The FDA will regulate e-cigarettes under its authority to regulate other tobacco products. The FDA has in the past detained or blocked incoming shipments of e-cigarettes from overseas manufacturers on the basis that e-cigarettes are unapproved drug delivery devices that must pass through the FDA's New Drug Application (NDA) process before they can legally be sold.
Two e-cigarette importers and distributers, Smoking Everywhere, Inc. and Sottera, Inc., brought a lawsuit against the FDA and sought a preliminary injunction to prevent the FDA from regulating e-cigarettes as a drug delivery device and from stopping the importation of e-cigarettes into the U.S. while the case is ongoing.21 The e-cigarette distributors argued that because their products use nicotine derived from tobacco, e-cigarettes should be regulated as "tobacco products," subject to much more limited restrictions that do not require pre-approval by the FDA. The United States District Court for the District of Columbia granted the preliminary injunction.
This ruling was affirmed by the United States Court of Appeals for the District of Columbia Circuit in December 2010.22 In April of 2011, the FDA decided it will not seek further review of this decision, but rather will regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act in accordance with the court's opinion.
In September 2009, the FDA announced that it will continue to bring enforcement actions against e-cigarette companies that make unsubstantiated health claims about their products.
E-cigarette sales are also subject to state law. Various state attorneys general have brought lawsuits alleging that e-cigarette distributors have violated state law by selling to minors or making unsubstantiated health claims.
The purpose of the TVECA is to ensure that member companies are responsible for their product quality, comply with all existing legislations both on a local and national level and provide for the public location to enact business. Below are the compliance regulations for member firms:
1. Make no medical claims regarding, but not limited to: safety, health benefits, smoking cessation. 2. Ensure product packaging does not appeal to young adults (e.g. cartoons, candy, etc.) 3. Ensure marketing materials do not appeal to young adults (l.e. BE COOL). 4. Show prominently, the TVECA approved warning on products that contain nicotine, on print materials, and throughout member websites. 5. When offering e-liquid, ensure all containers have child-safety caps. 6. When offering e-liquid, the maximum size bottle containing nicotine will be 30ml. 7. Show clearly, lot numbers and product manufactured dates on individual cartridge packaging (applies also to e-liquid). 8. Show clearly, nicotine level on individual cartridge packaging (applies also to e-liquid). 9. List all basic ingredients on any two items below: A) Product Packaging B) Instruction Card C) Company Website 10. All TVECA members will have in-office staff available to expeditiously field incoming customer service issues during normal business hours. 11. All TVECA members must display on their websites their place of business and address where consumers may conduct business in person. No P.O. Boxes. (Brick and Mortar Business Only). 12. Display cartridge or e-liquid nicotine levels numerically (e.g. 0 mg/ml, 6 mg/ml, 12 mg/ml etc.) and/or show nicotine percentage per content of (e.g. 24 mg/ml =2.4%). 13. When offering e-liquid, sell a maximum nicotine level to the consumer to be no greater than 36 mg/ml or 3.6% of total volume of e-cig cartridge. 14. Instruct consumers on e-cig packaging that all components of the electronic cigarettes are fully recyclable. 15. Ensure, with reasonable certainty (e.g. verification services), online buyers to be of legal age to purchase ln area consumer resides and/or more specifically where the product will be shipped. E-cig distributors are responsible to abide by all state legislation in regard to age verification for the purchase of product. 16. Ensure, with reasonable certainty (e.g. state issued photo ID), in-person buyers to be of legal age to purchase in area consumer resides and/or more specifically the area of the place of business. 17. Ensure auto-ship can be cancelled at anytime and refunds expedited in a timely manner: 18. Not offer Free Trials (a money back guarantee is sufficient). 19. Have and enforce a Terms and Conditions Agreement with any resellers who will accept and enforce all the TVECA rules and regulations regarding the sale of e-cigs (violation of rules by a company, regardless of the direct or indirect nature of infraction, will result in suspension). 20. Submit to, and pay for, cartridge/e-liquid random testing once every 6 months and that all samples will be sent within 3 days of notification. 21. Adhere to the terms and conditions of the TVECA Bylaws and Constitution.
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