Is Melittin legal in the United States?

The main peptide in bee venom, about half its dry weight, and a non-selective membrane lytic toxin. Isolated melittin has never been tested for a therapeutic purpose in a human trial; whole bee venom has, in randomised trials of 26 to 538 people with mixed results and a documented anaphylaxis risk.

Melittin is a 26 amino acid peptide that makes up roughly half the dry weight of honey bee venom. It is a cationic, amphipathic molecule that inserts into cell membranes and opens pores, lysing cells without much regard for what kind they are.

Mechanism: In people, the only direct measurement is the 2000 pain study: intradermal melittin produces immediate severe pain and a flare of increased skin temperature lasting over an hour, consistent with an axon reflex and mast cell activation, which lidocaine gel reduced the flare but not the pain. Everything else about melittin's action in humans is inferred from whole venom exposure, where melittin is one of several active components, and from the well documented consequences of bee stings: local pain, swelling, histamine release, and in sensitised people anaphylaxis.

Regulatory history: Not FDA approved. No trial of isolated melittin for a therapeutic purpose is registered. Whole bee venom extracts are approved only as allergen immunotherapy for bee sting allergy, which is a different use.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Melittin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.