Private label products: what you are responsible for

Whose name goes on a private label product?

Yours, as a rule. US labeling rules require a packaged food, a cosmetic or a dietary supplement to name the manufacturer, packer or distributor. When the business named did not make the product, the name must be qualified by a phrase that shows its connection, such as "Manufactured for ______" or "Distributed by ______". The rule is 21 CFR 101.5 for foods, which FDA's supplement labeling guide also points to, and 21 CFR 701.12 for cosmetics.

So your label does not have to reveal your manufacturer. But the name on the label is the one regulators and customers contact, and several federal duties attach to it. Whether you call your product private label or white label, those duties follow your name.

What do I owe for a private label cosmetic or skincare product?

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic's label (FDA: MoCRA). If that is your brand, you must:

• report serious adverse events from use in the United States to the FDA within 15 business days
• list each cosmetic product you market with the FDA, including its ingredients, and update the listing every year
• keep records that adequately support each product's safety

The FDA can also order a mandatory recall if the responsible person refuses to recall a product voluntarily. Our guide on how to start a skincare line covers which MoCRA duties a small business is exempt from and how to keep a product a cosmetic rather than a drug.

What do I owe for a private label supplement or food?

For dietary supplements, FDA's small business guide to its manufacturing rule addresses exactly this case. A distributor who contracts with a manufacturer to make a supplement, and then sells it under its own label, has an obligation to know what manufacturing is done and how, so it can decide whether the product meets its specifications and whether to approve and release it for distribution. Hiring a manufacturer does not hand that decision over. See how to start a supplement brand for the labels, claims and reports that follow.

For food and pet food, the facility that manufactures, packs or stores the product registers with the FDA, so check that your manufacturer is registered; the FDA says a broker that does not manufacture, process, pack or hold food does not have to. Our guide on how to start a pet food brand walks through the animal food rules.

What about other products, like candles, jewelry or toys?

Consumer products such as candles, jewelry, clothing and toys fall under the Consumer Product Safety Commission (CPSC). Products subject to CPSC rules may need a certificate. For general-use products that is a General Certificate of Conformity, and the CPSC says the domestic manufacturer or, for products made overseas, the importer is responsible for issuing it (CPSC: General Certificate of Conformity FAQ). Children's products need a Children's Product Certificate based on testing by a CPSC-accepted lab, and tracking labels that make the manufacturer, importer or private labeler's name ascertainable (CPSC: Children's Product Certificate).

Reporting problems is shared. Manufacturers, importers, distributors and retailers must tell the CPSC immediately, which the CPSC says means within 24 hours, when they learn of information that reasonably supports the conclusion that a product they distribute fails to comply with an applicable consumer product safety rule, among other conditions the law lists (CPSC Recall Handbook).

What changes if my manufacturer is overseas?

If you bring the goods in, you may be the importer of record. U.S. Customs and Border Protection says the importer of record is responsible for using reasonable care to enter, classify and value imported goods and to give CBP what it needs to determine whether other legal requirements have been met (CBP: Reasonable Care). For CPSC-regulated products, the importer of record is also the one who issues the safety certificate.

Origin claims need care. The FTC's standard is that a product labeled Made in USA must be all or virtually all made in the United States: final assembly or processing here, all significant processing here, and all or virtually all ingredients or components made and sourced here (FTC: Complying with the Made in USA Standard). Marketers now face civil penalties for an unqualified Made in USA label on a product that does not meet it, including online.

Do I own my brand if someone else makes the product?

The product may be your manufacturer's, but the brand can be yours. A trademark is any word, phrase, symbol or design that identifies your goods. You are not required to register one, but federal registration gives you a legal presumption that you own the mark and may use it, the right to sue in federal court, and use of the ® symbol; unregistered rights may only be enforceable where you actually use the mark (USPTO: Why register your trademark?). Our guide to business names, DBAs and trademarks explains how to check a name is free.