November 7, 2022

Do you need FDA approval to sell CBD?

The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. Therefore, all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell.

Why won’t the FDA approve CBD?

Do you need FDA approval to sell CBD
Do you need FDA approval to sell CBD

But the agency has repeatedly said it can’t set any regulations for over-the-counter hemp products because it doesn’t have enough data to say they’re safe. The FDA also says that because CBD is an active ingredient in a prescription drug, Epidiolex, it can’t regulate nonpharmaceutical CBD.

Who approves CBD?

The CSA prohibits the possession and distribution of Schedule I-controlled substances without prior registration with, and approval by the Drug Enforcement Administration (DEA), including Cannabis sativa L. that contains more than 0.3% THC content.

What CBD products has the FDA approved?

EPIDIOLEX is the only FDA-approved prescription CBD medicine, which among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials.