Category: Regulation

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.”

U.S. President Donald Trump has signed into law a bill raising the federal age requirement for tobacco and vapor product purchases to 21 from 18.

The Food and Drug Administration has 180 days to update its regulations and the new rules will go into effect 90 days after that.

A bill to raise the legal age to buy tobacco was introduced earlier this year by Senate Majority Leader Mitch McConnell and Virginia Senator Tim Kaine and was combined with another bipartisan bill on the issue to become part of a massive spending package.

Proponents of the legislation argue that most underage teens who use tobacco get it from older friends. An estimated 90 percent of smokers start before age 18.

Delaying access to cigarettes is expected to produce major downstream health benefits, with one government-funded report estimating nearly 250,000 fewer deaths due to tobacco over several decades.

More than 34 million adults in the U.S., or about 13.7 percent of the population, smoke cigarettes, according to the Centers for Disease Control.

While the number of smokers has decline steadily in recent years, the number of underage nicotine users has increased along with the rising popularity of e-cigarettes.

Youth tobacco use has been a point of discussion in Washington as the prevalence of e-cigarette use and vaping among teenagers seemed to skyrocket.

Altria Group and Juul Labs were among the biggest supporters of the measure, blanketing Capitol Hill with lobbyists and advertisements touting their support for a national “Tobacco 21” law.

Health groups criticized their efforts as a tactic to forestall measures that would be more damaging to the tobacco and vapor business, such as banning flavored nicotine juices.

“Altria and Juul clearly support this in order to argue that no other action is necessary,” said Matthew Myers of the Campaign for Tobacco-Free Kids.

The legislation leaves unchanged a requirement that adverting be targeted to people who are at least 18, according to Stanton Glantz, director of the Center for Tobacco Research Control & Education at the University of California in San Francisco.

The U.S. Congress would raise the tobacco purchasing age to 21 from 18 under a government spending bill unveiled on Monday.

If signed into law, the legislation would give the U.S. Food and Drug Administration six months to develop regulations. The agency would then have three years to work with states on implementing the change.

The tobacco legislation was originally sponsored by Senator Tim Kaine and Senate Majority Leader Mitch McConnell and has broad bipartisan support.

Tobacco companies have also been pushing for a higher purchasing age, which they see less disruptive to their business than other measures that have been under discussion.

Earlier this year, federal authorities vowed they would “clear the market” of flavored products, but the Trump administration appears to have backtracked amid industry opposition and warnings that a flavor ban could cost the president votes in the 2020 election.

While welcoming a higher buying age, the Campaign for Tobacco-Free Kids (CTFK) said the initiative shifts attention from efforts to ban flavored e-cigarettes.

“Juul and Altria have hijacked the tobacco 21 issue for their own nefarious reasons as a shield to fight efforts to prohibit flavored e-cigarettes,” said Matthew L. Myers, president of the CTFK. “It is deeply disappointing that the budget agreement gives these tobacco companies what they want without addressing the crisis caused by flavored e-cigarettes.”

Republican and Democratic lawmakers hope to pass the $1.4 trillion spending bill before current government funding runs out on Saturday to avoid a partial government shutdown.

Philip Morris International has applied to the Therapeutic Goods Administration (TGA) in Australia to legalize its heat-not-burn tobacco products. In Australia, only nicotine in “tobacco prepared and packed for smoking” can be legally sold. Australian health minister Greg Hunt said that any vapor product would need to be approved by the TGA to be sold in the country.

Legalise Vaping Australia’s campaign director, Brian Marlow, noted that the TGA approval process would require millions of dollars to complete.

“This is a retrograde move orchestrated by our federal government and is designed to protect Big Tobacco and kill off Australia’s rapidly growing vaping industry, which is made up of small family retail businesses and highly innovative and world-leading e-liquid manufacturers,” he said.

“Australia’s 300,000 vapers and 2.6 million smokers should not be forced to access just one TGA approved nicotine vaping product owned by a multinational tobacco company, but they should have the freedom to purchase one of the many hundreds of combinations of available vaping products that suits them and helps them quit smoking,” said Marlow.

Philip Morris International has applied to the Therapeutic Goods Administration (TGA) in Australia to legalize its heat-not-burn tobacco products. In Australia, only nicotine in “tobacco prepared and packed for smoking” can be legally sold. Australian health minister Greg Hunt said that any vapor product would need to be approved by the TGA to be sold in the country.

Legalise Vaping Australia’s campaign director, Brian Marlow, noted that the TGA approval process would require millions of dollars to complete.

“This is a retrograde move orchestrated by our federal government and is designed to protect Big Tobacco and kill off Australia’s rapidly growing vaping industry, which is made up of small family retail businesses and highly innovative and world-leading e-liquid manufacturers,” he said.

“Australia’s 300,000 vapers and 2.6 million smokers should not be forced to access just one TGA approved nicotine vaping product owned by a multinational tobacco company, but they should have the freedom to purchase one of the many hundreds of combinations of available vaping products that suits them and helps them quit smoking,” said Marlow.

Massachusetts officials ended their emergency ban on the sale of vapor products on Dec. 11. The ban had been set to expire Dec. 24, but Governor Charlie Baker had said his administration would end the ban early in light of new legislation restricting the sale and use of flavored tobacco and vapor products.

Retailers will now be allowed to sell unflavored vapor products, which account for a small share of pre-ban sales.

A handful of states have imposed temporary bans on vapor products, but Massachusetts is the first with permanent restrictions.

The new law restricts the sale and consumption of flavored tobacco and vapor products to licensed smoking bars. The restriction extends to popular menthol cigarettes and flavored e-cigarettes, cigars, pipe tobacco and chewing tobacco.

Retailers will have to place vapor products behind the store’s counter, just like tobacco products.

The new law also places a 75 percent excise tax on nicotine vapor products and restricts nicotine concentrations to less than 35 milligrams per milliliter of vaping solution.