The U.S. Food and Drug Administration (FDA) is a scientific and regulatory agency of the federal government charged with protecting public health through overseeing the safety of consumer products. The FDA has various departments that serve to regulate the beauty industry: Office of Cosmetics and Colors, Plastic and Reconstructive Surgery Devices Branch, and Center for Drug Evaluation and Research. The primary laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
Federal Food, Drug, And Cosmetic Act
The FD&C Act defines products by their intended uses, including cosmetics, drugs, and medical devices. The FDA defines cosmetics as products applied to the human body for cleansing, beautifying, or altering appearance, without affecting the body’s structure or function. These include hair care products, skin care products, makeup, and perfume. The FDA defines drugs as products intended for the diagnosis, cure, treatment, or prevention of disease by affecting the structure or function of the body. According to the FDA, medical devices such as surgical implants are products that are intended to affect bodily structure or function but do not achieve this through the chemical action of a drug.
A product’s intended use as a drug, cosmetic, or medical device is established by claims made in its product labeling, and advertisements. Some products marketed as cosmetics may be considered drugs if claims establish their intended use to affect the structure or functions of the human body. For example, hair products that claim to restore hair or prevent hair loss, which may seem to be cosmetic goals, are considered drugs because of the mechanism they use to invigorate hair growth. Other products marketed as cosmetics that are considered drugs include those that eliminate cellulite or reduce varicose veins, acne medicine, sunscreen, and products designed to treat hair and skin ailments.
When a product has two intended uses, it must comply with the requirements for both cosmetics and drugs. For example, an antidandruff shampoo is considered both a cosmetic and a drug: it is used to treat dandruff (and alter the structure of the hair follicle) and clean hair. Other examples of products with both cosmetic and drug applications are fluoride toothpastes, antiperspirant deodorants, and moisturizers or makeup that include sunscreen.
Each type of product is subject to different laws and regulations. Drug companies must register with the FDA and list their various drug products, while cosmetics companies may choose to register under the FDA’s Voluntary Cosmetic Registration Program (VCRP). While the FDA reviews and approves drugs and medical devices before they enter the consumer market, cosmetic products and their ingredients are not reviewed before they are publicly available.
Soap is a special category under the FD&C Act. Soap products are considered neither cosmetics nor drugs and are exempt from the FD&C Act. The FDA assigns the term soap to a product only when it is labeled and sold exclusively as soap and consists primarily of alkali salt of fatty acids. Cleansing products that include detergents and are intended for cosmetic or health uses are regulated as cosmetics or drugs, respectively.
Fair Packaging And Labeling Act
The Fair Packaging and Labeling Act (FPLA) is designed to protect consumers from potential health hazards that may result from cosmetics and also to guard against deceptive practices by ensuring accurate labeling that can help consumers make informed decisions about their cosmetics and drug purchases. Every label must include an identity statement indicating the nature and use of the product, an accurate statement of the contents, and any applicable safety warnings. Misbranding occurs when a label is false or misleading or fails to properly give required information. Products with two intended uses, such as drugs that have cosmetic purposes, must comply with label regulations for both drug and cosmetic ingredient labels.
The FDA reviews products implanted into the body that could have health consequences. These include surgical and nonsurgical cosmetic alterations. Surgical alterations are categorized as medical devices. The FDA regulates the use of silicon implants for breast augmentation; surgical procedures such as stomach flattening, or tummy tucks; and facial cosmetic surgery. The FDA also regulates products that affect the structure of the face and could have such health consequences. For example, soft tissue fillers such as Restylane (hyaluronic acid) are approved by the FDA to treat facial wrinkles. The regulation of such treatments typically falls under the FDA’s regulation of a drug. For example, Tretinoin (retinoic acid) is not banned from use in cosmetics, but when applied to the skin to treat acne, sun damage, and other skin conditions, it alters the skin’s cellular makeup by increasing collagen, and thus the FDA regulates it as a drug. When evaluating such cosmetic treatments, the FDA uses a benefit-to-risk ratio. The FDA may allow greater risk from products intended to treat medical conditions than from those that are approved for cosmetic purposes. While cosmetic products regulated by the FDA are supposed to be extraordinarily safe, some consumer groups criticize the regulation of products as too lenient: for example, since fragrance formulas are considered trade secrets, companies are not required to reveal fragrance ingredients on the label. The FDA bans 10 chemicals from use in cosmetics, but many of the thousand ingredients used in cosmetics are considered toxic. A recent study by the Campaign for Safe Cosmetics found that 15 of 33 popular lipsticks had detectable traces of lead. The FDA claims that it does not tolerate high risk for a drug with a primary use as a cosmetic; nevertheless, what is safe and the degree to which beauty products are taken as seriously as other commodities is continually debated.
FDA Globalization Act
The FDA Globalization Act of 2008 is intended to provide the FDA with the authority to regulate food, cosmetics, drugs, and medical devices in a global marketplace. Under the act, companies must register all cosmetic facilities serving American consumers, and these facilities must report adverse events resulting from the use of their products. Such companies must comply with American manufacturing practices, and the FDA may monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.