By Jeffrey C. Raber
The Pennsylvania Division of Well being bought it flawed with its recall of medical marijuana merchandise that comprise “sure vaporization merchandise containing added components, resembling externally sourced flavorings or terpenes,” that “haven’t been accredited for inhalation by the USA Meals and Drug Administration.” This recall is predicated upon a flawed understanding of how FDA regulates inactive components in inhaled merchandise.
With a Ph.D. in chemistry, I’ve targeted my enterprise on the chemistry of medical marijuana since 2010. I’m an internationally acknowledged knowledgeable within the discipline having printed a number of peer-reviewed articles and lectured broadly on the subject. Through the drafting of Pennsylvania’s Medical Marijuana Act, I used to be incessantly known as upon by lawmakers to share my data of marijuana chemistry. DOH has utterly ignored the legislative priorities of the Medical Marijuana Act with this motion.
DOH’s motion impacted over 650 merchandise, inflicting turmoil for sufferers. Marijuana vape merchandise have been repeatedly demonstrated to be helpful for sufferers because the components might be standardized such that sufferers utilizing them can obtain constant outcomes — one thing tough to realize with marijuana flower and extracts.
The recall reduces affected person entry primarily based upon a litmus check that demonstrates little understanding of the merchandise DOH regulates. This motion leaves sufferers, practitioners, and suppliers in a horrible place. Sufferers are being denied their present medication and finally compelled to hunt merchandise from illicit sources. Illicit sources of not regulated vape merchandise have been on the heart of the Vape Disaster of 2019.
Standardized marijuana inhalation merchandise provide constant and dependable reduction to sufferers, as has clearly been demonstrated in additional mature markets. Vape merchandise have been out there for nearly a decade in California and all through different states that regulate entry to marijuana. Limiting entry to standardized vape merchandise is a good disservice to each PA affected person.
Any ingredient, lively or inactive, that’s to be delivered to the lungs needs to be examined to satisfy excessive requirements of purity. We should take a powerful have a look at what we use in these merchandise to greatest inform our perspective on tips on how to regulate them most successfully. To claim the dearth of FDA approval as grounds for prohibition is flawed. FDA doesn’t approve particular person substances — solely completed drug merchandise. DOH’s determination fails to understand this. By actively prohibiting compounds naturally occurring in marijuana they’re in impact recriminalizing marijuana. The FDA has not accredited the important thing lively components present in medical marijuana, particularly THC and CBD, for inhalation use both. Moreover, FDA has not accredited inhalation drug merchandise containing the commonest marijuana terpenes, resembling beta-caryophyllene and limonene.
We all know marijuana has been inhaled for greater than a century. Massive-scale evaluation has indicated the most important potential hurt comes from scorching air coming into the airways, not the marijuana molecules current. This makes for an exceptionally robust case that molecules present in marijuana, at their pure focus ranges, are acceptable for inhalation, particularly when the temperature is managed as is the case for vape merchandise.
Myself and my colleagues strongly assist accountable regulation to guard and allow affected person entry. A big-scale ban will not be the reply. These components are crucial to offering standardized medical marijuana to sufferers. DOH must act swiftly to appropriate this error and attain out to consultants and their colleagues in states the place this situation has been successfully addressed, resembling Oregon, Washington, and Colorado, and search perception about what they clearly don’t perceive.
Jeffrey C. Raber grew up in Pennsylvania and obtained a biochemistry diploma from Lebanon Valley Faculty earlier than relocating to Southern California, the place he earned a Ph.D. in natural chemistry and now runs a enterprise that focuses on the chemistry of marijuana.