Proposed FDA Rule May Force Some Smokeless Products Off Shelves

Public-comment period set to close July 10

MINNEAPOLIS -- With the public-comment period on a proposed chemical standard for smokeless products coming to a close July 10, NATO is asking that retailers communicate the potential harm the rule may have on their businesses to staff at the U.S. Food and Drug Administration (FDA).

The proposed rule, which the FDA formally published Jan. 23, 2017, would limit the level of a chemical called N-nitrosonornicotine (NNN) in finished smokeless-tobacco products to one part per million, according to Minneapolis-based tobacco-outlet association NATO (National Association of Tobacco Outlets). The FDA classifies NNN as a harmful or potentially harmful element in tobacco products.

Challenges to meeting the rule could force some products off store shelves, hurting sales opportunities for retailers, opponents said.

In a letter sent to the FDA dated July 1, NATO officials said the “financial harm” to c-store retailers would be “serious” because cigarettes and other tobacco products (OTP) account for nearly 36% of all in-store sales at c-stores nationwide and 87% of smokeless-tobacco purchases are made at c-stores, citing NACS and CSP magazine, respectively.

In addition to the harm to retailers, NATO offered up other reasons opposing the new standard, including how the proposed three-year compliance date within the new rule could be “considered arbitrary and unattainable”; the rule could amount to a ban on all smokeless products, which current laws prohibit; and that because weather is a factor in NNN levels, “there is no means by which farmers and manufacturers can control the weather.”

Initially, the FDA set an April 10, 2017, deadline for public comment, but it has extended it to July 10, 2017 after initial feedback from industry stakeholders. In a recent newsletter, NATO officials asked that retailers reach out to the FDA on the proposed standard.

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