The Food and Drug Administration said Thursday there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress to create new rules for the growing and mass market.
Marijuana-derived products have become increasingly popular in lotions, tinctures, and foods, while their legal status has been murky in the US.
There is not enough evidence on CBD to confirm that it is safe for use in food or as a dietary supplement, FDA Deputy Commissioner Dr. Janet Woodcock said in a statement.
“For example, we have not found adequate evidence to determine how much CBD can be consumed and for how long before causing harm,” he said.
Questions remain about the effects of CBD on the liver, the male reproductive system, and on pregnant women and children, according to the statement.
The new rules could include clear labels, regulations on contaminants, limits on CBD levels and requirements, such as a minimum purchase age. Regulations are also needed for CBD products for animals, the agency said.
CBD often comes from a cannabis plant known as hemp, which is defined by the US government as having less than 0.3% THC, the compound that causes the mental aging effect of marijuana. CBD isn’t quite as high, but fans of the products claim benefits including pain and anxiety relief.
The agency also rejected three petitions from advocacy groups that had asked the agency to allow products containing the hemp ingredient to be marketed as dietary supplements.
“The use of CBD raises several safety concerns, especially with long-term use,” the statement said, adding that the FDA’s current regulatory structure provides limited tools to manage the risks associated with CBD products.
The move comes after repeated calls by lawmakers, advocates, and consumer groups to allow CBD in foods and supplements.
The FDA has sent warning letters to some companies making health claims about CBD. The agency will continue to crack down on CBD and other cannabis products to protect the public, according to the Thursday statement.
Marijuana itself remains federally illegal in the US, although it has been allowed for medical and recreational use in many states, including use in marijuana-laced food and beverages.