By Dylan C. Summers
Vice President of Government Affairs
Lazarus Naturals
From the perspective of the public sector, not much has changed since the passage of the 2018 Farm Bill. Hemp has been descheduled and thus removed from the purview of the Drug Enforcement Agency (DEA). The regulation of hemp cultivation and the marketing of products not meant for human consumption is now the responsibility of the United States Department of Agriculture (USDA) and cannabinoid products intended as food, dietary supplements, drugs, etc. is under the jurisdiction of the Food and Drug Administration (FDA).
Currently, the USDA plans are drafted and in interagency review, which in a general sense, means it is on the President’s desk for approval. USDA should have rules for cultivating hemp before the 2020 growing season.
Regarding FDA’s perspective, hemp-derived CBD is still considered an unapproved ingredient and the agency maintains the need for substantial, population-level data on the efficacy and long-term safety of CBD to inform their final classification and regulations of CBD products for human and animal consumption. Realistically, the FDA is not expected to have rules regarding CBD until 2022 to 2025.
While seemingly all phases of the hemp industry remain optimistic that the USDA regulations will be soundly in favor for ease of access to hemp farming, FDA’s process needs particular attention. Recently, there have been two important initiatives from the industry and the legislature in putting pressure on FDA for expediting their processes to reach sound regulation for hemp-derived CBD.
It is undeniable that there is already a sizable amount of hemp-derived CBD already in the marketplace. The priority is to get FDA to at least define interim expectations for CBD products to protect consumer safety. We at Lazarus Naturals agree with the sentiment that the current lack of regulation of hemp-derived CBD products leaves the marketplace prone to fraudulent and/or adulterated products. Hearing and appreciating positions like ours, two recent pleas to the FDA have been made by national legislators.
On Sept 12th Rep. Chellie Pingree (D-MA) and Rep. James Comer (R-KY) issued a letter urging FDA to (1) “act quickly to provide legal and regulatory clarity”; (2) “to adopt a risk-based policy of enforcement discretion that targets bad actors while eliminating uncertainty for responsible industry stakeholders and consumers;” and, (3) “to issue an interim final rule to regulate CBD as a dietary supplement and food additive.” To this date, it includes 24 signatures from other representatives in support.
On Sept 17, Sen. Mitch McConnell issued report language via the Senate Agricultural Appropriations Committee allotting $2M for “research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities with respect to products under the jurisdiction of the [FDA] which contain [CBD],” further instructing FDA to provide the committee with a report detailing progress toward informing enforcement discretion within 90 days and issuing such a policy within 120 days, all in the interim with the intent to continue the greater research into final classification of CBD and its place in the market.
Check back with us to stay updated on how hemp-derived CBD finds its official place in the American marketplace. And, as always, continue to write your representatives to share your story and to compel them to advocate for reasonable regulation of CBD products.