E-Cigarettes Ads Claiming They Help People Stop Smoking Are Illegal: FDA

  • Written by: Staff Writers

Federal regulators are warning electronic cigarette manufacturers that marketing claims that suggest the devices help people quit smoking are unfounded and illegal. 

The FDA issued warning letters to five electronic cigarette (e-cigarette) makers on Thursday, in the latest move in an ongoing battle between FDA and the burgeoning industry regarding the agency’s right to regulate the devices. The letters were sent to E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC. In some cases, the companies were also warned that they had poor manufacturing standards as well.

E-Cigarettes are battery-powered devices, usually shaped like a pen, cigarette or cigar, which heat up a flavored nicotine solution when the user inhales. The resulting vapors are inhaled in the same manner as smoking a cigarette.

The warning letters state that all five companies have run ads claiming that their products can be used to help quit smoking. The FDA has determined that the liquid in E-cigarettes is a drug and that the E-cigarettes themselves are drug-delivery devices, which the manufacturers dispute. The FDA says in its letters that it is illegal for the manufacturers to claim their drugs can be used as a smoking cessation treatment without FDA approval first. The agency says the companies have conducted no clinical trials or shown scientific evidence supporting their claims.

The FDA has said that it has not had the opportunity to evaluate e-cigarettes for safety or effectiveness, and that limited laboratory studies have raised concerns about the manufacturing process and quality control processes that the FDA says appears to be “substandard or non-existent.” The federal regulatory agency has also indicated that E-cigarettes contain toxins and carcinogens.

In addition to the warning regarding the claims that the devices can aid people to stop smoking, the FDA also warned Johnson Creek Enterprises that it found significant deficiencies in its manufacturing process, and that the company did not appear to have any quality control or testing procedures as required by the FDA. Johnson Creek makes Smoke Juice, a liquid used to refill E-cigarette cartridges.

The FDA also warned E-Cig Technology that it is marketing the erectile dysfunction drug, tadalafil, and the weight loss drug, rimonabant, illegally as refill cartridges for e-cigarettes. Rimonabant has not been approved for use in the U.S.

The FDA’s jurisdiction has been challenged in court by E-cigarette manufacturers. The agency has been stopping shipments of E-cigarettes, a Chinese invention, at the borders for examination, which has developed into an ongoing legal battle.

E-Cigarettes are sold mostly at mall kiosks and through the internet. The FDA is also concerned that the devices appear to be directly marketed to young people, do not contain any health warnings, and are currently virtually unregulated. They come in flavors such as bubblegum, chocolate, and mint.

Public health experts expressed concern that the cigarettes could increase nicotine addiction in young people, and that they are being marketed as being safer than they really are.

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  1. qaz668 Reply

    They may not be able to market them as a device that helps people to quit but my mother, who had smoked for over 50 years had tried and failed to quit tobacco smoking many times and she was able to switch to electronic cigarettes without any moodiness or withdrawal symptoms and she is happy to have switched to a product that does not deposit any tar in her lungs.

    The propylene glycol used in them is the same thing used in theatrical smoke machines (which club owners expose their customers and workers to nightly). Propylene glycol is the same chemical which has been used in foods and medications for decades. Furthermore, all the flavorings added to the PG are food grade materials.

    The FDA can whine all they want to that they have not been tested but I would much rather my mom be using these than to continue to smoke tobacco which the FDA allows to be sold, knowing they are full of toxins. If you are not going to ban cigarettes, and we all know you are not going to, leave this better alternative alone!

  2. Elaine Reply

    There is no disease called “smoking” in the diagnosis code books. Therefore it is not a therapeutic claim for a product to be promoted as helping one to stop smoking. Cigarrest, Smoke Deter, End the Habit and others all openly claim their product helps to quit smoking and the FDA sends them no warning letters. When used as directed, the FDA-approved nicotine products have a smoking-cessaton rate of 7% at 6 months, 5% at 1 year, and 2% at 20 months. Does that sound like “efffective” to you? In contrast, surveys of e-cigarette users show that up to 80% are using the devices as a complete replacement for all their tobacco cigarettes. The reason these devices work so much better is that they don’t demand nicotine cessation. The accusation that the devices are marketed to young people is pure hogwash: 87% of users are over age 30 and 32% are older than 50.

  3. Meghan Reply

    Well, I agree that manufacturers that make marketing claims that suggest the devices help people quit smoking are unfounded and illegal. But, the FDA allows Nicorette Gum to be sold practically ANYWHERE & it also delivers nicotine to one’s system (which, of course comes with all of nicotines’ Evil effects.)

    I don’t sell or advocate Nicorette. But, I can see where it could help someone reduce their smoking. According to their ads: ” It’s a temporary therapeutic aid that reduces withdrawal symptoms and helps you quit smoking. Your body gradually adjusts to having less nicotine until you no longer need any.”

    One of the big problems that smokers have (and, I use to BE one!) — is that we have to wean ourselves away from “having to do something with our hands” (the physical habit of putting the cigarette to the mouth, etc.). I imagine that Nicorette could be a first step in that direction.

  4. Kathleen Reply

    Why is it every time a helpful product comes on the market Federal Regulators try to find a way to abolish it? There are a lot of people with their fingers in the tobacco industry, and anything that threatens the almighty $ is deemed not appropriate.

    I had Vascular surgery because of over 40 years of smoking. If it wasn’t for E-Cigarettes that helped me to quit, I don’t know where I would be. Nothing else I tried would work. The FDA should take another look at real cigarettes, and the rising cost of tobacco. That is the real drug that young people are getting addicted to. Think about who makes the money on all the FDA approved smoking cessation products that never seem to work!

  5. Jason Reply

    The FDA doesn’t want you to quit smoking because smoking causes cancer and cancer is big money. They don’t give a damn about you. The quicker the public wakes up and realizes what this is truly about (and why)….the quicker we can all stop them from killing people. The FDA are MURDERERS. Now they are going to be putting CHEMO DRUGS into all starch foods but you won’t see much about it YET because all the news sites were forced to take that information down. Look it up. WAKE UP.

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