On February 21, the Natural Products Association (NPA) submitted a file Citizen’s petition With the Food and Drug Administration (FDA) regarding certain cannabidiol (CBD) relief where it requires discretion for pre-approval of CBD products.
In its petition, the NPA asks the U.S. Food and Drug Administration (FDA) to do so One of three things:
- determined that CBD is not excluded from the definition of a dietary supplement under 21 USC § 321 (ff) (3) of the Federal Food, Drug, and Cosmetic Act (FDCA)
If you’ve been keeping an eye on this issue, you know that for the past three years, the Food and Drug Administration He held the position that CBD could not be marketed as a food ingredient because it was first studied and approved as a pharmaceutical ingredient in GW Pharmaceuticals’ Epidiolex (Drug exclusion rule). According to the NPA petition, the United States Pharmacopeia (USP), which sets standards for drugs, nutritional ingredients, and supplements, first documented the use of hemp-derived products in 1850. This means that CBD must be treated as an “ancient food supplement” by law. Health and Education for Dietary Supplements 1994 (DSHEA), and therefore, is not excluded from the definition of a dietary supplement (in another meaningThe drug exclusion rule does not apply to CBD).
- Exercise enforcement discretion review of safety data for a CBD dietary supplement consistent with a pre-marketing safety review of a new food ingredient notification.
If the FDA does not grant the first NPA required assistance, the organization requires the FDA to scientifically review its product’s safety data and provide a substantive response. Although the NPA’s blanket petition has been mostly revised — to protect its confidential data without really knowing whether the FDA would set aside the drug exclusion rule and complete a full scientific review of the data — the NPA is confident in its ability to show that the ingredients in a CBD product meet all Safety standards applicable under the DSHEA.
- Issue notice and comment rule-making to prove that CBD is legal under the FDCA.
Since the enactment of the 2018 Farm Act, which has tasked the Food and Drug Administration with the authority to regulate CBD products, the agency has been failing to fulfill its regulatory responsibilities, claiming, in part, the insufficient reliable scientific data needed to assess the safety of CBD-infused products.
While the NPA is the third company to file a petition in the past four years, the Food and Drug Administration has yet to provide substantive responses to previous petitioners, including the Consumer Health Care Products Association (CHPAand the Council for Responsible NutritionCRN). Instead, the federal agency informed these petitioners through “interim” responses, which you can find here And the here, They need more time to review the petitions because of the “complexity of issues” raised in them.
Meanwhile, more than thirty countries have managed to establish it Regulatory Standards For human consumption of CBD and other cannabinoids derived from hemp. This wide array of often conflicting state regulations, combined with the lack of any formal federal legal pathway for the sale and marketing of CBD cannabis products, has made it nearly impossible for the industry to meet compliance standards, exposing it to greater risks from enforcement action.
In filing this citizen petition, the NPA continues industry efforts to lobby the Food and Drug Administration by reviewing and submitting a safety decision on CBD products. In addition, this new petition also aims to correct regulatory uncertainties that have hindered economic opportunities for the industry and that have failed consumers to access safe products.