient presents a hazard.

Authorizes citizens' civil actions against any person who is alleged to be in violation of the safety substantiation provisions of this Act.

Includes as a prohibited act the maintenance or submission of any required data, information, or reports which contain false or misleading information.

Sets forth civil penalties of $10,000 for any person found to be in violation of the Federal Food, Drug, and Cosmetic Act. Increases the criminal penalty to $10,000 for a person who acts knowingly, willfully, without the care, skill, prudence and diligence that a prudent man acting in a like capacity would use, in violation of the Act.

=Title II: Registration and Compliance= - Requires every person who processes cosmetics to register with the Secretary of Health, Education, and Welfare each year by December 31. Requires in such registration: (1) a list of cosmetics processed; (2) the product classifications; (3) a list of ingredients used; (4) the name and place of business of the manufacturer, distributor, or guarantor; and (5) the hazards from accidental ingestion.

Provides trade secret status to all formula data submitted. Requires the filing of quarterly reports with the Secretary of Health, Education, and Welfare regarding adverse reactions to any product.

Authorizes inspections of all records, files, papers, processes, controls and facilities bearing on whether a product is adulterated. Provides for administrative detention of any product which an inspection officer has reason to believe is adulterated or misbranded.

=Title III: Cosmetic Labeling= - Provides that a cosmetic is misbranded unless its labeling lists all ingredients, except flavor and fragrance and incidental ingredients in alphabetical order.

=Title IV: General Provisions= - Requires the Secretary to establish a system, through poison control centers, to make accidental ingestion information available to the public.

Directs the Secretary to cooperate with the Small Business Administration regarding loans for small businesses to comply with the requirements of this Act.

Declares that the cosmetic labeling provisions of the Federal Food, Drug, and Cosmetic Act supercede State and local laws regarding labels or labeling of cosmetics.

Authorizes the establishment of advisory committees to assist in carrying out the provisions of this Act.