Direct comparison
Dropshipper vs Reseller vs Affiliate (Medical)
Dropshipper, reseller or affiliate for medical supplies? See which FTC, FDA 21 CFR 807 and anti-kickback rules attach to each model, from primary texts.
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How do Dropshipper, Reseller, Affiliate compare side by side?
The table below compares Dropshipper, Reseller, Affiliate across 9 procurement-relevant dimensions, from role in the sale (editorial description) through source.
Side-by-side comparison
| Dimension | Dropshipper | Reseller | Affiliate |
|---|---|---|---|
| Role in the sale (editorial description) | Sells to the buyer under its own store; a supplier ships the product. Editorial description of common usage; the term is not defined in the regulations read. | Buys product and sells it on to customers. Editorial description of common usage; the term is not defined in the regulations read. | Recommends a product it does not sell and is paid when a buyer acts on the recommendation. Editorial description of common usage; the term is not defined in the regulations read. |
| Defined in FDA device regulations? | No. 21 CFR 807.3 defines "commercial distribution" and "wholesale distributor" but not "dropshipper". | No. 21 CFR 807.3 does not define "reseller". It defines "wholesale distributor" as a person other than the manufacturer or initial importer who distributes a device from the original place of manufacture to the final user. | No. 21 CFR 807.3 does not define "affiliate". |
| FDA 21 CFR 807.65 exemptions that may be relevant | Section 807.65(e) exempts "pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale" to the ultimate user. The section does not mention dropshippers, so whether a given business fits is a question for the text and counsel. | Same 807.65(e) retail exemption; 807.65(i) separately exempts persons who dispense devices to the ultimate consumer. The section does not mention wholesalers or distributors as exempt or required. | Recommending a product is not itself distributing the device (editorial reading of the 807.3 definitions; the actual arrangement controls). |
| FTC Endorsement Guides, 16 CFR 255.5 (material connection) | Applies if the seller also publishes endorsements or reviews with a payment or free-product connection. | Applies in the same circumstances: if it publishes paid or incentivised endorsements. | Central. A material connection "must be disclosed clearly and conspicuously"; connections can include monetary payment or free or discounted products, and the disclosure must clearly communicate the nature of the connection. |
| FTC Mail, Internet, or Telephone Order Merchandise Rule, 16 CFR 435.2 | Applies to the seller that solicits the order: a reasonable basis to expect to ship; with no stated time, shipment within 30 days of a properly completed order (50 days if the buyer applies for credit when ordering). How the FTC treats dropshippers specifically was not read. | Applies when it solicits orders: same reasonable-basis and 30-day default duties. | Does not attach to the recommending activity if the affiliate does not take the order (editorial reading). |
| Late shipment duty | If it cannot ship on time, the seller must offer, clearly and conspicuously and without prior demand, the option to consent to a delay or to cancel (16 CFR 435.2). | Same duty as the seller of the order. | Not applicable unless the affiliate is the seller. |
| Anti-kickback statute, 42 USC 1320a-7b(b) | Concerns remuneration for referring or arranging items payable under a Federal health care program. Relevant only to such items; the statute text does not address dropshipping. | Same scope: only items payable under a Federal health care program. | Most directly relevant. It is a felony to knowingly and willfully solicit or receive remuneration for referring an individual, or for purchasing, ordering, arranging for or recommending covered items, or to offer or pay it. The statute text reads "fined not more than $100,000 or imprisoned for not more than 10 years, or both". Federal health care program items only. |
| When to pick each (editorial) | When you will take orders under your own name and can rely on a supplier to deliver within the time you promise. | When you will take orders as the seller of record. | When you will recommend products you do not sell and can disclose the payment clearly; read the anti-kickback statute first if the items could be paid by a Federal health care program. |
| Source | 21 CFR 807.3, 807.65; 16 CFR 435.2 (law.cornell.edu, read 2026-11-01) | 21 CFR 807.3, 807.65; 16 CFR 435.2 (law.cornell.edu, read 2026-11-01) | 16 CFR 255.5; 42 USC 1320a-7b(b) (law.cornell.edu, read 2026-11-01) |
Common questions
Common questions about Dropshipper vs Reseller vs Affiliate
Are dropshipper, reseller and affiliate defined in FDA regulations?
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No. 21 CFR 807.3 defines terms such as "commercial distribution" and "wholesale distributor", not these three commercial labels. What applies depends on what the business actually does.
Does an affiliate have to disclose payment?
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Under the FTC Endorsement Guides (16 CFR 255.5), a material connection, including monetary payment or free or discounted products, must be disclosed clearly and conspicuously.
Which rule covers shipping times for a dropshipping seller?
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The FTC Mail, Internet, or Telephone Order Merchandise Rule (16 CFR 435.2) applies to the seller that solicits the order: a reasonable basis to ship, a 30-day default, and a delay-or-cancel option if shipment will be late.
