Private label supplements for medical practices

A functional medicine practice orders a magnesium formula from a contract manufacturer and sells it in bottles with the practice logo. A med spa launches a serum and a cleanser under its own brand. A chiropractor sells a joint supplement with “Dr. [name]’s formula” on the front. A dermatology group puts its name on a sunscreen made by someone else. The product came from a supplier, but the label now carries the practice name, and federal law attaches duties to the name on the label.

This guide reads the federal label rules for supplements and cosmetics, the adverse event reporting duties that fall on the business named on the label, FDA’s structure/function notice rule, and the FTC Act’s ban on false advertising, and explains what a practice or health company takes on when it private-labels. Claims about what a supplement does, the required FDA disclaimer and disclosing your financial interest to patients are covered in selling supplements in a medical practice; evidence for efficacy claims in “clinically proven” and “doctor recommended” claims; origin claims in Made in USA claims for health products; and “natural” and “organic” in natural, organic and eco-friendly claims. California warning duties for a practice brand sold online are covered in our guide to Prop 65 warnings for health products sold online. If you sell the line through a third-party marketplace, see our guide to selling health products on online marketplaces. For chemical peel claims and take-home peel products, see our guide to chemical peel advertising rules. If your line includes a lash or brow serum, see our guide to eyelash serum advertising rules. Before you sell a brightening or lightening product, read our guide to melasma treatment marketing.

This is general information, not legal or medical advice. Sources cited were checked on November 1, 2026: 21 CFR 101.5, 101.36 and 101.93 and 21 CFR 701.3 and 701.12 in the eCFR version up to date as of October 29, 2026; and 21 USC 321, 343(y), 364, 364a, 364d, 364e and 379aa-1 and 15 USC 45 and 52 on Cornell’s Legal Information Institute. We did not read FDA’s supplement manufacturing rules in 21 CFR Part 111, cosmetic registration and listing under 21 USC 364c, FDA guidance documents, or state law; those may also apply. Private-labeled devices and drugs have their own rules and are not covered here.

The short version

Your name on the label is a legal statement. For both supplements (21 CFR 101.5) and cosmetics (21 CFR 701.12), the label must name the manufacturer, packer or distributor, and if the named business did not make the product, the name must be qualified with wording such as “Manufactured for” or “Distributed by”.
The named business owns adverse event reporting. For supplements, 21 USC 379aa-1 makes the business whose name appears on the label the responsible person who must report serious adverse events to FDA within 15 business days. For cosmetics, 21 USC 364 and 364a do the same.
Cosmetics need safety substantiation on file. 21 USC 364d requires the responsible person to ensure, and keep records supporting, adequate substantiation that the product is safe.
Structure/function statements need a notice. 21 CFR 101.93(a) requires the manufacturer, packer or distributor to notify FDA no later than 30 days after first marketing a supplement that carries one, and to certify that it has substantiation that the statement is truthful and not misleading.
The claim decides what the product is. A skincare product sold to affect the structure or function of the body, or a supplement labeled to treat or prevent disease, can be a drug under 21 USC 321(g)(1) and 21 CFR 101.93(f)-(g).
Ads are on you, whoever made it. 15 USC 52 makes it unlawful to disseminate a false advertisement likely to induce the purchase of food, drugs, devices, services or cosmetics.

Who is the responsible person

Private labeling usually means a contract manufacturer makes the product and the practice or company sells it under its own brand. The federal rules look at the label, not the factory. Under 21 CFR 101.5(a) the label of a packaged food, which includes a dietary supplement, must conspicuously state the name and place of business of the manufacturer, packer or distributor. 21 CFR 701.12(a) sets the same rule for cosmetics. In both, when the product is not made by the business named, the name must be qualified by a phrase that reveals the connection, such as “Manufactured for” or “Distributed by”, or other wording that expresses the facts (101.5(c), 701.12(c)). For a corporation, only the actual corporate name satisfies the rule; a business run as an individual, partnership or association uses the name under which it does business (101.5(b), 701.12(b)). The place of business includes street address, city, state and ZIP code, with the street address allowed to be omitted if it is in a current city or telephone directory (101.5(d), 701.12(d)).

