Under the law, some of the products commonly known as personal care products are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, nail polishes, facial and eye makeup preparations, shampoos, permanent waves, hair colors, toothpastes and deodorants. FDA's legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA pre-market approval, with the exception of color additives.
However, FDA may take enforcement action against products in the marketplace that do not comply with the law, or against companies or individuals who break the law. A cosmetic is any substance used to clean, improve, or change the complexion, skin, hair, nails, or teeth. Cosmetics include beauty preparations (makeup, perfume, skin cream, nail polish) and hygiene products (soap, shampoo, shaving cream, deodorant). A skin product to conceal acne is a cosmetic, but an anti-acne product is a medicine.
A personal care product can be defined as a substance or mixture of substances that is generally recognized by the public for use in daily cleaning or grooming. Consumer (retail) cosmetic products subject to the FPLA must bear a label with the product identity and the name and place of business of the manufacturer, packer or distributor, as well as the net quantity of the content on the label's main display panel. The FDA also disagreed with the suggested audit of the cosmetics industry, which the consumer group proposed to determine the current participation rate in the VCRP and estimate how many ingredients and products the FDA receives in the database compared to the total produced. Products included in this definition include skin moisturizers, perfumes, lipsticks, nail polishes, facial and eye makeup, cleansing shampoos, permanent waves, hair dyes and deodorants, as well as any substance intended for use as a component of a cosmetic product.
FDA guidelines have provided the cosmetics industry with considerable flexibility for product development and claims. The agency's ability to issue regulations on cosmetic products is limited by the agency's legal authorities or lack thereof. If the coal tar hair dye product does not contain that information, the coal tar dye is subject to regulations as a cosmetic charcoal additive and must be approved by the FDA and included in the CFR prior to marketing. Combination drug and cosmetic products must meet OTC drug and cosmetic labeling requirements, that is, drug ingredients must be listed alphabetically as active ingredients, followed by cosmetic ingredients, either in descending order of predominance, such as inactive or inactive ingredients Ingredients in particular groups, such as concentrations of more than one percent of coloring additives.
As mentioned earlier in this report, FDA does not have the authority to require pre-market approval or pre-market review of cosmetic ingredients or products, except color additives. Historically used tests include measures of skin irritation, eye irritation, allergic reactions, and toxicity caused by various ingredients used in the manufacture of cosmetics on a number of different animals, including rabbits, mice, rats and guinea pigs. In addition, cosmetics are explicitly excluded from the definition of a consumer product in the Consumer Product Safety Act, which is enforced by the Consumer Product Safety Commission. Products such as dandruff shampoo, fluoride toothpaste, and antiperspirant deodorant are cosmetics and medicines.
FDA supports and adheres to the provisions of applicable laws, regulations and policies that govern animal testing, including the Animal Welfare Act and the Public Health Service Policy on Human Care and Use of Laboratory Animals. The FDA has also received at least 33 adverse event reports, seven additional reports of hair loss, and a series of inquiries regarding the safety of Brazilian Blowouts and similar professional use only hair treatment products, which may contain or release formaldehyde into the air when used by stylists for straight hair, despite being labeled formaldehyde-free. Some ingredients used in cosmetic products have received special attention due to concerns about their potential health risk. .
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