FDA Begins Crackdown On E-Cigarette Industry Announces Intent To Regulate E-Cigarettes
On September 9, 2010, the Food and Drug Administration (“FDA”) announced its intent to regulate electronic cigarettes and issued warning letters to five e-cigarette manufacturers for violations of the Food, Drug, and Cosmetic Act (“FDCA”). Warning letters were issued for various violations of the FDCA including violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients. A copy of the FDAs press release can be read here: FDA Acts Against E-Cigarette Distributors.
E-cigarettes are battery-powered devices that allow users to inhale vaporized liquid nicotine instead of tobacco smoke. As these devices have become more popular, the FDA has become increasingly concerned with the safety and effectiveness of these devices as smoking cessation aids. In July, the FDA issued a press release expressing its concerns with the e-cigarette stating that because e-cigarettes have not been submitted to the FDA for evaluation or approval, the levels of nicotine and other chemicals that the products deliver to its users are unknown. The press release regarding safety concerns with the e-cigarettes can be read at FDA Warns of Health Risks Posed by E-Cigarettes.
In a letter to the Electronic Cigarette Association on September 8, 2010, the FDA advised the e-cigarette industry of its intent to regulate e-cigarettes. The FDA has determined that e-cigarettes “meet the definitions of both a drug and a device under the [FDCA] and the definition of a combination product in 21 C.F.R. Part 3, with a drug primary mode of action.” A full copy of the FDAs letter to the Electronic Cigarette Association can be read at FDAs Letter to the E-Cigarette Association.
As a result of this new classification by the FDA, e-cigarette manufacturers will have to comply with the FDCA and numerous regulations regarding the marketing and approval of drugs. Under the FDCA, a company must demonstrate that a drug is safe and effective for its intended use before that product will gain FDA approval. This will require e-cigarette manufacturers to provide proof that e-cigarettes safely and effectively reduce its users dependence on nicotine. Additionally, manufacturers must demonstrate that its manufacturing practices preserve the strength, quality, and purity of the drug. The FDCA also prohibits a company from claiming that a drug can treat or mitigate a disease, including nicotine addiction, unless the drugs safety and effectiveness has been proven.
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