Team Nexreg

Apr. 17 US: Safe Cosmetics and Personal Care Products Act of 2013 Mirrors Toxic Substances Control Act TSCA Proposals, Would Greatly Expand FDA Authority Over Cosmetics

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This article is brought to you by The National Law Review.

Representative Janice Schakowsky (D-IL), with fifteen co-sponsors, has introduced legislation in the House of Representatives to dramatically increase Food and Drug Administration (FDA) oversight of chemicals in cosmetics and other personal care products.[1] The Safe Cosmetics and Personal Care Products Act of 2013, H.R. 1385,[2] includes a number of provisions also included in the Safe Chemicals Act of 2013, S. 696, a bill to modernize the Toxic Substances Control Act (TSCA).[3] The bill would fundamentally transform the regulation of cosmetics and their ingredients. It expands on prior proposals in a number of respects.[4] The bill, introduced March 21, 2013, has been referred to the House Committee on Energy and Commerce and to the Committee on Education and the Workforce.

The bill would add a major new subchapter to the Federal Food, Drug, and Cosmetic Act (FFDCA) chapter on cosmetics.[5] This new subchapter would impose significant new obligations on FDA and on “brand owners,” the entities responsible for bringing a cosmetic to market, whether domestic or foreign establishments. Obligations would also be imposed on ingredient manufacturers and suppliers.

Some of the key provisions as follows:

Labeling

  • FDA currently requires cosmetic ingredients to be listed on a label, except that a flavor or fragrance may be listed as such, and trade secret ingredients may be listed as “other ingredients.” Incidental ingredients present at insignificant levels and without technical or functional effect do not have to be listed.[6]
  • The bill would require all ingredients to be listed by name. Contaminants would have to be listed if present at more than 1 part per billion (or lower in some circumstances).
  • Like the Safe Chemicals Act of 2013, there would be no trade secret protection for ingredient names. There would be trade secret protection for the concentration of cosmetic ingredients used in a finished cosmetic.
  • Nanomaterials would have to be identified as “nano-scale,” using standard of 1% of particles having at least 1 dimension of 100 nanometers or less.
  • Vendors of cosmetics sold over the Internet would have to include the ingredient list on their websites.

Reporting

  • A brand owner would have to submit to FDA “all data and information that the brand owner can access” regarding the safety of the cosmetic and of its ingredients. The required information would span a wide range of chemical identity, hazard, risk, and use information. The information would have to be updated annually or within 60 days of receiving information on adverse effects suspected to be caused by an ingredient or a cosmetic.
  • If a brand owner were to request that a supplier or manufacturer of an ingredient provide any of the information required to be submitted to FDA, the supplier or manufacturer would have to provide it to the brand owner within 90 days of the request.
  • A provision would be added for mandatory reporting by brand owners of any serious adverse event associated with the use of a brand owner’s cosmetic, similar to FDA’s current reporting requirements for drugs and medical devices.
  • FDA would have to maintain a database of all non-confidential information received under the above requirements.
  • Brand owners would have to submit to FDA a cosmetic and ingredient statement providing product use and ingredient information and any warnings and directions for use from the cosmetic label or insert. Failure to submit this statement would render all cosmetics sold by the brand owner misbranded.
  • As under the Safe Chemicals Act of 2013, chemical identity could not be claimed confidential business information.

For more information, the full review of the legislation and more key provisions please refer to the link above.