Skincare Product Regulations
Artisan skincare products can be made in the home and may be a good option for expanding your farming enterprise. This page covers the regulations associated with making skincare products in Sonoma County.
US Food & Drug Administration (FDA) regulates skincare products that are defined as cosmetic and/or drug.
Definitions: Is your skincare product a soap? Cosmetic? Drug? Cosmetic and drug?
Soap: The regulatory definition of soap is a product that only contains fats or oils and an alkali (lye). Very few ‘soaps’ meet this definition, most contain other ingredients such as synthetic detergents, scents, colors, herbs, and so on. Refer to FDA’s Soap FAQ’s. If your product meets the regulatory definition of soap (only fats or oils and an alkali), it is regulated by Consumer Product Safety Committee, there is no approval required for marketing this product however the manufacturer is responsible for ensuring the soap they create is not hazardous as defined by FHSA (Federal Hazardous Substances Act). Labels must warn of harsh cleansers if applicable.1
Cosmetic: Most skincare products are defined as cosmetics. Cosmetics are regulated by FDA. No licensing or approval is required however it is your responsibility to ensure the product is safe when used as intended and is properly labeled. Under the Food, Drug & Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, currently do not require FDA approval before they go on the market.2
Product labels must include the ingredients and cannot contain misleading or false statements. Refer to FDA’s Fact Sheet for Small Businesses and Homemade Cosmetics. FDA encourages cosmetic manufactures to participate in the Voluntary Cosmetic Registration Program.
Drug: FDA considers skincare products a drug when the intended use is to “cure, mitigate, treat, or prevent a disease” and is intended to “affect the structure or any function of the body” of either human or other animals. Drugs must obtain premarket approval by the FDA through the New Drug Application process or conform to FDA monographs (rules) for specific OTC (over the counter) drug categories such as acne medications, sunscreens and treatments for dandruff and others. Note: a search of the FDA site did not provide the ‘monographs’ if you intend to for your skincare product to be a ‘drug’ please contact firstname.lastname@example.org for assistance.
Federal Trade Commission check their Advertising and Marketing pages to learn about labeling requirements under the Fair Packaging and Labeling Act.
- California Safe Cosmetics Program If your skincare product contains any chemical agents from guidance list of chemical agents known or suspected to cause cancer, birth defects, or other reproductive harm AND your company makes $1,000,000 or more annually in cosmetic sales, your company is subject to mandatory reporting requirements of the California Safe Cosmetics Act.
- California Department of Public Health for organic products. If you want to market organic products, your products must be made with at least 70% of product, by weight, from certified organic ingredients. Annual gross sales of greater than $5,000 requires organic registration with CDPH. Refer to California Organic Products Act (pdf) section 110838 page 19.
- Business Registration with the State of California refer to FAQ’s for filing requirements.
- Board of Equalization to register and pay sales taxes.
- Business license is required if your business is located within city limits. It is not required if your business is located in the unincorporated area of the county.
- Fictitious business name statement is required if your business name does not include your surname.
Talk to your insurance agent to make sure you and your business operation are covered.
Not associated with UCCE:
- Marie Gale information about labeling and good manufacturing practices (GMP) for handcrafted soaps and cosmetics. Books available including soap recipes, reference guide, GMP's and Soap & Cosmetic Labeling.
- Soap Queen blogs about selling soap.
- According to the Federal Hazardous Substances Act, a product is determined to be a hazardous substance if the substance or a mixture of substances is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, and if the substance or mixture of substances may cause substantial personal injury or substantial illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.
- Senate Bill 1014 Personal Care Products Safety Act, introduced 4/20/2015, would change regulations for all cosmetic products. To stay informed, you can subscribe to updates via Congress.gov. 11/2017 Update: this bill appears to be stalled.