On August 8, 2016, new regulations by the FDA went into effect that have a profound impact on a major segment of the electronic cigarette industry: vape shops. The shops that mix flavors for vaping products are now considered to be manufacturers and subject to the same requirements as manufactures owned by the companies that make Marlboros, Camels, and Newports.
The new rules will require each and every flavor variation of electronic cigarettes to be approved by the FDA as a new tobacco product. The cost associated with each application is estimated by the agency to average over $300,000. Vape shops had typically created many dozens of varieties of “e-juice” every month and, under the new rules, the revenues from these flavor varieties would account for only a small fraction of the cost for submitting new tobacco product applications. This has led some vape shops to close their doors.
Today the Public Health Advocacy Institute submitted comments to the U.S. Food and Drug Administration on its proposed rule to include cigars, little cigars, electronic cigarette products, and tobacco for hookah smoking among the products for which it can legally issues rules and regulations. This is known as a “deeming rule.” The deeming rule is a first step toward regulating tobacco products beyond the cigarettes, smokeless tobacco, and roll-your-own products that the agency now regulates through its Center for Tobacco Products.
The Center for Tobacco Products solicited a wide range of comments and posed many questions to stakeholders and the public in its proposed rule. PHAI focused its comments on the question of how best to regulate electronic cigarettes once they have been deemed tobacco products and are regulated by the FDA.
PHAI found that the vast majority of the American public believes that electronic cigarettes are a reduced risk product and that manufacturers and sellers of electronic cigarettes have marketed their products directly and indirectly as safer products. Only tobacco products that are approved as “modified risk tobacco products” are permitted to advertise and market their products as posing a reduced risk to users. As a result, electronic cigarette advertising focuses on other sorts of appeals such as sex appeal and conceptual themes that may attract new users and result in youth initiation. Electronic cigarettes are supposed to be an alternative to the most dangerous tobacco product, cigarettes, not a new pathway to addiction and eventual cigarette use for young people.
Electronic cigarette companies are benefiting from the perception that these are reduced risk products without going through the necessary approval process to attain that status from the FDA.
1. Electronic cigarettes should not be approved as “new tobacco products” because the public already believes that they are reduced risk products.
2. Electronic cigarette manufacturers should apply for approval by FDA under the “modified risk tobacco product” category and demonstrate that their products will be a real benefit to public health.
3. FDA should require a statement in all electronic cigarette advertising stating that the agency has approved the product as a “modified risk tobacco product.” If electronic cigarettes were approved only as “new tobacco products,” they could not advertise because they could not carry the statement required on all advertising. This would ensure that there would only be advertising for electronic cigarettes that were demonstrated to be beneficial to public health and drive consumers to purchase those products that carry the proposed required FDA statement.
4. In addition, PHAI urged the agency to include premium cigars in its regulatory authority by deeming them to be tobacco products. Even if there is no need to impose new rules on premium cigars at this time, if the need did arise, having already deemed these tobacco products as “tobacco products” for regulatory purposes would allow the FDA to issue rules and regulation should evidence indicate such a need.
5. PHAI urged the FDA to develop comprehensive regulations for flavors in all newly deemed tobacco products. Candy flavors should be banned and any other flavors proposed to be retained by manufacturers should only be approved upon a showing that the flavor contributes to improving public health.