On September 9, 2010, the U.S. Food and Drug Administration (FDA) sent official warning letters to five electronic cigarette distributors for violating the Federal Food, Drug and Cosmetic Act (FDCA). The letters accuse distributors in the Electronic Cigarette Association of making unsubstantiated claims and practicing poor manufacturing techniques.
The companies named in the letters include: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC. The letters outline the regulations for marketing drug products in compliance with the FDCA and invites distributors to work in cooperation with the agency to ensure that electronic cigarettes are lawfully marketed.
The biggest impact of these warnings is that the FDA has now determined that electronic cigarette products are subject to the same regulations as drugs. This means that distributors of electronic cigarette products cannot claim that the products can treat or mitigate a disease unless scientifically proven. Also, the FDA requires that significant testing of side effects and health repercussions are also necessary in order to safeguard consumers.
If you or someone you care about has been injured or killed by products sold without regulation, you must contact a lawyer to fight for your rights. Consumers have the right to be protected from unregulated products and treatments and have legal recourse options available for pain, suffering and other damages.