FDA says 'CBD has the potential to harm you'

At the Private Label Manufacturers Association’s (PLMA) Washington Conference in September, food regulatory lawyer Miriam Guggenheim said the Food and Drug Administration (FDA) was under tremendous pressure from Congress to enact federal guidelines to open the cannabidiol (CBD) market to private branded and branded food and beverage products. The hope of CBD companies and food groups and associations was that the FDA would come up with a plan by the end of the year.

But that now appears to be a long shot. In fact, after the FDA said earlier this week that “CBD has the potential to harm you, and harm can happen even before you become aware of it,” it could be some time before the FDA approves CBD to be used as an ingredient in food and beverage products.

The FDA also warned that CBD can cause liver injury; affect the metabolism of other drugs, causing serious side effects; and increase the risk of sedation and drowsiness, which can lead to injuries, if used with alcohol or other central nervous system depressants.

In addition, the FDA reiterated that it’s currently illegal to market CBD by adding it to food or labeling it as a dietary supplement, and that it has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.

The FDA said there are important questions about CBD that it doesn’t know the answers to, such as:

• What happens if you take CBD daily for sustained periods of time?

• What is the effect of CBD on the developing brain (such as children who take CBD)?

• What are the effects of CBD on the developing fetus or breastfed newborn?

• How does CBD interact with herbs and botanicals?

• Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

In a press release, the FDA said it plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks. 

The FDA also issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate. We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA.”

Not surprisingly, CDB stocks were down after the FDA’s announcement. In a statement, Owen Bennett, an equity analyst for Jefferies Financial Group, said: “We've argued for a while that some near-term industry estimates for CBD are too high given the unclear regulatory outlook and this will likely be a catalyst for re-basing. Longer term, we see significant potential but do not expect material contribution to coverage names from U.S. CBD in the next 12 months.