Federal Regulation of Hemp: Next Steps From The FDA

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On December 20, 2018, the Agricultural Improvement Act of 2018 was signed into law, which removed hemp from the Controlled Substances Act and ensured that hemp is no longer an illegal substance under federal law. You can find more information on the Agricultural Improvement Act of 2018 here.

FDA’s Potential Regulatory Pathways for Hemp-Based CBD

On April 2, 2019, the FDA released a second statement from FDA commissioner Scott Gottlieb, which outlines the next steps the FDA will take to advance their continued evaluation of potential regulatory pathways for cannabis-containing and cannabis derived products. The FDA’s statement details the agency’s current approach to hemp-based CBD products and the next steps the agency will take to develop regulations for this industry.

“When the 2018 Farm Bill became law, I issued a statement explaining the FDA’s current approach to these products and our intended next steps. Consistent with the approach and commitments described in that statement, today the FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities. These new steps include:

  • public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
  • The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
  • Updates to our webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
  • The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.”

Pressing Concerns for Those In The Hemp Industry

The FDA’s FAQ webpage has been updated to address (albeit somewhat vaguely) many of the most pressing questions for those interested in entering the hemp industry. Below are two such questions that the FDA has answered:

Q: Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

Q: Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

Contact the cannabis and hemp industry attorneys at Rogoway Law Group if you’d like to discuss how current federal regulations may affect your hemp business.

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