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FDA Claims There’s Market Freedom While Blocking Tobacco Harm Reduction Products

The opinions expressed by columnists are their own and do not necessarily represent the views of

In July, a National Public Radio (NPR) segment reported the United States is in the midst of a “significant shortage of injectable opioids.” Consequently, doctors are worried that injectable opioids, commonly used to treat severe pain, will be in short supply—and there isn’t much the federal government can do about it. According to Valerie Thompson, associate director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research Drug Shortages program, the FDA “cannot control how much manufacturers make … it’s really up to the market.”

When it comes to injectable opioids, Thompson’s assessment might be partially accurate, but one thing is abundantly clear: FDA doesn’t apply this laissez-faire approach to many of the products it’s tasked with regulating, including tobacco harm reduction (THR) products. THR products include smokeless tobacco, electronic cigarettes, and heat-not-burn devices.

Despite their many positive health impacts, FDA deemed electronic nicotine delivery systems as “tobacco products” in 2016, and since then, no new THR products have come to market. Furthermore, FDA has essentially blocked all new THR product developments.

THR products are a consumer-driven, disruptive technology. They deliver nicotine to consumers without the harmful constituents in combustible cigarette smoke, and evidence of their high efficacy as a safer alternative to traditional cigarettes continues to mount.

After decades of analysis, smokeless tobacco has been proven “at least 98 percent safer than smoking.” Furthermore, using electronic cigarettes and vaping devices is “unlikely to exceed 5% of the harm [caused by] smoking tobacco.”  Many public health groups—including Public Health England, the Royal College of Physicians, and the American Cancer Society—acknowledge the reduced harm of electronic cigarettes. The United Kingdom even promotes the use of e-cigarettes in its national anti-smoking campaigns.

Heat-not-burn is an even newer technology designed by Phillip Morris International (PMI) and Reynolds American. These products are designed to heat tobacco, rather than burn it. After PMI’s heat-not-burn device called iQOS was introduced in Japan, cigarette sales dropped. Studies found iQOS reduced exposure to the harmful components of combustible smoke and using iQOS “can significantly lower the risk of [chronic obstructive pulmonary disease].” Unfortunately, due to the 2016 FDA regulations, these products are not available in the United States.

Additionally, JUUL, an electronic vaping device, entered the market in 2015, but despite being an extremely effective tool that helps people quit using combustible cigarettes, FDA launched in April 2016 an investigation into JUUL Labs, Inc. In its investigation, FDA requested information on the company’s “marketing practices and research on marketing, effect of product design, public health impact, and adverse experiences and complaints related to JUUL products.”

Attacking JUUL is easy for a powerful government agency such as the FDA, but it’s completely unjustified. JUUL is a THR company that has captured a significant portion of the market because of its safe and effective product line. Wired wrote in 2015 JUUL has developed “the first great e-cig.”

How does FDA justify its regulations on the THR industry? It claims they are necessary because the regulations on THR products protect children from the hazards of smoking. According to FDA, THR products are a gateway for combustible cigarettes. Furthermore, FDA argues THR products increase youth smoking habits.

Such alarmism threatens the research behind THR products and ignores the facts. As numerous studies from European health agencies and researchers in the United States have concluded, the presence of THR products improves public health.

It’s not fair to limit the options available for combustible tobacco users looking to quit by removing THR products from the marketplace or preventing new THR products from receiving government approval. This is especially true since many nicotine replacement therapies, such as gum, have a dismal track record.

The market shows there is robust demand for THR products, yet FDA seems intent on preventing consumers from purchasing these safe and beneficial products. FDA should reverse course on this important issue and embrace sound science.

Lindsey Stroud ( is a state government relations manager at The Heartland Institute.

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