2019 is starting to look like the year Congress may make good on its efforts to pass federal cosmetics reform legislation, with legislation in the works in both the U.S. Senate and the U.S. House of Representatives that would increase federal regulatory oversight for cosmetics. In addition, Senate and House committees have been active in demanding more information and action from the Food and Drug Administration (FDA) to ensure cosmetics safety.
Feinstein/Collins Personal Care Products Safety Act Bill
As they have in previous sessions of Congress, Sens. Dianne Feinstein (D-California) and Susan Collins (R-Maine) re-introduced the “Personal Care Products Safety Act” (S. 726) in March, a bill that would strengthen the FDA’s efforts to regulate ingredients in personal care products.
The Personal Care Products Safety Act bill would amend the Federal Food, Drug & Cosmetic Act (FDCA) by:
- • Requiring annual registration of cosmetic facilities with the FDA and impose tiered registration fees;
- • Requiring cosmetic ingredient statements for all cosmetics, including fragrances, flavors and colors, as well as a range of possible amounts of each ingredient;
- • Providing the FDA the authority to suspend registration of a facility (and any import, export or distribution of cosmetics from the facility) or a cosmetic ingredient statement (and all cosmetics that are the subject of the statement) if there is a reasonable probability of serious adverse health consequences or death to humans;
- • Directing the FDA to review ingredients and non-functional constituents, including coal tar chemicals) for safety at a rate of at least five ingredients per year;
- • Directing the FDA to issue regulations to establish Good Manufacturing Practices for cosmetics;
- • Requiring timely reporting of serious adverse events and annual reporting of adverse events;
- • Allowing the FDA wide authority to inspect records;
- • Providing mandatory recall authority to the FDA;
- • Requiring labeling of cosmetics that are not appropriate for use in the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product;
- • Requiring ingredients, warnings and statements on professional products;
- • Requiring complete label information to be placed online for online sales of cosmetics; and
- • Requiring a telephone number or electronic contact information on the label.
In the first year, the FDA would evaluate the safety and appropriate use of the following five chemicals, which could be banned from cosmetics or limited in their allowed use:
• Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
• Diethyl phthalate, which is used as a binding agent in some fragrances and cosmetics.
• Methylene glycol/formaldehyde, which is used in hair treatments.
Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion.
• Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.
Pallone/Shimkus Discussion Draft
Meanwhile, House Energy & Commerce (E&C) Committee Chairman Frank Pallone Jr. (D-NJ) and Rep. John Shimkus (R-Ill.) in March released a bipartisan discussion draft of legislation that is very similar to the Personal Care Products Safety Act, which is expected to be introduced in the House soon.
Action by Congressional Committees
Congressional committees have also been flexing their investigative and oversight muscles by demanding additional information from and calling for more action by the FDA, separately from the status of any reform legislation.
After the FDA announced in March that its testing (almost two years after the fact) confirmed the presence of asbestos in cosmetics, including eye shadows, compact powders and contour palettes, sold in 2017 at children and teen stores Claire’s and Justice stores, Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called for further investigation by the FDA into whether cosmetic products that contain talc “may be contaminated with asbestos.” Sen. Murray is also urging the FDA to conduct additional testing to ensure the safety of cosmetic products containing talc, and in particular cosmetics that are marketed to children and teenagers. Separately, Sen. Murray demanded that Claire’s provide more information about the possible sources of asbestos contamination and the process and procedures Claire’s takes to assess the safety of its products before they reach customers.
There have been further regulatory and legislative developments on these subjects in June 2019. Additional cosmetics, including a JoJo Siwa makeup set sold by Claire’s, were found to be contaminated with asbestos and were recalled in June 2019. Rep. Pallone then sent a letter to the FDA requesting updated information about the agency’s inspections of imported cosmetic products. Specifically, Rep. Pallone sought FDA foreign inspections data from Fiscal Year (FY) 2017-2019, including the number and kinds of personal care products imported each year, the number of imported products subjected to inspections each year, and the number of contaminated products intercepted each year. According to Rep. Pallone, the FDA has not conducted any foreign cosmetic inspections in FY 2019 and intends to conduct no foreign cosmetic inspections in FY 2020.
This was not the first such request to the FDA, as Rep. Pallone previously sent a letter to the FDA requesting similar information in 2016. In response, the FDA stated that in FY 2016, less than one percent of cosmetic products that arrived in U.S. ports were physically examined by FDA inspectors; of those inspected, inspectors reported adverse findings such as illegal color additives and microbial contamination in 15 percent of the imports.
The push toward federal cosmetics reform has been many years in the making, and now gathers industry support from such heavyweights as The Estee Lauder Companies, Johnson & Johnson, L’Oreal and Procter & Gamble. While the industry by and large appears to agree that updates are needed to the current regulatory system and would increase consumer confidence, there are concerns about the extent of the reform and the scope and breadth of the power to be vested in the FDA. Key stakeholders are involved in the process and engaging with the House, Senate and FDA.
While it remains to be seen whether 2019 will be the year of significant cosmetic legislation reform, one thing is certain – increased regulation for the personal care products industry is inevitable, and the question is just one of how much regulation and the extent to which the FDA will preempt state and local regulations.
Cosmetics manufacturers should take heed as they plan their product formulations, manufacturing and labeling of existing and planned product lines, whether made in the U.S. or abroad. Conkle, Kremer & Engel attorneys stand ready to help clients plan their responses to current and developing regulatory changes affecting the beauty industry.