FDA Standing in the Way of Natural Pain Management

Why the many health benefits of CBD could be the reason it gets put out of reach for many consumers. Action Alert!

The FDA recently held a Stakeholder Call with the hemp industry to provide further information on the agency’s plans to regulate CBD. Recall that the agency has rejected CBD as a supplement and is working with Congress to develop a “new pathway” for CBD. Details on this new pathway are scarce, but the idea seems to be to regulate CBD more than supplements but less than drugs. This will likely drive up the price of CBD and make it less available to consumers. We need to support bills that take this issue out of the FDA’s hands to create a legal pathway to market CBD supplements.

On the Stakeholder Call and in previous communications, the FDA holds up safety as the key issue preventing CBD from being a food or supplement. When the agency denied three Citizens Petitions arguing for CBD to be allowed as a supplement, they explained “it is not apparent how CBD products could meet the applicable safety standard for dietary supplements.” In a Wall Street Journal interview earlier this year, an FDA official said the agency is looking at whether CBD can be safely eaten every day for a long period or during pregnancy. In November 2020, the FDA posted information to its website warning consumers of the harms that CBD can cause, including liver damage and male reproductive toxicity.

Presumably, the “new pathway” for CBD that the FDA is working towards will impose additional pre-market requirements and regulatory hurdles for CBD products. This move will increase prices for consumers and decrease the available product options since not all companies will be able to comply with the regulations. It also means less competition for the FDA-approved CBD drug, Epidiolex. As usual, consumers are the ones who lose.  

As we’ve argued previously, the FDA’s view on CBD’s safety is not supported by experts in the industry and elsewhere. A 2020 meta-analysis looked at human trials to assess CBD efficacy and safety. The authors concluded that most studies reported no adverse events with acute administration of CBD and mild to moderate effects with chronic administration, with the most common side effects being tiredness, diarrhea and changes of appetite/weight. Harvard Health Publishing, the publication of the Harvard Medical School, states simply that, for adults, “CBD appears to be very safe.” We believe that the safety question is a smokescreen to protect drug industry profits. Epidiolex costs $32,500 a year. Allowing CBD supplements on the market would cut into these profits.

Because cannabis and CBD have been considered a Schedule 1 drug, it’s been difficult to conduct research on CBD’s health effects. But as these restrictions loosen, we’re starting to learn about the incredible healing power of CBD. Research is finding that CBD can help with many kinds of pain, such as neuropathic pain from multiple sclerosis, arthritis, and chronic pain. But that’s just the start. There is evidence supporting CBD’s use in treating anxiety disorders, managing opioid withdrawal, helping people quit smoking, reducing some effects of Alzheimer’s disease, and more.

The amazing array of health benefits of CBD could very well be why the FDA is trying to hamstring our access to it. Widely available CBD could reduce our reliance on certain pharmaceutical drugs, which the pharmaceutical industry obviously does not want. Remember, as ex-FDA official David Graham once said, the FDA sees Big Pharma as its client whose interests it represents. After all, the drug industry provides 45 percent of the FDA’s budget through the fees it pays to have the FDA approve drugs.

This is why we need Congress to create a legal pathway for CBD supplements. There are current bills that do this, notably one introduced by Rep. Morgan Griffith (R-VA). We cannot let the FDA stand in the way of wider access to this naturally occurring compound.

Action Alert! Write to Congress in support of bills that allow CBD in dietary supplements. Please send your message immediately.