In February 2019, former FDA Commissioner Scott Gottlieb, MD, testified before Congress regarding CBD. The discussion focused on the FDA’s goal to create “an appropriately efficient and predictable regulatory framework for regulating CBD products.” This was good news for those in the hemp and cannabis market. However, the FDA still has not implemented any regulatory framework or issued guidance on the status of CBD products. This means that CBD-infused products are still illegal in the U.S.
CBD-infused products are located in almost every market where cannabis (medical or adult use) has been legalized. Carl’s Jr. sells a 420 Burger infused with CBD. Many thought the floodgates opened wider with the passage of the 2018 Farm Bill. It removed hemp from the DEA’s Schedule 1 list of controlled substances (THC, the narcotic fraction of the plant, is still on the list). That was a misreading of the legislation by many. On Dec. 20, 2018, Dr. Gottlieb issued a statement reiterating the FDA’s authority to regulate CBD as an ingredient. He also noted that according to the FDA, CBD is not a legal dietary ingredient.
Dr. Gottlieb reaffirmed this position on February 28, 2019. He stated it remained unlawful to introduce food or supplement products into interstate commerce that contained added CBD. “As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing,” he said.
At the State Level
Many people have heard about New York City starting to enforce its ban on CBD-infused edibles. However, there was no discussion about if such a ban would be applied or was being applied to the rest of the state. The state of New York provided its answer. On July 19, 2019, the New York State Department of Agriculture and Markets issued a statement clarifying its position on this issue, stating, “No food or beverage product may be made or sold in New York State if it contains cannabidiol (CBD) as a food, a food additive or an ingredient.”
“Food or beverage products that are found by Department inspectors, in either a processing facility or in the marketplace, to contain CBD are considered adulterated (FD&C Act, sec. 301(b) and AML, sec. 200).” The department stated that such products “are subject to enforcement actions taken by the Department or the U.S. Food and Drug Administration” possibly including:
According to the New York State Department of Agriculture and Markets sections 200.1 and 200.2 of the Agriculture and Markets Law applied. The law reads as follows:
Food shall be deemed to be adulterated:
Cannabidiol (CBD) as a dietary supplement or as an infused ingredient (water/food) has been illegal if transported across state lines. We knew that New York City was starting to enforce its ban on such products. New York’s Department of Agriculture and Markets has now unequivocally stated it is also illegal throughout the entire state. This is a massive blow to an area of business many companies were looking to enter or had already entered. The demand and curiosity regarding CBD and its uses continues to grow. This may lead to further stagnation of the hemp business within New York state as the infused products market is now shut for the foreseeable future. The question will now turn on what steps New York state will take if the FDA provides guidance in the opposite direction of what New York just decreed.
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