Are Peptides Illegal? What Are The Legal Implications Of Using Them?

There’s always been a steady growth in peptide popularity, especially in the US. But, with the recent development, the emergence of internet pharmacies and scientific studies, the demand for these tiny amino acid strings reached new heights.

Of course, with popularity comes a lot of attention and many people are starting to wonder what’s the legal status of peptides in the US. Are they legal, are they maybe illegal, and is the FDA actively banning them?

We’re going to answer all of these questions in today’s article.

What Are Peptides?

Peptides are short chains of amino acids (usually 2 to 50), linked together with peptide bonds. Even though they are built up of amino acids just like proteins, they are much shorter and their chemical structure is less complex.

What Do Peptides Do Within Our Body?

Even though you might not even have heard of peptides, there are a lot present within our body, with different roles and functions. These functions include:

Signaling – many peptides serve as neurotransmitters which regulate various processes within the body
Antimicrobial – certain groups of peptides can serve as anti microbiotics, to kill viruses, bacteria and fungi
Communicative – some peptides serve as signaling molecules between different tissues within the body allowing their communication
Enzyme – this is the function researchers are most interested in since it offers a huge potential for future development of various types of medication

Peptides Legal Status in the US

At the time of this report (May 2024), peptides are legal in the United States. But as a general rule, they are only recommended for lab research purposes.

Speaking of regulations and jurisdictions, peptides fall under a number of these (though they are primarily under the jurisdiction of FDA – Foods and Drug Administration).

Peptides Restrictions

The use and application of peptides is strictly regulated and under intense scrutiny. All peptide-based drugs must undergo rigorous testing and the FDA approval process to ensure they are both effective and safe to use. The approval process is long and involves preclinical trials, clinical trials, studies, testing and adhering to good manufacturing practices (GMP).

Compounding Peptides Regulations

Compounding pharmacies may produce peptides for an individual patient based on their needs; even if these peptides are not FDA-approved, they must adhere to certain, strict guidelines.

Cosmetic Peptides

Cosmetic peptides are a bit different in that they do not require FDA approval before hitting the market, but they need to be properly labeled.

Dietary Supplements

Peptides used as dietary supplements are regulated under DSHEA. The Dietary Supplement Health and Education Act (from 1994), or DSHEA, is a federal law that regulates all dietary supplements. The goal of the law was to protect the public and provide a framework for FDA which would allow it to regulate such products.

Peptides Legality In The US

As we already said, peptides are legal in the United States, though they fall under heavy regulation and depend on the intended use and the state you are in.

Generally speaking, these are the legal terms of peptide usage:

Though peptides are legal in the US, they are intended for research purposes only and are regulated by the Food And Drug Administration, under Food, Drug and Cosmetic act.
The distribution of peptides for human use has to be done with appropriate labeling and compliance with Good Manufacturing Practices.
Using peptides in medical purposes without proper authorization may pose a threat to the individual’s health as well as cause legal problems
Violation of any of these may result in severe penalties, fines and even imprisonment.

References:

Federal drugs and cosmetics act (fd&c act), 21 usc 9