CBD, the second most prevalent active ingredient in marijuana, is readily obtainable just about everywhere in the United States. By itself, it does not cause a “high” and the World Health Organization finds no evidence of public health-related problems associated with the use of pure CBD.
The U.S. Food and Drug Administration has decided there is enough danger associated with CBD to call in the ultimate of food safety authorities — the U.S. Congress. FDA has denied three citizen petitions that wanted to green-light the marketing of CBD products as dietary supplements.
FDA has announced it is not going to be in the business of approving CBD in food or supplements. There is a hint that CBD products already on the shelves might be targets of FDA raids unless Congress acts by creating a new category for the cannabis product.
FDA announced that “after careful review,” it concluded that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
“The agency is prepared to work with Congress on this matter,” it said.
Among FDA’s concerns are:
— The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system.
— CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.
— CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD.
Because it is not apparent how CBD products could meet the safety standard for substances in animal food, FDA does not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.
In its decision, FDA argued that “a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, would have to meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods, said FDA’s Janet Woodcock, the senior deputy commissioner.
Congress might be a friendly ground for CBD products. In 2018, Congress passed and President Donald Trump signed into law the Agriculture Improvement Act. This law removed hemp from the federal Controlled Substances Act, effectively legalizing CBD if it comes from hemp. However, a few states have not removed hemp from their state’s controlled substance acts, so the legality of CBD products remains somewhat in flux.
CBD is marketed in many consumer products including foods, oils, lotions capsules, and cosmetics.
FDA promises it will continue to “take action” against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, “when appropriate. “
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Dan Flynn