The much awaited proposed FDA ecig regulation has already been announced. It was Thursday morning, April 24th, when the FDA has posted these policies on the Federal Register. These first ever federal regulations on ecigarettes will ban sales to minors below 18 years old and will require manufacturers to gain the approval of the agency on their products.
The proposed FDA ecig regulation goes amiss of those for traditional cigarettes. Ads as well as internet sales will not be banned. Lawmakers fighting for the elimination of ecigarette flavors were disappointed because the regulation proposals still allow these flavors.
Proposed policies are not all yielding. In fact, consumer groups are probably pleased as ecig makers will be required to divulge their used chemicals. Distribution of free samples will also not be allowed. New health warnings will also be required wherein it will be indicated that the nicotine could be addictive.
Less Restrictive Than Expected
These proposed rules are less limiting than what many have anticipated. Morgan Stanley tobacco analyst David Adelman described the regulations very light, not disruptive and not likely to impact. He, however, added that subsequent actions by the health agency will curb the category at some point in the future.
Big Tobacco Company Lorillard Inc that owns Blu cigs applauded these FDA rules. It said that the proposed policies are reasonable and added that it looks forward to a robust process of give and take in the months to follow when the review stage is launched. Murray Kessler, chief executive of Lorillard, said that it seems that the agency is taking an approach that is based on science.
These initial rules appear to be fair to the vaping community and industry; but are below par to the ecigarette critics who think that the products are gateway to smoking and nicotine for non-smokers and teenagers.
Head of Center for Tobacco Control Research and Education at University of California in San Francisco Stanton Glantz remarked that the proposal does nothing to impact the Wild West ecig marketing to children.
The proposed regulations will also apply to pipe tobacco, cigars, water pipe tobacco and nicotine gels. Officials said that for cigars, they will still wait for public comments before all cigars are regulated or merely those flavored products criticized as targeting the children.
The typically lower costs of ecigarettes compared to cigarettes would be affected. The new rules will require companies to submit to the FDA scientific evidences that will substantiate claims that ecigs are safer than standard cigarettes. The costs of studies to obtain these evidences could reflect on the future prices of products.
A 75-day comment period is planned by the FDA before these proposed regulations are finalized. At that point, some provisions like requiring scientific evidence on the health benefits of ecigs will immediately take effect. Yet, there are some provisions that will take effect a couple of years later.
Among the biggest requirements is for ecig makers to apply to the FDA within 2 years in order to keep their products still available on the market. It is here where the agency could roughly rule on applications as it typically does with other tobacco products.
This is where the FDA could have greater leverage on what products could be allowed in the market. This is the part that concerns many ecigarette makers. The application process could take longer than necessary and could stifle innovations, which are key elements to the success of cigarette industry.
President of Logic Technology Development Miguel Martin said that new technology is imperative for the category.
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