As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075).
Overall, the proposed legislation would amend the Federal Food, Drug, and Cosmetic Act with respect to FDA’s regulation of cosmetics by creating new requirements such as the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each marketed cosmetic. It also would require cosmetic manufacturers, packers, and distributors to report to FDA any serious and unexpected adverse events caused by a cosmetic product. Likewise, cosmetic labels would be required to include contact information for consumers to report such events to the manufacturer or distributor.
Below, we break down in detail pertinent sections of the Sessions bill, as it was introduced in the previous Congress (although reports indicate that the reintroduced version has not been altered significantly).
Section 605 would require every domestic and foreign manufacturer intending to sell a cosmetic in the U.S., and not exempt under another part of the proposed bill, to register with FDA within 60 business days after the first commercial sale of a cosmetic in the U.S. Registration would only be required for the final establishment the manufacturing process. FDA would then issue a “unique cosmetic establishment registration number,” and that number would be added to publicly available electronic list of registered establishments.
Section 606 would require every domestic and foreign manufacturer intending to sell a cosmetic in the U.S., and not otherwise exempt, to submit a “cosmetic and ingredient statement” within 60 business days after the first commercial sale of a cosmetic in the U.S. The statement would need to include the manufacturing facility’s unique cosmetic establishment registration number and the product’s brand name, applicable cosmetic category, and ingredients (including flavors and fragrances), as well as contact information for the person handling the statement’s preparation and submission. FDA would be mandated to compile and maintain an up-to-date and publicly available electronic list of submitted cosmetics and ingredients.
Section 607 would require any domestic or foreign manufacturer, packer, or distributor whose name appears on a cosmetic label to submit to FDA adverse event reports no later than 15 business days after the event is first reported to the place of business identified on the label (analogous to what is currently required for drugs and dietary supplements). The bill specifies that a submission of a serious and unexpected adverse event report “shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event; and may be accompanied by a statement that denies that the report constitutes an admission that the cosmetic involved caused or contributed to the adverse event.”
Section 608 would allow FDA to establish “principles and standards for good manufacturing practice for the manufacture of cosmetics.” Interesting, the bill states that a cosmetic manufacturer would not be responsible for the good manufacturing practice of its suppliers. This carve-out of responsibility for ensuring downstream members of your supply chain are in compliance with GMPs may be subject to change, as the trend in pharmaceutical and food manufacturing has been towards imposing greater obligations on finished product manufacturers to oversee the quality of all incoming ingredients and product components.
Section 609 would create a list of safe ingredients for manufacturers and distributors to substantiate the safety of their cosmetic products. The list ranges from color additives to fragrance ingredients previous recognized as generally safe by various authorities.
Section 610 would establish a “National Cosmetic Regulatory Databank” within FDA to contain information submitted to the Agency under other sections of the bill, and other pertinent information.
Representative Sessions’s bill stands in contrast to the Personal Care Products Safety Act, cosponsored by Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME). We wrote about the PCPA when it was first introduced in May 2015, and more recently in October 2016.
While both bills give FDA a greater ability to ensure cosmetic product safety in the marketplace, Collins and Feinstein’s bill would allow FDA to collect annual user fees from companies, unless they have an average gross annual sale of less than $500,000 for the three-year period preceding the fee collection for a specific fiscal year. And although both bills call for manufacturer registration with FDA, compliance with GMPs, and the submission of ingredient statements, Collins and Feinstein’s bill would require FDA to review at least five cosmetic ingredients for safety every year. It also would create new authority for FDA to order mandatory recalls of unsafe cosmetic products. Moreover, there is a discrepancy between the two bills when it comes to the proposed definition of a “cosmetic.” The Sessions bill provides for a definition that would incorporate topical products that are able to temporarily alter the structure and function of human skin – thus expanding the existing Federal definition of a “cosmetic” – whereas the Collins and Feinstein bill makes no change to the current statutory definition, such that such topical treatments would continue to be treated as “drugs” by FDA based on their claimed effects on structure and function.
Finally, the bills also differ in terms of industry support. Without any mention of industry user fees, the Sessions bill is backed by smaller cosmetics companies, mainly represented by the Independent Cosmetic Manufacturers and Distributors (ICMD). On the other hand, Collins and Feinstein’s bill is backed by heavyweights such as the American Cancer Society, Johnson & Johnson, Procter & Gamble, Revlon, Estee Lauder, and L’Oréal. The Personal Care Products Council (PCPC), the trade association representing most of these national brands, issued a statement on January 18 in support of bipartisan reforms to the current cosmetics framework, but it did not call out any single piece of legislation by name. PCPC has previously said that Federal preemption language in any new cosmetics law would be critical in order to garner the association’s support.
We will be keeping track of both these bills and the progress of cosmetics reform negotiations during the 115th Congress.