Compliance, labeling and claims
General information for health, beauty and personal care brands. Rules change and vary by product, so confirm details with the regulator or counsel. This is not legal advice.
Who regulates cosmetics and personal care products in the United States?
The U.S. Food and Drug Administration regulates cosmetics, and the Modernization of Cosmetics Regulation Act of 2022 expanded its requirements. Check the FDA's cosmetics pages for current rules on facility registration, product listing, safety substantiation and labeling, and confirm what applies to your business.
What is the difference between a cosmetic and a drug claim?
In the United States, what a product claims to do helps decide whether it is treated as a cosmetic or a drug. A claim to treat acne or protect from the sun is a drug claim, and drugs face stricter rules. Review claims on packaging and sell sheets before you pitch.
Are sunscreens and acne products regulated differently?
Yes. Sunscreens and acne treatments are generally regulated as over-the-counter drugs in the United States, with their own labeling and manufacturing rules. If your product makes those claims, confirm requirements with the FDA or a regulatory consultant before selling.
Who regulates supplements?
Dietary supplements are regulated by the FDA under a different framework from drugs. Labels need a Supplement Facts panel and structure-function claims have their own rules and disclaimers. Confirm label and claim wording with a qualified regulatory advisor.
What documents do retail buyers ask for in health and beauty?
Buyers commonly ask for ingredient lists, safety data, product liability insurance, lot tracking information and, for supplements, certificates of analysis. Having these ready shortens the time between a buyer saying yes and the first order.
What is product liability insurance and do I need it?
Product liability insurance covers claims that your product caused harm. Distributors and many retailers ask for a certificate of insurance before approving a supplier. Ask an insurance broker which coverage fits your category.
Do I need a certificate of analysis for supplements?
Many buyers in health and wellness ask for one, especially for supplements and sports nutrition. It shows what a lot contains and is issued by a testing lab. Ask your manufacturer for lot-level certificates and keep them organized.
What does third-party testing mean for buyers?
Third-party testing means an independent lab checks that a product matches its label and meets purity standards. Some specialty buyers favor brands that provide it. State what you test, and keep reports available for any account that asks.
Can SellToStores review my product claims?
SellToStores flags common claim problems and points you to the regulator or counsel to confirm. It does not give legal or regulatory advice, and the audit is an opinion based on the information you provide.
What should I do about ingredient restrictions at specific stores?
Many natural grocers and some boutiques publish ingredient standards. Check each store's list before pitching, and mention compliance on your sell sheet when it applies, so the buyer does not need to ask.
What is lot tracking and why does it matter?
Lot tracking records which production batch each shipment came from. If a quality issue appears, you can tell exactly which accounts received the affected lot and notify them quickly. Buyers in health and beauty often ask about it.
What happens if a product needs to be recalled?
Write a recall contact and process into your terms, and keep lot numbers tied to every shipment. If a problem appears, notify affected accounts directly and promptly, and follow the rules of the regulator for your product category.
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Answers about SellToStores come from this site's pages and terms. Everything else is general wholesale guidance with illustrative numbers, and regulatory points are not legal advice, so confirm them with the regulator or counsel.
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