National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
July 28, 2009 • Volume 6 / Number 15

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FDA Update

FDA Issues Warning on Electronic Cigarettes

A sparging apparatus is used to test the levels of nicotine and related compounds in an e-cigarette. A sparging apparatus is used to test the levels of nicotine and related compounds in an e-cigarette.

Carcinogens and a chemical commonly used in antifreeze were discovered during a laboratory analysis of "electronic cigarettes," also called e-cigarettes, conducted by the FDA, the agency announced last week. Resembling cigarettes in shape and size, but containing no tobacco, electronic cigarettes are battery-operated devices that have small cartridges filled with nicotine, propylene glycol (a chemical used in an array of products), and often candy-like flavorings that are transformed into vapor and inhaled by users. They are commonly sold online and in malls and are often promoted for use in settings where smoking is not permitted.

The FDA's Division of Pharmaceutical Analysis tested 18 cartridges from two leading brands of electronic cigarettes, NJOY and Smoking Everywhere. Diethylene glycol, a toxic chemical used in antifreeze, was detected in one sample and a number of carcinogens, including nitrosamines, were detected in other samples.

"Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user," the agency explained in a MedWatch report.

"The FDA is concerned about the safety of these products and how they are marketed to the public," said FDA Commissioner Dr. Margaret A. Hamburg. Of special concern to parents, stated the FDA, is the fact that e-cigarettes are sold without any legal age restrictions and their different flavors (e.g., chocolate, strawberry, and mint) may appeal to youths. E-cigarettes also lack any health warnings like those used with conventional cigarettes and FDA-approved nicotine replacement products.

The agency believes that electronic cigarettes should be classified as a "combination drug-device product" that can be regulated under the Federal Food, Drug, and Cosmetic Act, but its jurisdiction has been challenged in a case pending in federal district court.

Labeling Change Narrows Use of Two Targeted Cancer Treatments

The FDA has approved label changes to cetuximab (Erbitux) and panitumumab (Vectibix) that advise against their use in patients with metastatic colorectal cancer whose tumors have certain genetic mutations. The changes are based on retrospective studies of several clinical trials which found that patients with specific mutations in the KRAS gene derive no benefit from the drugs. Both agents target the epidermal growth factor receptor.

In January, the American Society of Clinical Oncology issued a "provisional clinical opinion" recommending that all patients with metastatic colorectal cancer be tested for these mutations and that those found to have the mutations should not receive either agent. In addition to sparing patients unnecessary toxicities, a study presented earlier this year estimated that using these agents based on the results of KRAS testing could save more than $600 million annually.

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