Category: News This Week

Shares in British American Tobacco (BAT) and Imperial Brands rose on Friday after the U.S. Food and Drug Administration (FDA) exempted menthol and tobacco from a list of e-cigarette flavors that it has banned under new guidelines.

“Following a significant period of disruption and uncertainty, this regulatory clarity is a welcome step towards returning the U.S. vapor market to stability,” BAT wrote in a statement.

The new FDA guidelines would also allow tobacco makers to bring back some of the banned flavors if their marketing applications passed a substantive review by the FDA.

“In addition to exempting menthol, the FDA guidance is clear that flavored products will return to the market once they have been approved through the premarket tobacco product application (PMTA) process,” said Simon Evans, spokesman for Imperial Brands.

BAT submitted a marketing application for its Vuse Solo e-cigarette to the FDA in November while Imperial Brands said it would submit its applications for its Blu e-cigarettes before May.

The Campaign for Tobacco-Free Kids (CTFK), however, said the Trump administration had broken its promise to eliminate the flavored e-cigarettes that are driving youth nicotine addiction.

“By leaving menthol flavored e-cigarettes widely available and completely exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic,” said Matthew L. Myers, president of the CTFK.

By contrast, Michael Siegel, a professor at the Boston University School of Public Health, described the decision to exempt open system products from the ban as a huge victory for public health.

“By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking,” he said.

But Robin Koval, CEO and president of the Truth Initiative, said that the argument that flavored e-cigarettes and vape shops are necessary for smokers to switch from cigarettes ignores the data.

“The data show that the majority of adult e-cigarette users either never previously used cigarettes or continue to smoke, thereby undermining any potential public health benefit,” she said.

Vapor industry representatives, meanwhile, expressed concern about the FDA’s determination that makers of the nicotine liquids are manufacturers and thus required to submit PMTAs for their products by the court-ordered deadline of May 12.

According to Gregory Conley, president of the American Vaping Association, there has been little “chatter” about liquid manufacturers actually filing such applications.

If they fail to do so by the deadline, many small vapor shops dependent on large nicotine liquid makers could begin closing in mid-May from lack of product from legal sources.

The U.S. Food and Drug Administration (FDA) today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes other than tobacco or menthol within 30 days risk FDA enforcement actions.

“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS [the Department of Health and Human Services] is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said HHS Secretary Alex Azar.

“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” he added.

The final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, comes as the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days)—with a majority reporting cartridge-based products as their usual brand.

On Aug. 8, 2016, all e-cigarettes and other ENDS products became subject to the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act. All e-cigarettes and other ENDS products on the market at that time needed to have authorization from the FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by the FDA—meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.

Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

• Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
• All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
• Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA said it has attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products.

The FDA insists its enforcement priorities are not a “ban” on flavored or cartridge-based ENDS. The FDA has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act.

Manufacturers that wish to market any ENDS product—including flavored e-cigarettes or e-liquids—are required by law to submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health.

If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.

The sudden enforcement of a new U.S. law raising the minimum tobacco buying age to 21 has caught some tobacco and vape shop operators by surprise.

The legislation signed by President Donald Trump on Dec. 20 gave the federal government 180 days to write new regulations barring the sale of tobacco to those under 21, plus another 90 days for those regulations to go into effect.

However, the Food and Drug Administration said the new rules would take effect immediately.

According to The National Association of Convenience Stores, the sudden implementation of the restrictions has left the association short-handed in terms of verification materials to provide to its members.

Some tobacco and vape shops responded by saying they don’t plan to enforce the age-21 restrictions until they have FDA signage in hand.

One health advocate cautioned that the rushed enforcement could backfire.

“Seeking to ban previously legal sales to those ages 18 to 20 without giving viable options to those who are dependent on nicotine is less likely to lead to abstinence than to disrespect for the law,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.

But others applauded the FDA’s swift action.

“If you put things off, you are likely to get in trouble down the road,” said health policy consultant Scott Ballin.

“Tobacco 21 is here to stay, and it is to the agency’s advantage to demonstrate that it is already on that road to implementation.”