Food and Drug Administration (FDA) Commissioner Scott Gottlieb is making headlines with a series of public consultations on slashing nicotine in cigarettes and regulating flavored tobacco products.
Regardless of the merits of these policies, they are in line with Gottlieb’s two-pronged tobacco and nicotine strategy.
{mosads}Last July, Gottlieb announced the FDA would clamp down on the most dangerous forms of nicotine use while encouraging innovation so that smokers unable to quit cold turkey can switch to safer nicotine alternatives and reduce their risk of an early death.
While the FDA is going hell-for-leather on the first part its strategy, there has been no serious action on the second. It is no easier today for safer nicotine products, like e-cigarettes, to enter or remain on the market than it was a year ago.
The e-cigarette industry faces near total prohibition, with 99 percent of products set to be withdrawn from the market by 2022 thanks to a prohibitively expensive and unreformed product approval process.
When the FDA does speak about the e-cigarette industry it is mostly to lambast it for the rise in teen vaping, the variety of flavors available and how they are advertised. The FDA runs campaigns emphasizing the potential harms of vaping to young people while failing to communicate the benefits of switching from smoking to vaping to adult smokers.
But e-cigarettes aren’t the only category of reduced risk products failing to catch a break from the FDA. The agency has so far refused to grant Swedish Match’s Snus products, a form of smokeless tobacco proven to be vastly safer than cigarettes, modified risk status which would allow them to be marketed as a safer alternative to cigarettes.
When Philip Morris International (PMI) put forward a one million page modified risk application for its heated tobacco product — IQOS — replete with scientific data and support from independent experts, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) rejected all but one of their proposed advertising claims.
TPSAC reached the eccentric conclusion that while switching from smoking to IQOS does significantly reduce the body’s exposure to harmful chemicals, it does not reduce the risk of continued smoking.
Responding to the decision, public health expert Clive Bates wrote on Twitter, “The idea that dramatically reduced exposure to toxins does not translate to reduced risk to health requires a novel and implausible theory of the human body.”
One TPSAC member, no doubt inadvertently, summed up committee’s attitude when he said: “I think this stuff is just too complicated for the average Joe.” Though TPSAC’s decision is not binding on FDA, it is symptomatic of how difficult it is for companies to convince regulators to allow them to tell consumers the most important facts about their reduced risk products, chiefly that they are safer than cigarettes.
The FDA talks a good game on encouraging innovation and supporting safer alternatives to smoking but actions speak louder than words. Clamping down on cigarettes is easy but changing an entrenched bias towards the precautionary principle, with its constant focus on hypothetical risks while ignoring tangible, real-world benefits is a tougher proposition.
Nevertheless, it is a challenge Gottlieb set himself when he committed the FDA to striking the right balance between regulation and encouraging the development of products that are less dangerous than cigarettes.
If the FDA is serious about using innovation as means to reduce tobacco-related disease it must take action to ensure e-cigarettes, heated tobacco products, and smokeless tobacco not just enter and remain on the market, but that smokers are aware of the benefits of switching to these products.
Granting modified risk status to IQOS and Swedish Snus would be a good first step in the right direction. Reforming the product approval process with a focus on industry standards rather than individual applications would ensure e-cigarettes remain available to consumers while securing product quality, safety, and transparency.
If these and other common-sense measures are taken, the FDA’s commitment to tobacco harm reduction will become a measurable, life-saving reality rather than a talking point.
Guy Bentley is a consumer freedom research associate at the Reason Foundation, a nonprofit libertarian think tank.