Selling supplements and retail products in a medical practice: ethics, FDA and FTC rules

A shelf of supplements by the checkout desk, a skin care line in the treatment room or an online dispensary linked from the patient portal can look like a simple add-on to a practice. It is not simple. The moment a clinician recommends a product the practice profits from, three sets of rules apply at once: medical ethics on the conflict of interest, FDA law on what the product label and labeling may say, and FTC law on every ad, page and post that promotes it. If federal program patients are involved, fraud and abuse laws can apply as well. This guide sets out what each source says and turns it into practical choices for the shelf, the website and the conversation in the exam room.

Neighboring topics have their own guides, so they are not repeated here. How a functional medicine practice explains its model, its lab panels and its supplement follow ups is covered in functional medicine practice marketing, and claims about integrative treatments in integrative medicine marketing claims. Gift cards, free items and the federal limits on gifts to Medicare and Medicaid patients are covered in med spa gift card and promotion rules. Emailing patients about what you sell is covered in healthcare email marketing, and paid endorsers in healthcare influencer marketing. Organic and natural labels on what you sell are covered in our guide to natural, organic and eco-friendly claims. Commissions on product links from your website or social posts are covered in affiliate links on health content. What to stop and say when a product on your shelf is recalled is covered in marketing during a product recall. Selling a product under your own practice brand is covered in private-label supplements and skincare. If you ship supplements to California, see our guide to Prop 65 warnings for health products sold online. For lash and brow serums on the retail shelf, see our guide to eyelash serum advertising rules. Practices that sell CBD should read medical cannabis and CBD clinic marketing.

What the AMA Code of Medical Ethics says

The AMA Code of Medical Ethics addresses this directly in Opinion 9.6.4, Sale of Health-Related Products. It defines health-related products as any products other than prescription items that, according to the manufacturer or distributor, benefit health. It defines selling broadly: dispensing items from the physician’s office or website in exchange for money, or endorsing a product the patient may order or purchase elsewhere that results in remuneration for the physician. So an affiliate link or a commission from an outside dispensary counts, not only a shelf in the waiting room.

The opinion says physician sale of these products raises ethical concerns about financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust. Physicians who choose to sell have five obligations under it. They should offer only products whose claims of benefit rest on peer-reviewed literature or other unbiased, sound, systematic and reliable scientific review, and should not offer products whose claims lack scientific validity. They should fully disclose the nature of their financial interest, in person or in writing, and tell patients the product or an equivalent is available elsewhere. They should limit sales to products that serve immediate and pressing needs of their patients; the opinion’s example is sparing a patient on crutches a trip to the pharmacy. They should explain the risks, benefits and limits of scientific knowledge about the products in language patients understand. And they should avoid exclusive distributorship arrangements that make products available only through physician offices.

The opinion also says that distributing products free of charge or at cost helps to eliminate the elements of personal gain and financial conflict of interest. That is the clearest signal in the text: the further a sale moves from convenience toward profit, the harder it is to square with the opinion. The opinion is written for physicians. Other licensed professions have their own ethics codes and boards, and state boards set their own rules, so check the code and board that cover your license as well.

What a structure/function claim is, and what it is not

Supplement benefit statements on labels are structure/function claims, a category created by 21 U.S.C. 343(r)(6). Under that section, a statement for a dietary supplement may describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterize the documented mechanism by which it acts to maintain that structure or function, describe general well-being from consuming it, or claim a benefit related to a classical nutrient deficiency disease if it also discloses how prevalent that disease is in the United States. FDA’s own examples on its Structure/Function Claims page are calcium builds strong bones and fiber maintains bowel regularity. If a label or product page says the supplement is made in the U.S., our guide to Made in USA claims covers the FTC standard for that statement.

The same section draws the line: a statement under it may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. FDA’s regulation at 21 CFR 101.93(g) spells out what counts as a disease claim. A statement crosses the line if it claims, explicitly or implicitly, an effect on a specific disease or class of diseases, or on the characteristic signs or symptoms of one, in scientific or lay terms. It also crosses the line through the product name, through a formulation claim about an ingredient FDA has regulated as a drug, through a cited article that implies a disease use, through pictures or symbols, by presenting the product as a substitute for a therapy for a disease, or by claiming it augments a drug or therapy for a disease. Under 21 CFR 101.93(f), a supplement whose label or labeling bears a disease claim will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.

For a practice, the practical reading is this. Supports healthy joints may be a structure/function claim; eases arthritis pain names a disease and its symptoms. Supports healthy circulation may be one; lowers high blood pressure is not, and the rule itself gives hypertension as an example of a disease state. A shelf talker, a product page or a clinician’s handout that names a diagnosis next to a product can turn a supplement into an unapproved drug claim, even if the bottle itself is labeled correctly.

