• Jeffrey Friedland

Mitch McConnell’s Latest Action in Support of America’s Hemp and CBD Industries

September 20, 2019 - Senate Majority Leader, Mitch McConnell, has acted to require that the Food and Drug Administration (FDA) provide temporary guidance regarding its enforcement intentions regarding the sale of CBD or products that include CBD.

McConnell’s request for guidance is viewed as a short-term solution, while the FDA implements its long-term CBD policy.

McConnell’s proposed language is to be included in the Senate appropriations bill. It compels the FDA to advise Congress regarding the agency’s progress in drafting its “enforcement discretion” policy regarding CBD.

While CBD was legalized by last December’s Farm Bill, the FDA has thrown a monkey-wrench into America’s fast-growing CBD industry by taking a position that CBD may not be sold as a nutritional supplement, nor as an additive to food or beverage products.

McConnell, a Kentucky Republican, the senior Republican in Congress has been a passionate advocate of the hemp industry, including CBD.

Before 1937, when the growing of hemp and marijuana were both made illegal, Kentucky was a major hemp producing state. McConnell, as the most important advocate for hemp and CBD in Congress, sees his actions as benefiting his Kentucky constituency and the state’s new and fast-growing hemp industry.

McConnell actions this past week, to require the FDA to finalize its rules regarding CBD are consistent with his advocacy of the industry. McConnell’s objectives include allowing CBD itself, and food, beverage, cosmetic, and nutritional supplements that include CBD, to be manufactured and sold without onerous FDA restrictions and compliance requirements.

Phyto Intel’s Conclusions

The FDA’s quandary regarding its CBD policy is complicated due to the agency’s approval last summer of the prescription drug, Epidiolex, which is plant-derived CBD. Epidiolex was approved by the FDA for treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

While it is clear that the FDA would prefer that CBD not be available as a nutritional supplement or as a food or beverage additive, political pressure and the significant media coverage regarding CBD makes that an impossibility.

There are precedents for drugs to also be allowed as nutritional supplements and food and beverage additives. These include omega-3 fatty acids, vitamin C (ascorbic acid), and fish oil, all of which are approved as drugs and are also available as nutritional supplements. Omega-3 fatty acids and ascorbic acid are also available as food and beverage additives. We believe that the FDA will be forced to adopt a similar policy for CBD.

We also see the likelihood that the FDA will try to limit the quantity of CBD in nutritional supplements, food and beverages, but view this as problematic for the agency to implement.

About Phyto Intel

Phyto Intel provides strategic assistance to enable businesses and entrepreneurs to enter and succeed in the fast-growing and fast-evolving legal cannabis, hemp and CBD markets in the United States and globally.

Phyto Intel’s services are focused on four general areas:

Formulation of food, beverage, and cosmetic products that include CBD

Providing of proprietary information on federal, state, and local regulations regarding CBD and products that include CBD

Development of branding, marketing, and sales strategy for products that include CBD

Post-product launch services including analytics and market feedback

Phyto Intel also provides market intelligence, formulation and “go to market” strategies for Consumer Packaged Goods (CPG) companies and CBD producers interested in developing, formulating, manufacturing and marketing food, beverage, nutritional supplement, and cosmetic products containing hemp seed oil and/or CBD.

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