Smoke and Mirrors

The Centers for Disease Control and Prevention (CDC) doesn’t mince words when it comes to tobacco users’ increased health risks. “Tobacco use is the leading preventable cause of death in the United States,” says the CDC. Cigarette smokers — both male and female — have a mortality rate three times higher than their nonsmoking peers. While smoking poses a trifecta of risks (cancer, respiratory disease, and vascular disease), smokeless tobacco products are not much safer. These products may cause ventricular arrhythmias and, as a result of irregular heartbeat, sudden death.

Tobacco is harmful. This isn’t news to any reader. The US has been getting a serious education about the very serious risks of tobacco products since the 1950s. But tobacco is big money, big influence, and so it has taken some time for warnings to be distilled and disseminated properly. Regulating tobacco means keeping it out of young, impressionable hands and mouths, but it took a long time to achieve this.

Compare the decades-long struggle to protect children from the allure and dangers of tobacco to the more recent war waged against electronic cigarettes and vaping. How quickly did the government take action to protect youth from these products — and how comprehensive are those protections?

If vaping products appeared in a cotton candy-scented cloud as a smoking cessation tool, consider the appeal of CBD oils and CBD-infused foods and cosmetics. These hit store shelves bearing the promise of reduced anxiety, depression, and pain — even reduced acne. And in states where it’s legal to obtain marijuana for medical or recreational use, the product pitch is pretty similar (perhaps without the promise of clear, glowing skin).

On a superficial level, these drugs aren’t so different. Smoke them, chew them, sniff them, ingest them for pleasure or relief. However, cigarettes, smokeless tobacco, CBD, and marijuana cannot be so neatly lumped together. And it’s been an incredible struggle to regulate them. Long-standing Emory Law Adjunct Professor William H. Kitchens 70C offers his perspective about the challenge of regulation.

Kitchens dedicated 40 years to his Food and Drug Law course at Emory Law, exposing students by both broad strokes and intricacies to food, drug, medical device, biologic and tobacco regulation. Within the course, Kitchens discussed Food and Drug Administration (FDA) enforcement tools and the administrative law process of how regulations are developed and implemented. At the start of his Emory Law career, few discussions centered around tobacco because the FDA had no jurisdiction to regulate tobacco products unless medical claims were made for such products. When Kitchens retired in 2019, the FDA had been given jurisdiction to regulate tobacco, and tobacco had to share discussion time with e-cigarettes, CBD, and marijuana.

It wasn’t just the introduction of new products and the ongoing legalization debates about marijuana that altered this course. The Family Smoking Prevention and Tobacco Control Act (TCA) became effective in 2009, giving the FDA responsibility for tobacco regulation. “It was a complete sea change for the regulation of tobacco,” Kitchens says. What’s more, it was a new challenge for the FDA, which exists to ensure that products are safe and effective for public use and health. Mountains of scientific research and evidence illustrate that tobacco is inherently unsafe for public use and health. “It was notable and somewhat controversial that Congress tasked the FDA with the responsibility to regulate tobacco because tobacco products have no purported health benefits. Consequently, FDA’s regulation of tobacco is so counter to its mission in other areas,” Kitchens says.

There were limits to the FDA’s new regulatory role. The FDA could neither ban cigarettes or other tobacco products, nor require prescriptions for them. The statute also defined tobacco products, but gave the FDA the power to expand the definition as it deemed necessary. The original definition included just cigarettes, cigarette tobacco, roll-yourown tobacco, and smokeless tobacco, but has grown to encompass electronic cigarettes, pipe tobacco, hookah tobacco, and cigars.

Tobacco product manufacturers are subject to certain requirements, including payment of user fees, establishment registration, premarket review, and postmarket surveillance, among others. All tobacco products originally covered by the TCA are required to undergo premarket review, unless they are grandfathered products. Kitchens explains that there are four different premarket review pathways for tobacco products: (1) premarket tobacco application, (2) substantial equivalence to a predicate tobacco product, (3) substantial equivalence exemption and (4) modified risk tobacco products. Since 2014, most new tobacco products have been legally marketed through the substantial equivalence pathway.

Following the FDA’s deeming rule in 2016, all newly deemed tobacco products became subject to premarket review requirements as well. This makes e-cigarettes and other electronic nicotine delivery systems problematic. “There’s an acknowledgment that at this time those devices have an uncertain status because there are no approved marketing applications [for them],” explains Kitchens. “Companies have filed premarket applications, but none have been approved.” Kitchens notes that “the premarket approval applications for e-cigarettes and other noncombustible tobacco products is currently August 2022.”

Authorities have been grappling with the essence of e-cigarettes and vaping devices. Depending on the source, they’re either smoking cessation devices or on-ramps for new nicotine addictions. In early 2020, the FDA acknowledged that the vast number of vaping products on the market is problematic, but it hasn’t made sweeping efforts yet to pull them off shelves, even though approximately 1,300 people in the US were diagnosed with vaping-related lung illnesses and injuries in 2019, says The New York Times. The FDA, Kitchens says, did not anticipate the surge in popularity of e-cigarettes with youth. “The FDA acknowledges fully that we have an epidemic on our hands, because vaping devices are the most popular tobacco products among youth, especially due to access to flavored products. FDA’s priority now is to prevent young people from having access to e-cigarettes,” he says.

Working within its scope, the most effective way to protect youth from accessing e-cigarettes is for the FDA to prevent the use of vaping products with appealing flavors. Combating the problem of youth vaping is “very difficult because, in fairness, the FDA has perhaps not been given congressional funding to aggressively implement the Tobacco Control Act,” says Kitchens.