The required FDA disclaimer and where it goes

A structure/function statement may only be made, under 21 U.S.C. 343(r)(6), if the manufacturer has substantiation that the statement is truthful and not misleading, and if the statement carries, prominently displayed and in boldface type, this text: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The manufacturer must notify FDA no later than 30 days after first marketing the supplement with the statement.

FDA’s regulation at 21 CFR 101.93 sets the details. Where there is more than one statement, each can carry the disclaimer, or a plural version can be used: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The disclaimer goes next to the statement with nothing in between, or is linked to it with a symbol such as an asterisk. On labels and in labeling such as pamphlets and catalogs, it appears on each panel or page where a statement appears, set off in a box where it is not next to the statement, in boldface type no smaller than one-sixteenth inch.

Two points matter for a practice. First, the substantiation and notification duties sit with the manufacturer, packer or distributor, so ask your supplier in writing whether each claim you plan to repeat was notified and what substantiation backs it. Second, if your website or printed handouts repeat a manufacturer’s claim, keep the disclaimer with it. FDA describes labeling broadly enough to include pamphlets and catalogs, and the FTC treats your pages and posts as advertising either way.

Why the disclaimer does not make an ad safe

The FTC’s Health Products Compliance Guidance says plainly that the FDA labeling rules for structure/function claims do not govern how the FTC assesses those claims in advertising. The FTC applies the same steps to any health-related claim, whether FDA would call it a health claim, a structure/function claim or a drug claim. Claims about the efficacy or safety of supplements require substantiation in the form of competent and reliable scientific evidence, a standard the guidance builds on 15 U.S.C. 45 and 52.

On the disclaimer itself, the guidance says the DSHEA disclaimer or similar statements will not cure an otherwise deceptive ad, particularly where the deception concerns claims about the health-related benefits of a product. Its example is an herbal supplement ad that claims to treat diabetes and carries the disclaimer prominently; the FTC calls the ad deceptive despite the disclaimer. The guidance also warns against implying that FDA has approved a claim because the manufacturer followed the notification and disclaimer rules. So never write FDA reviewed, FDA approved or FDA compliant about a supplement or its claims.

The guidance also matters for who is responsible. It says the FTC has taken action not just against product marketers but, in appropriate circumstances, against individual owners and corporate officers, ad agencies, distributors, retailers, catalog companies, infomercial producers, expert endorsers and others engaged in deceptive marketing. A practice that sells a product and a clinician who recommends it can be both a retailer and an expert endorser. Repeating a manufacturer’s claim does not shift responsibility for it to the manufacturer.

Blood pressure is one place where supplement copy drifts into disease claims. Lowering-without-medicine wording, the FDA definition of a drug claim and the emergency steps a blood pressure page needs are covered in our guide to hypertension program marketing.

Disclosing your financial interest

The AMA opinion asks for full disclosure of the nature of the financial interest. FTC law points the same way whenever the recommendation is public. Under 16 CFR 255.5, when a connection between an endorser and the seller might materially affect the weight or credibility of the endorsement, and the audience would not reasonably expect it, the connection must be disclosed clearly and conspicuously. Material connections include monetary payment and free or discounted products. A clinician who recommends a product on the practice’s social accounts, in a video or in a newsletter, and earns a margin or commission on it, has that kind of connection.

A disclosure that works in both settings is short and specific. In the office, a printed note at the shelf and on the receipt: We sell these products and earn money on each sale. The same or equivalent products are available from other stores, and you are free to buy them anywhere. Online, the same sentence on each product page and in each post that links to a product, placed where the reader sees it before the link, not in a footer.

Pressure, convenience and the exam room

The AMA opinion flags undue pressure on the patient as a core risk. The exam room is where that risk is highest, because the person recommending the product is the person the patient trusts with their care. A few habits keep the recommendation clinical. Give the recommendation as an ingredient, form and amount the patient can buy anywhere, not as your product name. Tell the patient they do not need to buy it from you. Keep payment for products at the front desk, separate from the visit, and never bundle a product into a visit fee without saying so. Do not tie a discount on care to a product purchase.

The opinion’s own test is useful here: is the sale meeting an immediate and pressing need, or is it a revenue line? A practice that cannot answer the first way for a product may decide not to stock it, or to stock it at cost, as the opinion suggests.

Federal program patients and an owned product line

Two federal fraud and abuse laws come into view when a federal health care program is involved, for example when a practice steers Medicare or Medicaid patients toward products from a line it owns or profits from. The anti-kickback statute at 42 U.S.C. 1320a-7b(b) makes it a felony to knowingly and willfully offer, pay, solicit or receive remuneration in return for referring, or for purchasing, ordering or recommending, any item or service for which payment may be made in whole or in part under a federal health care program. If a manufacturer pays the practice for recommending or ordering items any federal program pays for, that statute is in view.

