Where the line actually sits
Under the Federal Food, Drug, and Cosmetic Act, what makes something a drug is its intended use. Intended use is established by evidence, and the evidence is everything the seller says and does: label text, website copy, social posts, customer service replies, packaging inserts, testimonials published, and who the buyers actually are.
A compound sold to a laboratory for research, described only as a chemical, with no claim about what it does in a person, is a research chemical. The same compound sold with a protocol attached is an unapproved new drug, and the disclaimer on the label does not change that.
The specific things that cross it
- Dosing language anywhere. A protocol, a milligram-per-week suggestion, a reconstitution calculator framed around body weight or injection units.
- Benefit claims in any tense. Describing what a compound does in a human body, including hedged versions.
- Consumer sales. A checkout with no research-buyer qualification, selling to individuals for personal use.
- Testimonials and results imagery. A customer review describing personal results is a claim the seller published.
- Adjacent content that completes the picture. A blog explaining protocols, or an influencer partnership doing it on your behalf.
Why underwriters care as much as regulators
Payment acquirers read exactly the same signals. The fastest way to lose a merchant account is to hold research labeling while running consumer-facing claim copy, because the compliance scan finds the mismatch long before any agency does. In practice most operators meet this boundary through their processor, not through an agency letter.
What a compliant operation looks like
- Research positioning consistent across every page, not just the disclaimer
- Buyer attestation collected and recorded on every order
- Labeling with no directions for use
- Business-to-business or qualified research buyers, not open consumer checkout
- Support replies that hold the same line the site does
Where we sit
We supply product and require a research‑use attestation on every order from every account. Claims made downstream are the buyer’s. We decline accounts that make human‑use claims, which costs us orders and is the reason our supply is still here.