Proliferating the market with the same showy tactics as Blue Razz-flavored vaping juice is non-hallucinogenic CBD, which takes form as gummy bears, beauty serums and even chocolate bars. If your local health food grocer has suddenly devoted an entire aisle to CBD products, there’s an explanation for that. The 2018 Farm Bill addressed hemp, formerly a prohibited, controlled substance. In the new bill, hemp with a low level of tetrahydrocannabinol (THC) was excluded from that list of controlled substances. “That triggered all of the CBD products,” says Kitchens. “There are all kinds of CBD products available now, and the FDA has a lack of knowledge about them.” Kitchens explains that there isn’t sufficient data at this time to prove risks or benefits of taking CBD, and many products are being marketed with unproven medical claims. “So the FDA is playing catch-up.” Kitchens adds, “Recently, FDA went a step further by revising a consumer update to state that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

What do we know about CBD? It has the potential for public harm; studies show it can affect the liver, impact how other drugs are metabolized, and that taking it with alcohol (whether that’s applying it topically or ingesting it, we are still learning) increases drowsiness that can lead to additional risks. The FDA has approved only one CBD-based drug for epilepsy treatment, but “otherwise takes the position that it cannot be added to food or cannot be a dietary supplement. That’s caused industry consternation because people want to use it in food and as a dietary supplement,” says Kitchens. People wanting to experiment with CBD topically in cosmetics will find a wide array of options; the FDA has authority over cosmetics but does not regulate them as heavily. Put simply: cosmetics’ ingredients must be safe and pose no harm to humans.

CBD products will not disappear from shelves anytime soon, FDAapproved or not. “We’re sort of in a gray area. The FDA has the authority to regulate [them], but there are limits to its resources to do so,” says Kitchens. The FDA is starting with the products that tout overt medical claims; those manufacturers receive warning letters. As the FDA winds its way through a flooded marketplace and weathers the buzzword phase of CBD popularity, the scientific research gradually accumulates and provides further reassurance or ammunition for future FDA decisions.

As long as consumers clamor for CBD, manufacturers will meet those needs. The same can be said for marijuana. “Very similarly to CBD, there’s consumer demand but no uniform federal policy to determine whether there’s a medical benefit to marijuana,” says Kitchens. “Indeed, marijuana remains prohibited on the federal level, although a number of states have legalized marijuana for medical use, recreational use, or both. The feds have taken the position of not changing their stance, but in the main have made it clear they’re not going to interfere with these state laws.”

Marijuana use is increasing for both medical and recreational purposes, so the marijuana business is growing, too— though the data is more transparent in states where it is legal. “Every state likely has its own reasons for its position and has its own regulatory system,” says Kitchens. “Some states have limited legal resources, so they’re no longer going to make possession of a small amount of marijuana a crime.” With evidence mounting that marijuana offers some medical usefulness and citizens showing their support for decriminalization, it becomes more challenging for states to justify putting their law enforcement resources against users. Kitchens points out that an obvious kink in the chain of decriminalization is a lack of regulation of production and cultivation in some states. If a state is relatively new to decriminalizing marijuana but has no state-grown products, it’s up to the consumer to procure marijuana elsewhere. In some cases, that could mean transporting the product through a channel or through states where it remains illegal to do so.

Dr. Ali J. Zarrabi, assistant professor of family and preventive medicine and palliative care physician at Emory Healthcare, uses CBD and THC as part of his palliative care plan for patients suffering with chronic and terminal diseases. Is CBD the new wonder drug? He’s uncertain. “There’s no substantial evidence that CBD — outside of pediatric seizure disorders — is a standard-option for certain medical conditions,” Zarrabi says. “Anecdotally it helps, but there’s a lack of research.” Zarrabi’s clinic serves thousands of patients in Georgia. While many of them are using CBD products, Zarrabi explains that they don’t need a medical marijuana card because the Farm Bill allows them access to products with 5 percent of THC.

“Access” is a key word. Anyone can purchase CBD products online or at a local retailer. There’s little hard-and-fast evidence to show that the products truly help to ease pain, quell anxiety, reduce nausea, or offer relief for the slate of ailments and symptoms that CBD purports to alleviate. By contrast, there is substantial evidence that THC can be helpful here. Accessing it in Georgia isn’t easy. In 2019, Zarrabi says, Georgia passed a law that allows dispensaries to open in the state. And in the meantime? “At Emory, we’re seeing patients get products shipped across state lines. This is illegal, but we don’t know of anyone getting arrested or prosecuted.” Zarrabi adds this further complication: “There’s no legal way to pay for these products with a credit card, so people use systems like Zelle.”

The benefits to this labyrinthine procurement process can be numerous. “In our clinical practice, for patients with chemotherapy-induced nausea, chronic pain, neuropathic pain — or patients who wish to use one substance to replace a variety of other pharmaceuticals — low THC oil often results in significant relief and a better overall sense of wellbeing,” Zarrabi says.

Of course, access needn’t be so challenging. “My position,” Zarrabi says, “is that the federal government needs to offer progressive legislation to study what patients are actually using, including vape pens, CBD oils, and THC products. What the federal government allows for research is not what’s on the ground.”

Insights into the products being used could offer new insights into proper regulation — because there is no one-size-fits-all regulatory policy for these products. There’s not even a one-size-fits-all way to use them. What is consistent among the histories of tobacco, e-cigarette, CBD, and marijuana regulation is that consumer demand spurs manufacturer creativity. And once a product mutates into a candy-flavored, simple delivery system, regulatory officials are more motivated to control its availability until they can determine whether it’s causing the user harm. Where there’s smoke, there’s lung damage, but where there’s CBD beauty serum, it’s less clear.