Frequently Asked Questions

FDA Approval Status of Peptides

Q: Do peptides have FDA approval?

Numerous peptides have received FDA approval, with many others currently undergoing clinical trials. However, the FDA specifies that compounded products lose their FDA approval status upon compounding. For safety purposes, assume that products on this website lack FDA approval since they are designated for research purposes only (with limited exceptions). FDA-approved products would include on-label indications and be classified as drugs.[1]

Using Non-FDA Approved Products

Q: Can I legally use products without FDA approval?

Disclaimer: Products sold on this website are exclusively for research purposes. FDA approval (synonymous with pre-market approval) restricts marketing claims for specific conditions, uses, safety profiles, and outcomes. OmeBio cannot discuss potential applications of research chemicals beyond research-based contexts.[2]

State medical licenses determine practitioners' scope of practice. Since FDA approval relates to pre-market authorization rather than medical practice governance, licensed healthcare providers maintain their practice autonomy. Consult your healthcare attorney for specific guidance.[3]

Prescription Services

Q: Does your company accept prescriptions for patient delivery?

No. OmeBio operates as a research chemical manufacturer, not a pharmacy. We do not supply products for human consumption, making prescriptions irrelevant to our operations.

Prescription Requirements for Peptides

Q: Do I need a prescription to use or administer peptides?

OmeBio exclusively supplies research-use chemicals without human application, eliminating prescription relevance. The following represents one legal perspective for general consideration (not representing OmeBio's position or product-related stance):

The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally allows non-drug, non-controlled substance sales without prescriptions. Dried and powdered products typically qualify as dietary supplements, biologics, or food products, subject to different regulations than prescription drugs. FDA guidelines permit prescription-free sales when products avoid drug claims and meet labeling requirements.[4] Product disclaimers align with these standards.

State-Specific Regulatory Considerations

Q: Do state regulations override federal compliance requirements?

Federal law allows prescription-free sales of these products, though state regulations differ. States like New York and California enforce stricter supplement and health product regulations:

California Regulations:

• Proposition 65: Mandates warnings for significant chemical exposures linked to cancer, birth defects, or reproductive harm. Review all products for compliance.[5]
• AB 82 and AB 1341: Regulate weight-loss supplements and OTC diet pills, prohibiting sales to minors under 18 without prescriptions and requiring health risk notices.[6]

Statement of Use Requirements

Q: What is a Statement of Use and why is it mandatory at checkout?

Chemical suppliers commonly require intended use explanations when customers purchase excipients and chemicals. Given our products' research-use designation, we require a brief research hypothesis or use description for ordered items.

Example: "Lyophilized GLP-1/GIP purchased for studying microdose potential at varied frequencies compared to standard clinical trial dosing protocols."

Research Use Only (RUO) Designation

Q: What does Research Use Only (RUO) mean and why is it widespread online?

"Research Use Only" (RUO) terminology falls under FDA governance for in-vitro diagnostic (IVD) definitions. RUO labeling indicates no clinical diagnostic applications based on manufacturer intent.[7]

RUO labels appear frequently in the supplement industry, though some companies incorrectly believe this permits clinical use promotion. As a research chemical manufacturer, OmeBio avoids clinical suggestions or insinuations. See FDA's non-binding recommendations for details.

Peptide Combination Concerns

Q: Are there risks with combining peptides in the same vial or syringe due to aggregation or "cross-linking"?

This represents a legitimate concern. However, our products utilize a proprietary inclusion complex that prevents these issues. This non-glycemic, sugar-based technology remains non-reactive and demonstrates safety for intended research applications.

References:

1. FDA compounding regulations and enforcement actions (https://www.fda.gov/drugs/office-prescription-drug-promotion/laws-regulations-guidances-and-enforcement-actions)
2. What are Biologics? – FDA (https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers)
3. FDA Regulatory Standards for Non-Drug Products (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=117.5)
4. FDA guidelines on dietary supplements and labeling (https://www.fda.gov/food)
5. California Proposition 65 FAQ – AHPA (https://www.ahpa.org/california_prop_65_faq)
6. California AB 82 and AB 1341 Regulations (https://legiscan.com/CA/text/AB82/id/2618899)
7. FDA guidance on RUO labeling (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distribution-in-vitro-diagnostic-products-labeled-research-use-only-or-investigational-use-only)