Adrafinil is an unapproved drug in the United States and is not permitted for use in dietary supplements or food. While it is not a controlled substance like its metabolite, Modafinil, it is currently in a legal "gray area" where it is unregulated but cannot be legally marketed as a supplement.

Most major retailers and specialty supplement shops (such as Nootropics Depot ) have discontinued Adrafinil due to shifting regulatory stances.