Recent media reporting of health issues associated with vaping began to raise my suspicions regarding the real issue. Vaping or e-cigarettes came on the market in 2003. There were no alarming health issues reported since 2003 until now. Why now?
In 2018, Congress legalized industrial hemp and President Trump signed the “Farm” bill. Hemp was defined as having no more than 0.3% THC (psychoactive compound delta-9-tetrahydrocannabinol).
I selected some of the testimony of Amy Abernethy, MD, Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health and Human Services before the Senate Committee on Agriculture, Nutrition, and Forestry on July 25, 2019. It states:
“The passage of the 2018 Farm Bill has led to the misperception that all products made from or containing hemp, including those made with CBD, are now legal to sell in interstate commerce. The result has been that storefronts and online retailers have flooded the market with these products, many with unsubstantiated therapeutic claims. FDA has seen CBD appear in a wide variety of products including foods, dietary supplements, veterinary products, and cosmetics. As this new market emerges, we have seen substantial interest from industry, consumers, and Congress. However, in the midst of the excitement and innovation, FDA’s role remains the same: to protect and promote the public health.”
“At present, any CBD food or purported dietary supplement products in interstate commerce is in violation of the FD&C Act due to the statutory provisions discussed above. However, FDA’s biggest concern is the marketing of CBD products that make unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, but have not obtained new drug approvals. For example, FDA has seen various CBD products with claims of curing cancer or treating Alzheimer’s disease. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life…”
“…It is also worth noting that, while investigating these unapproved CBD drug products, FDA identified other concerns. For example, laboratory analysis of some of these products revealed they did not contain the amount of CBD that was claimed on a product’s label, and/or the products contained other substances that were not on the product’s label, such as other cannabinoids like THC.”
“Through the approval of the CBD-containing drug Epidiolex, which was based on adequate and well-controlled clinical studies, FDA has learned that CBD is not a risk-free substance. During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. In that context, the risks are outweighed by the benefits of the approved drug to the particular population for which it was intended.”
“FDA is wrestling with questions not only about the intrinsic safety of CBD, but also about potentially unsafe manufacturing processes for products containing CBD. FDA knows from CBD products it has tested that they may not contain the amount of CBD indicated on a label, or they may contain other potentially dangerous compounds that are not listed on the label…”
“FDA has made it a priority to address these questions, and we are working diligently to make progress. However, FDA will only consider creating legal pathways for CBD to be marketed as a dietary supplement or in a food if the Agency is confident that it can develop a framework that addresses safety concerns. Another issue that FDA plans to consider is whether allowing CBD to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds. Less research into the promise of cannabis-derived compounds and fewer drug approvals in this area would be a significant loss for American patients.”
I was aware of the first ever FDA approval of medical CBD oil (Epidiolex) for specific medical reasons. The effectiveness of prescription CBD in clinical trials were positive. I asked and received an article for “The Coalition” (the official magazine of the National Narcotics Officers Association Coalition, NNOAC) from Greenwich Biosciences outlining the process of producing medical marijuana to extract medical grade CBD from the marijuana plant. I was surprised that marijuana extracts various heavy metals and other contaminants from the soil.
On October 4, 2019, the Food and Drug Administration (FDA) released this statement: “This is why today, we’re strengthening our message to the public in an updated consumer alert stating that they should not use vaping products containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. Additionally, consumers who choose to use any vaping products should not modify or add any substances such as THC or other oils to products purchased in stores and should not purchase any vaping products, including those containing THC, off the street or from other illicit channels.”
The Center for Disease Control (CDC) released data that states: “As of October 1, 2019, 1,080* lung injury cases associated with using e-cigarette, or vaping, products have been reported to CDC from 48 states and 1 U.S. territory. Eighteen deaths have been confirmed in 15 states. All patients have reported a history of using e-cigarette, or vaping, products. Most patients report a history of using THC-containing products. The latest national and regional findings suggest products containing THC play a role in the outbreak.”
To my knowledge there is no instant drug test to ensure any product contains no more than 0.3% THC. How does law enforcement check compliance?
So why do our politicians want to rush to legalize marijuana without any FDA findings of health safety? State legislators’ public comments regarding the vaping problem show their ignorance. Their comments lack any factual information on vaping health issues. Yet, those same legislators will support legalizing marijuana in Connecticut for tax revenue.
Addendum: After completing the above article, I learned that Connecticut solved the vaping problem by enacting PA 19-13, which raised the age to purchase and use tobacco and vaping products from 18 to 21. However, legislators created a new problem when they deleted the language making simple possession illegal. So, an underage adolescent can walk around school with a vape in his pocket, and the police can’t touch him unless he is caught using it or unless he is caught misrepresenting his age to purchase it. Good job legislature! Furthermore, the bill did not address CBD oil or THC, which are the leading causes of the recent hospitalizations and deaths.
William E. Butka is Editor in chief of “The Coalition” magazine.