The law that governs research-use-only sales is old. Section 201(g)(1) of the Food, Drug, and Cosmetic Act dates from 1938, and the idea of objective intent behind 21 CFR 201.128 is decades older than online retail. What is changing is everything around the law: how the agency finds violations, how quickly it acts, what it can read, and what records it expects businesses to have. This article separates what has already happened from what we expect to happen, and sets out what that means for the platforms that intend to remain in this market.
What has already changed
These developments are matters of public record:
- Online surveillance is routine. FDA's drug compliance office describes surveillance to identify unapproved and misbranded drugs sold online as part of its ongoing work, and its 2025 report records dozens of warning letters arising from GLP-1 products alone.
- Research-use-only sellers are a named target. FDA has stated publicly that it has warned companies selling unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that were falsely labeled "for research purposes" or "not for human consumption".
- Letters arrive in sweeps. In 2026, groups of warning letters to online peptide sellers were issued on single dates, in March and again in August, each following a documented review of the seller's website.
- The agency has deployed AI. FDA launched an agency-wide generative AI tool in June 2025, stating that it was already being used to help identify high-priority inspection targets. In December 2025 it announced agentic AI capabilities intended to assist with, among other things, post-market surveillance, inspections and compliance.
- Records are requested remotely. FDA's compliance office reports expanding remote regulatory assessments, including mandatory records requests, to obtain information quickly and plan inspections.
- Supply is controlled at the border. Import Alert 66-80 restricts GLP-1 active ingredients to a green list of manufacturers whose facilities appear to comply with good manufacturing practice, and Import Alert 66-41 allows detention of unapproved new drugs promoted in the United States.
- Prosecutions conclude in prison sentences. In July 2026, the operators of an online peptide business were sentenced to 70 and 16 months for introducing unapproved new drugs into interstate commerce with intent to defraud and mislead.
Much of this record consists of FDA's interpretations and priorities, not settled law. Warning letters are, in FDA's words, informal and advisory
; enforcement priorities shift with leadership and resources; and the regulations themselves are revised from time to time. The record is the best available guide to the present, and only a guide.
What we expect
The following is our analysis, not a description of announced policy. It is what the record above suggests about the direction of travel. Because it rests on FDA's current interpretation, it could be overtaken by a change in that interpretation, by new rules or by the courts, in either direction.
1. Review at the scale of the whole market
When reading a website is the main investigative step, and reading can be done by machine, the limiting factor on enforcement is no longer staff time. We expect every seller in a category to be reviewed, not a sample, and reviewed repeatedly. A site will be judged on all of its pages at once, and on how they change over time.
2. Evidence gathered across channels
Intended use can be shown by statements of a seller's representatives and by the circumstances of distribution. As review becomes cheaper, we expect the evidence to be drawn more often from beyond the store: social accounts, affiliate content, discount-code partners, marketplaces and community groups that point back to a seller.
3. Knowing the buyer becomes the expectation
A claim to sell for research is easier to believe when the seller can show who its buyers are and why they are buying. We expect buyer qualification, with records, to move from an unusual practice to a baseline that regulators, payment providers and partners assume.
4. Traceability borrowed from regulated supply chains
Prescription drug supply chains in the United States already operate under the Drug Supply Chain Security Act, with package-level tracing between trading partners. Research materials are outside that statute, but the expectation it sets is spreading: that a supplier can trace any unit to its source, its testing and its buyer.
5. Records on request
Remote records requests are already a standard tool in regulated industries. We expect any business that claims to sell for research to be asked, sooner or later, to prove it: every statement made about a product, every buyer it was sold to, and the terms on which it was sold.
6. Gatekeepers move first
Payment providers, advertising platforms, hosting companies and carriers each carry their own risk. We expect them to tighten their own rules ahead of formal regulation, so that a seller's access to the basic infrastructure of commerce depends on being able to demonstrate compliance, not merely assert it.
7. The end of the disclaimer era
Taken together, these changes end the period in which a research-use-only label could stand in for a research-use-only business. What will matter is evidence, gathered automatically, across every channel, and compared against the records the seller can produce.
The question regulators ask will not be "what does your label say?" It will be "show us".
