FDA gives Big Tobacco a big win — approval for e-cigarette for vaping

vuse-117x300The federal Food and Drug Administration has infuriated health and anti-smoking advocates by handing Big Tobacco a major first — the agency’s seal of approval for an e-cigarette as a way for consumers to reduce or stop harmful use of burning tobacco cigarettes.

The decision allowing RJ Reynold’s Vuse product (shown, left) to stay on public markets is the latest in a series of disastrous actions by the agency, putting a smoking alternative for adults ahead of the health and safety of young people, critics said. They repeated their contention that  with bungled oversight on alternative delivery devices and the vaping fad, the FDA has opened the way for a new generation to get addicted to toxic nicotine and lethal tobacco items.

Erika Sward, national assistant vice president for advocacy at the American Lung Association, told the New York Times this of the FDA ruling allowing an e-cigarette delivering high levels of nicotine:

  “This throws young people under the bus.”

Rep. Raja Krishnamoorthi, an Illinois Democrat and chair of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy, said in a statement, quoted by CNN:

“[The] FDA has turned its back on the public health by approving a high-nicotine e-cigarette. Many [other] countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, told Politico this of the FDA action, barring flavored Vuse vaping cartridges but permitting a tobacco-tasting version:

“I think it’s disturbing. The tobacco flavor decreases its appeal to youth, but the high level of nicotine increases the risk that a youth who experiments will become addicted.”

The FDA insisted that it has rejected flavored vapes that kids flock to. The agency said it will monitor closely youthful use of Vuse’s e-cigarettes, and if it finds it has abusive popularity, it will withdraw its approval.

The agency said it has imposed tough restrictions on sales, advertising, and marketing of the device, which looks like a tobacco cigarette, barring campaigns that target young people, for example, allowing promotions only on broadcast programming in which teens are a small part of the audience.

Critics assailed that claim, noting that Big Tobacco can promote Vuse and vaping by copying its broadcast ads and posting them on channels kids flock to — such as YouTube.

Regulator already have been blindsided by e-cigarette makers’ skill in hyping their product, with Juul — a San Francisco-based tech company and a market leader — helping to boost vaping via social media as a hot trend among young people.

The FDA has not decided whether it will allow Juul to keep its fashionable e-cigarettes, which look like small computer flash drives and can cost kids a pretty penny to use, on U.S. markets.

Though the agency argued that it was acting to protect the public’s health by banning flavorings for replaceable e-cigarette cartridges, such as those used by Vuse and Juul, the FDA did not rule on one of the most common and addictive taste-altering alternatives: menthol. RJ Reynolds said it will keep offering this flavoring until the FDA stops it from doing so.

The agency also may find that its efforts to oversee e-cigarettes and vaping may be for naught, as the phenomenon has become too rooted in consumer behavior and makers and vendors have raced ahead of regulators — with pricey, popular, and disposable e-cigarettes, with devices that use large tanks to hold vaping liquids, and with non-tobacco derived “synthetic” nicotine or with yet other delivery systems, such as with chews or products placed on the gum.

The e-cigarette and vaping debacle was avoidable, as the FDA, at the close of the Obama Administration, was ready to crackdown on the devices, an action overruled and postponed by Trump officials. They insisted that more study was needed on nicotine’s powerful addictive qualities (well known already at the time), with the hopes that reducing those might help curb the proven damages that burned tobacco use can cause, including various cancers, heart, and other conditions.

The FDA spent months chasing companies when e-cigarettes and vaping boomed, including when it caused a concerning outbreak of dozens of young patients hospitalized with serious lung conditions. Experts traced those cases to kids seeking cheaper, illicit vaping products, including those that were promoted as producing a more powerful high.

Vaping also has become a popular and prominent way for users to not only get a nicotine buzz (with higher concentrations of the substance in vapes) but also to ingest the intoxicant found in marijuana, which is becoming a concern itself in its overuse.

In my practice, I not only see the harms that patients suffer while seeking medical services, but also the clear benefits they may enjoy by staying health and far away from the U.S. health care system. It is fraught with medical errorpreventable hospital acquired illnesses and deaths, and misdiagnoses. Dealing with doctors or being in the hospital are among the last places anyone may want to be for the foreseeable future with the coronavirus pandemic.

If you don’t smoke, please don’t start. If you smoke, talk to your doctor, and make the challenging effort to stop. There are other ways to do so without taking up vaping. No one argues it is good for you — just that it is less harmful and another possible way to quit smoking. That’s a dubious health argument, akin to asking whether it’s “better” to die in a car or plane crash. Neither, thank you. During a killer coronavirus pandemic, does the nation need anything that can worsen people’s respiratory health, especially as smoking has been shown to inflict major damage on the lungs, heart, and other parts of the body with cancer and other diseases? And, by the way, it always has been clear that marijuana smoking isn’t beneficial to the lungs.

We’ve got a lot of work to do to make ourselves, our loved ones, and our nation healthier, notably by dealing with avoidable or preventable causes of sickness and death.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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