The physician self-referral law at 42 U.S.C. 1395nn bars a physician from referring Medicare patients for designated health services to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. The statutory list of designated health services includes durable medical equipment and supplies, parenteral and enteral nutrients, equipment and supplies, and outpatient prescription drugs. If any part of an owned product line falls on that list and is billed to Medicare, the law is in view.

Separately, 42 U.S.C. 1320a-7a(a)(5) sets civil penalties for offering or transferring remuneration to a Medicare or state health care program beneficiary that the person knows or should know is likely to influence the beneficiary to order or receive from a particular provider any item or service payable by those programs. Free samples and product giveaways to these patients fall under that question; the nominal value limits are explained in our gift card and promotion rules guide. Whether any of these laws applies to your arrangement depends on facts this guide cannot see, so take the details to health care counsel before you launch.

Illustration: a family practice adds a supplement shelf

Illustration: a family practice plans a shelf of vitamin D, fish oil and a heart blend, with a sign reading Feel better with doctor-recommended supplements, and a clinician script that names the heart blend for patients with high blood pressure. Before launch, the practice asks each supplier in writing whether every claim was notified to FDA and what substantiation supports it. It drops the heart blend’s blood pressure language and keeps only the manufacturer’s structure/function statement, with the disclaimer. The sign is replaced by a price list, a disclosure that the practice earns money on each sale and a note that equivalent products are sold elsewhere. Clinicians recommend an ingredient and amount, not the shelf.

Illustration: an aesthetic practice launches an online store for its skin care line and posts weekly videos in which a clinician uses the products. Each video now opens with a spoken and on-screen note that the practice sells the products shown. The store’s product pages drop claims about treating acne and rosacea and describe what each product is and how to use it. The practice decides not to sign a supplier contract that would make it the only outlet for one line, in light of the AMA opinion on exclusive distributorships. If the store ships orders, the FTC mail order rule sets what your shipping promises must rest on and when refunds are due.

Checklist

• Every product meets the AMA Opinion 9.6.4 test: benefit claims rest on sound, unbiased scientific review, and the sale meets a real patient need.
• Financial interest disclosed in writing at the shelf, on receipts and on every product page and post (AMA 9.6.4; 16 CFR 255.5).
• Patients told, in person and in writing, that the same or equivalent products are available elsewhere.
• No exclusive distributorship that makes a product available only through physician offices.
• Only structure/function language; no claim that a product treats, cures, mitigates or prevents a disease or its symptoms (21 U.S.C. 343(r)(6); 21 CFR 101.93(g)).
• No disease words in product names, images, cited articles or shelf signs.
• The FDA disclaimer kept with every repeated structure/function claim, in boldface, next to the claim or linked by an asterisk (21 CFR 101.93).
• Written confirmation from each supplier that claims were notified to FDA and are substantiated.
• No FDA approved, FDA reviewed or FDA compliant wording about any supplement or claim.
• Ad and social claims backed by competent and reliable scientific evidence (15 U.S.C. 45, 52; FTC Health Products Compliance Guidance).
• Product payment separate from visit payment; no product bundled into a fee without saying so.
• Any manufacturer payment, owned product line or free products for Medicare or Medicaid patients reviewed by health care counsel first (42 U.S.C. 1320a-7b(b), 1395nn, 1320a-7a(a)(5)).

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a practice that sells supplements or other health products, we can build a website that keeps clinical pages and retail pages apart, puts the financial interest disclosure and the FDA disclaimer where they belong, and keeps disease claims out of product pages, posts and ads. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We do not sell lead lists and we do not pay for referrals. For the wider rules, see our healthcare marketing rules hub.

Sources

• AMA Code of Medical Ethics: Opinion 9.6.4, Sale of Health-Related Products (CEJA Report 3-A-16; page updated December 17, 2024)
• 21 U.S.C. 343(r)(6): Misbranded food, statements for dietary supplements
• 21 CFR 101.93: Certain types of statements for dietary supplements
• FDA: Structure/Function Claims (content current as of March 28, 2024)
• 15 U.S.C. 45: Unfair methods of competition unlawful; prevention by Commission
• 15 U.S.C. 52: Dissemination of false advertisements (FTC Act section 12)
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 255.5: Disclosure of material connections
• 42 U.S.C. 1320a-7b(b): Illegal remunerations (anti-kickback statute)
• 42 U.S.C. 1395nn: Limitation on certain physician referrals
• 42 U.S.C. 1320a-7a(a)(5): Civil monetary penalties, inducements to beneficiaries

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