That printed name then decides who carries the reporting duties:

Supplements. 21 USC 379aa-1(b)(1) defines the responsible person as the manufacturer, packer or distributor whose name appears on the label of a dietary supplement marketed in the United States. Under 379aa-1(b)(2), a retailer whose name appears on the label as distributor may, by agreement, authorize the manufacturer or packer to submit the reports, as long as the retailer directs to it all adverse events reported to the retailer through the label’s address or phone number.
Cosmetics. 21 USC 364(4) defines the responsible person as the manufacturer, packer or distributor of a cosmetic product whose name appears on its label.

A practice brand on the front of the bottle and a small “Distributed by [Practice LLC]” on the back makes the practice the responsible person. Put the practice’s actual legal name there, not a marketing name, unless the business is actually conducted under that name, and agree in writing with the manufacturer who does what when a report comes in.

Adverse event reports: the duty that comes with the name

For supplements, the label must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event; a supplement without one is misbranded under 21 USC 343(y). The responsible person must submit any report it receives of a serious adverse event, with a copy of the label, no later than 15 business days after receiving it, using the MedWatch form, and must send new medical information received within a year of the first report within 15 business days of receiving it (379aa-1(b)-(d)). Records of each adverse event report received must be kept for 6 years (379aa-1(e)(1)).

For cosmetics, 21 USC 364e(a) requires each cosmetic product label to include a domestic address, domestic phone number or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports. A statutory note says 364e(a) took effect 2 years after December 29, 2022. Under 364a, the responsible person must submit any report received of a serious adverse event, with a copy of the label, no later than 15 business days after receiving it, and keep records of each adverse event report for 6 years, or 3 years for a small business that qualifies under 364h and does not make the product types listed in 364h(b).

A serious adverse event is defined in each statute. For supplements (379aa-1(a)(2)), it is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or that requires medical or surgical intervention to prevent one of those. The cosmetics definition (364(5)) adds an infection and significant disfigurement, including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance, other than as intended.

For a practice this has a marketing side. The phone number or web address on the label is now a safety intake channel. Whoever answers it, including a front desk, a call service or an AI front desk, needs a script that recognizes a reaction report and routes it to a named person the same day, so the 15-business-day clock is not lost in a general inbox. Both statutes say a report may be accompanied by a statement denying that it is an admission that the product caused or contributed to the event (379aa-1(f)(1), 364a(g)(1)).

Skincare: cosmetic, drug, or both

21 USC 321(i) defines a cosmetic as an article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance; soap is excluded. 21 USC 321(g)(1) defines a drug to include articles intended for the diagnosis, cure, mitigation, treatment or prevention of disease, and articles, other than food, intended to affect the structure or any function of the body. The intended use comes from how the product is presented, so the words on the jar, the product page and the ads all count.

A med spa serum that “improves the appearance of fine lines” is written as a cosmetic claim. The same serum described as one that “repairs collagen”, “treats acne” or “reverses sun damage” is written as a claim to affect the body’s structure or to treat a condition, which is drug language under 321(g)(1). A practice brand does not change that, and a clinician’s name on the front tends to make the medical reading more likely, not less. Our dermatology practice marketing guide covers treatment claims for in-office procedures.

For a product that stays a cosmetic, the responsible person must ensure, and maintain records supporting, adequate substantiation of safety (21 USC 364d(a)). The statute defines that as tests or studies, research, analyses or other evidence or information considered, among qualified experts, sufficient to support a reasonable certainty that the product is safe (364d(c)(1)), and safe as not injurious to users under the labeled or customary conditions of use (364d(c)(2)). Ask the manufacturer for that file before launch, and keep a copy, because the duty sits with the business named on the label.

