In Wake of Receiving 50 Health Complaints, FDA Proposes new Regulations for E-Cigarettes
The Food and Drug Administration is currently proposing new regulations on the sale of electronic cigarettes after it has received more than 50 e-cigarette complaints of respiratory problems, nicotine toxicity, and allergic reactions over the last year. The new regulations would ban the sale of e-cigarettes to minors and require the inclusion of health warning labels on the packages. The FDA stated it wants to set a foundation for the product regulation of e-cigarettes. The new proposed regulations come at the heels of the request of Members of Congress and advocacy groups questioning the existing marketing and regulation of electronic cigarettes. [reuters.com/article/2014/04/17/us-usa-health-ecigarettes-idUSBREA3G06N20140417, April 2014]
FDA Commissioner Dr. Margaret Hamburg said in a statement, additional regulations, “will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits.” FDA Center for Tobacco Products director Mitch Zeller stated that the proposal, “) would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA.” The FDA also proposed new regulations for pipe tobacco, dissolvable tobacco products, cigars, nicotine gels, and hookah pipes. [abcnews.go.com/Health/wireStory/fda-proposes-regulations-cigarettes-23448511?singlePage=true, April 2014]
Public health advocates see the new proposed regulations as a positive step for regulating the marketing of these new tobacco products. However, some groups, like the Campaign for Tobacco-Free Kids, have pointed out that the FDA is waiting too long to regulate the devices, since the FDA first agreed to regulate e-cigarettes back in 2011. As of April 2014, the FDA has not finalized the new regulations. Once the new regulations are finalized, the FDA could then propose additional restrictions or changes to the existing rules on an unspecified timetable. The FDA is allowing industry members, the public, and advocacy groups 75 days to comment on the new proposed regulations. Then the FDA will evaluate the comments before creating the new rules.
According to the FDA, e-cigarettes provide the same nicotine high that traditional cigarettes offer, but without the chemicals and second-hand smoke trail of the original product. No scientific evidence shows that smoking e-cigarettes will help someone quit smoking. Data collected by the Associated Press shows that since 2006, the number of electronic cigarette users has skyrocketed from just a few thousand to over several million. Estimated sales of e-cigarette products were around $2 billion in 2013.
A Wells Fargo Securities analyst stated that the FDA proposal was on the conservative side, and “not as restrictive as some had feared.” Even Jason Healy, the president of electronic cigarette company Blu e-cigs stated that “it seems to be a responsible approach, and shows the FDA’s commitment to look at particular e-cigarettes in a science-based way rather than just conjecture.” The proposed regulations would prevent the sale of e-cigarettes to minors, require health labels stating the addictive nature of the product, and would have to show an ingredient list. Manufacturers would also have to register their products with the FDA or make safety claims about e-smoking. Other regulations would ban free samples, sale in vending machines, or use words like “mild” to describe the effects.
The FDA is allowing two years for current electronic cigarette manufacturers to register their products. The FDA will allow the continued sale of products while the applications are under review. All e-cigarette companies would have to apply for registration within two years and any new companies would also have to register before selling their products to the public.