More than two years have passed since Congress promulgated the 2018 Agricultural Improvement Act ( 2018 Farm Act) To legalize the commercial production of cannabis and entrust the Food and Drug Administration (FDA) to supervise cannabis-derived products for human consumption. Despite this, the FDA has not yet opened up legal legal channels for these products.

The FDA’s failure to fulfill its regulatory authority has led to the establishment of a very unregulated market, in which the safety of many products has been questioned, and states have to control the market by formulating their own manufacturing and sales regulations, and these Marketing of the product.In turn, this resulted in Patchwork of needs This makes it difficult for the industry to ensure compliance, if not impossible.

The FDA tried to prove its failure to regulate cannabis-derived products, especially CBD products, by hiding the Food, Drug, and Cosmetic Act (FDCA), which prohibits any new dietary ingredients, food or beverages from entering the U.S. market. If it has been researched and approved by the agency as a pharmaceutical ingredient ( Drug exclusion rules) – If you remember, the Convention on Biological Diversity was approved as a pharmaceutical ingredient in the following countries: Epidiolex In July 2018, just a few months before hemp and its derivatives became federal law. Although the FDA is indeed required to follow and implement FDCA, the agency also has the right to exclude substances from the “Drug Exclusion Rules.” At this time, the agency can manage the substance as any other dietary or food ingredient. For hemp and CBD, the FDA only chose not to take action on the authorization.

Since the passage of the Farm Bill in 2018, Congress has repeatedly tried to pass the introduction of bills, proposing that dietary supplements and/or foods mixed with hemp be specifically exempted from this federal ban, thereby forcing the FDA to perform its administrative functions.

In 2020, Congress introduced HR 5587 with HR 8179, A bipartisan bill that proposed to exempt CBD products from the Drug Exclusion Rules in order to regulate them as dietary supplements, but failed to pass due to COVID and the need to solve more pressing issues.

This year, federal lawmakers came together again and introduced the HR 5587 and HR 8179 versions, namely:

• “Cannabis and Cannabis-derived CBD Consumer Protection and Market Stability Act” (HR 841) The use of CBD is only allowed in dietary supplements, provided they meet the current federal requirements imposed on these products.
• Marijuana Use and Consumer Safety Act ( 1698) It is recommended to legalize the use of hemp-derived cannabinoids (including CBD) in food and dietary supplements. Specifically, the bill will amend the FDCA’s definition of dietary supplements and foods to exempt “marijuana, cannabis-derived cannabidiol or substances containing any other ingredients derived from cannabis” in the Drug Exclusion Rules.In addition, the bill will enable companies to continue the FDA’s existing customs clearance procedures for these products, namely Notification of New Drug Ingredients And GRAS statement. S. 1698 also prioritizes consumer protection by requiring these products to comply with all regulations applicable to products containing cannabinoids and ensuring that they are properly labelled.

The promulgation of these Congressional bills will obviously help alleviate regulatory uncertainty surrounding the legality of cannabis-derived products and improve the quality and safety of these products, thereby assuring consumers that these products are safe.

Industry leaders, including U.S. Cannabis Roundtable, This U.S. Marijuana Administration, National Industrial Hemp Committee (National Institutes of Health), including national groups such as the American Wine and Spirits Wholesalers and Consumer Brands Association, and the American Herbal Products Association (High performance liquid chromatography) Expressed strong support for one or both of these bills, which indicates that it is likely to see CBD and cannabis-derived products regulated by the federal government before the end of this year-assuming that the FDA does not withdraw these regulations, further delaying Congress’ eventual legalization ability.

We will continue to monitor these bills and keep you informed of future developments.