Two more label points from the rules read here. 21 CFR 701.3(a) requires a declaration of each ingredient in descending order of predominance, with fragrance or flavor allowed to be listed as such. And under 21 USC 364e(c), a cosmetic intended to be used only by a professional, defined as someone licensed by a state in cosmetology, nail care, barbering or esthetics, must carry a clear and prominent statement that it shall be administered or used only by licensed professionals. A back-bar product relabeled for retail needs a retail label.

The cosmetics statute’s definition of facility, which governs registration, excludes physicians’ offices and health care clinics, and establishments that only label, relabel, package, repackage, hold or distribute (21 USC 364(3)(B)). That exclusion is about the facility. It does not remove the responsible person duties above from the business whose name is on the label.

Supplements: label panel and structure/function notice

A supplement offered for sale must carry nutrition labeling in a “Supplement Facts” panel under 21 CFR 101.36(a)-(b), with serving size and the dietary ingredients listed as that section specifies. If the formula uses a proprietary blend, 101.36(c) requires the blend to be identified by the term “Proprietary Blend” or another appropriately descriptive term or fanciful name, and the other dietary ingredients in it to be listed in descending order of predominance by weight. The manufacturer usually prepares this panel; check that the version printed under your name matches the formula you approved.

If the label or labeling carries a structure/function statement, 21 CFR 101.93(a) requires the manufacturer, packer or distributor to notify FDA’s Office of Dietary Supplement Programs no later than 30 days after first marketing the product. The notice includes the name and address of the business, the text of the statement, the ingredient and the product name, and is signed by a responsible individual who certifies that the notifying firm has substantiation that the statement is truthful and not misleading (101.93(a)(2)-(3)). If your contract manufacturer filed the notice for its own stock brand, ask whether it covers your product name and your wording; a notice names a product and a statement. Get a copy for the file either way.

The disclaimer text and its placement, size and boxing rules are in 101.93(b)-(e), and our supplements guide walks through them. The line that matters most for a practice brand is in 101.93(f)-(g): a structure/function statement may not be a disease claim, and a supplement whose label or labeling makes one is regulated as a drug unless the claim is an authorized health claim it qualifies for. 101.93(g)(2)(iv) lists the product name and pictures, vignettes or symbols among the ways a label can imply a disease claim. A practice-branded product named after a condition the practice treats, or with an organ or symptom image on the label, deserves a second look.

Advertising the line

The label rules govern the package. The FTC Act governs the ads. 15 USC 52(a) makes it unlawful to disseminate, or cause to be disseminated, any false advertisement likely to induce the purchase of food, drugs, devices, services or cosmetics, and 52(b) makes that an unfair or deceptive act or practice under 15 USC 45. Private labeling raises a few specific risks:

“Our formula” or “developed by Dr. [name]”. If the product is a manufacturer’s stock formula with your label, say so or do not imply otherwise. A claim that the clinician formulated it needs to be true.
Borrowed evidence. A manufacturer’s study on its own formula supports your product only if the formula, dose and form are the same. Our clinically proven claims guide covers what the FTC expects.
Recommendations from the exam room. When the brand is the practice’s own, a clinician’s recommendation is also a sales pitch. The disclosure and ethics points are in our supplements guide.
Origin and “natural” claims. “Made in USA”, “clean” and “organic” are claims about the manufacturer’s inputs, which you need to document. See our Made in USA and natural and organic guides.
Product page and label must match. A website product page, an email or a social post that describes the product’s intended use is part of how the product is presented. A cosmetic label with drug claims on the website is a drug claim.

