Other countries

Palmitoylethanolamide is not an approved medicine anywhere that this site could find. It is sold as a food supplement, a food for special medical purposes, or a dietary supplement, depending on the country. This page separates what is verified from a primary source from what is only claimed by sellers.

Italy

Verified from the trial papers on this site. The Epitech products used in the Italian trials are sold as foods for special medical purposes, a food category for products used under medical supervision. Versace 2023 states that Glialia is licensed in Italy as an oral food product for special medical purposes. That is a food classification. It is not a drug approval and carries no approved therapeutic indication.

The 636-patient sciatica trial Guida 2010 was published in Spanish in a Spanish pain journal, which is why the product was also marketed in Spain.

United States

Verified: the FDA has not approved palmitoylethanolamide as a drug, and the database on this site contains no US-approved product. It is sold in the United States as a dietary supplement ingredient. Supplement ingredients in the US do not need approval before sale.

Not verified by this site: whether the FDA has issued any formal position on the ingredient, such as a response to a new dietary ingredient notification. Sellers state that none is required. This site has not located an FDA document either way.

European Union and United Kingdom

Not verified. Whether palmitoylethanolamide counts as a novel food in the EU, which would require authorisation before sale as a food supplement, depends on its history of use before May 1997. Italian products have been sold since the 1990s, which is the usual argument that it is not novel, but this site has not found the entry in the European Commission’s novel food status catalogue and does not repeat claims about it. The UK inherited the EU novel food rules after 2019. If you need the answer for a product, the catalogue and the national food authority are the sources.

New Zealand

Not researched. New Zealand regulates supplements separately from Australia; an Australian AUST L listing does not transfer.

Claims this site has seen and could not confirm

Supplier and marketing pages state various approvals: Canada, India, Brazil, Germany, Spain. None of those pages cited a document, and this site has not checked a regulator’s register for any of them. They are listed here only so a reader knows they are unverified.

Sport

Human anti-doping status (WADA) and horse sport status (FEI) are on their own pages: human sport and horse sport.

How to check for yourself

1. Find the regulator’s own register, not a seller’s page.
2. Search for palmitoylethanolamide and for palmidrol, the international non-proprietary name.
3. Read what category the entry gives: medicine, food, supplement, cosmetic. The category decides what may be claimed for it.

Checked 22 September 2026. This page is general information, not legal advice. Corrections with a source are welcome through the contact page.