Seven months ago, Congress enacted the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Although referred to as a farm bill, the implications for America beyond the farming community are significant. Most notably, as a consequence of the 2018 Farm Bill, hemp is no longer a controlled substance. But the fact that hemp is no longer a controlled substance does not take products that contain it out of federal regulation. The Food and Drug Administration (FDA) has regulated, and for the foreseeable future will continue to regulate, how these products can be marketed.
The FDA does not currently have an established policy for products that contain hemp beyond its standard policies for addressing foods and drugs that are marketed to consumers. Mindful that there has been a recent proliferation of these type of products and states have been encouraging companies to bring these products to market, the FDA is now soliciting comments on how to treat products that contain hemp. However, the enactment of the 2018 Farm Bill did not halt the FDA’s practice of issuing warning letters to companies that it believes are improperly marketing their products in contravention of the Food, Drug, and Cosmetic Act (FD&C Act).
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