Personal Care Products Regulation Lawby Roseann B. Termini, Esq.
Today, more than ever, consumers turn to personal care products for reasons beyond 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? Revenue estimates are approximately over $55 billion annually and this is… See more details below
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Today, more than ever, consumers turn to personal care products for reasons beyond 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? Revenue estimates are approximately over $55 billion annually and this is projected to rise. This volume focuses important issues concerning the regulation of personal care cosmetic products.
The Office of Cosmetics and Colors (OCAC) within the United States Food and Drug Administration (FDA), regulates personal care products such as cosmetics. This volume focuses on those personal care cosmetic products regulated by OCAC. The majority of these 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.
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 focus of this volume is to:
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.
The critical issue that remains is the authority of the United States Food and Drug Administration in terms of pre-market approval rather 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. This would be in keeping with the public protection mandate of the Food, Drug and Cosmetic Act and mission of FDA to protect the public.
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