Editors Note: The regulation of e-cigarettes will require FDA to develop a harm reduction program that complies with the Data Quality Act and reviewable by TPSAC.
Agency Will Not Regulate E-Cigarettes Under the Stricter Rules That Apply to Medical Products
WebMD Health News
April 27, 2011 — The FDA has decided to oversee electronic cigarettes the same way it does tobacco products. The agency will not regulate the vapor-producing devices under the stricter federal rules that apply to medical products.
The FDA says it decided not to appeal a federal appeals court ruling asserting that e-cigarettes could be regulated as tobacco products and “are not drugs or devices” unless specifically marketed for therapeutic purposes, such as purporting to help people quit smoking.
The decision not to appeal was announced in a letter to the public and stakeholders from Lawrence R. Deyton, MD, MSPH, director of the FDA’s Center for Tobacco Products, and Janet Woodcock, MD, director of the agency’s Drug Evaluation and Research.
E-cigarettes are marketed as cigarette substitutes but with claims to be safer than tobacco cigarettes.
The electronic devices are powered by a battery, and a liquid nicotine mixture derived from tobacco is converted into a vapor that can be inhaled by a user.
Courts Step Into E-Cigarette Controversy
The FDA had previously wanted to regulate e-cigarettes as drug-delivery devices such as nicotine gum and patches.
But the U.S. Court of Appeals for the D.C. Circuit decided in December 2010 that e-cigarettes are not medical devices and therefore must be regulated as tobacco, since the devices vaporize liquid nicotine.
Deyton and Woodcock, in a letter posted to the FDA’s web site, said the agency will take steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco.
“We look forward to working with all stakeholders to ensure that the existing authorities granted the agency are harnessed to best protect and promote the public health,” their letter said.
The federal court suit was brought by Sottera Inc., based in Scottsdale, Ariz., which does business as Njoy. It claimed its device, because it generates a nicotine vapor and not smoke, is a tobacco product, and not a drug.
The FDA’s acceptance of the appeals court ruling means the manufacturers of e-cigarettes will not be required to conduct animal or human studies, which the government requires for drugs and medical devices.
The FDA’s decision not to appeal to the Supreme Court could be seen as a victory for the e-cigarette makers and distributors.
But the FDA’s letter makes it clear that the agency plans to maintain focus on making sure the products aren’t pitched by marketers as therapeutic devices.
The FDA said in a letter September 2010 sent to e-cigarette distributors that their products were being marketed illegally and were subject to rules governing drugs. Distributors reacted with a suit that ruled in the December 2010 decision that accepted the e-cigarette industry’s position.
What Are E-Cigarettes?
E-cigarettes have been marketed as a safer substitute for real cigarettes. The metallic tubes, which look like cigarettes, consist of a heating element and a cartridge containing a liquid with nicotine from tobacco plants. When users inhale, a nicotine vapor is emitted. The tips appear to glow.
Matthew L. Myers, president of the Washington-based Campaign for Tobacco-Free Kids, says the organization was disappointed that the FDA did not appeal the federal appeals court ruling. The status quo now means manufacturers can “add nicotine to a wide range of products without the stringent regulation traditionally applied to smoking cessation medications and other non-tobacco products to which nicotine has been added.”
However, he also says in a letter posted on the group’s web site that the FDA “has taken appropriate action to protect public health by announcing that it intends to assert authority over other tobacco products that meet the statutory definition of ‘tobacco products’” under federal law.