In late April, the Food and Drug Administration (FDA) finally decided to start regulating e-cigarettes, the increasingly popular battery-operated devices that deliver nicotine via inhaled vapor instead of tobacco smoke. The agency has issued a draft of their proposed regulations, which are similar to their approach to tobacco. The draft is available for public comments until July 9th.
Long-time tobacco industry critic Michael Siegel, M.D., M.P.H., a public health professor at Boston University—and current supporter of the e-cigarette movement—says he considers the proposed FDA regulations disastrous. He agrees with some components, but is concerned that others may hinder the efforts of e-cigarette makers to enter the marketplace.
Dr. Siegel outlines at least four reasons for his negative take on the draft regulations. Here's an evaluation of his thoughts, based on possible health concerns:
1. The regulations fail to limit the marketing of electronic cigarettes to youth.
True, and they should. The FDA deferred the decision to regulate youth marketing for the moment, but the agency needs to act aggressively on that front. There’s no reason to market e-cigarettes to young people—particularly since ingredients vary from brand to brand and we don’t yet know what the long-term effects of use might be.
2. The regulations require FDA’s pre-approval for all new electronic cigarette products.
This means manufacturers must agree to follow certain restrictions and marketing rules before their products can be released to the public. (Alternatively, companies may demonstrate that a new product is at least as effective and safe as another e-cigarette device that is already legally marketed.) Dr. Siegel sees this as an obstacle to innovation and says it will limit the market. But many tobacco products undergo the process, so why should e-cigarettes get special treatment?
3. The regulations require the makers of almost all electronic cigarette products already on the market to go back and seek the same approval.
Dr. Siegel thinks the FDA will be too slow in processing applications from the current 250 brands of e-cigarettes. While I can’t speculate on the length of the process, it only seems fair for all e-cigs to be subject to the same scrutiny.
4. The draft regulations apply what’s known as “modified risk product provisions” to electronic cigarettes.
The regulations say that if companies want to claim that their e-cigarettes have fewer negative health effects than traditional tobacco products, they will have to prove this first. Seems appropriate, doesn’t it? However, according to Dr. Siegel, e-cigs are undoubtedly safer and the FDA should simply issue a blanket acknowledgement of this.
The truth is, we don’t yet have scientific evidence that e-cigs are safer. There are only a few studies on the effects of inhaling nicotine vapor, which is addictive. Also, there’s no uniform formula for what ingredients an e-cigarette should or shouldn’t include, so we can’t be certain that all ingredients are safe. In fact, initial FDA lab analyses found suspected carcinogens in some samples of e-cigarettes. Another new small study from the Roswell Park Cancer Institute in Buffalo, New York, found that when e-cigarettes get very hot, they can produce formaldehyde—a known carcinogen.