Cosmetrics Analysis and the FDA

The Food and Drug Administration is not legally required to approve cosmetic products and ingredients, other than color additives, but there are regulations in place that apply to cosmetics as it relates to interstate commerce. The two most important laws pertaining to cosmetics are the Federal Food, Drug and Cosmetic Act (FD&C; Act) and the Fair Packaging and Labeling Act (FPLA).

The FD&C; Act defines cosmetics by how they are used and are defined as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance." The products referred to include perfume, lipstick, skin moisturizer, nail polish, shampoo, eye and facial make-up, hair color and deodorant. It does not include soap. The FD&C; Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce.

In addition, the FDA requires a list of ingredients for cosmetics that are marketed on a retail basis to consumers and can take action against cosmetics that are in violation of this law. Although the law states that cosmetics and their ingredients do not need premarket approval, the FDA can take enforcement action against products that are not in compliance with the law or who violate the law. Manufacturers can use any ingredient in the formulation of a cosmetic if the ingredient and the finished cosmetic is safe and properly labeled. The FDA has stated that the safety of a product can be substantiated through reliance on already available toxicological test data on individual ingredients and product formulations that are similar in composition to that particular cosmetic or on new toxicological tests appropriate to existing data and information.

International Research Services Inc. is a clinical research facility serving the cosmetic and pharmaceutical industries. We specialize in dermatological safety and efficacy testing and we are a leader in the biophysical instrumental analysis of test product effects on human skin. IRSI was the first clinical trial firm to offer Cosmetrics Analysis and we are still a leader in the field of non-invasive dermatological assessment. We analyze the melanin, collagen and hemoglobin content of the skin, as well as moisturization, elasticity, oil content, and lines and wrinkles.

If you would like additional information, or to make an appointment to visit our facilities, email sschwartz@irsi.org or ffriscia@irsi.org. You can also call 914-937-9483 or 1-800-548-0158. We are located in Port Chester, NY and are looking forward to hearing from you.