The FDA regulates skin care products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Here’s how:
Classification: Skin care products are classified as cosmetics, drugs, or both. Products intended to cleanse, beautify, or alter appearance are considered cosmetics. Those intended to treat or prevent disease, or affect the structure or function of the body, are classified as drugs.
Safety and Labeling: The FDA requires that skin care products are safe for their intended use and properly labeled. Manufacturers are responsible for ensuring their products comply with safety standards and that labels are truthful and not misleading.
Ingredients: The FDA monitors the ingredients used in skin care products. Certain ingredients are prohibited or restricted, and color additives must be approved by the FDA for safety.
Adverse Event Reporting: The FDA collects reports of adverse events or reactions to skin care products. Manufacturers, consumers, and health care providers can report issues, which the FDA reviews to identify potential safety concerns.
Good Manufacturing Practices (GMPs): While the FDA does not require pre-market approval for cosmetics, it expects manufacturers to adhere to GMPs to ensure product quality and safety.
Inspection and Enforcement: The FDA can inspect manufacturing facilities and take enforcement actions, such as issuing warning letters, seizing products, or initiating recalls, if products are found to be unsafe, misbranded, or adulterated.
Understanding these regulations helps ensure that skin care products are safe and effective for consumers.