For other types of tobacco, the law required the agency to conduct a “deeming” process to subject them to the same FDA tobacco product authority. That two-year process is now complete, and the resulting FDA Rule, anxiously awaited by the public health community, now extends the FDA’s authority to e-cigarette, cigar, hookah tobacco and pipe tobacco products introduced into the market after February 2007. The FDA now regulates their manufacturing, import, packaging, labeling, advertising, promotion, sale and distribution as it does with all tobacco products. However, there are challenges to the new rule, including introduced legislation in Congress and a lawsuit entered by Nicopure Labs, a manufacturer of e-cigarette devices and liquids.
The FDA rule will:
•Require manufactures to register with the FDA and list all products
•Require premarket application for review and approval for each product
•Prohibit sale of these products to those under 18
•Require reporting of all ingredients, including harmful or potentially harmful components
•Require health warnings on product packages and advertisements
•Prohibit selling any products that claim to be “light”, “low”, or “less harmful” without FDA authorization
•Prohibit sale in vending machines unless located in an adult-only venue
•Include regulation of e-cigarette liquids, flavorings and delivery-device components
•Require child-resistant packaging of e-liquids.
Expanding FDA’s regulation to cigars, hookah tobacco and pipe tobacco seems like a natural extension of its current authority. The big news is that the rule includes e-cigarettes. The rule will have profound effects on this industry, which was forecast to potentially reach $50 billion in sales by 2025. Until now, the e-cigarette industry has been virtually unregulated.
Control of e-cigarettes is considered a public health priority. Their use is rapidly expanding, especially among youth. Adolescent use tripled between 2011 and 2013 and tripled again between 2013 and 2014. Currently, 5.3 percent of middle school students and 16 percent of high school students use e-cigarettes. National studies indicate their use is now higher than cigarettes in children; in adults, e-cigarette use may surpass traditional cigarette use within a decade.
The debate over e-cigarettes continues. The long-term health effects of e-cigarettes are unknown. Proponents claim it is a much safer alternative than combustible tobacco and serves as a cessation aid for smokers. Public health officials, although increasingly acknowledging that electronic devices may be less toxic than combustible tobacco, consider them unsafe and a threat to unraveling 50 years of tobacco control efforts by reintroducing smoking-like behavior into society. This is especially true among youth, who risk a lifetime of nicotine addiction with their use. There is evidence e-cigarettes are a poor cessation aid, and their use promotes eventual progression to tobacco smoking among children.
The rule is necessary to protect individuals from an unregulated product. The public deserves evidenced-based information about the health effects of these electronic devices, knowledge of the ingredients, restrictions on harmful components, protection from misleading marketing claims by manufactures, and safeguards for our nation’s youth.
The rule may, however, have an unintended consequence. The rule includes a requirement that e-cigarette manufacturers submit an extensive premarketing application to the FDA for each specific e-cigarette product (every flavor and nicotine level). Each application may cost up to $1 million and be cost-prohibitive to the small businesses that now largely comprise the industry. It would be ironic if that left only the powerful big tobacco companies, the masters of deception and corruption, to capture the entire e-cigarette market.
Resource :http://www.indystar.com/story/opinion/2016/06/20/feldman-cigarette-regulation-needed/86141320/
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