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  • Writer's pictureJohn Kim

FDA--Existing Regulatory Frameworks for Foods & Supplements are Not Appropriate for Cannabidiol


The use of cannabidiol (CBD) has gained widespread popularity in recent years due to its potential therapeutic benefits, including its ability to relieve pain, reduce anxiety, and improve sleep. However, the regulatory landscape surrounding CBD has been complex and often confusing. In a recent announcement, the U.S. Food and Drug Administration (FDA) concluded that the existing regulatory frameworks for foods and supplements are not appropriate for CBD, which has significant implications for consumers, manufacturers, and the CBD industry as a whole.


CBD is a naturally occurring compound found in cannabis plants, including hemp and marijuana. Unlike tetrahydrocannabinol (THC), which is the psychoactive compound in cannabis that produces a "high" effect, CBD is non-psychoactive and does not produce intoxication. This has led to the widespread use of CBD in various products, including oils, tinctures, capsules, topicals, and even food and beverages.


In 2018, the Agricultural Improvement Act, also known as the Farm Bill, was passed, which legalized hemp-derived CBD at the federal level. This led to a surge in the availability and popularity of CBD products in the market. However, the FDA has maintained that CBD cannot be added to food or dietary supplements because it is a drug ingredient that has been approved for use in a prescription drug product to treat epilepsy.


On March 22, 2023, the FDA issued a press announcement stating that the existing regulatory frameworks for foods and supplements are not appropriate for CBD. The FDA reiterated its stance that CBD cannot be added to food or dietary supplements due to its status as a drug ingredient. The FDA also expressed concern about the safety of CBD, citing potential liver injury, drug interactions, and other adverse effects that have been reported in some studies.

Furthermore, the FDA highlighted the lack of data and scientific evidence regarding the safety and efficacy of CBD in different populations, including pregnant women, children, and elderly individuals. The FDA emphasized the need for further research to better understand the long-term effects of CBD and to establish appropriate dosing recommendations.


The FDA's conclusion that existing regulatory frameworks for foods and supplements are not appropriate for CBD has significant implications for consumers. Many consumers have turned to CBD products for various health concerns, and the lack of clear regulations may result in confusion and uncertainty about the quality, safety, and efficacy of CBD products in the market.


Consumers should be cautious when purchasing CBD products and should look for reputable brands that prioritize quality and transparency. It is important to read product labels, check for third-party testing, and consult with healthcare professionals before using CBD, especially if you are pregnant, nursing, taking medications, or have underlying health conditions.


The FDA's announcement also has implications for manufacturers of CBD products. Many manufacturers have been marketing CBD as an ingredient in foods, dietary supplements, and other consumer products. However, the FDA's stance that CBD cannot be added to food or dietary supplements underscores the need for manufacturers to review and revise their product formulations and marketing strategies to comply with federal regulations.


Manufacturers should ensure that their CBD products are in compliance with the FDA's current regulations and guidelines, including those related to drug claims, labeling, and good manufacturing practices. They should also stay updated on the evolving regulatory landscape surrounding CBD and be prepared to adapt their business practices accordingly.

Implications for the CBD Industry: The FDA's conclusion that existing regulatory frameworks for foods and supplements are not appropriate for CBD has significant implications for the CBD industry as a whole. The CBD industry has experienced rapid growth in recent years, with an increasing number of companies entering the market and offering

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