After the Food and Drug Administration issued a proposed rule to regulate all tobacco products, 24 leading public health and medical organizations representing over 560,000 healthcare and public health professionals now urge that the FDA issues a final rule by April 25 of next year and rejects a proposal to exempt so-called “premium cigars.”
In a document sent to the FDA’s Division of Dockets Management, the group of organizations, which includes entities such as the American Lung Association and the Lung Cancer Alliance, considers the proposed rule as critical to protecting the public health against the risks posed by tobacco products, as well as to ensuring an accelerated progress toward eliminating tobacco-related disease and death. Assuming a “sense of urgency” in this rulemaking process, the 24 organizations claim that the FDA should issue a final deeming rule within one year of publication of the proposed, thus the April 25, 2015 deadline.
On the other hand, they stress that this rule must be strengthened to prevent the tobacco manufacturers from designing and marketing their products in ways that undercut the full potential of the Tobacco Control Act.
The health groups are specifically referring to the exemption from regulation for “Premium Cigars,” a possibility proposed by the tobacco industry. For these organizations, “there is no justification for exempeting any cigars from FDA regulation,” as “all cigars are harmful and potentially addictive to users.” According to the letter sent to the FDA, the industry argues that premium cigars are not hazardous because their users do not inhale and youngsters do not use premium cigars. “These premises are not consistent with the scientific evidence. Moreover, all cigars threaten the health of non-users by giving off significant amounts of harmful secondhand smoke,” the organizations wrote.
In addition to these claims, the organizations highlight the importance of applying to newly-deemed products the full scope of statutory provisions applicable to tobacco products. Furthermore, the FDA should not only implement the sales and marketing restrictions it has proposed for the deemed products, but it must impose them on cigars, e-cigarettes and other deemed products the restrictions in the cigarette and smokeless regulations promulgated by FDA in 2010 pursuant to the mandate in the TCA.