Flavored Vapes Still in Stores Despite Federal Ban

By Dennis Thompson
HealthDay Reporter

TUESDAY, Dec. 28, 2021 (HealthDay News) — Kid-friendly flavored e-cigarettes are nonetheless extensively accessible on-line and in shops, regardless of a federal decide’s ruling that ought to have pulled the merchandise off retailer cabinets by early September, a brand new report exhibits.

The decide’s ruling follows on U.S. Food and Drug Administration motion that’s practically two years outdated.

Citing dangers to weak kids, the FDA first introduced in January 2020 that “firms that don’t stop manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes [other than tobacco or menthol] inside 30 days danger FDA enforcement actions.”

That was then, that is now, critics say.

Today, greater than 100 flavored vaping merchandise with engaging flavors like Gummy Bear, Funnel Cake, Fruit Punch, Berry Crunch Cereal and Blueberry Lemonade are nonetheless offered by way of the 5 prime on-line e-cigarette retailers, the Campaign for Tobacco-Free Kids report discovered.

Flavored vapes additionally had been extensively accessible in comfort shops and gasoline stations situated in eight cities throughout the nation, the report added.

“Flavored e-cigarettes of exactly the sort that youth are utilizing are extensively accessible each on the web and in shops,” stated Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“Flavors appeal to them. Nicotine addicts them,” Myers continued. “Without the flavors, many fewer children can be attracted to those merchandise — 85% of the children who use an e-cigarette use a flavored one.”

A federal courtroom had set a deadline of Sept. 9 for e-cigarette producers to both get U.S. Food and Drug Administration approval for his or her merchandise or face having them pulled from the market.

Unauthorized e-cigarette merchandise stay available on the market months previous that deadline, regardless that they’re topic to FDA enforcement motion, the report discovered.

In-store assessments performed in eight cities discovered that:

• Juul was offered in all cities, and types like Vuse, NJOY and blu had been accessible in most.
• Flavored e-liquids had been present in most cities, in flavors like Green Apple, Cola, Peachy Rings, Tropical Fruit, Strawberry Macaroon and Island Orange.
• Disposable e-cigarettes had been accessible in each metropolis in flavors like Coconut Pineapple Smoothie, Strawberry Ice Cream, Gummy Bear, Mango Slushee and Blue Razz Lemonade.

The cities included within the survey had been Denver; Detroit; Los Angeles; Portland, Maine; Portland, Ore.; Seattle; Tempe, Ariz.; and Washington, DC.

The report helps clarify why e-cigarette gross sales proceed to skyrocket within the United States, Myers stated.

Sales of disposable e-cigarettes elevated by practically 250% between February 2020 and September 2021, rising from 2.8 million unites to 9.6 million items, in keeping with latest gross sales monitoring reported by the CDC Foundation.

Four out of 5 disposable e-cigarettes offered are available in flavors aside from tobacco, mint and menthol, the CDC Foundation famous.

Total e-cigarette gross sales elevated by greater than 60% throughout the identical time frame (from about 15 million to 24 million items), the CDC Foundation reviews. That contains gross sales of non-tobacco flavored e-cigarettes rising by 86%.

About 1 in each 5 highschool seniors have used an e-cigarette inside the final month, in keeping with federal survey information cited by Myers.

FDA but to behave

“That’s 5 occasions as many children utilizing e-cigarettes as are utilizing cigarettes,” Myers famous.

The FDA says it has acted on greater than 98% of the e-cigarette purposes it is acquired, and has issued denial orders for greater than 1 million flavored vaping merchandise, the report famous.

However, the company has dragged its toes in reviewing purposes from the e-cigarette producers with the biggest market shares, comparable to Juul, Vuse Alto, NJOY, blu, Smok and Suorin, the report famous.

Until choices are made on these purposes, the FDA has indicated that the merchandise can nonetheless be offered. Attempts to succeed in the company for remark had been unsuccessful.

“It’s clear that FDA actually must shortly act and resolve the remaining purposes that it has to go,” stated Erika Sward, assistant vp of nationwide advocacy for the American Lung Association. “They’ve claimed to undergo thousands and thousands of purposes, however whenever you depart the merchandise with the very best market share available on the market, it is actually solely a drop within the bucket.”

