If you manufacture or sell shampoo bars in the United States, the Food and Drug Administration (FDA) generally regulates them as cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Modernization of Cosmetics Regulation Act (MoCRA). FDA does not pre-approve cosmetic products or issue manufacturing licenses, but it does enforce safety, labeling, registration, and recordkeeping requirements.

Is a shampoo bar a soap, cosmetic, or drug?

Your first compliance step is determining how FDA classifies your product.

  • True soap: A product made mostly from alkali salts of fatty acids and marketed only as soap is not considered a cosmetic under FDA rules. However, most modern shampoo bars use synthetic detergents, so they are cosmetics.
  • Cosmetic: A shampoo bar intended to cleanse, beautify, or condition hair is a cosmetic.
  • Drug: If your shampoo bar claims to treat dandruff, prevent hair loss, or otherwise affect the structure or function of the body, it is also an over-the-counter drug and must meet additional drug requirements.

Core FDA requirements for shampoo bar manufacturing

1. Safety substantiation

FDA requires that cosmetics be safe under labeled and foreseeable conditions of use. You are responsible for having adequate substantiation. Keep records showing your formula, ingredient safety review, stability testing, and any preservative efficacy testing if the product can support microbial growth.

2. Ingredient and color additive compliance

Use only ingredients that are not prohibited or restricted by FDA for cosmetic use. Any color additives must be approved for cosmetics and, if required, come from a certified batch. Avoid ingredients with known safety concerns or uncertain cosmetic status.

3. Labeling requirements

Shampoo bar labels must include:

  • Identity statement: such as “Shampoo Bar.”
  • Net quantity of contents: weight in ounces and grams.
  • Name and place of business: manufacturer, packer, or distributor.
  • Ingredient declaration: ingredients in descending order of predominance using INCI names.
  • Required warnings: any caution statements required for specific ingredients.

If the bar is too small for full labeling, the ingredient list and other required information may appear on an attached tag, card, or outer package.

4. Avoid drug claims

Cosmetic claims like “cleanses,” “softens,” “shines,” and “conditions” are acceptable. Avoid drug claims such as “treats eczema,” “fights dandruff,” “regrows hair,” or “antibacterial” unless the product meets FDA drug requirements. Improper drug claims can make your shampoo bar an unapproved new drug.

MoCRA: registration, listing, and adverse event reporting

MoCRA added major new obligations for cosmetic manufacturers and processors, including shampoo bar makers.

  • Facility registration: Facilities that manufacture or process cosmetics for U.S. sale must register with FDA and renew every two years.
  • Product listing: Each shampoo bar formula must be listed with FDA, including ingredients and responsible person information. Listings must be updated annually.
  • Serious adverse event reporting: Serious adverse events must be reported to FDA within 15 business days.
  • Adverse event records: Maintain records for at least 6 years, with some modifications for small businesses.
  • Good manufacturing practices: MoCRA directs FDA to establish mandatory cosmetic GMPs. Even before final rules are fully enforced, following ISO 22716 or similar cosmetic GMP standards is strongly recommended.

Small businesses may qualify for certain exemptions or modified requirements, but labeling, safety substantiation, and adverse event reporting still generally apply. Check FDA’s current small-business guidance for details.

Practical compliance checklist

  1. Confirm whether your shampoo bar is a cosmetic, soap, drug, or combination.
  2. Use compliant ingredients and approved color additives.
  3. Prepare a formula file with safety substantiation and stability data.
  4. Create FDA-compliant labels with an INCI ingredient list.
  5. Register your facility and list your products with FDA.
  6. Establish adverse event handling and recordkeeping procedures.
  7. Review all marketing claims to avoid unapproved drug language.

Because FDA rules and guidance continue to evolve under MoCRA, always consult the FDA’s cosmetics webpage or a qualified regulatory consultant before launching a shampoo bar line. Federal compliance is the baseline, and state or local requirements may also apply.