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Clearing a Way for Hemp Oil

The trafficking of interstate cannabis products has been fraught with legal entanglements and federal restrictions in the banking industry, research efforts, interstate marketing, quality assurance enforcement and other crucial areas necessary for public health and safety. The Farm Bill of 2018 opened the doors for a ballooning hemp and CBD industry, an industry sorely in need of regulation clarity and federal commitment to cooperation with other legal entities.

A House Appropriations Committee quietly published a report on June 3, 2019, stating its concern about the proliferation of CBD products and the plethora of health-related claims that accompany the burgeoning industry. Concern over possible side effects of the over-consumption of CBD and too little research on these potential excesses were highlighted in the committee report.

The Committee expects the FDA to assert its authority in laying out a regulatory pathway to assess the parameters that would allow CBD to be included in edible products and in supplements that would guarantee the health and safety of the public at large. The Committee also expects the FDA to preserve the integrity of the drug approval process of any products based on CBD or other hemp-derived products. Quality, safety, and efficacy should be of paramount concern to the FDA.

The Committee further urged rigorous research into the safety, efficacy, and use of hemp-derived products and supported established pathways to assure that this could occur without interruption in the process. Currently, interstate trafficking, quality assurance enforcement, research efforts, and banking attempts have all been hampered by a lack of a viable route to implementation.

To spearhead the Committee’s report and get something happening on the FDA’s front, a bill was recently introduced by Mitch McConnell urging the FDA to act on paving a regulatory pathway for CBD products to be legally and safely marketed and studied.

As previously mentioned, the Committee provides $2,000,000 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 Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o)...

As it currently stands, claims for medical consumption cannot be made for CBD products and the FDA does not sanction its use in food or supplements. In reality, the market is flooded with all sorts of CBD products, including vaping products and claims about the benefits of CBD run rampantly unchecked.

There is an exclusion clause in dietary supplements that state no substance can be sold as a supplement that has proven usefulness as a therapeutic drug called the Drug Exclusion Rule. According to the FDA, CBD cannot be sold as a supplement because it has been approved as an epileptic drug, Epidiolex. However, to prove the Drug Exclusion Rule applies, the FDA needs to prove that CBD was not marketed as a food or supplement prior to 2014.

It is up to the FDA to forge a regulatory framework for CBD products. Now the FDA has been given a timeline and accountability to Congress to act. We will have to wait for now for the FDA to act to get the hemp and CBD cobwebs cleared up.


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