FDA Regulation

The ban targets safrole specifically at concentrations above 10 parts per million in commercial food products. Critics argue the 2018 FDA reclassification of ECT defies the clinical evidence of harm. 21 CFR Section 189.180 bans sassafras oil and safrole as food additives in commercial products sold in the United States. Every major commercial root beer brand reformulated after the regulation, switching to artificial flavoring. In 2018 the FDA downgraded ECT from a Class III high-risk to a Class II moderate-risk device designation. ECT was never formally approved by the FDA through the standard review process; it was grandfathered in via a regulatory loophole. The regulation does not ban sassafras the plant, root, bark, or traditionally brewed home sassafras tea. A properly fermented sassafras root beer made by the Appalachian method falls within legal compliance because safrole levels stay below 10 ppm.