Our Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products

September 7, 2023

We appreciate the opportunity to comment on the Food and Drug Administration proposed guidance: Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly support the purpose and requirements included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which was part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) related to the regulation of cosmetic products. These regulations are long overdue and an essential first step toward protecting public health through the disclosure of the ingredients in these ubiquitous products and the registration of the facilities that make these products. Research has documented scientific concerns about the presence of endocrine disrupting chemicals in cosmetics and their effect on consumers’ health.[1],[2],[3] Some hormone disruptors such as phthalates and parabens are found in a wide range of cosmetic products. Other hormone disrupting substances are used in specific cosmetics, such as triclosan in toothpaste and mouthwash; this chemical ingredient was previously banned from soap products by the FDA in 2016. It is essential that the public be made aware of the potential for cumulative exposure to substances in many different makeups, creams, and other cosmetic products used every day.

We are very supportive of the requirements included in MoCRA, but have four recommendations to improve the proposed guidance:

  • We are concerned that the FDA does not plan to transfer the voluntary cosmetics registration program to this new system. We agree that previous submissions to the voluntary cosmetics registration program fail to satisfy the registration and listing requirements, since that information differs from the information required to be submitted under MoCRA. However, there is likely to be substantial overlap of information. We recommend that these entities should be required to register their facilities and submit product listings even if they voluntarily provided similar information previously. If information is not transferred, where will previously submitted voluntary information be stored? Will it be available to the public?
  • Regarding the requirements set for a product listing, we strongly urge that all fragrance ingredients be required to be listed. Fragrance ingredients in self-care products such as shower gels, shampoos, body lotions, and shaving creams are often labeled “unscented.” This is because manufacturers are not obligated to label the fragrance in the ingredient list if the amount added is just enough to cover the scent of other ingredients versus giving the product a noticeable scent.[4] This is not an appropriate justification. All fragrance ingredients added to the product, no matter how minimal, should be included in the product listing. It is not enough to simply list the product as containing “fragrance” or “flavor” as is required under section 701.3 of title 21, Code of Federal Regulations. A more detailed ingredient list is essential and would not jeopardize trade secrets since according to the guidance document, brand names will not be disclosed publicly.
  • Regarding the requirements set for a facility registration, we support the requirements listed in the guidance but also recommend the disclosure of the amount of the product manufactured or processed in each facility in the year prior to the initial registration. Production levels should also be included in each renewal of registration biennially.
  • According to the guidance, the “FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.” The guidance does not specify how violations or inaccuracies in the registrations and product listings will be enforced.  It is essential the manufacturers comply with the requirements in order to ensure transparency, and enforcement is necessary to achieve that goal.

1. Ejaredar, M., Nyanza, E., Eycke, K., Dewey, D. (2015). Phthalate Exposure and Childrens Neurodevelopment: A Systematic Review. Environ Res 142:51-60.

2. Diamanti-Kandarakis, E., Bourquioqnon, J., Giudice, L., et al. (2009). Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocr Rev 30(4):293-342.

3. Harley, K., Kogut, K., Madrigal, D., Cardenas, M., et al. (2016) Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environ Health Perspect In Press.

4. Sun, A. (2023) Everything you need to know to choose safe cosmetic products. National Center for Health Research. https://www.center4research.org/cosmetics-safety-regulations-law-tips/