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My Review of Comments Submitted to the FDA

By Tanya Martin October 05, 2021

In July the Food and Drug Administration (FDA) began taking public comments regarding scientific data and information about products containing cannabis-derived compounds such as CBD. They made this request in order to determine whether to allow these products at all and if so how best to regulate them, particularly CBD due to the popularity and diversity of products on the market. In all, there are 4273 comments available for public review. I reviewed all of these in the effort to understand what people submitted so that I could share what I learned with customers.  Several of these comments were anecdotal, as individuals described their experiences and benefits they had in their use of cannabis products. The majority of those were associated with pain relief, anxiety relief, seizure reduction, PTSD, and benefits in pets for many of the same conditions.

Most of the negative comments regarding CBD were from those it failed to help, although there may be several factors involved that could be the cause. Some of these folks could have ended up with a product falsely claiming to contain CBD, and not have any third-party lab reports done to show for it. There may also be some that have unrealistic expectations such as seeing results right away and often these people do not give it enough time to produce results as some may not see benefits until weeks of use. Results vary for everyone and unfortunately, there are one in a few cases where people won’t be helped by it. The majority of negative comments were attributed to the effects of THC or were from those that had never tried cannabis in any form and believe in propaganda like the film “Reefer Madness” used to demonize cannabis that was a widely used plant for so many years. Some claim that it caused deaths using examples such as Bobbi Kristina Brown drowning in a bathtub much like her mother Whitney Houston. It is true Bobbi had Cannabis in her system as well as alcohol, morphine, and other substances. I don’t believe it is fair to blame cannabis as the other substances listed have a greater propensity to cause harm. In the Bobbi Kristina Brown case, her cause of death was attributed not only to the drug cocktail in her system but pneumonia as well.

One negative comment referenced CBD turning into THC in the stomach. This information has since been shown false. In the original study, they were able to show these results in a petri dish with simulated gastric juices but have been unable to reproduce these results in the human body. One commenter claimed that this happened to her friend, who had to be hospitalized due to a severely bad reaction. One can only hypothesize what really happened here. Perhaps the product was mislabeled and did contain THC or it was contaminated and these contaminants caused a bad reaction. Not having documentation of this from the overseeing physician it is impossible to know what truly happened.

Some cited research that claimed to show CBD causes liver toxicity. This was a study performed on mice, not people, and is full of flaws. They force-fed eight-week-old mice 246mg, 738mg or 2460 mg of CBD per kg of body weight. This is an attempt to mirror the recommended dose of Epidiolex,  a cannabis-based pharmaceutical used to treat seizures with Lennox-Gastaute syndrome or Dravet syndrome. With these doses, 20mg per kg would equate to me taking 1,440 mg of CBD daily. We find our customer base on average, takes 10mg to 30mg daily, some may be taking 50mg or more daily but well below what this study claimed caused liver toxicity. Many studies were done on humans in the approval of Epidiolex and did show some concern with elevated liver enzymes at the higher doses. It is therefore recommended that additional liver function testing be done when using Epidiolex, particularly with other pharmaceuticals. Anyone currently on pharmaceutical drugs or those having a concern with liver function should consult their doctor prior to taking any cannabis product or any supplement for that matter.

Some doctors hoped to see more clinical testing before allowing CBD to be purchased without a prescription. There are several medications known to cause multiple issues such as dependence, gangrene of the genitalia, or even death. Misinformation given to doctors by pharmaceutical companies and a lack of research are both primary causes of the current opioid crisis and medical mistakes are the third leading cause of death in the US. Several doctors in their comments quoted the oath “do no harm” and they are concerned about the safety of people using cannabis-derived compounds such as CBD.

Cannabis has been used for centuries and perhaps the reason why it is understudied is due to misinformation spread to demonize the plant and tie the hands of those wishing to study it due to it being classified as a schedule one drug. Being the most widely used illegal substance on the planet I feel we would be well aware if there was any greater harm in the use of it over any supplement we have access to at any store wishing to carry them.

The resounding response is calling for some level of regulation. Testing for purity and quality are the two primary concerns most often advocated for so that the consumer can have confidence in the products they purchase. Some regulation is a good idea to protect the public from those hoping to make a quick buck in a currently booming market. However, I don’t believe the regulations should be any greater than that which supplements are required. In my opinion, THC should be regulated much like alcohol and cannabis should be removed from schedule one status so it can be researched and be treated like the substance it is, which in no way should be on par with heroin or methamphetamine.

The FDA claims they will have some response and possible guidelines announced this fall. Hopefully, they will be of a sensical nature and truly in the best interest of the public, not big pharma. As we learn more we will be sure to keep everyone posted with any upcoming news about potential regulations that may be coming into place.


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