Research use only.

The federal framework

Three separate federal regimes can touch a research compound. They are independent of one another, and conflating them is the most common mistake. We address each in turn.

1. DEA and the Controlled Substances Act: these compounds are not scheduled

None of the compounds in our catalog is a controlled substance under the federal Controlled Substances Act (21 USC 801 et seq.). They do not appear on any DEA schedule (Schedules I through V). There is no general "Schedule I peptide" list, and these molecules fall outside DEA scheduling entirely. As a present-tense matter, no DEA registration is required to possess or sell them, and no controlled-substance criminal penalties attach to handling them as reference materials.

Two cautions belong with that statement. First, scheduling status can change by DEA rulemaking, so "not scheduled" describes the law today, not a permanent guarantee. Second, and most important: not being scheduled by DEA does not mean a compound is approved by FDA or legal for human use. DEA scheduling (an abuse-potential question) and FDA approval (a safety-and-efficacy question) are entirely separate. The absence of one says nothing about the other.

Reference: DEA Controlled Substance Schedules.

2. The Federal Analogue Act: explained, and why it does not reach these compounds

The Federal Analogue Act (the Controlled Substance Analogue Enforcement Act of 1986) lets the government treat a non-scheduled substance as a Schedule I drug, but only when two conditions are both met. The substance must (a) fit the "controlled substance analogue" definition in 21 USC 802(32), and (b) be "intended for human consumption" under 21 USC 813. The Act does not schedule anything on its own; it borrows Schedule I treatment for qualifying analogues that are intended for human consumption.

The analogue definition is a structure-plus-effect test. A substance qualifies only if its chemical structure is substantially similar to a Schedule I or II controlled substance and it has, or is represented or intended to have, a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to or greater than that of a scheduled drug. Most federal courts read the structural element as required in addition to the central-nervous-system effect or representation. A compound that is neither structurally similar to a scheduled drug nor a central-nervous-system stimulant, depressant, or hallucinogen is outside the definition on its face.

The "intended for human consumption" trigger is the hinge of the whole doctrine. Section 813(a) applies Schedule I treatment only "to the extent intended for human consumption," and 21 USC 802(32)(C) expressly excludes "any substance to the extent not intended for human consumption." A compound sold, labeled, and described strictly as a reference material for laboratory research, with no dosing, no human-use claim, and no therapeutic representation, sits on the not-for-human-consumption side of the line. Courts weigh marketing, labeling, claimed efficacy, pricing, and distribution channels in deciding intent (21 USC 813(b)), and section 813(c) cautions that a disclaimer alone does not by itself prove the absence of human-consumption intent. Clean research framing helps; it is necessary, not magic. After McFadden v. United States, 576 U.S. 186 (2015), the government must also prove the defendant knew the substance was regulated, which further protects a good-faith research supplier.

Applied to this catalog, the analogue analysis simply does not reach the merits: these research peptides and small molecules are not structural analogues of any scheduled drug, and they are not central-nervous-system stimulants, depressants, or hallucinogens in the statutory sense. The doctrine is worth understanding, but it is generally inapplicable here.

References: 21 USC 813; 21 USC 802(32); McFadden v. United States.

3. FDA and the Food, Drug, and Cosmetic Act: the live regime

The real federal exposure in this area is under the Federal Food, Drug, and Cosmetic Act (FDCA), administered by FDA. It turns on a single concept: intended use.

Intended use (21 CFR 201.128). A product's status as a "drug" is determined by the objective intent of the persons responsible for it, inferred from labeling claims, advertising matter, oral or written statements, the design or composition of the article, and the circumstances surrounding its distribution. FDA's 2021 final rule confirmed it may rely on these sources and added design and composition as an explicit factor. The same rule clarified the protective side: a firm is not regarded as intending an unapproved use based solely on its knowledge that others use the product that way. Mere knowledge that some buyers misuse a research chemical is, by itself, not enough; knowledge combined with any human-use claim, dosing chart, reconstitution-for-injection guidance, testimonial, benefit language, or disease linkage is what converts a reference chemical into a "drug." The 2021 rule deliberately removed a "totality of the evidence" phrasing, so the standard is objective intent inferred from the surrounding circumstances, claims, and statements, not a codified totality test.

Unapproved new drug (21 USC 355(a), prohibited by 21 USC 331(d)). None of these compounds is FDA-approved, and none is generally recognized as safe and effective. So once a compound is "intended" for human use, it is an unapproved new drug, and introducing it into interstate commerce is prohibited. This is the central federal theory in FDA actions against peptide sellers. These compounds also cannot be lawfully sold as dietary supplements: peptides such as BPC-157 were studied as drugs first and fall outside the dietary-ingredient definition, so a "supplement" framing creates the same exposure rather than avoiding it.

Misbranding (21 USC 352). A drug is "misbranded" if its labeling is false or misleading, or if it lacks adequate directions for use by a layperson for its intended uses. A product marketed for human use without a prescription and without approval is misbranded almost by construction. Introducing a misbranded drug into interstate commerce is prohibited by 21 USC 331(a), and courts have held the baseline misbranding violation can be a strict-liability offense (no intent required for the misdemeanor; intent to defraud or mislead only elevates the penalty under 21 USC 333). Misbranding can therefore attach to misleading copy even where the unapproved-drug analysis is debated, which reinforces conservative, claims-free research labeling.

How this plays out in enforcement. FDA has issued warning letters, and the Department of Justice has brought criminal charges, against sellers who labeled products "research use only" or "not for human consumption" while the same sites carried human-use signals: dosing or reconstitution instructions, benefit or comparative claims, testimonials, or co-sold bacteriostatic water and syringes. The marquee criminal cases generally rest on fraud or actual adulteration rather than the clean "research-labeled site with dosing copy" pattern, so that theory remains primarily a warning-letter and civil lever; but the lesson is consistent: a disclaimer is not a defense when other content evidences human-use intent. FDA and the Department of Defense's Operation Supplement Safety identify BPC-157 specifically as a prohibited peptide and an unapproved drug found in health and wellness products. Research-use labels are widely understood to be used in an effort to avoid FDA regulation, and they do not work when other evidence shows intended human use.

The single federal variable a supplier and purchaser most control is intended use. Our protection, and yours, is behavioral, not merely a label: no dosing, no administration or reconstitution content, no benefit or comparative-to-approved-drug claims, no testimonials, and no pairing of a product with a health outcome or with telehealth or clinic content. The purchaser is the responsible investigator.

References: 21 CFR 201.128; Intended Uses final rule (2021); 21 USC 355; 21 USC 352; 21 USC 331.

A note on FDA compounding (sections 503A and 503B)

You may encounter news about FDA "compounding" rules for peptides and GLP-1 drugs. That regime governs what licensed pharmacies (section 503A) and registered outsourcing facilities (section 503B) may compound for human use; it does not authorize or regulate a research-use reference-material supplier. Kodiac compounds nothing and fills no prescriptions. We mention it only because it is the clearest example of how unsettled and fast-moving this area is, and to be explicit that we do not operate in it. Several GLP-1 drug shortages were resolved by FDA across 2024 and 2025, closing the enforcement-discretion windows for compounded copies, and in 2026 FDA has active rulemaking and advisory-committee review on whether specific peptides and GLP-1 substances belong on the compounding bulk-substance lists. Treat any specific statement about these proceedings as point-in-time and verify it against the primary FDA and Federal Register dockets before relying on it.

References: FDA: compounding questions and answers; FDA in the Federal Register.