As ‘synthetic’ nicotine loophole shuts, warnings about cannabis edibles

blueberryicepuffbar-179x300Grownups have gotten stark reminders why they must stay vigilant against buck-raking enterprises that exploit young people’s experimentation with intoxicants. Even as Congress has shut a legal loophole used by the vaping industry to keep addicting its customers to harmful nicotine, other dealers are pushing candy-like marijuana edibles on youths.

In passing a $1.5 trillion bill to keep funding the federal government, lawmakers on Capitol Hill also extended the authority of the federal Food and Drug Administration to regulate not only nicotine from tobacco but also its synthetic varieties.

This was not an esoteric matter of chemistry or pharmacology. It became a flashpoint between regulators anxious to crackdown on harmful vaping and vendors who tweaked their products, so customers could get potent, addictive jolts from nicotine  purportedly was made in a lab. This, vendors claimed, put their vaping devices — notably the pen-like “Puff Bar” that surged in popularity among youths — beyond FDA oversight.

As the New York Times reported:

“The Food and Drug Administration’s crackdown on flavored e-cigarettes in 2020 was meant to be a comprehensive, aggressive strategy to curtail the epidemic of teenage vaping. But two years later, sales of disposable, flavored e-cigarettes have soared. Some companies have moved just beyond the reach of the FDA by swapping out one key ingredient. They have circumvented federal oversight of tobacco plant-derived nicotine by using an unregulated synthetic version. The agency had nearly wiped out the use of flavors in devices like Juul, once the teenage favorite, that could be refilled with pods in flavors like crème brûlée and mango. Jumping into the breach, though, companies like the teen favorite Puff Bar are selling disposable devices filled with candy flavors and tobacco-free or synthetic nicotine. Scientists are just beginning to study the unknown health effects of synthetic nicotine, even as research is expanding into the harm caused by vaping and flavor ingredients alongside continuing cases of devastating vaping-related lung injury.”

To its credit, and as part of the parental clamor that has inundated lawmakers over the problematic teen vaping fad, Congress heeded regulators and has acted as a small section of the omnibus budget bill, as the Washington Post reported:

“The FDA already has authority over nicotine extracted from tobacco plants. The new legislation would provide the agency with explicit jurisdiction over nicotine made in labs … In 2020, sales of Puff Bar’s flavored disposable e-cigarettes boomed after the FDA temporarily barred sweet and fruity e-cigarettes featuring refillable cartridges. The restrictions did not apply to Puff Bar’s products because they are not refillable. Anti-tobacco advocates decried what they called the ‘Puff Bar loophole’ as young people flocked to the brand.

“In July 2020, the FDA ordered the company’s products off the market, saying they did not have the needed authorization. Under the agency’s regulations, tobacco products introduced after August 2016 are required to get clearance from the FDA before going on sale. But last year, Puff Bar reemerged, using a new synthetic nicotine formula that put it beyond the reach of the FDA tobacco regulators. Some other vaping companies took similar steps and still others are considering it, including ones whose marketing applications for tobacco-derived products were rejected by the FDA.”

Under the law approved in another late-night, deadline-tense congressional session:

“[M]akers of synthetic nicotine products would be required to file an application seeking authorization from the FDA within 60 days of enactment of the law. Any product not authorized by the agency within 120 days of enactment would become illegal. Industry officials said they doubted that the synthetic-nicotine companies would apply to the FDA for permission to sell their products, given that some acknowledged they were striving to avoid FDA regulation. And they questioned whether the firms would have the scientific data necessary to meet the FDA’s standard for granting marketing clearance — that the product be ‘appropriate for the protection of public health.’”

Frank Pallone Jr., the New Jersey Democrat who heads the House Energy and Commerce Committee, said in a statement, quoted by the Washington Post before the synthetic nicotine measure won congressional approval:

“[S]ome bad actors have attempted to avoid FDA regulation by pivoting to using synthetic nicotine in their products. That ends with passage of this bill, which will close this loophole and clarify FDA’s authority to regulate all tobacco products, including those containing synthetic nicotine.”

