In a letter this week to FDA Commissioner Dr. Robert Califf, the U.S. Hemp Roundtable requested FDA apply its playbook on NAC (N-acetyl-L-cysteine) to another ingredient widely marketed in dietary supplements—CBD—and exercise “enforcement discretion.”
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, made additional requests to FDA’s commissioner: Consider a rulemaking to make CBD lawful in supplements, create a pathway to include CBD in beverages and food and grant a meeting with FDA’s Cannabis Product Committee to discuss issues he raised in the letter, including results of a safety study completed by Validcare.
Michael Felberbaum, an FDA spokesman, said the agency would respond directly to the letter from the U.S. Hemp Roundtable.
FDA in recently published draft guidance announced its intent to exercise enforcement discretion concerning the distribution and sale of products containing NAC. The agency also is considering commencing a notice-and-comment rulemaking to make NAC lawful in supplements, in response to a citizen petition filed by the Natural Products Association (NPA), which also sued FDA last year regarding NAC.
FDA has concluded NAC and CBD are both excluded from the definition of a dietary supplement under U.S. law because the ingredients…
