Legal
As a Pure Peptides affiliate, it’s essential to understand and communicate the regulatory guidelines for our products. Here’s what you need to know:
Understanding the Regulatory Framework
Difference Between Us and Compounding Pharmacies
Compounding Pharmacies:
Regulated by the FDA: Compounding pharmacies fall under FDA oversight because they manufacture and dispense drugs for human use. These entities must adhere to strict Good Manufacturing Practices (GMP), register with the FDA, and often comply with state boards of pharmacy regulations.
Patient-Specific Prescriptions: They are legally required to only compound medications based on prescriptions for specific patients.
Quality and Labeling: Their products must meet stringent labeling, sterility, and purity standards, ensuring safety for human administration.
Purpose: These pharmacies supply drugs explicitly intended for human consumption and medical use.
Us (Peptide Wholesalers for Research Purposes):
No FDA Drug Oversight: We sell products labeled “For Research and Development Purposes Only” or “Not for Human Consumption”. This distinction removes us from the “drug” category as defined by the FDA.
Non-Medical Intent: Our peptides are marketed for use in research, testing, and laboratory environments, not for direct human application.
No Preparation or Instructions: We do not reconstitute, dilute, or provide protocols. This ensures we do not cross into "drug compounding" territory.
Terms of Sale: Every customer agrees to the terms of use (e.g., no human use, research only), reinforcing our compliance and shielding us from claims of misrepresentation.
FDA vs. DEA and When Law Enforcement Gets Involved
FDA (Food and Drug Administration):
The FDA governs drugs, supplements, and medical products that are intended for human consumption.
They will step in if:
You market peptides as a treatment for medical conditions.
You provide instructions or protocols for human use.
You prepare or reconstitute peptides before sale.
Selling products labeled for research but covertly marketing them for human consumption can lead to FDA enforcement actions (e.g., fines, injunctions, or shutdowns).
DEA (Drug Enforcement Administration):
The DEA enforces laws related to controlled substances, which peptides generally are not. However:
If peptides are sold as human drugs without proper licensing, the DEA may collaborate with the FDA for criminal enforcement.
Selling to individuals without ensuring compliance with your research-only terms can expose you to allegations of illegal drug distribution, triggering law enforcement actions.
The DEA's involvement typically escalates when products are misrepresented or diverted into unregulated markets for misuse.
Why Affiliates Must Stay in Compliance
It’s critical that affiliates understand their role in maintaining our compliance and protecting the company. Here's how we keep things kosher:
Language Matters:
Affiliates must never describe peptides as cures, treatments, or supplements for any condition.
Avoid phrases like "this peptide will help with X" or "use it for Y purposes." Stick to “intended for research use only.”
Avoid Reconstitution or Preparation:
Never reconstitute peptides or provide prepared solutions. This turns a “research product” into a regulated drug in the eyes of the FDA.
If affiliates provide pre-mixed products, they could be classified as compounding pharmacies and face severe regulatory consequences.
Do Not Sell Without Agreement to Terms:
Every customer must agree to the terms of sale, acknowledging they understand the “not for human consumption” restriction. This documentation is your legal shield.
Affiliates selling directly without enforcing these agreements risk personal liability and could expose the entire operation to enforcement action.
Focus on Education, Not Medical Advice:
Provide technical information (e.g., molecular structure, research potential) but avoid any statements that could be interpreted as medical advice or guidance.
If a customer asks for protocols, direct them to third-party sources without endorsement or input.
When Problems Happen
To illustrate, here’s how law enforcement and regulatory agencies could get involved:
Action
What Happens
Selling peptides for human use
FDA and DEA may classify this as illegal drug distribution.
Providing protocols or instructions
FDA views this as promoting a drug, triggering enforcement actions.
Reconstituting peptides
This crosses into compounding territory, requiring FDA and pharmacy oversight.
Not enforcing terms of use
Sales without acknowledgment of research-only terms can lead to liability.
