Monday, January 28, 2013

Problem is Not that Electronic Cigarette Companies are Making False Claims; Problem is that Anti-Smoking and Health Groups Are

Many anti-smoking groups and advocates have expressed grave concern that electronic cigarette companies are widely misleading the public about the scientific truths regarding these products. Accordingly, they have called for strict regulation of these claims, with some groups calling for prohibition of these statements. For example, Stan Glantz on his blog last week expressed concern about "false advertising" claims being made by electronic cigarette companies. According to Glantz and others, electronic cigarette companies are falsely claiming that their products may be helpful in smoking cessation, and immediate measures are necessary to protect the public from this false advertising.

Since there is in fact strong evidence that electronic cigarettes may be useful in smoking cessation, these claims do not represent false advertising. Whether they represent therapeutic claims is debatable, and I have already explained why I do not believe that a smoking cessation claim, in and of itself, is a therapeutic claim.

There is, however, a large number of entities that are grossly misrepresenting the scientific evidence, widely misleading the public, and often lying about the scientific facts regarding electronic cigarettes. Who are they?

Not the electronic cigarette companies, but anti-smoking and health groups.

The Rest of the Story

A review of 10 of the most popular electronic cigarette brand web sites revealed that not a single one of these companies is making a smoking cessation claim for its products, not a single one is making any drug claims, and each company offers a specific disclaimer making it clear that the product is not approved for any purposes by the FDA and that it is not intended for smoking cessation nor to cure, treat, or prevent any disease or condition:

Blu Cigs: "blu e-cigs® electronic cigarettes are not a smoking cessation product and have not been evaluated by the Food and Drug Administration, nor are they intended to treat, prevent, or cure any disease or condition."

V2 Cigs: "V2 Cigs products are not marketed for use as a smoking cessation product. Just like traditional tobacco cigarettes, V2 Electronic Cigarettes are not approved by the American FDA. ... Our products do not treat, diagnose, or cure any disease, physical ailment, or condition."

Safe Cig: "This product is sold for recreational use only. Our products are neither intended nor marketed as a quit smoking aid or cessation device. ... Electronic Cigarettes and Cigars are not FDA approved. Statements made about our products are not intended to diagnose, treat, cure or prevent any disease. Electronic cigarettes and cigars are not FDA approved."

Green Smoke: "This product is sold purely for recreational purposes - it is not a smoking cessation product and has not been tested as such."

NJOY: "NJOY products are not a smoking cessation product and have not been tested as such.  This product and the statements made within have not been evaluated by the US Food and Drug Administration or any other international health or regulatory authority, unless otherwise noted in NJOY’s materials. These statements and NJOY products are not intended to diagnose, treat, cure, or prevent any condition, disorder, disease or physical or mental conditions and should not be used as a substitute for your own physician’s advice."

Johnson Creek: "Johnson Creek Original & Red Oak Smoke Juice is not a smoking cessation product and has not been tested or guaranteed as such. Johnson Creek Original & Red Oak Smoke Juice has not been evaluated by the Food and Drug Administration nor is it intended to treat, prevent or cure any disease or condition."

South Beach Smoke: "Our products do not treat, diagnose, or cure any disease, physical ailment, or condition. If you are allergic to nicotine or any combination of inhalants, if you are pregnant or breast-feeding, or if you have a heart-condition, diabetes, high blood pressure or asthma, consult your physician before using South Beach Smoke nicotine products. Just like traditional tobacco cigarettes, South Beach Smoke Electronic Cigarettes are not approved by the American FDA." 

Premium Electronic Cigarette: "Premium Ecigarette does not market or intend its product to be used as a quit smoking aid or a cessation device.  Premium Ecigarettes are not intended to diagnose, treat, cure or prevent any disease."

Vapor Couture: "Our products do not treat, diagnose, or cure any disease, physical ailment, or condition. ... Vapor Couture products are not marketed for use as a smoking cessation product. Just like traditional tobacco cigarettes, Vapor Couture Electronic Cigarettes are not approved by the American FDA."

Crown 7: "The FDA will regulate e-cigarettes under its authority to regulate other tobacco products. The FDA has in the past detained or blocked incoming shipments of e-cigarettes from overseas manufacturers on the basis that e-cigarettes are unapproved drug delivery devices that must pass through the FDA's New Drug Application (NDA) process before they can legally be sold. Two e-cigarette importers and distributors, Smoking Everywhere, Inc. and Sottera, Inc., brought a lawsuit against the FDA and sought a preliminary injunction to prevent the FDA from regulating e-cigarettes as a drug delivery device and from stopping the importation of e-cigarettes into the U.S. while the case is ongoing. The e-cigarette distributors argued that because their products use nicotine derived from tobacco, e-cigarettes should be regulated as "tobacco products," subject to much more limited restrictions that do not require pre-approval by the FDA. The United States District Court for the District of Columbia granted the preliminary injunction. This ruling was affirmed by the United States Court of Appeals for the District of Columbia Circuit in December 2010.22 In April of 2011, the FDA decided it will not seek further review of this decision, but rather will regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act in accordance with the court's opinion. In September 2009, the FDA announced that it will continue to bring enforcement actions against e-cigarette companies that make unsubstantiated health claims about their products.
E-cigarette sales are also subject to state law. Various state attorneys general have brought lawsuits alleging that e-cigarette distributors have violated state law by selling to minors or making unsubstantiated health claims."

