Launch Your Peptides business
with LumaLex Law

Peptides are small chains of amino acids that have attracted attention in the health and wellness industry, as well as in sports medicine and anti-aging markets. They are often marketed for muscle recovery, fat loss, skin health, and other potential benefits. As interest grows, so does the confusion about whether peptides can be legally manufactured, sold, or used.

At LumaLex Law, we help companies in the peptide industry understand the complex legal and regulatory landscape that governs this space. From FDA peptide regulations to state-specific sales laws, we guide businesses through compliance so they can operate with confidence.

Are Peptides Legal?

The question “Are peptides legal?” does not have a simple yes-or-no answer. The legality depends on how the peptide is classified, how it is marketed, and whether it is intended for research or human use.

Section 503A of the Food, Drug, and Cosmetic Act

At the federal level, Section 503A of the Food, Drug, and Cosmetic Act (FDCA) governs pharmacy compounding and includes the interim Bulk Drug Substances List. This list separates compounds into categories that determine whether they may be used in pharmacy compounding for human consumption.

• Category 1 Peptides: Allowed for human consumption in compounding if other requirements are met.

   

• Category 2 Peptides: Not allowed for human consumption in compounding. These may only be sold for research purposes, such as laboratory use, but they cannot legally be marketed for human use.

   

This distinction is crucial. Selling a Category 2 peptide as a supplement or medication is unlawful, even if the product appears “clean” or is labeled professionally.

FDA and Marketing Claims

The Food and Drug Administration (FDA) also regulates how peptides are marketed. Even if a peptide is legal to sell for research purposes, marketing it as safe or effective for human use can trigger enforcement action. Similarly, making claims that a peptide can “treat,” “cure,” or “prevent” diseases may violate FDA and Federal Trade Commission (FTC) rules on advertising.

State Laws and Local Oversight

In addition to federal peptide sales laws, each state may impose additional restrictions. Some states require specific licensing for companies selling peptides, while others restrict their distribution altogether. Businesses must navigate both state and federal requirements to remain compliant.

Risks for Peptide Companies

Operating without a clear compliance strategy creates significant risks:

• FDA enforcement actions: Unapproved marketing claims or sales for human use can lead to warning letters, fines, and injunctions.

   

• Product seizure: Regulators may confiscate products deemed illegal for human consumption.

   

• Civil and criminal liability: Misrepresenting research-only peptides as safe for human use can result in serious penalties.

   

• Reputational harm: Being associated with non-compliance can damage trust with customers, investors, and partners.

   

Even implying that a Category 2 peptide is safe for people – through product descriptions, social media, or influencer marketing – can expose a company to liability.

How LumaLex Helps Peptide Businesses

The regulatory environment for peptides is challenging. LumaLex provides the legal guidance companies need to minimize risk while pursuing growth in this evolving market. Our services include:

• Peptide classification review: We determine whether a peptide falls into Category 1 or Category 2 under Section 503A and advise on lawful uses.

   

• Marketing and labeling compliance: We develop compliant marketing strategies that avoid unlawful health claims while meeting FDA and FTC requirements.

   

• Business structuring: We help structure peptide businesses to reduce regulatory risk, whether operating as research suppliers, compounders, or wellness-focused companies.

   

• Licensing and registration: We guide companies through state-specific licensing requirements and ensure that distribution channels align with applicable law.

   

• Healthcare-related compliance: Peptide businesses operating in medical or wellness settings may also need to comply with broader healthcare laws, such as the Corporate Practice of Medicine doctrine, federal anti-kickback statutes, and self-referral (Stark) laws. LumaLex advises clients on these overlapping regulations to prevent costly mistakes.

Why Work With a Peptide Business Attorney?

The peptide industry represents opportunity, but it is also subject to heightened regulatory scrutiny. A single misstep, such as misclassifying a peptide or making a prohibited marketing claim, can bring enforcement that threatens the entire business.

Working with a peptide business compliance attorney provides:

• Clear answers to complex regulatory questions
• Protection against costly enforcement actions
• Legal strategies designed for both compliance and growth
• Guidance tailored to the unique challenges of the peptide industry

   

At LumaLex, we combine legal expertise with practical business insight to help our clients succeed in this highly regulated market.

FAQs About Peptides and the Law

Are peptides legal in the United States?

Some peptides are legal for human use in compounding under Category 1 of Section 503A. Others fall into Category 2 and may only be sold for research purposes, not for human consumption.

Can I sell peptides as supplements?

No. Selling peptides as dietary supplements or medications for human use without FDA approval is unlawful. Marketing claims about health benefits can trigger FDA and FTC enforcement.

What happens if I sell Category 2 peptides for human use?

Selling Category 2 peptides for human consumption violates federal law. Consequences may include FDA enforcement, product seizures, fines, and possible criminal liability.

Do state laws matter if I comply with federal rules?

Yes. States often impose additional licensing or sales restrictions. Compliance requires meeting both federal and state requirements.

Why should I hire a peptide business attorney?

A qualified attorney helps ensure compliance with FDA peptide regulations, Section 503A classifications, state licensing rules, and healthcare-related laws. Legal guidance reduces the risk of penalties and supports long-term business success.

Work With LumaLex on Peptide Compliance

If your business manufactures, sells, or distributes peptides, compliance is not optional. Understanding FDA peptide regulations, peptide sales laws, and state-specific rules is essential to protecting your business.

At LumaLex Law, we help peptide businesses navigate this complex environment with clarity and confidence. Contact us today to learn how we can protect your company and position it for sustainable growth.