Compliance Policy

Last updated: April 9, 2026

Pepta Labs distributes chemical reference materials for in-vitro laboratory use. This policy documents how we structure our operations to remain within the regulatory framework applicable to chemical reference material distributors in the United States.

What Pepta Labs Is — and Is Not

We are not: a compounding pharmacy under 503A or 503B of the FD&C Act; a drug manufacturer subject to cGMP requirements; a dietary supplement manufacturer under DSHEA; a food producer subject to FSMA; or a medical device manufacturer. We hold no pharmacy license, drug manufacturing license, or DEA registration, because our products are not drugs, supplements, medical devices, or controlled substances.

Our products are not drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). They are not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. They are not intended to affect the structure or any function of the body. They are chemical reference materials supplied as lyophilized powder for in-vitro laboratory analysis.

Intended Use Under 21 CFR 201.128

Under FDA regulations, a product's classification as a "drug" depends on its intended use as defined in 21 CFR 201.128. Intended use is established by objective evidence including labeling, advertising, oral or written statements, and the totality of circumstances surrounding distribution.

Pepta Labs has structured every aspect of its operations to ensure that no objective evidence establishes drug intended use:

1. Labeling

Every product — on the physical vial and the website — is labeled: "For In-Vitro Laboratory Research Use Only. Not for Human or Animal Consumption. Not Intended to Diagnose, Treat, Cure, or Prevent Any Disease." This language appears prominently, not in fine print or buried disclaimers.

2. Product Descriptions

Product pages describe chemical properties only: compound name, molecular formula, molecular weight, CAS registry number, amino acid sequence, purity percentage, and testing methodology. We do not describe biological activity, receptor binding, mechanism of action, therapeutic effects, or clinical applications on any product page.

3. No Dosing Information

We provide no dosage recommendations, titration schedules, administration protocols, cycling instructions, or any guidance suggesting use in humans or animals. We do not publish "cheat sheets," usage guides, protocol documents, or any material describing how to use our products outside of in-vitro laboratory analysis.

4. No Benefits or Effects Claims

We make no claims — explicit or implied — that any product produces any effect in a human or animal body. We do not use language such as "weight loss," "muscle recovery," "anti-aging," "fat burning," "cognitive enhancement," "appetite suppression," "improved glycemic control," or any other outcome-oriented terminology anywhere on our website, labeling, or marketing materials.

5. No Community Forums or Social Content

We do not operate, sponsor, link to, or endorse any community forums, social media groups, Discord servers, Skool communities, Telegram groups, or other platforms where our products could be discussed in a use-oriented context. We do not publish or solicit user testimonials describing effects, outcomes, or experiences.

6. No Reconstitution Products or Instructions

We do not sell bacteriostatic water, sterile water, syringes, needles, alcohol swabs, or any product associated with injection or administration. We do not publish reconstitution guides, mixing instructions, or injection preparation content. Our products are supplied as lyophilized powder in sealed vials.

7. No Co-Marketing with Administration Supplies

We do not bundle, cross-sell, recommend, or link to any administration supplies or accessories. We do not partner with or reference any supplier of syringes, bacteriostatic water, or other injection-related products.

8. No Research Citations on Product Pages

Product pages do not cite, reference, link to, or discuss published research studies, clinical trials, PubMed articles, or preclinical findings. Products are described by chemical identity and analytical specifications only.

Product Labeling Standards

Buyer Certification & Anti-Diversion

Purchase Certification

Every buyer certifies at checkout: (a) purchasing for in-vitro laboratory research only; (b) at least 21 years of age; (c) will not use, administer, or cause to be administered any product to any human or animal; (d) accepts our Terms of Service. Certifications are recorded with each transaction.

Order Screening

We review orders for patterns indicating non-research use. We reserve the right to decline, cancel, or refund any order at our sole discretion. Factors include purchasing patterns, order frequency, communications content, and publicly available information.

Account Termination

Any indication — through any channel — of intent to use our products for human or animal administration results in permanent account termination, order blocking, and documentation in compliance records.

Labeling Integrity

Removal or alteration of "Research Use Only" or "Not for Human or Animal Consumption" designations constitutes a material breach of our Terms of Service and may be reported to regulatory authorities.

Analytical Quality Program

Website Content Policy

No Therapeutic Language

We do not use verbs or phrases implying therapeutic action in connection with any product, including: "treats," "heals," "cures," "prevents," "improves," "enhances," "boosts," "reduces," "stimulates," "inhibits," "activates," "modulates," or "regulates."

No Receptor or Pathway Descriptions

Product pages do not describe receptor binding, signaling pathways, biological mechanisms, or structure-activity relationships. Products are identified by chemical name, CAS number, sequence, formula, molecular weight, and analytical purity.

No Condition-Based Marketing

We do not organize, categorize, or position products by disease condition, health outcome, or body system effect.

Regulatory Awareness

FDA Enforcement Landscape

We monitor FDA enforcement actions against chemical distributors. We are aware that the FDA has taken action against vendors who, despite "research use only" labeling, established drug intended use through: product descriptions referencing receptor pathways or biological mechanisms; dosing guides or "cheat sheets"; community forums with usage protocols; sale of administration supplies alongside peptide products; and testimonials describing physiological effects.

Pepta Labs does not engage in any of these practices.

Compounding Pharmacy Restrictions

FDA restrictions on certain bulk drug substances under 503A/503B apply to compounding pharmacies preparing patient-specific formulations. Pepta Labs is not a compounding pharmacy. We distribute chemical reference materials in their original lyophilized form.

ITC Actions

Pepta Labs monitors ITC proceedings and adjusts its product catalog to comply with applicable exclusion orders.

Regulatory Cooperation

Pepta Labs will cooperate fully with any legitimate inquiry from the FDA, DEA, FTC, DOJ, state attorney general, or other regulatory authority. We maintain transaction records, buyer certifications, and compliance documentation.

Reporting Concerns

Suspected misuse or diversion: compliance@peptalabs.com

Compliance policy questions: legal@peptalabs.com