How to start a skincare line

Is my skincare product a cosmetic or a drug?

This is the first question, because drugs face far heavier rules. The FDA explains that it depends on the product's intended use. A cosmetic is meant for cleansing, beautifying, promoting attractiveness or altering the appearance. A drug is meant to diagnose, cure, mitigate, treat or prevent disease, or to affect the structure or any function of the body.

Intended use is judged from what you say on labels, in ads, online and in other promotion, from what consumers expect, and from ingredients with a well-known therapeutic use. The FDA's examples of claims that make a product a drug include restoring hair growth, reducing cellulite, treating varicose veins, changing melanin production and regenerating cells. Some products are both: a moisturizer with sun-protection claims must meet the rules for cosmetics and for drugs.

• "Cosmeceutical" has no meaning in the law; a product is a cosmetic, a drug or both.
• Essential oils follow the same logic: a fragrance sold to make someone more attractive is a cosmetic, but one sold with claims that it helps you sleep is a drug.
• Drugs generally need FDA approval or must conform to an over-the-counter monograph. Cosmetics and their ingredients, apart from color additives, do not need FDA approval before sale.
• Some soaps are regulated by the Consumer Product Safety Commission rather than the FDA; the FDA's page explains which soaps meet its definition.

What does MoCRA require from a small skincare brand?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest expansion of the FDA's authority over cosmetics since 1938. Its duties fall on the responsible person: the manufacturer, packer or distributor whose name appears on the label. If your brand is on the label, that is you.

A small business, as MoCRA defines it, has average gross annual US sales of cosmetic products below $1,000,000, adjusted for inflation, over the previous three years. The exemption does not apply if you make products that regularly touch the mucous membrane of the eye, are intended for internal use, or are meant to alter appearance for more than 24 hours where removal is not part of normal use. The FDA's registration page has a decision tool, and stresses that registration is not approval and that it issues no certificates.

What goes on a cosmetic label?

The FDA's labeling guide divides the outer package into a front panel and information panels:

• Front (principal display) panel: the product's identity and the net quantity of contents.
• Information panels: directions for safe use, any warnings, the name and place of business, and the ingredient declaration.
• Ingredients: listed by their common or usual names in descending order of predominance, generally in letters at least 1/16 inch high.
• Name and place of business: street address, city, state and ZIP code. A P.O. box or website alone is not enough. A brand that hires a manufacturer uses wording such as "Distributed by" or "Manufactured for" with its own name and address.

On "natural" and "organic": the FDA has not defined "natural" for cosmetics, and the USDA, not the FDA, regulates "organic" for agricultural ingredients. Every claim must still be truthful, and "natural" must not appear inside the ingredient list.

Can I make skincare products at home?

Yes. The FDA's fact sheet for small businesses says it is not against the law to make cosmetics at home, but you must make them where they cannot become adulterated. The FDA lists the ways that happens:

• Using a color additive that is not approved for the purpose, or not from a certified batch where certification is required.
• Using a prohibited or restricted ingredient outside its limits.
• Packaging that makes the contents harmful, such as a container coated with lead.
• Microbial contamination. Cosmetics need not be sterile, but they must not contain harmful microorganisms, and the FDA notes that contamination can come from use, such as customers dipping fingers into a jar.
• Other contaminants, or anything else that makes the product unsafe when used as directed.

The FDA does not license cosmetics firms, but your state or city may have requirements. If you lack the technical expertise to protect a product from contamination, the FDA suggests working with a consultant, and suppliers often have safety data on their ingredients that you can use to support your safety records.

How do I describe my products without making drug claims?

Describe what the product does to appearance and feel, not what it does to the body. "Leaves skin feeling soft", "cleanses" and "a light, fresh scent" describe cosmetic uses. Words about treating a condition, healing, or changing how the skin functions move the product toward the drug category. The same applies to the testimonials and reviews you repeat on your site, since intended use is judged from all of your promotion, not only the label.

Read every product page, social post and label before launch with that test in mind, and keep the safety records behind each product with your batch numbers so you can answer a customer or the FDA quickly.