NATO Submits Comments to FDA’s Flavor and Nicotine ANPRMs
The National Association of Tobacco Outlets (NATO) has submitted comments in response to the U.S. Food and Drug Administration’s (FDA) advanced notice of proposed rule making (ANPRM) regarding nicotine levels and flavors in tobacco products.
Earlier this year the FDA issued three ANPRMs, each examining a different issue impacting tobacco products. Flavors, nicotine levels and how it handles regulating the premium cigar category all were under the microscope, indicating that the FDA is potentially willing to reevaluate how it regulates and treats different tobacco products. Whether this reevaluation produces a positive or negative outcome for the tobacco industry is still negotiable but the ANPRMs offer the industry, businesses, stakeholders, advocates and consumers to submit data, research against federal regulation.
For the ANPRM addressing nicotine levels, NATO focused on several different issues including the need for heat-not-burn and other noncombustible tobacco products to be regulated before establishing a standard nicotine level; the need for the FDA to launch an educational media program dissuading adults from providing tobacco products to minors; reconsidering the near-zero level of nicotine in tobacco products that was proposed because it violates a restriction imposed by Congress that nicotine levels be set near zero; the possibility of an illicit market being created for tobacco products due to overregulation; the negative consequences on local governments due to a decline in collection of taxes collected from the sell of tobacco products; the public being confused about the harmful effects of using low-level nicotine products and the overall impact of low nicotine on public health.
In its response to the flavored tobacco product ANPRM, NATO stressed the importance of consumer choice in any product, including tobacco products; the Congressional limit already in place that prevents the banning of an entire class of tobacco products; the First Amendment issues presented by banning flavors in terms of commercial speech in advertising; the need for an educational program that would deter adults from selling tobacco products to minors; the financial consequences to local governments if tobacco products are banned and there’s a decline in taxes collected; and the public health situation brought on by banning flavors.
With the ANPRM commenting period having ended, it is now up to the FDA to review all of the comments submitted and decide whether any changes are necessary to its regulation of tobacco products’ flavors and nicotine levels, along with its overall regulation and handling of premium cigars. There’s no strict timetable for this process but the tobacco industry is hoping for a prompt review and positive outcome from the comments submitted.
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