Do You Need a License to Make Hair Products?

In the United States, shampoo does not require FDA approval before being marketed or sold. However, shampoos are regulated under the Federal Food, Drug, and Cosmetic Act (FDCA), which means they must meet certain safety standards, but they do not require pre-market approval like drugs or medical devices. Here's a breakdown of how shampoos are regulated:

1. Cosmetic Regulations

• Shampoos are considered cosmetics by the FDA because they are intended for cleansing or beautifying the hair without affecting the body's structure or functions.
• As a cosmetic product, shampoo must be safe for use as intended, and its ingredients must be properly labeled, but it does not require FDA approval before it is sold to the public.
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2. Ingredient Safety

• The ingredients used in shampoo must be safe when applied to the skin and hair. The FDA monitors any new or harmful ingredients but does not review the individual formulations before products go to market.
• Manufacturers are responsible for ensuring the safety of their products. If a shampoo contains an ingredient that is harmful, the FDA has the authority to take action, such as issuing recalls or warnings.
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3. Labeling Requirements

• The FDA requires that shampoo labels be truthful and not misleading. Labels must list ingredients and follow the correct labeling format, especially if the product includes any claims such as "hypoallergenic" or "dermatologist-tested."
• If a shampoo makes medical claims (such as treating dandruff or hair loss), the product may be classified as a drug, which would require FDA approval. For example, shampoos with active ingredients like ketoconazole or salicylic acid for dandruff treatment must be approved by the FDA as over-the-counter drugs.
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4. Cosmetic Ingredient Review (CIR)

• While not mandatory, many shampoo manufacturers voluntarily submit their products to the Cosmetic Ingredient Review (CIR) panel, which assesses the safety of cosmetic ingredients.
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5. FDA Action on Unsafe Products

• If the FDA receives reports of adverse reactions to a shampoo or determines that a shampoo is not safe for its intended use, the agency has the authority to take regulatory action. This might include warning letters, product recalls, or even banning certain ingredients.
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Shampoo does not require FDA approval unless it makes drug-related claims (like treating a medical condition). However, manufacturers must ensure their products are safe, properly labeled, and comply with regulations.