Lack of Authority Hampers Attempts To Increase Cosmetic Safety

HRD-78-139: Published: Aug 8, 1978. Publicly Released: Aug 8, 1978.

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Cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act which requires that a cosmetic be free of injurious substances and be produced under sanitary conditions. Many ingredients available for cosmetic use are suspected of causing cancer or birth defects or of having adverse effects on the nervous system.

In spite of the significant risk of injury to consumers, the Food and Drug Administration (FDA) does not have an effective program for regulating cosmetics. The act does not authorize FDA to require manufacturers to register their plants or products, file data on ingredients, file reports of cosmetic-related injuries, or test their products for safety. Also, exemptions in the act do not permit effective regulation of coal-tar hair dyes. FDA has not effectively used its existing authority. For example: (1) it has not inspected most manufacturers' plants or sampled products for compliance with the act; (2) it established regulations governing the use of only 11 ingredients used in cosmetics; (3) the safety of about 25 color additives has not been established; and (4) it had difficulty developing appropriate tests to be used by manufacturers in evaluating safety.

Recommendation for Executive Action

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Recommendation: FDA should: (1) require the listing of known allergens; (2) help to develop product standards; (3) define adequate substantiation of safety; (4) ensure childproof packaging of toxic cosmetics; (5) evaluate data from literature on cosmetic product safety; (6) evaluate restrictions of other countries; (7) establish an information system on cosmetic-related injuries and complaints; (8) establish regulations related to cosmetics containing drugs; (9) hasten the review of color additive safety; (10) evaluate safety data on coal tar hair dye ingredients; and (11) establish a more effective market surveillance program. Congress should amend the act to: (1) give FDA adequate authority for regulating cosmetic products; (2) authorize FDA to require cosmetic manufacturers to submit data to FDA supporting the effectiveness of preservatives used; and (3) repeal exemptions concerning coal-tar hair dyes. It should also authorize FDA to obtain access to cosmetic manufacturers' production and control records and to assess civil penalties for violations of the act.

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