FDA Steps Up Enforcement of Youth Tobacco Prevention Plan

Agency's New Policies Focus on Flavored Tobacco Products

March 19, 2019 02:59 pm News Staff – The FDA has been busy during the past couple of weeks, announcing on March 4 new actions it is taking to enforce its Youth Tobacco Prevention Plan at the retail level, among other things. The agency followed up with a March 13 announcement that it was issuing draft compliance guidance for flavored e-cigarette products and cigars.

Pointing to a Feb. 7 release in which FDA officials had called out Walgreens for accumulating almost 1,800 violations nationwide, Gottlieb's statement labeled that company "the top violator among pharmacies that sell tobacco products," with 22 percent of its more than 6,350 stores the FDA inspected having illegally sold tobacco products to minors.

Furthermore, the FDA said it has identified 15 additional national retail chains whose rates of violative inspections exceed 15 percent of their total inspected stores since the inception of the FDA's retailer compliance check inspection program in 2010. Those retailers will similarly be held accountable, the agency said.

The agency also cited letters sent last month to 43 companies seeking information about whether more than 50 products -- including various flavored e-cigarette products -- are being illegally marketed and sold outside the agency's current compliance policy.

Some of these companies may be attempting to capitalize on trendy devices such as JUUL, the FDA noted.

"We also need to determine if any of these products may be counterfeit knockoffs," the statement said. "If tobacco products are being unlawfully marketed and sold outside the FDA's compliance policy, we'll take action."

In addition, the agency explained it also sent its first warning letters to five companies for, among other things, selling electronic nicotine delivery system (ENDS) products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement.

The FDA statement also highlighted its "boots-on-the-ground" activities, saying that as of fall 2018, it had conducted a total of 1 million tobacco retailer inspections since beginning this practice in 2010. "This work has resulted in more than 81,570 warning letters to retailers for violating the law as well as the issuance of more than 19,800 civil money penalties and about 145 no-tobacco-sale orders for repeated violations," said the statement.

Future efforts will include attacking these issues at the local level in areas of the country that have high rates of violations, said the agency, as well as partnering with state attorneys general to help combat youth e-cigarette use in their states.

Finally, the statement pointed to ongoing studies, some of which the agency commissioned, designed to examine the "potential for direct effects of harm from e-cigarettes on the lungs and other health factors."

"While we believe that e-cigarettes offer a potentially safer alternative to combustible tobacco for currently addicted adult smokers who completely switch to these products, these products are not without risks."

Updating Flavored Tobacco Products Policy

In the statement issued March 13, the FDA claimed that a recent surge in e-cigarette use among youth is threatening progress made to date in reducing youth tobacco use.

Recent data show that more than 3.6 million middle and high school students across the country were current (past 30 days) e-cigarette users in 2018 -- an increase of 1.5 million children from the previous year. The data also indicate that youth who used e-cigarettes were using them more frequently and using flavored e-cigarette products more often than in 2017.

"This is particularly troubling given that research shows that kids using e-cigarettes are more likely to take up combustible cigarettes," the statement said. "The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities."

Citing mounting evidence that youth are particularly attracted to flavored e-cigarette products, which minors continue to purchase from both brick-and-mortar and online retailers despite federal restrictions, the agency announced policy updates to help crack down on youth access to -- and the appeal of -- flavored e-cigarettes and cigars.

Specifically, the FDA is proposing to end its current compliance policy as it applies to all flavored ENDS products (other than tobacco-, mint- and menthol-flavored) that remain on the market, instead calling for manufacturers of these products to submit premarket applications that demonstrate they meet the agency's public health standard by Aug. 8, 2021.

The agency had previously said it did not intend to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market in the interim.

The FDA said it expects its policy changes will lead to some flavored e-cigarette products continuing to be sold -- but in a way that prevents youth access -- and some flavored e-cigarette and cigars will just no longer be sold.

That's especially important given that recent data show nearly 1.3 million U.S. middle and high school students were current cigar users in 2018. Research has shown that compared to adults (ages 25 and older) who smoke cigars, a higher proportion of youth use flavored cigars.

"Youth continue to use these dangerous combusted tobacco products due, in part, to the availability and appeal of fruit and other flavors," the FDA said in its statement. Eliminating flavors from cigars would likely help prevent young people from initiating cigar use, the agency added.

Under the proposed new compliance policy, any flavored cigars (other than tobacco-flavored) that were on the market on Aug. 8, 2016, and that meet the definition of a new tobacco product, would be subject to enforcement. The FDA said it would prioritize enforcement of products that are not off the market 30 days after the guidance is finalized; manufacturers would have to seek premarket authorization to reintroduce these products to the market.

The FDA is accepting comments on the draft compliance policy through April 15.