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FDA Misleads on CBD Safety

FDA Misleads on CBD Safety
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…providing further evidence that the agency is trying to engineer a ban on affordable CBD to protect drug industry profits. Action Alert!

As the evidence of CBD’s myriad health benefits continues to pile up, it increasingly looks to us like the FDA is preparing to issue a ban on CBD supplements. We must support bills in Congress that take the issue out of the FDA’s hands by allowing the sale of CBD in supplement form.

Lawmakers do appear to be taking this issue seriously. In addition to the bill introduced by Representative Morgan Griffith (R-VA), another similar bill has just been introduced by Senators Ron Wyden (D-OR), Rand Paul (R-KY), Jeff Merkley (D-OR), and Representative Earl Blumenauer (D-OR) to allow the sale of CBD in supplements. Additionally, Congress is holding a hearing on July 27 during which members will formally scrutinize the impact of the FDA’s failure to develop a regulatory pathway for the sale of CBD in supplements and food. Let’s show the FDA the scale of our opposition to its unjustified plan and demonstrate the huge level of grassroots support for CBD supplements ahead of the hearing.

We want to make it crystal clear what we face if we don’t stop the FDA in its tracks. CBD, or cannabidiol, is one of over 100 natural compounds called cannabinoids found in a wide range of plants, most notably the hemp plant. The cells of our bodies are laced with cannabinoid receptors that form part of the endocannabinoid system that is essential to life and to robust health. We produce cannabinoids internally (endocannabinoids) and we also consume them in some foods (exocannabinoids). Most of these cannabinoids, including CBD, are not psychoactive – THC being an exception – but they all offer profound benefits. CBD is one of the most well researched non-psychoactive cannabinoids and it has an incredible array of health benefits, with evidence showing that has profound anti-inflammatory and immune modulating effects and can help with painanxietydepressioncertain cancers, and even heart health.

Let that sink in for a moment. The opioid epidemic is killing an astonishing number of Americans every year; rates of anxiety and depression are reaching new highs, particularly among young people; heart disease is the leading cause of death for adults in the US. CBD has been found to help with all of these conditions, but instead of working to make this compound more widely available as a supplement, which is the way it should be sold according to the Dietary Supplement and Health Education Act of 1994 (DSHEA), the FDA wants to stop all supplement sales of CBD. The FDA’s justification is the protection of the profits of one pharmaceutical company that has a CBD drug that will cost patients a stunning $32,500 per year. It will also mean citizens who have been benefiting from low-cost health support from  CBD supplements since they became widely available a few years ago will have no further access to the supplements they have relied on. There is something deeply wrong with this picture.

How did we get here? For starters, the FDA says that CBD can’t be a supplement because it has approved a drug version of CBD called Epidiolex that is used to treat two rare forms of epileptic seizure, Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in children over 2 years. This ability for FDA to rule in favor of drug companies has to do with the FDA back-channel that we’ve written about many times before. In short, if a substance is studied as a drug (i.e. a drug company has made an Investigational New Drug application) before there is evidence it was sold as a supplement (i.e. evidenced by a supplement company’s New Dietary Ingredient notification), then the drug company can ask the FDA to ban the supplement form of that compound.

Yet, as pressure mounts from Congress and a variety of stakeholders to make CBD more widely available, the FDA has been reviewing scientific information on CBD. Earlier this year, the agency released a statement explaining that the “existing regulatory framework” for foods and supplements is not appropriate for CBD and that a new regulatory pathway is needed.

One of the main issues raised by the FDA is that of safety. The agency claims that CBD presents various safety concerns, specifically the potential for harm to the liver and the reproductive system and concerns for vulnerable populations such as children and pregnant women.

These views are articulated in a review article authored in part by FDA staff. To support the assertion that CBD can pose threats to the male reproductive system, the authors cite a 1981 animal study in which monkeys were administered 30, 100, or 300 milligrams per kilogram of body weight per day (mg per kg bw/day) of CBD orally. But consider that 300 mg per kg bw/day for a human weighing 154 pounds would be 21,000 mg, or 21g, of CBD—far, far more than anyone would ever take as a supplement!

This is emblematic of a larger problem we’ve discussed before: the deeply flawed risk assessment models used by federal bureaucrats to prevent us from utilizing natural medicines to stay healthy. These types of models have been used by European regulators to set absurd limits on supplement dosages (known as tolerable upper limits, or ULs). ANH’s founder and Executive and Scientific Director, Robert Verkerk, PhD, has published several papers critiquing this approach that was originally developed by the Institute of Medicine (now the National Academy of Medicine), pointing to a fundamental flaw: in trying to restrict vitamin or other micronutrient dosages in this way, regulators completely ignore the fact that risks vary greatly depending on the form and dose of a nutrient used, and for most populations you’ll find overlap in the doses that cause health benefits for the majority and risks for a few. So if you then create a law that aims to eliminate a potential risk for everyone, you actually deprive the vast majority access to the micronutrient and all the benefits it offers.

Bringing it back to CBD: the fact that the FDA is, in part, using a decades-old animal study in which an absurdly high CBD dose was used to demonstrate that CBD has safety concerns once again demonstrates that the federal approach to assessing risk and benefit is fundamentally broken. It’s based on a defunct toxicological model that should have no place in modern day food or supplement law-making. The agency is also not giving proper weight to the incredibly favorable safety record of CBD used as a supplement or the multitude of benefits we can get from using CBD as a supplement. Instead, the FDA has chosen to focus on old evidence of harm that was only found when absurdly high doses were taken experimentally. To us, it seems like the agency is simply grasping at any information it can to demonstrate harm so it can justify its proposed ban on CBD supplements. The driver? Nothing less than preventing competition for the pharmaceutical drug version of CBD, given its the drug companies that are the FDA’s principal paymasters.

And, indeed, 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. Again, these side effects must be weighed against the benefits of CBD use for combatting opioid misuse, heart disease, anxiety, and depression. Harvard Health Publishing, the publication of the Harvard Medical School, states simply that, for adults, “CBD appears to be very safe.”

We cannot allow the FDA to cater to the drug industry at the expense of public health.

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

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