SolRUO
SolRUOCompliance
Research Library

The exact rules our scanner audits against.

Verbatim FDA guidance on peptide marketing, the 21 CFR §201.128 intended-use doctrine, Stripe's restricted-business policy, and Mastercard's BRAM program. Use this as your source of truth before writing product copy, gating researcher access, or responding to a payment-processor inquiry.

FDA Peptide Warning Letter Patterns (2024–2026)

Exact claim phrases, product categories, and contextual evidence the FDA has cited to issue warning letters to peptide vendors.

Open source ↗
Source: FDA Warning Letters — public corpus
FDA PEPTIDE WARNING LETTER PATTERNS — 2024-2026 ENFORCEMENT
(Synthesized from public warning letters to Summit Research, Xcel Peptides, Prime Peptides, SwissChems, USApeptide.com, and related vendors.)

FDA cited the following violations under FD&C Act §§ 301(a), 301(d), 505(a), and 502(f)(1):

CLAIM PHRASES FDA HAS CITED VERBATIM:
- "supports recovery", "speeds healing", "regenerates tissue"
- "promotes fat loss", "for weight loss", "comparable to Ozempic / Wegovy / Mounjaro"
- "enhances performance", "boosts endurance", "increases muscle"
- "libido-enhancing", "improves sexual function"
- "anti-aging", "reverses aging", "increases lifespan"
- "improves cognition", "neuroprotective", "boosts mood"
- "tans skin", "increases melanin" (Melanotan II)
- Any cycle, dose, mg/kg, IU, or administration route ("subcutaneous", "IM", "twice weekly")

PRODUCT CATEGORIES FDA HAS DETERMINED CANNOT BE SOLD RUO:
- GLP-1 receptor agonists (semaglutide, tirzepatide, retatrutide, cagrilintide) — these are FDA-approved drugs; selling OTC under any disclaimer is misbranding + unapproved new drug.
- Compounds on FDA's 503A/503B Difficult to Compound and Category 2 lists: BPC-157, Thymosin Beta-4 (TB-500), Melanotan II.
- Investigational new drugs without an active IND.

CONTEXTUAL VIOLATIONS FDA HAS USED TO DEFEAT "RUO" DISCLAIMERS:
- RUO label paired with consumer-friendly checkout (no gate, no institutional verification, retail pricing).
- Blog posts or linked educational content describing human dosing protocols.
- Sale of bacteriostatic water, insulin syringes, or reconstitution kits alongside peptides.
- Customer reviews describing personal results (weight loss, muscle gain, libido) left visible on the site.
- Social media accounts (linked from site) making human-use claims.
- Meta descriptions or image alt text containing therapeutic language for SEO.
- Prior FDA correspondence on file: continued sale after a Warning Letter constitutes evidence of objective intent under §201.128.

ENFORCEMENT OUTCOMES:
- Warning Letter → 15 business days to respond
- Failure to respond → Import Alert, seizure, injunction, criminal referral
- Payment processors (Stripe, Square, Authorize.net) terminate accounts within 7-30 days of any FDA Warning Letter being public on fda.gov

21 CFR §201.128 — Meaning of 'Intended Uses'

The single regulation the FDA uses to defeat 'Research Use Only' disclaimers. Read this before writing any product copy.

Open source ↗
Source: Code of Federal Regulations, Title 21
21 CFR §201.128 — MEANING OF "INTENDED USES" (VERBATIM)

"The words 'intended uses' or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug … based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use."

REGULATORY CONSEQUENCE:
An "RUO" or "not for human use" disclaimer does NOT cure intended-use liability if surrounding evidence (product positioning, advertising, customer base, dosing language, social posts, accessories sold, prior FDA correspondence) shows the firm knows or has reason to know the product will be used in humans. FDA has cited §201.128 to override RUO disclaimers in every recent peptide warning letter.

Stripe Restricted Businesses — Verbatim

The categories Stripe uses to terminate peptide and research-chemical merchants, plus the enforcement pattern we've documented.

Open source ↗
Source: Stripe Legal
STRIPE RESTRICTED BUSINESSES — VERBATIM EXCERPTS
(Source: https://stripe.com/legal/restricted-businesses)

Restricted businesses include but are not limited to:

— "Pseudo pharmaceuticals" (including but not limited to "research chemicals," "designer drugs," and any product marketed as a research chemical that is structurally similar to a controlled or scheduled substance).

— "Products making health claims that have not been approved or verified by the applicable regulatory body."

— "Drug paraphernalia" — items "primarily intended or designed for use in manufacturing, concealing, or using a controlled substance."

— "Substances designed to mimic illegal drugs."

— "Prescription drugs or devices, including those that require a prescription but are being sold without one."

— "Items that infringe upon or violate any copyright, trademark, right of publicity or privacy, or any other proprietary right under the laws of any jurisdiction."

— "Any business that we believe poses elevated financial risk, legal liability, or violates card network or bank policies."

STRIPE RUO / RESEARCH CHEMICAL ENFORCEMENT PATTERN:
Stripe has terminated peptide merchants under the "pseudo pharmaceuticals" category when:
- Site contains any therapeutic claim language
- Products are sold without a verified researcher/institutional gate that blocks content BEFORE render
- RUO disclaimer is paired with consumer-style messaging (free shipping, "buy now", cycle guides)
- GLP-1 analogs (semaglutide, tirzepatide, retatrutide, cagrilintide) are sold without prescription verification
- Site sells injection accessories (bac water, syringes, alcohol swabs) alongside peptides

To remain in good standing, the merchant must have "preventive measures in place to ensure these are not accessible to those who would purchase research chemicals for nonresearch purposes."

Mastercard BRAM — Business Risk Assessment & Mitigation

Network-level rule that drives acquirer reviews, per-violation assessments, and GMAP listings for non-compliant peptide merchants.

Open source ↗
Source: Mastercard Standard GLB 11691.1
MASTERCARD BRAM — BUSINESS RISK ASSESSMENT & MITIGATION
(Standard GLB 11691.1)

Acquirers and merchants are required to monitor merchant websites and transaction activity for:
- Sale of illegal or brand-damaging products
- Sale of products implicated in cyber-enabled financial crime, including unregulated pharmaceuticals
- Misrepresented merchant categories
- "Transaction laundering" — processing transactions for an undisclosed line of business

Peptide merchants flagged under BRAM face:
- Mandatory acquirer review within 7 business days
- Per-violation assessments up to USD $25,000 per occurrence
- Mandatory Global Merchant Audit Program (GMAP) listing on repeat findings

A merchant must be able to demonstrate, on request, the documented researcher verification process, audit logs of buyer credentialing, and a content monitoring program that prevents human-use claims from appearing on any indexed page.

External primary sources

Bookmark these. When the scanner cites a finding, the underlying authority will be one of these documents.

Not legal advice. This library is reference material the SolRUO scanner uses. It is not a substitute for review by FDA regulatory counsel or your payment processor's risk team. See our Terms for the full disclaimer.