Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume, also contained in the new eighth print edition, emanateS from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of implementation procedures for the Pennsylvania Plain Language Act. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel Uni-versity and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the com-mittees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials.
Personal Care Products Regulation Lawby Roseann B. Termini, Esq.
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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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