Sward and Myers suspect the FDA is being cautious and meticulous in reviewing purposes from main producers in order that its closing choices will maintain up in courtroom.

The company already faces greater than 45 lawsuits from firms whose merchandise have been denied, Myers stated.

“Those purposes are maybe extra full and extra substantive than a variety of the merchandise from the smaller firms,” Sward stated of the main e-cigarette manufacturers. “I might additionally assume FDA is attempting to get all of its I’s dotted and T’s crossed, as a result of whereas among the smaller producers are suing FDA over advertising and marketing denials, they’re attempting to keep away from large lawsuits from the large firms.”

The FDA is also grappling with a serious loophole that some firms are utilizing to maintain promoting flavored merchandise.

Puff Bar and different producers have began promoting e-cigarettes containing artificial nicotine. The firms assert that this “tobacco-free nicotine” does not fall beneath the jurisdiction of the FDA’s Center for Tobacco Control.

The FDA issued a warning letter towards Puff Bar in July 2020, ordering the corporate to take away its flavored disposable e-cigarettes from the market as a result of they did not have the required authorization.

In response, Puff Bar re-launched this February with a brand new artificial nicotine components that they declare does not fall beneath the FDA’s present guidelines for vaping merchandise.

Synthetic nicotine a brand new trick

The company has stated in a web based FAQ that it is potential that artificial nicotine “wouldn’t be regulated by the FDA as a tobacco product,” including that it’ll determine on a case-by-case foundation.

However, Sward and Myers imagine that the FDA nonetheless has approval energy over these merchandise. Even if it is not derived from tobacco, artificial nicotine stays a brand new drug that must be regulated, they argue.

“It is obvious to us that even when the Center for Tobacco Products doesn’t have jurisdiction over these merchandise, the Center for Drug Evaluation can assert jurisdiction over these merchandise as unapproved medicine — however hasn’t,” Myers stated.

The method firms have been touting their artificial nicotine merchandise seems to justify treating the substance as a drug, stated Linda Richter, PhD, vp of prevention analysis and evaluation for the Partnership to End Addiction.

“A variety of the businesses which might be promoting these artificial nicotine merchandise are saying, ‘Hey it is purer than nicotine that comes from tobacco, it is obtained these nice components and it is not going to hurt you. They’re form of selling it by way of well being advantages, which places it beneath the drug regulation authority of the FDA,” Richter stated.

Even higher can be for Congress to intervene concerning artificial nicotine, Myers stated.

“The very best resolution can be for Congress to make clear the definition of a tobacco product to particularly embrace these merchandise,” Myers stated. “Otherwise, FDA might be taking part in whack-a-mole from now to kingdom come.”

Overall, the FDA has been timid within the face of continued opposition from the vaping trade, and must step up its efforts, Myers and Sward stated.

“They’ve had greater than three months previous their deadline from the federal decide to take care of these merchandise, and it’s totally disheartening that they haven’t to this point,” Sward stated.

“The clear takeaway is that so long as flavored merchandise are on the market, children will get them. The solely technique to shield children from flavored merchandise is to make it unlawful to promote them,” she concluded.

However, the FDA may merely be outgunned and overwhelmed, stated Richter.

“I simply do not know that it has the employees and the funding to maintain up with this extraordinarily well-funded trade, particularly given that there is loads of individuals inside the authorities who do not suppose the laws must be as sturdy as they’re,” Richter stated.

“Even with one thing like cigarettes that clearly don’t have any redeeming worth, you continue to have very well-funded tobacco lobbyists who proceed to limit the laws round cigarettes due to their financial curiosity,” she added.

“Then you flip to a product like vaping that’s offered as considerably more healthy, so you’ve lots of people inside Congress and regulators who say, hey, let’s watch out how a lot limit these as a result of it’d deter individuals from quitting smoking. That’s the murkier panorama that permits a variety of this to go on,” Richter concluded.

More data

The Partnership to End Addiction has extra about new nicotine merchandise that focus on children.

SOURCES: Matthew Myers, president, Campaign for Tobacco-Free Kids; Erika Sward, assistant vp, nationwide advocacy, American Lung Association; Linda Richter, PhD, vp, prevention analysis and evaluation, Partnership to End Addiction; An E-cigarette Market Update, Campaign for Tobacco-Free Kids, Dec. 17, 2021