Efforts to update FDA’s personal care products regulations continue as Rep. Jan Schakowsky (D-IL) recently introduced H.R. 6903, the “Safe Cosmetics and Personal Care Products Act of 2018.” The measure, which would increase FDA’s regulation of the cosmetics industry, is the latest reform bill of its kind to be introduced in Congress in recent years.
In her introductory statement, Rep. Schakowsky expressed concern that cosmetics are one of the “least regulated” consumer products on the market given their significant presence in the marketplace and the resulting consumer exposure to potentially unsafe chemicals.
The new bill would impose a variety of new compliance costs on cosmetics companies and would be an added burden on small manufacturers, who generally have limited resources available to expand compliance activities.
Major provisions of the legislation include the following:
- Annual establishment registration for “brand owners” (i.e., the party responsible for bringing the cosmetic to market) - companies with sales of $10 million annually would be required to pay an annual registration fee;
- Provide a list of marketed products to FDA along with available product safety information, including, in part, functions and uses, toxicity, exposure data, etc.;
- Establish guidance covering good manufacturing practices (GMPs) for cosmetics; Require adverse event reporting for serious adverse events involving cosmetics; and
- Ban the use of the following toxic ingredients: Benzophenones (benzophenone, benzophenone-1, benzophenone-3 aka oxybenzone); Octinoxate; Butylated Hydroxyanisole and Butylated Hydroxyoluen; Coal tar dyes (p-Phenylenediamine); Cocamide Diethanolamine; Dibutyalated Phthalate (Phthalates DBP), Bis(2-ethylhexyl) Phthalate (DEHP); Toluene; Styrene or Styrene acrylates; Formaldehydes (Methylene glycol/methanediol/formaldehyde) and Formaldehyde-releasing preservatives (DMDM hydantoin, diazolidinyl urea, imidazolidinyl urea, methenamine, quaternium-15 and sodium hydroxymethylglycinate); Triclosan; Lead acetate or other lead compounds; and Parabens (isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, pentylparaben, propylparaben and butylparaben).
After introduction in the House, Rep. Jan Schakowsky’s reform bill was referred to the House Energy and Commerce Committee and House Committee on Education and the Workforce for further action. Given the timing of the upcoming 2018 Congressional elections and sunset of the current Congress at the end of December, the bill will need to be held over and reintroduced in the House at the beginning of the next Congress in January 2019.
Once this occurs, Rep. Schakowsky can work to build support for the bill and attempt to move it forward to committee consideration and possible passage. However, the Trump administration has not been supportive of imposing new regulations on American industry and may also prove to be an obstacle to passage of such a reform initiative.