Electronic cigarettes (or e-cigarettes) have created quite the stir in the market; its popularity has skyrocketed meanwhile the Food and Drug Administration (FDA) and the manufacturers engage in a heated discussion about their regulation.
In September of last year, the FDA announced its intention to regulate the sale of e-cigarettes stating that it’s a “medical delivery device” that needs
more clinical trials to confirm its safety and receive FDA approval. Under the Food, Drug and Cosmetic Act, medical delivery devices require clinical testing for FDA approval of the product. The FDA’s concern stems from the actions of some e-cigarette manufacturers; according to the FDA website some products labeled as not containing nicotine indeed do. They also feel that further testing will determine if in fact the e-cigarette helps in smoking cessation, as some of the companies claim.
Just last week, however, the U.S. Court of Appeals ruled that the FDA doesn’t have the authority to regulate e-cigarettes as medical delivery devices. Instead, the Court stated that the FDA can regulate e-cigarettes as a tobacco product.
Several organizations have opinioned in the process, including the Legacy Foundation, which suggests that e-cigs should be taken off the market until further studies confirm they’re safe . Legacy issued a statement saying they were “disappointed” in the court’s decision.
According to Dr. Byron Thomashow, Medical Director at the Center for Chest Disease at the New York Presbyterian Hospital and chairman of the COPD Foundation, most e-cigarettes still use nicotine (which is addictive) and the manufacturers apparently have repeatedly refused to undergo clinical trials suggested by both the FDA and World Health Organization.
The FDA is currently evaluating its next steps.
For quick reference, visit the Legacy Foundation’s fact sheet on e-cigarettes.