Shampoo bars are generally regulated by the U.S. Food and Drug Administration (FDA) as cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended to cleanse, beautify, or otherwise change the appearance of hair. They are not eligible for the FDA’s traditional “true soap” exemption because shampoo bars typically contain synthetic detergents, are labeled as shampoo, and make cosmetic claims.
If a shampoo bar claims to treat or prevent a medical condition - such as dandruff, seborrheic dermatitis, psoriasis, or hair loss - FDA will regulate it as a drug, and it must meet drug requirements, including appropriate active ingredients and labeling.
No FDA premarket approval
FDA does not approve cosmetic products or their ingredients before they go on sale, with the exception of color additives. The manufacturer, packer, or distributor is responsible for ensuring that the product is safe and properly labeled.
Labeling requirements for shampoo bars
Shampoo bars sold in the United States must comply with FDA cosmetic labeling rules, including:
- Identity statement: The product must be identified as a shampoo bar.
- Net quantity of contents: The weight of the bar must be stated on the label.
- Ingredient declaration: Ingredients must be listed in descending order of predominance, using standard INCI names. Ingredients present at less than 1% may follow in any order.
- Name and place of business: The label must identify the manufacturer, packer, or distributor, with a domestic address.
- Warning statements: Any necessary directions for safe use or warning statements must appear on the label.
- Responsible person contact information: Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the label or packaging must include a domestic address, phone number, or electronic contact information for receiving adverse event reports.
Modernization of Cosmetics Regulation Act (MoCRA)
MoCRA significantly expanded FDA’s authority over cosmetics. Key requirements that apply to shampoo bars include:
- Facility registration: Cosmetic manufacturing or processing facilities must register with FDA and renew biennially.
- Product listing: The responsible person must list each cosmetic product with FDA, including product category and ingredients.
- Safety substantiation: The responsible person must ensure and maintain records showing adequate safety substantiation for the product.
- Adverse event reporting: Serious adverse events must be reported to FDA within 15 business days, and records must be kept.
- Good manufacturing practices: MoCRA directs FDA to establish mandatory GMP rules for cosmetics. Makers should monitor current FDA guidance for compliance dates.
Some small businesses may qualify for limited exemptions from registration and listing, but they should confirm current FDA guidance.
Prohibited and restricted ingredients
Cosmetic ingredients must not make the product adulterated or misbranded. FDA prohibits or restricts certain ingredients, and all color additives must be approved for cosmetic use. Shampoo bars must not contain ingredients that are unsafe under labeled or customary conditions of use.
Drug claims change the rules
Claims matter. A shampoo bar marketed as “cleansing,” “hydrating,” “volumizing,” or “color-safe” is a cosmetic. A shampoo bar marketed as “treating dandruff,” “stopping hair loss,” or “controlling scalp psoriasis” is a drug and must comply with the appropriate over-the-counter drug monograph or an approved new drug application.
Practical checklist
- Determine whether the shampoo bar is a cosmetic, a drug, or both based on its intended use.
- Use safe ingredients and approved color additives.
- Follow FDA cosmetic labeling rules.
- Register the facility and list the product with FDA if required.
- Maintain safety substantiation and adverse event records.
- Monitor FDA guidance for GMP and other MoCRA compliance dates.
FDA does not issue a “shampoo bar approval” or license. Compliance is the responsibility of the company placing the product on the U.S. market.