Cigarettes are bad for you. The science is clear on that, and there have been warnings about the dangers of smoking on packs of cigarettes for decades. From heart disease to high blood pressure and cancer, the list of illnesses and health problems that arise from tobacco use is long.
Tobacco company Phillip Morris wants to sell a product that it claims is a "reduced risk" e-cigarette called iQOS, but a panel of advisers to the FDA has ruled that the language in some of the marketing of the product is misleading.
iQOS is similar to a vape pen. Sticks of tobacco, made by Phillip Morris and branded as Marlboros are heated up by the device, but the plant isn't burned. The company alleges that the "heat not burn" action of the e-cig means that users are exposed to less tar and chemicals, and the device is, therefore, safer than traditional cigarettes. The FDA has only recently been given authority to regulate e-cigarette devices.
The iQOS device is known as a "Modified Risk Tobacco Product" (MRTP), and marketing language and claims about safety must meet FDA standards. The advisory panel to the FDA said that while they would allow the company to say that the heating process does cause less exposure to chemicals, they found that there was no evidence to prove that this correlates to a lower risk of disease in users.
The device is already available in about 30 countries. Most e-cigarettes and vapor pens do not include actual tobacco, but fruit- flavored juices, some of which contain nicotine. Many smokers who are trying to quit use them to break the habit, but some say that the flavor they like from tobacco is missing from e-cigs. The FDA advisory panel cited irregularities in some of the clinical trials that Phillip Morris conducted as well as a lack of evidence that the product is less dangerous than regular cigarettes. To date, no MRTP products have been approved by the FDA. Phillip Morris was counting on being first to the market with their device, but it doesn't look as if they will succeed.
In a letter to the FDA's commissioner Scott Gottlieb, ten United States senators urged the agency to "avoid rushing through new products, such as IQOS, to fit within this evolving FDA policy, without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use." While the product has been available in other countries since 2014, the US market remains elusive. The advisory panel's recommendations are not binding, and the FDA will issue its decision on the product in a few weeks. While smoking has fallen to record lows in the United States, with only 15% of Americans reporting that they smoke on a regular basis, it's still the leading cause of preventable deaths and illnesses.
The video below has an in-depth look at the product and the research behind it. For now, it remains to be seen if these new devices will become available.
Sources: Reuters, Associated Press/Time.com, FDA