In fact, the only misleading statement on any of these web sites is the assertion that "like tobacco cigarettes," the FDA has not approved electronic cigarettes. Actually, the FDA has approved tobacco cigarettes, which are statutorily legal and officially approved by the agency.

In contrast, just in the last few weeks, numerous anti-smoking and health groups have made misleading or blatantly false scientific claims about electronic cigarettes:

1. The Malaysia Health Ministry has apparently communicated that electronic cigarettes are more hazardous than the real ones: "The Health Ministry has urged smokers who have switched to electronic cigarettes to refrain from using liquid nicotine as it was more hazardous. Its minister Datuk Seri Liow Tiong Lai said liquid nicotine was a controlled drug under the Poisons Act 1952. ... Liow said it was safe if smokers used the e-cigarettes without nicotine to slowly quit the habit. “But adding liquid nicotine can make the e-cigarettes more harmful than the normal cigarettes,” he said...".

2. A German health official apparently also communicated that electronic cigarettes can cause more harm than smoking: "They are billed as a healthier alternative to smoking, yet experts now warn that electronic cigarettes may be more damaging than the habit they replace. ... To vaporise the nicotine solution, the chemical propylene glycol is put into the cartridges, and accounts for up to 90 per cent of their content. This can cause ‘acute respiratory system irritation’, claims Dr Elisabeth Pott, director of the Federal Centre of Health Education in Cologne, Germany, who has studied e-cigarettes."

3. The Department of Health in the Phillippines apparently has communicated that electronic cigarettes cannot be helpful in quitting smoking: "Electronic cigarettes (e-cigarettes), increasingly popular among young Filipinos, are not advisable for those who want to quit smoking, the Department of Health (DOH) warned last week. Anthony Leachon, DOH consultant for non-communicable diseases, e-cigarettes could not help a person who wants to stop smoking. 'Electronic cigarettes are not advisable since you don’t kick the habit. You can easily go back to smoking,' said Leachon. He said if a person wants to quit but can’t do it on his own, he should consult a doctor for proper counseling and medication. Maricar Limpin, executive director of the Framework Convention on Tobacco Control Alliance Philippines, has expressed concern over the proliferation of e-cigarettes. Limpin warned that e-cigarettes give a false sense of security because these are being marketed as something that would help one quit smoking 'when, in fact, there is no evidence to prove that.'"

4. The Canadian Lung Association is warning smokers not to use electronic cigarettes to quit smoking because they contain carcinogens and anti-freeze, harm the lungs, are marketed to and appeal to kids, and may be a gateway to smoking: "For National Non-Smoking Week, the Canadian Lung Association encourages people who want to quit smoking to use scientifically proven methods and to avoid gimmicky unproven methods, like electronic cigarettes. "Don''t be fooled by e-cigarettes. These electronic devices could be potentially harmful to lung health and are not an approved quit smoking aid by either Health Canada or the U.S. Federal Drug Administration," says Margaret Bernhardt-Lowdon, a tobacco issues spokesperson for the Canadian Lung Association. ... "People who use e-cigarettes inhale unknown, unregulated and potentially harmful substances into their lungs," says Dr. Theo Moraes, a medical spokesperson for the Canadian Lung Association and an assistant professor at the University of Toronto. ... E-cigarettes may contain ingredients that are known to be toxic to humans including carcinogens and diethylene glycol, a toxic chemical used in antifreeze. In initial lab tests, the U.S. Food and Drug Administration found detectable levels of carcinogens and toxic chemicals in two leading brands of e-cigarettes and 18 various cartridges. ... The Canadian Lung Association is greatly concerned that e-cigarettes with candy-like flavours, such as chocolate and vanilla, are being marketed and sold to youth. "We are afraid that e-cigarettes, if not regulated, may lead more young people to start smoking," says Dr. Moraes, who is also a staff respirologist at The Hospital for Sick Children in Toronto. "These products have candy-like flavours, which appeal to children and teenagers and can be bought by those under the age of 18. We are also concerned that e-cigarettes may lead kids to try other tobacco products."

The statements being made by these health officials are far more concerning than the statements being made by electronic cigarette companies, which are largely truthful. In contrast, the statements being made by these health officials are either misleading and deceptive or outright false. 

If public health policy makers and federal health officials want to ensure that the public receives truthful information about the health risks of smoking and electronic cigarette use, then the place to start is not with the electronic cigarette companies, but with anti-smoking and health groups which are deceiving and lying to the public because they simply don't like the idea of a behavior that looks like smoking actually helping to save lives.

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