A launch checklist

Decide the product category from the claims you want. Cosmetic, supplement or drug. If the marketing needs treatment language, the product is not a cosmetic or a supplement under the definitions read here.
Get the files from the manufacturer. Formula, Supplement Facts or ingredient declaration, safety substantiation for cosmetics, any 101.93 notice and the evidence for every claim.
Set the label name correctly. Actual legal name, “Distributed by” or “Manufactured for”, full place of business.
Put a working contact on the label. Domestic phone or address for supplements; domestic address, phone or electronic contact for cosmetics. Test that it reaches a person.
Write the adverse event procedure. Who receives reports, who decides if one is serious, who files within 15 business days, where records are kept for 6 years. Put any reporting agreement with the manufacturer in writing.
File or confirm the structure/function notice. Within 30 days of first marketing, for each statement.
Review every ad and page against the label. Same claims, same intended use, no disease claims, true statements about who formulated and made it.
Plan for recalls. Lot numbers on every unit and sales records linked to lots. See marketing during a product recall.

Use and avoid

Use: “Distributed by [Practice legal name], [street, city, state, ZIP].” Avoid: only the practice logo and a web address.
Use: “Supports healthy joint function.*” with the disclaimer and a filed notice. Avoid: “Joint pain relief formula” as the product name.
Use: “Helps improve the look of dry skin.” Avoid: “Treats eczema” or “repairs your skin barrier” on a product sold as a cosmetic.
Use: “Made for our practice by a contract manufacturer.” Avoid: “Formulated by Dr. [name]” when the formula is the manufacturer’s stock blend.
Use: a label contact line answered by staff trained to route reaction reports. Avoid: a general info inbox that is checked weekly.

An illustration

This is a made-up example, not a client. A med spa launches a three-product skincare line with its name on the front. The back says “Made in USA” and lists only the med spa’s website. The product page calls the serum a “collagen-rebuilding treatment”, and one product is a back-bar peel relabeled for retail without changing the label.

The fix: add “Distributed by” with the med spa’s legal name and full address, and a contact line for adverse event reports; rewrite the serum claim to describe appearance only, or treat the product as a drug question for regulatory counsel; get the manufacturer’s safety substantiation and the evidence for the origin claim; take the peel off the retail shelf until it has a retail label, since its label says it is for professional use; and set up an intake script at the front desk for reaction calls.

How we help

We build product pages and practice websites, write search-focused content, run Google Ads and lead generation, and set up an AI front desk that can route product reaction calls to the right person. We check copy against the rules as read on the day, but we are not a law firm and do not give legal or regulatory advice. Related guides: functional medicine practice marketing, med spa marketing ideas and our guide to healthcare marketing rules.

Can a medical practice sell supplements under its own brand?

Federal law does not prohibit it, but the business named on the label takes on duties. 21 CFR 101.5 requires the label to name the manufacturer, packer or distributor, qualified with wording such as “Distributed by” when it did not make the product, and 21 USC 379aa-1 makes that named business the responsible person for serious adverse event reports. State law and licensing board rules may also apply; we did not read them.

Who reports adverse events for a private-label supplement?

The business whose name appears on the label, under 21 USC 379aa-1(b)(1), within 15 business days of receiving a serious adverse event report. A retailer named as distributor may, by agreement, authorize the manufacturer or packer to file, if it forwards all reports it receives (379aa-1(b)(2)).

Does our private-label skincare need a contact on the label?

Yes. 21 USC 364e(a) requires a cosmetic label to include a domestic address, domestic phone number or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports.

Is our manufacturer’s structure/function notice enough?

21 CFR 101.93(a) requires a notice naming the product and the statement, filed by the manufacturer, packer or distributor within 30 days of first marketing. Confirm that a filed notice covers your product name and your exact wording, and keep a copy.

Can a private-label skincare product say it treats acne or repairs collagen?

A claim to treat a disease or to affect the structure or function of the body is drug language under 21 USC 321(g)(1). A cosmetic under 321(i) is for cleansing, beautifying, promoting attractiveness or altering the appearance. Get regulatory counsel review before using treatment claims.

Can we sell a professional-use product to patients?

21 USC 364e(c) requires a cosmetic intended only for professional use to carry a statement that it shall be administered or used only by licensed professionals. A product sold at retail needs a label for that use.

Sources

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Private-label supplements and skincare: label rules