E-Cigs in the Pharmacy? OTC Classification Looms

E-Cigs in the Pharmacy? OTC Classification Looms

April 18, 2018

As studies across the globe continue to find evidence suggesting that e-cigarettes can be beneficial as a smoking cessation tool, the American FDA is finally reconsidering its stance on vaping. E-cigs could soon start appearing in pharmacies as an OTC product if the administration ultimately decides to regulate vapor products as over-the-counter drugs.

Could E-Cigs Be Sold OTC?

Could E-Cigs Be Sold OTC?

Nicotine replacement therapies, or NRTs, like nicotine gum, patches, and lozenges, already fall under OTC regulations. More and more public health officials are revising their stance on e-cigs; even the American Cancer Society has reversed its previously hostile stance toward vaping. Now, public health officials want to classify e-cigarettes as medical devices in the same category as nicotine gum and patches.

In this regard, American health care professionals are a little late to the game. Since 2015, the Royal College of Physicians has OK’d doctors in the United Kingdom to recommend electronic cigarettes fortheir patients who smoke. That same year, a landmark study from Public Health England revealed that vaping is 95 percent safer than smoking. In Australia, you actually need a prescription for certain vape-related products. American vapers probably won’t require a doctor’s note to vape, but they would likely notice the effects of new FDA regulations when purchasing their vaping products.

The FDA’s Ideology in Reclassification

FDA Commissioner Scott Gottlieb claims that transitioning e-cigs from a consumer good to an OTC pathway will permit the administration to better study the benefits and safety of such products. The first step of the process will be developing new criteria for what counts as a smoking cessation aid.

Despite the FDA leaderships’ more conciliatory tone toward vaping as of late, many e-cig advocates are skeptical. The Pacific Legal Foundation is suing on behalf of vape shops from five U.S. states, arguing that the proposed e-cig regulations would cripple their business models. Meanwhile, tobacco harm reduction proponents argue that such restrictions could make it more difficult for people who are trying to quit tobacco altogether.

It remains unclear whether all vapor products would be required to undergo the rigorous process to be classified as an FDA approved over-the-counter medical treatment. If so, most manufacturers and vape shops wouldn’t survive the costs and new standards that the transition would introduce to the industry. The pharmaceutical industry, however, stands to benefit substantially from such e-cig regulations. Hopefully, the FDA will prioritize the interests of public health above “Big Pharma” profits.

Sweeping Tobacco Regulation Overhauls

Sweeping Tobacco Regulation Overhauls

The newest round of proposed FDA regulations are part of a broader campaign to reduce Americans’ dependence on tobacco, for good. Other proposals include capping the amount of nicotine allowed in 

tobacco cigarettes and e-liquids. Flavored e-juices, and even menthol tobacco cigarettes, could be banned with the intention of making both smoking and vaping less appealing to young people.

Of course, these changes would limit the choices of responsible adults who are searching for an alternative to tobacco cigarettes. Although public health advocates have already sued the FDA for not acting fast enough, Commissioner Gottlieb has assured the public that the administration will take its time conducting research and analyzing the data to come up with a fair and sensible solution.

“If you’re in favor of getting adults to quit smoking, you can’t turn a blind eye to the people who want to get access to nicotine,” Gottlieb told a reporter at the CNBC “Healthy Returns” conference. “At the very time I am trying to take nicotine out of combustible tobacco, I don’t want to be sweeping the market of products that provide an alternative.”