• G. Liu


Updated: Feb 3

Cannabidiol (CBD) is regulated in the US under the FD&C Act

We hear a lot about CBD's therapeutic claims, its application in new products, and its legal status. What’s the Federal government’s regulation on CBD products? Let’s take a look at the US policy on CBD.

The 2018 Farm Bill removed Hemp from the list of Controlled Substance which allowed it to be cultivated as a commercial plant. Futhermore, hemp and hemp derived products can be transported across state lines. After the 2018 Farm Bill was passed, industrial analysts estimated hemp-derived CBD product markets in the US to be worth $23 billion by the 2020s.

Growers, manufacturers and consumers are all passionate and excited about the new federal hemp regulatory system. However, under the FD&C Act, THC or CBD products cannot be sold as dietary supplements or food products. This means that companies cannot market CBD as a dietary supplement or a food additive.

On November 2019, FDA issue a warning letter to 15 companies for illegally selling product containing CBD that violate the FD&C Act. The complete list of companies and the article may be visited at: https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

The reason for that is there is not enough research data to verify the safety of CBD in human food. FDA stated that it is “actively evaluating” possible pathways for CBD to be marketed as a dietary supplement, while also attempting to quantify potential risks for consumers so that products are safe if approved. FDA issued an update to Congress on March 5th on the status of rulemaking for CBD.

“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions” “Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”

Essentially, the legality of selling CBD is entirely dependent upon the labelling of the product. For a CBD product to be sold legally, it must be classified as a hemp product under the 2018 hemp farm bill. The product may not contain over 0.3% THC on a dry weight basis. The formal language is:

“The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

The same federal regulations from the FDA would apply on an interstate basis, so the guidelines above would not be changed.

The conclusion is that as long as a company’s product is not labelled with CBD, does not make therapeutic claims, is THC compliant, the hemp derived product is at minimum risk of violating the FDA guidelines. It’s understandable that many consumers are eager to try more new CBD products. However, before purchasing, check the qualification of the manufacturer, and reputation of the brand would be a wise choice.

VK Organics has FDA registered and GMP certified manufacturing facility, it provides premium quality ingredients and finished products. If you are interested in knowing more about VK products, please contact sales@vkorganics.com.

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