On Dec. 15, 2010, the Food and Drug Administration (FDA) took new steps aimed at keeping consumers safe from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients.
FDA has found that these products are often promoted for weight loss, sexual enhancement, and bodybuilding.
The new steps FDA has taken include:
A letter from Commissioner of Food and Drugs Margaret A. Hamburg to the dietary supplement industry emphasizing its legal...
Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.
“The FDA is concerned about the safety of these products and how they are marketed to the public,” says Margaret A. Hamburg, M.D., commissioner of food and drugs.
The agency is concerned that
e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death
the products may contain ingredients that are known to be toxic to humans
because clinical studies about the safety and efficacy of these products for their intended use have not been submitted to FDA, consumers currently have no way of knowing 1) whether e-cigarettes are safe for their intended use, or 2) about what types or concentrations of potentially harmful chemicals or what dose of nicotine they are inhaling when they use these products.
The potential health risks posed by the use of e-cigarettes were addressed in a July 22, 2009, phone conference between Joshua M. Sharfstein, M.D., principal deputy commissioner of food and drugs; Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium; Jonathan Samet, M.D., director of the University of Southern California's Institute for Global Health; and Matthew T. McKenna, M.D., director of the Office on Smoking and Health at the national Centers for Disease Control and Prevention.
Conference participants stressed the importance of parents being aware of the health and marketing concerns associated with e-cigarettes. It was stated that parents may want to tell their children and teenagers that these products are not safe to use.
Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people.
In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.
During the phone conference, which was shared with the news media, FDA announced findings from a laboratory analysis that indicates that electronic cigarettes expose users to harmful chemical ingredients.
FDA’s Division of Pharmaceutical Analysis—part of the agency's Center for Drug Evaluation and Research—analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarette samples.