What a next-generation platform will need
If that expectation is right, the platforms that remain will need capabilities that ordinary e-commerce software does not provide. Each answers a part of the intended-use test.
| Capability | What it must do | What it answers |
|---|---|---|
| Continuous content review | Check every page, product description, email, notification and support reply against intended-use rules before publication, and re-check everything when rules or the record change | Expressions and labeling |
| Catalogue governance | Make product selection, names, groupings, blends and accompanying items compliance decisions, with a record of why each was made | Design, composition and circumstances of distribution |
| Buyer qualification | Verify identity and age, capture organisation and research purpose, and refuse buyers who do not qualify | To whom products are sold |
| Recorded agreements | Store each buyer's acceptance of research-use terms, and each order's attestation, with the version of the terms in force | What the seller required, and when |
| Communication discipline | Decline use questions consistently, log them, and act on what they reveal | Oral and written statements; the seller's knowledge |
| Control of representatives | Ensure no one speaks for the business whose statements the business does not control | Statements of representatives |
| Lot traceability | Link every unit sold to its lot, its testing and its certificate of analysis, and every lot to its source | Whether the product is what its labeling says |
| Permanent history | Keep an unalterable record of content, catalogue, buyer and order changes | Records on request |
| Regulatory monitoring | Track warning letters, import alerts, statements and rule changes, and apply what they show to the catalogue and content | A record that keeps moving |
Why it cannot be added later
None of these capabilities is difficult to describe. What makes them difficult is that they depend on each other. A records request does not ask for a page, or a customer, or a lot. It asks for all of them at once: what was said about a product, to whom it was sold, on what terms, from which lot, with what testing, and what the business knew. Answering that requires a platform in which content, buyers, agreements, orders, lots and communications are joined in one record from the first sale.
A storefront theme, a plugin or a policy page cannot supply that after the fact. Neither can a team that starts building it on the day a letter arrives: the record a regulator asks for is a record of the past, and it either exists or it does not.
Compliance that can be proven has to be built before it is needed. By the time it is asked for, it is too late to start.
Why we publish this
Most sellers in this market would rather not discuss any of this. We publish it because it describes the standard we hold ourselves to, and because researchers, partners and regulators are entitled to know that some suppliers have chosen to meet it in full, at whatever cost to growth.
Frequently asked questions
- Is any of this new law?
- No. The definitions and the intended-use test are long established. What is changing is the scale and speed of enforcement, and the records businesses are expected to hold.
- Which parts of this article are fact and which are forecast?
- The first section describes the public record and cites it. The section headed "What we expect" is our analysis of where that record points.
- Will AI review replace human judgment at FDA?
- FDA describes its tools as assisting staff, with human oversight. What they change is how much can be reviewed, and how quickly.
- What is the single most important capability?
- The joined record. Each capability in the table matters, but only a platform that connects content, buyers, agreements, orders and lots can show the whole picture that intended use is judged on.
Sources & Further Reading
- Federal Food, Drug, and Cosmetic Act § 201(g)(1); 21 U.S.C. § 321(g)(1).
- 21 CFR 201.128, Meaning of "intended uses".
- Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance. Annual Report 2025. April 2026.
- Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Drug alerts and statements; content current as of October 1, 2026.
- Food and Drug Administration. FDA launches agency-wide AI tool to optimize performance for the American people. Press announcement, June 2, 2025.
- Food and Drug Administration. FDA expands artificial intelligence capabilities with agentic AI deployment. Press announcement, December 1, 2025.
- Food and Drug Administration. Import Alert 66-80: GLP-1 receptor agonist active pharmaceutical ingredients (green list).
- Food and Drug Administration. Import Alert 66-41: Detention without physical examination of unapproved new drugs promoted in the U.S.
- Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act, Pub. L. 113-54 (2013).
- Food and Drug Administration, CDER. Warning letters to online peptide sellers dated March 31, 2026 and August 24, 2026, as listed in the second article of this series.
- United States Attorney's Office, Northern District of Indiana. United States v. Matthew Kawa; sentencing of July 30, 2026.
- Food and Drug Administration. Regulatory Procedures Manual, Chapter 4: Advisory Actions (Warning Letters and Untitled Letters).
See also
For in vitro laboratory research only. Not for human or veterinary use. This library describes chemistry, analytical methods and published laboratory research; it gives no guidance on use in people or animals.