What Exactly are Peptides?
Peptides are compounds composed of two or more amino acids linked by peptide bonds which are formed through a chemical reaction known as a "condensation reaction," where amino acids at the ends of chains interact with one another to create a bond. A single peptide can be comprised of just a few amino acids (three to ten), or many, even hundreds (more than 10 amino acids). Larger peptides are generally called polypeptides, but this distinction is not always adhered to.
Peptide bonds only form between certain amino acids, and these usually involve the amino group from one amino acid forming a bond with the carboxylic acid group from another. Peptides are typically represented in shorthand by their amino acid structure , followed by a one-letter and three-letter code which can be used to denote the amino acid. These abbreviations are examples of common amino acids, and also show the way that they can be represented using this shorthand. These are only a small number of the more than 500 naturally occurring peptides, many of which are found in the human body.
Peptides are involved in a number of body functions, and are important for both organizational and cell signaling purposes. They can also be used in a variety of research and medical applications.
US Regulatory Framework for Peptide Use
While the vast majority of peptides are legal for research, some are on the Controlled Substances Act, making them illegal in certain cases. The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA), two governmental organizations with overlapping jurisdiction in this area, influence the legality of specific peptides too.
The FDA is a government body tasked with regulating a wide range of healthcare matters, from food safety to prescription drugs. This regulatory jurisdiction extends to peptides. For instance, all peptides for human use must be approved by the FDA.
Importantly, however, many peptides are primarily used in laboratories and research settings, not for human use. In fact, as long as peptides are clearly marked as "research purposes only" and do not claim to be safe or effective for human use, they should not pose an issue when it comes to FDA regulations.
The federal Controlled Substances Act governs various classes of drugs at the federal level. The Drug Enforcement Administration is the CSA’s enforcement body. The DEA classifies certain compounds, including some peptides, as controlled substances, which have different restrictions than pharmaceutical drugs.
Research and Human Use of Peptides
It is important to understand that peptides are first sold as research materials and are not intended for human consumption or a medical purpose. There are two primary reasons why this distinction is so important: the first concerns FDA regulations on what substances are allowed for human consumption; the second concerns how to best protect yourself when buying research peptides. From a regulatory viewpoint, it is critical that you distinguish between research use and human use or consumption. The U.S. Food and Drug Administration (FDA) is concerned with the sale of substances intended to be used by humans that have not been approved by the FDA. When the FDA approves substances for human use, clinical trials are required before approval and the review process is lengthy, expensive and laborious.
"Lately we have seen a proliferation of companies offering substances that are illegal to sell or import into the U.S., and often their business model is predicated on the fact that these chemicals are breaking the law."
Food supplements, medical substances and chemicals that have been approved for human consumption fall into one of three categories: Generally Recognized As Safe (GRAS), Generally Recognized As Effective (GRAE), and dietary supplements. GRAS are naturally occurring herbs, minerals or foods that have been thoroughly tested. GRAE files are approved for very specific uses. Both are outside the scope of the FDA’s jurisdiction, as are dietary supplements. Dietary supplements can include any kind of vitamin, mineral, herb or chemical that is available to individuals without a doctor’s prescriptions. That said, the FDA does not approve the vast majority of dietary supplements, and supplements are never as closely regulated as pharmaceuticals are. Angelus Medical and Dental is a trusted supplier for research-grade peptides, including some precursors of peptides which would not go through the FDA process and find the application of GRAS standards to be questionable in most instances.
Penal Consequences for Peptide Misuse
Violating US laws in peptide usage can lead to both civil and criminal repercussions. These can range from fines and confiscation of illicit materials to more severe penalties like imprisonment. Federal penalties for illegal peptide uses are dictated by several laws and agencies, including the FDA, DEA, and the FDCA. For instance, the FDCA includes provisions that penalize individuals and companies involved in the unlawful production and sale of drugs and chemicals. In this context , peptides fall into the category of drugs. Civil liabilities often involve substantial monetary penalties. In some cases, prohibited peptide products may be seized and destroyed. On the criminal side, individuals facing these dangers might be subject to imprisonment. Instances of accidental misuse or misunderstanding of regulations do not typically result in criminal prosecutions, but overseeing authorities do not exempt such cases from liability.
Legitimate Ways to Buy Peptides
Purchasing peptides legally is not a straightforward affair. There are companies that are set up as peptide shops, where the consumer can select an item from a catalogue and check out with a credit card. Even though the peptide is shipped to an address in the United States, the supplier may or may not be in the United States. The consumer may or may not even be purchasing from a compliant vendor. While US law does not prohibit the importation of peptides, the FDA’s Customs Enforcement agencies are on the lookout for illegal items.
There are two types of peptide "shops". One type operates within legally compliant structures, such that the final product is compliant with all applicable laws. The items available for purchase from this store appear in the catalogue or are available upon request of the vendor. For example, any material offered for sale by a company for in vitro research use under the auspices of an FDA approved IRB is legal to purchase in the United States both by the IRB and by the consumer. Competent US manufacturers and distributors of these in vitro research use materials (known as IVDs) typically engage in practices consistent with good manufacturing practices just as a manufacturer of other types of biomedical products, and these manufacturers provide full documentation and regulatory compliance guarantees.
On the other hand, other vendors are simply foreign sources of products that may have circulated through multiple supply chains and/or are sold for AP that may or may not have been inspected by a competent authority. These vendors have no visibility into the integrity of the chain, nor do the end-users, who may simply be purchasing online or over the phone. This means that the end-user cannot say with certainty that the material entering into the United States is compliant with US laws governing the manufacture of therapeutic peptides. Buyers should conduct their own due diligence when selecting a peptide vendor and verify if the vendor is in compliance with importing regulations. Buyers should also check to see if their peptide supplier abides by closely held quality standards for their products, and if they can demonstrate this competence to others.
The Next Steps in Peptide Regulation
As the field of peptide science and its applications continue to advance at breakneck speed, so do discussions surrounding the necessary government regulations that should accompany such growth. Two areas ripe for investigation include the legality of home applications of peptides, and whether health sellers can promote such products for uses not approved through the FDA.
Outside the United States yet on the cutting edge of peptides, the European Union has already taken radical steps to prevent illegal peptide sales online by adopting Regulation 575/2017/European Medicines Agency 746000. It’s designates peptides as medicines; therefore, requiring that they be approved by the EMA before they can be marketed. The United States, however, has chosen a different path . Surprisingly only one peptide has been approved by the FDA, while concurrently discussing the future of peptides in the US. The FDA is also discussing the possibility of restricting online peptide sales, particularly those that could cause a medical hazard, although no legislation has yet been introduced. Many in the scientific community agree that when the opportunity arises, the FDA should enact new rules for peptides. Such legislation would likely target large peptide bundles contributing to organ or body manipulation and those designed for body building. At a minimum, the FDA may require more stringent vetting before peptides are approved. But this much seems clear; any regulatory changes will wait until scientific research catches up with popular culture and the FDA becomes involved with peptides in ways that are more complex than a simple enforcement of the law.