New Citizen Petition Filed by CBD Company

On February 21, the Natural Product Association (NPA) filed a citizen petition with the Food and Drug Administration (FDA) on specific cannabidiol (CBD) relief in which it requests enforcement discretion for the premarket approval of CBD products.

In its petition, the NPA is asking the FDA to do one of three things:

Determine that CBD is not excluded from the definition of dietary supplement under Section 21 U.S.C. § 321(ff)(3) of the Federal Food, Drug, and Cosmetic Act (FDCA)
If you keep a pulse on this issue, you know that for the past three years, the FDA has held the position that CBD cannot be marketed as a dietary ingredient because it was first studied and approved as a drug ingredient in GW Pharmaceuticals’ Epidiolex (Drug Exclusion Rule). According to NPA’s petition, the U.S. Pharmacopeia (USP), which sets standards for medicines, food ingredients and supplements, first documented the use of hemp-derived products in 1850. This means that CBD should be treated as an “old dietary supplement” under the Dietary Supplement Health and Education Act of 1994 (DSHEA), and therefore, not excluded from the definition of a dietary supplement (i.e., the Drug Exclusion Rule does not apply to CBD). Exercise enforcement discretion

Read More Here...