The Office of Cosmetics and Colors (OCAC) within the United States Food and Drug Administration (FDA), regulates personal care cosmetic products. This Book focuses on those personal care cosmetic products regulated by OCAC. The majority of personal care cosmetic products are regulated by OCAC; however, it depends on the specific product. For example, the Center for Drug Evaluation and Research regulates over-the-counter personal care products such as sunscreens. Further, the Consumer Product Safety Commission regulates some soaps. Today, more than ever, consumers turn to personal care products for reasons beyond that of grooming. Increasingly, personal care products are used for health purposes. Did you know that the United States is at the forefront in terms of market sales of personal care cosmetic products in the entire world? Suffice it to state, revenue from personal care cosmetics is in the billions. The goals of this Book are as follows:
Discuss the regulatory authority of FDA over personal cosmetic care products;
Explain issues involved in product classification;
Detail specific terminology related to cosmetics;
Provide information on the cosmetic registration program;
Detail specific enforcement actions; and
Discuss the "quest for beauty" in culture.
Safety issues remain paramount especially with ingredients used and harmonization of ingredient nomenclature. Issues related to harmonization, such as varied regulatory rules, remain complicated. For example, only colors approved for use in the United States are permitted in cosmetics and safety substantiation is required. The critical issue that remains is the authority of the United States Food and Drug Administration in terms of pre-market approval rather than the current system of post market enforcement. Perhaps a mandatory cosmetic registration program is in order. Perhaps FDAs OCAC should revisit how these products are regulated to keep in step with the 21st century. Stakeholder collaboration from industry could prove valuable. However, more needs to be done to protect the public in fulfilling the mandate of the Food, Drug and Cosmetic Act such as enforcement of the proliferation of claims concerning personal care cosmetic products and classification.
The Microbead-Free Waters Act was enacted during the 114th Congress bans rinse-off cosmetics that contain intentionally added plastic microbeads. https://www.congress.gov/bill/114th-congress/house-bill/1321.The Safe Cosmetics and Personal Care Products Act of 2019 H.R.4296 was introduced and the Cosmetic Safety Enhancement Act of 2019 both were introduced in the 116th Congress and both failed to pass.