By: Kevin P. Caputo, M.D., FAPA, medical director, Magellan Behavioral Health of Pennsylvania

Skydiving, casino gambling, binge drinking, tightrope walking are all legal. But does that mean they are safe? There are many things in life that meet the strict letter of the law, and do not violate local, state, or federal legislation. We assume they are safe because nothing stops us from participating in them.

This includes the sale of psychoactive substances that are sold in vitamin stores, herbal shops, and supermarkets around the country. I am specifically referring to the Cannabinoid Frenzy, in which THC products and their derivatives are sold liberally to ill-informed consumers. When I go shopping in the local grocery store, it’s hard for me to fathom that I can also purchase a THC product—a product that can kill me. What’s worse is my son, who is not 21 years old, can do the same.

With the explosion of over-the-counter remedies to help us with our ailments or improve our moods, we have lost a fundamental tenet, that I as a physician subscribe to, which is ‘Do No Harm.’ Many consumers believe that these natural products are safe. However, pharmaceutical and prescribed drugs, which can also come from nature, can be powerful, as well as, addicting or deadly. That is the reason they are regulated by the FDA, to ensure quality, sameness, and a comprehensive list of side effects. These regulated drugs also include dosing recommendations to achieve a therapeutic effect.

Unlike regulated drugs, Delta 8 is an example of a synthetic marijuana-like substance that is sold over the counter. It comes from a psychoactive compound found in hemp and is made in a lab. It is sometimes referred to as “diet weed” and is marketed to treat pain, promote relaxation, help with stress, and create an overall sense of wellness. Delta 8 can be eaten in gummies or brownies, taken as a liquid, vaped, ingested as capsules, or prepared topically as a lotion, cream, or a patch.

Since it is not regulated by the FDA, you should be aware that it is possible to get a dose much stronger than anticipated. This can result in anxiety, confusion, nausea, vomiting, tremors, lightheadedness, drowsiness, dizziness, rapid heart rate, slowed heart rate, hallucinations, psychosis, and loss of consciousness. It is uncertain what the long-term effects are. More importantly, due to impurities and potential dangers, Delta 8 is currently banned in multiple states with legislation pending in several others.

The FDA’s drug approval process in the United States is rigorous, time consuming and necessary. Before a company can submit a new drug for approval, it is required to conduct animal studies, human studies and laboratory testing to ensure the drug works as it is intended, and more importantly it is safe. The 4-step process of applying for a new drug application (NDA) include: the drug test results, manufacturing information to assure that the drug will be properly manufactured, data gathered during the animal and human trials, and the company’s proposed labeling for the drug. The proposed labeling must include side effects, risks, indication for use, and how it is to be administered. The FDA, as part of the approval process, also inspects the manufacturing plant to make sure there is consistency, and quality monitoring of the drug.

I would like to see safe legal sales of psychoactive substances that promote wellbeing and more importantly prevent harm. Perhaps, when I go shopping in the grocery store, I will be able to make purchases in Aisle 7, ‘The Safe Aisle.’

 

Information provided to TVL by:
Aubrey Proud
Director, Communications and Community Relations
Magellan Behavioral Health of Pennsylvania
Magellan Healthcare Division