Representative Leonard Lance (R-NJ) Introduces Industry-Supported Bill to Modernize Cosmetics RegulationApril 27, 2012
By Riëtte van Laack—
On April 18, 2012, Rep. Leonard Lance introduced the Cosmetic Safety Amendments Act of 2012, a bill (H.R.4395) “to establish new procedures and requirements for the registration of the cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes.” The bill would significantly increase FDA’s oversight of cosmetic products.
The proposed requirement for registration would apply only to manufacturing establishments that perform the final manufacturing of the cosmetic. Packers, distributors and facilities that perform part of the manufacturing but do not manufacture the final product need not register. Establishments that have registered voluntarily under 21 C.F.R. Part 710, are exempt from the registration requirement. FDA may suspend the registration if an establishment violates the FDC Act and the violation presents a significant risk of serious adverse health consequences or death to humans. Also, FDA may cancel the registration if, after a notice of cancellation, the establishment has not updated its registration. There is no requirement for registration fees.
The registered manufacturing establishments would be required to submit to FDA cosmetic and ingredient statements that contain the establishment registration numbers where the product is manufactured, the brand names of the cosmetic products, the cosmetic category for the cosmetic, the ingredients in the cosmetic products (in accordance with FDA regulations, 21 C.F.R. § 701.3), and information about the party responsible for submission of these statements. FDA, in turn, must assign a unique number to each cosmetic and ingredient statement. FDA also must establish and maintain a database containing these statements. As with the establishment registration, products for which the manufacturer already has submitted cosmetic and ingredient statements under 21 C.F.R. part 710, are exempt from this requirement.
The bill also adds a requirement that FDA establish regulations for mandatory Good Manufacturing Practice (GMP) for cosmetics. However, it does not provide a time line for this activity.
The bill aims to create formal processes, with specific timelines, for FDA to review ingredients for safety, set safety levels for trace impurities (called nonfunctional constituents), and review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. For example, FDA must publish a petition for review of a trace impurity in the Federal Register no later than 60 days after receipt of the petition, provide 180 days for public comment to the petition, publish a proposed rule or guidance within 180 days after the public comment period closes, keep the proposed rule or guidance open for public comments for 90 days, and publish a final rule or guidance another 90 days after closing of the comment period. Except under certain circumstances, industry gets time to implement or adapt to a regulation or guidance because the bill proposes that these new regulations or guidances go into effect two years after they have been issued.
With respect to post-market requirements, Rep. Lance’s bill includes a requirement for serious adverse event reporting. The provisions are similar to those for dietary supplement adverse event reporting. The bill specifies that a cosmetic label must include a phone number through which a serious adverse event may be reported.
In an effort to create national uniformity for cosmetics regulations, the bill would preempt state requirements that differ from those established at the federal level. Preemption, however, would not apply to pre-existing State requirements adopted by a State public initiative or referendum, presumably including California’s Proposition 65.
To fund FDA’s increased responsibilities, Rep. Lance included an appropriation provision authorizing almost 12 million dollars per fiscal year 2014 through 2018. This would cover the equivalent of 11 full-time positions, ten in the Office of Regulatory Affairs and one in the Office of Chief Counsel.
The bill has the support of the Personal Care Products.