Dietary Supplement Health and Education Act

The Dietary Supplement Health and Education Act of 1994 is the federal law that defines dietary supplements and sets the rules for how they are labeled, marketed and regulated.

It created a category separate from foods and drugs, allowed structure/function claims with a disclaimer, required a Supplement Facts panel, and placed the burden on the FDA to show a supplement is unsafe rather than on the manufacturer to prove it safe before sale. It also defined what can be a dietary ingredient and excluded substances first studied or approved as drugs.

That exclusion is the crux for CBD: because cannabidiol was investigated and later approved as a drug before it was marketed as a supplement, the FDA has taken the position that it cannot be a dietary supplement ingredient. CBD products that use supplement-style labeling are borrowing a format the law does not clearly extend to them. The FDA has said a new regulatory pathway would be needed, but no such pathway has been enacted.