The FDA continues refusing to provide a pathway for CBD supplements, all in an effort to protect drug industry profits. We need to force their hand. Action Alert!
Last month, the FDA’s Science Board conducted a hearing concerning the safety of CBD in dietary supplements. After almost four years, the agency is still pointing to safety concerns with CBD that prevent the agency from devising a regulatory structure for these products on the marketplace. It seems clear, though, that the real reason for the FDA’s years-long delay is to protect drug industry profits, since CBD has been approved as a drug. We cannot trust the agency to do the right thing. To protect access to affordable CBD, we need to support bills in Congress that take the matter out of the FDA’s hands.
Access to affordable CBD would help a wide variety of patients. We’re learning more and more about the benefits of CBD as more research gets conducted. There is research supporting its use for pain, anxiety, depression, certain cancers, and even heart health. But the FDA is standing in the way of access to CBD because there is an approved drug with CBD as the active ingredient. This drug costs $32,500 a year and is indicated to treat rare forms of seizure; it will likely be prescribed off-label for all kinds of things, generating a windfall for the drug’s sponsor.
The FDA has consistently complained that there isn’t enough safety data to support the use of CBD in supplements. This view does not seem to be supported by experts in the industry and elsewhere. For example, NSF International, an independent product testing, inspection, and certification organization said at the FDA’s hearing that there is “plenty of safety data on CBD.” This is supported by the fact that an American CBD company won approval from European authorities to sell its product in the United Kingdom and the European Union as a novel food.
This should be a big vote of confidence for CBD’s safety, given how restrictive European authorities have been with regard to supplement safety. Our friends at ANH-International, who are intimately familiar with the novel foods regulatory process, write that the biggest challenge to a successful novel food application is providing sufficient data on human safety. If CBD can get past the strict EU regulators, why is the FDA still dragging its feet?
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.”
Cannabinoids have been consumed safely in a variety of foods and herbal products for decades in things like hemp oil, Echinacea, black truffles, and cacao. As far back as 2900 BC, cannabis was noted for its medicinal effects. We also generate cannabinoids internally when we engage in rhythmic exercise like walking, jogging, and swimming.
The problem, ironically, seems to be one created by the FDA’s inaction. The CBD market is currently a “Wild West” where there has been an explosion of companies selling CBD products, not all of them being reputable. Part of what causes this is the patchwork of laws in states across the country faced with federal inaction.
But, as we’ve been saying for years, the crux of the problem is that, according to FDA rules, CBD cannot be a supplement because it is a component of an approved drug. We believe the FDA has no intention of allowing CBD to be sold in supplements because, in their view, it would undermine the integrity of the drug approval process. The FDA has affirmed the illegality of CBD as a supplement in the warning letters it has been sending out to CBD and hemp companies, though the agency seems to be focusing its enforcement on companies making health claims about CBD and hemp. (This article provides background on how we got to where we are now.)
The FDA has already provided cover for a ban on all CBD products. In late 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.
Bills currently being considered in Congress would allow CBD supplements to be sold. There are two bills, one in the House and one in the Senate. The bills are slightly different, but both allow CBD to be used in supplements and provide an exemption for hemp-derived CBD from rules that apply to dietary supplements when there is an approved drug with that ingredient or if that ingredient is being investigated as a new drug.
If we want to protect our right to access this incredibly beneficial compound at reasonable prices, we must support these bills.
Action Alert! Write to Congress in support of HR 841 and SB 1698. Please send your message immediately.