14 March 2019
New Bill Would Strengthen FDA Oversight over Personal Care Products
Sens. Dianne Feinstein (Democrat-California) and Susan Collins (Republican-Maine) recently introduced legislation designed to strengthen the Food and Drug Administration’s regulatory authority over ingredients of personal care products, including cosmetics and skin and hair care products. The co-sponsors note that the FDA does not have the same authority to regulate the US$60 billion personal care products industry as it does for medicines and dietary supplements. The legislation is supported by a number of cosmetics manufacturers, who presumably would prefer to have regulatory certainty and reduced problems from bad actors, as well as by various health and environmental groups.
Sen. Collins’ decision to co-sponsor the so-called Personal Care Products Safety Act of 2019 (S. 726) is noteworthy for two reasons: she is a member of the majority on the Senate Health, Education, Labor, and Pensions Committee and Republican lawmakers have often been less supportive of similar regulatory actions in the past. Collins indicated in a statement that “by updating FDA oversight of the ingredients in cosmetics and personal care products for the first time in nearly 80 years, our legislation will help increase safety for consumers, protect small businesses, and provide regulatory certainty for manufacturers.”
According to the two senators, the legislation would:
- require labelling of any products that include ingredients not appropriate for children and those that should be professionally administered;
- require complete label information for other products to be posted on-line, including ingredients and product warnings;
- require companies to provide contact information on their products for consumers and report serious adverse events to the FDA within 15 days, including disfigurement, death and hospitalisation (including incidents that would have led to hospitalisation without medical intervention);
- require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their products (although there are exemptions for smaller producers, including those that do not make products intended to go on the eye area, lip products with colour, products that are injected, products that are intended for internal use, or products that are meant to alter appearance for more than 24 hours);
- direct the FDA to issue regulations on good manufacturing practices for personal care products; and
- review five chemicals of particular concern (diazolidinyl urea, diethyl phthalate, methylene glycol/formaldehyde, propylparaben and quaternium-15), with at least five ingredients subject to annual reviews in the future.
The bill’s requirements would apply to foreign as well as domestic manufacturers. For foreign manufacturers, the FDA submission would include the name, street address, telephone number, emergency contact information, name of the U.S. agent for the facility, and, if available, the electronic contact information of the U.S. agent. To fund these new oversight activities, the bill would authorise the FDA to collect user fees from personal care product manufacturers similar to what is done for pharmaceuticals and medical devices.
The two lawmakers introduced a similar bill in May 2017 that attracted 15 other co-sponsors in the Senate. However, no action was taken after its referral to the Health, Education, Labor, and Pensions Committee. The new bill differs in certain respects from the older version. For example, instead of assessing fees on firms with US$2 million in average gross annual sales for the preceding three-year period it sets the level at a much more sizable US$10 million. The previous version of the bill had a section on alternatives to animal testing that would have directed the FDA to take a number of specific actions to encourage a reduction in the use of animals for product testing, but the new version includes much vaguer “sense of Congress” language.
Language on coal tar usage was also changed in the 2019 version of the legislation. It now states that if the FDA reviews a coal tar ingredient found in hair dye and makes a safety determination under section 607(d) for such ingredient, the determination must include consideration for the safe use of such ingredient through appropriate conditions of use, which may include a specific label requirement, specified concentration limits or other such conditions of use determined by the FDA, including a finding of not safe under any conditions if appropriate.
While companion legislation had not been introduced in the House of Representatives as of 12 March, Rep. Jan Schakowsky (Democrat-Illinois) did introduce a competing and much tougher bill in September 2018. That bill was supported by The Campaign for Safe Cosmetics, an umbrella coalition of groups with a focus on perceived risks of chemicals used in cosmetics, because it would have immediately banned numerous chemicals that are ostensibly toxic and would have directed the FDA to assess the safety of 300 cosmetic ingredients within two years.