Selling directly to individuals
Affiliates risk violating rules, especially without adhering to research-only purposes.
Affiliate Handbook Guidelines
To ensure compliance:
Use only approved marketing language from company materials.
Direct all questions regarding use to the company or publicly available research—not personal advice.
Always require customers to agree to the terms and conditions.
Report any suspicious behavior or requests for human-use products immediately.
Doctors and Clinic Waiver
For affiliates working with clinical settings, we have a Doctor and Clinic Waiver form available. This document clearly explains that our products are intended for research, allowing healthcare providers to guide clients without stepping into the role of prescribing.
Legal Phrasing: DO NOT SAY vs. DO SAY
DO NOT SAY
To avoid crossing into regulatory danger zones, affiliates must steer clear of these terms and phrases:
Trademarked Names:
Do not say: “Ozempic,” “Monjaro,” or any other brand or trademarked names.
These terms imply a connection to regulated pharmaceuticals.
Medical Terminology:
Do not use terms like: “Medications,” “Drugs,” or “Therapies.”
These words reframe research products as medical treatments.
Prescriptive Language:
Do not say: “We prescribe peptides,” “This peptide is for medical treatment,” or “This is how you should use it.”
Affiliates are not licensed medical professionals and cannot legally prescribe or recommend.
Dosage Recommendations:
Do not say: “We recommend this dosage,” or “This is how to use the peptide.”
Even suggestions or sharing personal use stories can cross regulatory lines.
DO SAY
Instead, use legally sound phrasing to maintain compliance:
Scientific Names:
Do say: “This peptide, [scientific name], is often used in research exploring XYZ.”
Focus on the peptide’s potential in research, avoiding any health or medical claims.
Research Context:
Do say: “In research settings, studies have indicated XYZ about this peptide.”
This keeps the discussion factual and tied to research applications.
Third-Party Resources:
Do say: “Our partners at Peptide-Protocols.com offer community-driven protocols for those exploring these compounds.”
Redirect inquiries about use to independent resources not directly affiliated with the company.
WHEN IN DOUBT
If you are unsure how to phrase something, always defer to third-party resources or customer support:
Refer Customers to Approved Resources:
Website: Peptide-Protocol.com
Direct Contact: Help@Peptide-Protocol.com
Clarify Company Policy:
Say: “Our company cannot offer protocols, dosages, or usage advice. For community-sourced information, please visit Peptide-Protocol.com.”
ADDITIONAL NOTES FOR AFFILIATES
What NOT to Do on Social Media:
Avoid any posts that suggest personal use, medical results, or dosage advice. For example:
Do not post: “This peptide worked great for my knee pain.”
Instead post: “Researchers are exploring peptides for potential joint health benefits.”
No Reconstitution Images:
Never post pictures or videos of reconstituted peptides, syringes, or related paraphernalia. This visually implies human consumption and violates the research-only positioning.
Avoid Using Personal Testimonials in Marketing:
Testimonials about human use (your own or others) are not allowed. These are considered medical claims.
Website Compliance Reminder:
Ensure that all product listings prominently state “For Research Purposes Only” and “Not for Human Consumption.”
Be Careful When Handling Inquiries:
If a customer pushes for medical advice or asks about personal use, respond:
“Our products are for research purposes only. Unfortunately, I cannot provide guidance on human use.”
Immediately redirect to the Peptide-Protocol.com website.
Reinforce Terms and Agreements:
Always ensure that every customer has read and agreed to the terms and conditions on the website. This legal shield is essential for both affiliates and the company.
A Final Word to Affiliates
By sticking to these guidelines, affiliates help protect the integrity of the company and ensure long-term success. Remember:
We are in the business of providing high-quality peptides for research and development.
Any deviation from these standards could result in regulatory action, fines, or worse.
Keep your communication professional, scientific, and strictly aligned with company-approved phrasing.
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