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Old 10-18-2018, 07:16 AM   #1
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FDA Updates Unified Regulatory Agenda

17 Oct FDA Updates Unified Regulatory Agenda
by Tori Ellington

Earlier today, the US Food and Drug Administration (FDA) updated its roadmap for regulations, called the Unified Regulatory Agenda. This outlines the regulatory priorities and perspective timeline for the FDA and other federal agencies.

Importantly, on its agenda, the FDA noted their recent review for premium cigars remains ongoing, meaning the agency still considers this issue an open item. However, the FDA did not prescribe a specific timeline for any potential action on item, instead noting that it is “Long-Term Action” that will be addressed at a date “To Be Determined.” In short, the premium issue is an agenda item, but it is unclear at the moment when any regulatory change will come to the product category.

Scott Pearce, IPCPR Executive Director, believes this underscores the need to continue pressing the FDA to act on the premium issue. “As an organization, our number one priority is to fight on behalf of our retailers and the industry at large to bring a quick resolution to arbitrary regulations on premium cigars. We have the right message and we’ve armed the FDA with government data disproving the need for regulations. However, the agency chose to prioritize other initiatives at the moment. I remain optimistic that the FDA will address this glaring issue – but it is on all of us, as a united voice for the industry, to continue applying pressure on the Administration and the Congress.”

The FDA recently solicited thousands of comments from industry and the public at large for data on the use and public health impact of premium cigars. IPCPR’s comment provided a significant amount of government sourced data and statistics that definitively show premium cigars are not a public health concern for youth or adults.

Regulatory requirements on premium cigars and the small businesses that sell them have been in place for over two years. In that time frame – the economic pressures of the ill-conceived Deeming Rule have been felt across the industry. Ken P Neumann, President of the IPCPR Board of Directors, reiterates this point- “Cigars have needlessly come off the market, retail jobs remain at risk and the uncertainty of rising product costs and reduced stock continue to threaten brick and mortar stores around the country. All of this without any proven benefit to the public health or the FDA’s goal of stopping youth use of tobacco products and mitigating adult addiction to nicotine.”

IPCPR will continue to press this issue on behalf of our retailers and the industry and provide any and all updates as necessary.

Flavors

Today’s Unified Regulatory Agenda also included a new FDA proposal to prohibit “characterizing flavors” in all cigar products. Earlier this year, the agency solicited comments from the industry and the public on flavors in all tobacco products and what, if any action the FDA should take. It is unclear what the FDA’s intended timeline for this initiative is. IPCPR will continue to engage with the agency and others in industry as the agency pursues this objective.
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