Electronic Cigarette Distributors Warned By FDA Regarding Unsubstantiated Claims

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Main Category: Smoking / Quit Smoking
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 09 Sep 2010 - 13:00 PST

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Warning letters were sent to five different electronic cigarette distributors by the FDA (Food and Drug Administration) for making unsubstantiated claims, as well as poor manufacturing practices. The FDA also informed the Electronic Cigarette Association that it means to regulate electronic cigarettes and related products "in a manner consistent with its mission of protecting the public health."

A drug product is required to demonstrate its safety to the FDA, it also needs to prove it is effective for its intended use. Manufacturing methods have to be shown to be adequate so that the strength, quality and purity of the product is preserved, the Agency added.

In the letter to the Electronic Cigarette Association, the FDA wrote:

FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed.

Electronic cigarettes are subject to FDA regulation as drugs, the Agency has determined. It explains in its warning letters that under FDCA (Federal Food, Drug, and Cosmetic Act), if a company makes a claim to treat or mitigate a disease, such as nicotine addiction, it is required to prove its safety and effectiveness.

All five electronic cigarette distributing companies make this claim, but with no relevant evidence that their products help users give up smoking.

Warning letters were sent to the following companies:

• E-CigaretteDirect LLC
• Ruyan America Inc.
• Gamucci America (Smokey Bayou Inc.)
• E-Cig Technology Inc.
• Johnson's Creek Enterprises LLC.

Some firms received warning letters for other reasons too:

• E-Cig Technology sells drugs in unapproved liquid forms, such as tadalafil, the active ingredient for the erectile dysfunction drug Cyalis, as well as rimonabant, a weight loss drug which has not been approved in the USA yet. Rimonabant is the active ingredient in the following brand named weight loss drugs, Acomplia, Bethin, Monaslim, Remonabent, Riobant, Slimona, Rimoslim, Zimulti, and Riomont. These liquid medications are designed to refill e-cigarette cartridges to that they may be inhaled through vapour.
• Johnson Creek Enterprises, distributor of Smoke Juice, a liquid solution used to refill empty e-cigarette cartridges, is cited by the FDA for several faults in its manufacturing process, including not establishing quality control and testing procedures required under the FDCA.

What are e-cigarettes?

E-cigarettes, also known as personal vaporizers, or electronic cigarettes, are battery-powered devices that look like cigarettes which provide inhaled doses of nicotine in a vaporized solution - some may also provide non-nicotine vaporized solutions. They are sold as alternatives to smoked tobacco products, such as pipes, cigars and cigarettes.

E-cigarettes are said to provide a flavor and physical sensation similar to what a tobacco smoker experiences, but without the smoke or combustion (you don't light it up).

Some e-cigarettes look just like cigarettes, while others look like ballpoint pens, and even pipes.

The majority of e-cigarettes are reusable and have replaceable and refillable parts. Some of them are disposable.

E-cigarettes in Europe - electronic cigarettes were brought to Europe in April 2006, and officially launched in Austria. Estimates place the number of regular e-cigarette users in Europe at over half-a-million.

E-cigarettes in the USA - classed as a drug by the FDA, and subject to market approval before sale under the FDCA. In January 2010 a federal judge overturned the FDA classification. However, an appeals court overruled the judge's classification in March 2010. Several online e-cigarette companies have emerged online in America.

Sources: FDA, Wikipedia.

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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