Showing posts with label Vape News. Show all posts
Showing posts with label Vape News. Show all posts
Gottlieb Releases New FDA Statement On Future Enforcement

Gottlieb Releases New FDA Statement On Future Enforcement



U.S. Food & Drug A dministration Commissioner Scott Gottlieb has released a new statement on the agency’s future plans for keeping vapor products out of the hands of underage users. While most of the release is known and reported information, there are a couple new wrinkled you may find interesting.
Part of Commissioner Gottlieb’s statement reads:
“For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use. Each of these companies market products that recently had been sold illegally to minors, either through brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address this public health crisis.”
As we have long maintained, enforcement of age verification and I.D. verification is the answer to this problem, far and away more effective than restricting access to adults of products that will help them transition away from smoking. There is a rational way to do both, and as Vape News has noted, that is to limit brick and mortar sales of vapor products to smaller, more responsive vapor-specific retailers and to mandate the adoption of standardized age and I.D. verification models for online retailers while prohibiting sales of vapor products from retailers, online or offline, which do not feature these verification capabilities.
Gottlieb echoes exactly this train of thought:
“The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the role that flavored e-cigarettes can also play in helping adult smokers quit. On this point, their proposals at the meetings reflected a range of ideas: for instance, that the FDA restrict distribution of certain flavored products to channels with enhanced age verification processes. Or that the agency require certain products that are more appealing to kids to come off the market until these products receive premarket authorization from the agency.
The companies also acknowledged the power of social sourcing of tobacco products – in other words, of-age purchasers sharing or selling products to underage friends – in contributing to youth tobacco use. To address this issue, some companies said that they would support raising the minimum age to purchase tobacco to 21 years of age. Companies also described their current actions to promote retailer compliance with age- and identification-verification requirements, and they committed to providing more information in their written submissions to the agency.”
At the same time, most vapers would rightfully want to see the FDA exercise the same vigor when combatting underage smoking, which both predates the advent of vaping and still continues concurrently with it. The impression, frankly, is that the FDA is going gangbusters about a relatively recent form of nicotine consumption by underaged users while totally ignoring its far longer running competition.
Take away their JUULs, by all means, but what do you plan to do when they go back to Camels? Are their lungs worth sacrificing?
Los Angeles Takes Legal Aim at Vape Companies

Los Angeles Takes Legal Aim at Vape Companies


Los Angeles City Attorney Mike Feuer has filed suit against three vaping retailers, charging that they sell products online without proper age verification. He has also accused them of marketing to underage customers through social media, and selling products not approved by the FDA.
The L.A. city attorney is just the latest ambitious prosecutor to take aim at the vaping industry. Earlier this year, Massachusetts Attorney General Maura Healey announced an investigation into JUUL Labs, the maker of the most popular vaping device on the U.S. market. Following Healey’s lead, the North Carolina AG has also begun an investigation.
Feuer is seeking injunctions against NEwhere Inc and its subsidiary VapeCo, and also KandyPens Inc. NEwhere operates three websites selling vapor products, according to Feuer: newhere.com, madhatterjuice.com, and vape-co.com. KandyPens also sells from its own website.
It’s unclear what the city attorney means when he says the products are “unapproved” by the FDA.
Feuer alleges that city employees were able to make online purchases “on multiple occasions” from the companies “while posing as teen customers using fake email accounts and a prepaid gift card.” The legal age for purchasing tobacco products (which includes vapes) in California is 21.
“Underage vaping is an emerging public health epidemic, and luring kids to use dangerous and addictive vaping products, as we allege here, has got to stop,” said Feuer in a press release. “In fact, kids shouldn’t have access to these products at all. The lawsuits we filed today send a strong message that if you put children at risk for the sake of profit, you’ll face serious consequences.”
Feuer says that “most, if not all” of the products on the NEwhere websites are being sold without FDA approval. All of NEwhere’s websites are currently offline, but an archived version of the NEwhere site (captured in August) shows typical vaping products that were likely available for sale before Aug. 8, 2016. It’s unclear what the city attorney means when he says the products are “unapproved” by the FDA.
Mad Hatter/NEwhere was cited by the FDA in May for selling e-liquid in packaging that resembled a children’s apple juice container. The company notified the FDA that the offending product was no longer being sold. The FDA did not accuse them of selling products introduced after the cutoff for deemed products to be sold without an approved PMTA.
The L.A. city attorney is just the latest ambitious prosecutor to take aim at the vaping industry.


It’s not clear if or why the Los Angeles city attorney’s office is investigating violations of the FDA prohibition on selling products brought to market after Aug. 8, 2016.
Feuer also contends that KandyPens is selling products not “approved” by the FDA. He further accuses KandyPens of not posting the FDA-required nicotine warning on its products or advertising, including social media posts. However, KandyPens doesn’t sell any products that are prefilled with e-liquid.
In fact, though KandyPens sells some devices that can be used for vaping e-liquid, it primarily offers products used for vaping cannabis concentrates and flower. Cannabis is legal in California for adults over 21, and is not regulated by the FDA. The company makes the claim that all of its products are intended “for aromatherapy purposes only.”
Feuer is asking the court to grant injunctions prohibiting the companies from selling online without appropriate age verification, selling deemed products with FDA approval, and “targeting youth” in their marketing.
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