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April 2021

Will the 2021 USDA Final Rule Impact CBD Products?

Most people are already confused about cannabis regulations in general, and to add to the confusion, new hemp regulations just went into effect. Here’s a breakdown of the new rules.

The 2018 Farm Bill was signed into law on December 20, 2018. The bill defined “hemp” as any part of the Cannabis sativa plant with THC concentrations of less than 0.3%, and made it no longer a controlled substance under federal law. It also established the U.S. Domestic Hemp Production Program with a set of interim rules. As of March 22, 2021, the USDA's final rule now replaces those interim regulations.

The descheduling of hemp opened the floodgates for commercially available CBD products. Despite clear rules defining “hemp” as containing less than 0.3% THC, many CBD products currently on the market have been found to contain higher concentrations. With this new ruling, transparency on testing should improve. The USDA final rule requires domestic hemp producers to apply for and maintain a USDA license. It also requires sample testing of each hemp crop no more than 30 days before harvesting. And testing must occur at labs that are registered with the Drug Enforcement Administration (DEA). Despite efforts in the hemp community to raise the THC threshold to 1%, 0.3% is still the limit in hemp. Anything over 0.3% must be disposed of. But producers won’t be hit with a violation as long as tested samples aren’t over 1%.

Some people might ask how this will impact CBD products. Having clearly defined THC limits and testing for hemp should improve consistency among CBD products derived from licensed hemp producers. It’s also expected to increase the production of hemp in the US and reduce the amount of CBD sourced from Canadian-grown hemp. If patients are concerned about THC contamination in CBD products, suggest they only consider products that source CBD from a licensed hemp producer. Beyond that – there isn’t much consumers can do to minimize risk for THC contamination.

Unfortunately, the legality of CBD remains complicated. While the Farm Bill made hemp-derived CBD legal, this was muddied by the FDA approval of Epidiolex, which made using CBD in dietary supplements illegal. Cosmetics containing CBD, on the other hand, can be legal per the FDA, provided they comply with cosmetic-specific regulations.

More cannabis legislation is likely to come in the near future, including a bill aimed at expanding scientific research in the area. We’ll keep you updated as we learn more. Until then, check out our monographs for information on the different uses and regulations related to cannabis- and hemp-derived products.

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2021 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.