The newspaper also reported this:

“Health groups say nicotine, which is highly addictive whether it comes from nature or is made in the lab, gets young people hooked on vaping and can lead to cigarette smoking. Pro-vaping groups argue that e-cigarettes can help adults stop the dangerous habit of smoking.”

Watch out for THC gummies, experts warn

Even as adults may be relieved at efforts to stop vape makers from hooking kids on nicotine with candy flavors, drug experts are warning parents about the rising risks of cannabis-containing sweets, the Wall Street Journal reported:

“Schools and doctors say more teens are getting high at school on candies or cookies containing cannabis. The expanding legalization of recreational marijuana across the U.S. has led to wider availability of cannabis edibles. Their popularity has created vexing problems for educators and families, who say it has become harder to detect teens’ cannabis use. Unlike joints, with their puffs of smoke and distinctive smell, and even vape pens, edibles — which can look just like regular candy and cookies — are almost impossible to spot.

“They are also more likely to lead to overconsumption. One small cookie or gummy can contain multiple doses of THC, the main psychoactive component of marijuana. And since edibles can take an hour or more to kick in, impatient kids can easily ingest too much. Edibles — which are growing in popularity for adults, too — have replaced vaping as many teens’ preferred covert way to get high in school, says Jonathan Avery, director of addiction psychiatry at Weill Cornell Medical College in New York. Awareness of the risks of vaping has increased, and concerns about catching Covid-19 have made kids less willing to share joints and vape pens, leading them to share edibles instead, Dr. Avery says.”

Just as with alcohol, tobacco, and vaping products, federal and state laws set age limits on selling and buying marijuana and cannabis products, where they have been legalized or allowed for medical use. But as with other “adults only” products, kids find workarounds, including older siblings who become providers, authorities say. They add that the consequences can be more serious than, say, slipping a kid brother a magazine with nude people in it:

“One standard unit of THC is 5 milligrams, as defined by the National Institute on Drug Abuse. But one candy bar or cookie could include 10 doses, says Staci Gruber, director of the Marijuana Investigations for Neuroscientific Discovery program at McLean Hospital in Massachusetts. And the way that eaten THC is processed by the liver increases its psychoactive properties, Dr. Gruber says. The high also lasts longer than from inhaling.

“Doctors and schools cite the growing body of research showing the negative impact of THC on the developing brain. Studies have found that the regular use of marijuana by teens is linked to poor performance in school and deficits in attention and memory, says Nora Volkow, director of the National Institute on Drug Abuse. Research is finding that THC seems to particularly affect the development of the hippocampus, which is involved in memory; the amygdala, which is involved in processing emotion; and the cerebellum, which is involved in motor coordination and the perception of time. Beginning marijuana use before the age of 18 doubles your odds of developing cannabis-use disorder, notes Dr. Avery, which is characterized by craving cannabis and an inability to cut down on use, among other things. Other research has found a link between marijuana consumption by teens and the development of depression and suicidal thoughts.”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs and by smoking, which is one of the leading, preventable causes of multiple, serious illnesses, including lung, heart, and circulatory diseases.

If you don’t smoke, please don’t start. If you don’t vape, please don’t start. If you smoke or vape, talk to your doctor and as soon as you can, quit. Rigorous research long ago established inarguably how smoking causes cancer, strokes, and other health problems. Although advocates argue that vaping offers a way to quit harmful tobacco smoking, no one argues it is good for you. And studies show that nicotine, which is powerfully addictive, can harm the optimal growth and development of young people.

As for marijuana and the various ways people consume it, well, the days have past of fear-mongering and blue-nosed attitudes toward grass. Again, however, those arguing for its benefits make a limited case — and, as is noted above, the research doesn’t advantage anyone arguing for giving it candy flavors and pushing it on teens, right? With the nation’s road toll spiking, the last thing the nation needs is marijuana-stoned motorists, especially teen drivers, getting behind the wheel.

We have lots of work to do to protect the present and future health of the young — and not let profiteers use sweet tastes to push intoxicants on them.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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