27 Mar FDA Releases ANPRM on Premium Cigar Regulations
The FDA has finally published its long awaited notice on premium cigars. The Advanced Notice of Proposed Rule Making (ANPRM) was released earlier today, and as anticipated, seeks input from industry, other stakeholders and the public on ifand how the agency should define and regulate premium cigars differently from the status quo.
This is the third of three solicitations from the Food and Drug Administration (FDA) that were part of the agency’s comprehensive plan on tobacco. Specifically, the ANPRM itself states that the FDA’s decision to re-examine how it regulates and defines premium cigars is a result of “ongoing interests from many parties and sectors, such as industry and Members of Congress.” Put another way, the reconsideration of the premium question is a result of sustained outreach by supporters on Capitol Hill and the sustained drumbeat by retailers, manufacturers and consumers asking the FDA for a fair shake.
According to Ken P. Neumann, President of the IPCPR Board of Directors, this opportunity is only possible because of the years of advocacy and hard work by IPCPR, its retail members and industry partners. “A federal agency like the FDA doesn’t just decide to go back and look at changing its rules on a whim. They have to recognize, through persistent outreach and the reliance on hard facts, that the status quo might be more harmful then helpful. It would have been easy for us to pack up shop and give up after the final rule was released in 2016, but as an industry, we knew we were in the right.”
He added, “However, this is just another step in an ongoing process. We plan to continue engaging with the FDA and once again attempt to show them why the premium cigar industry is so dramatically different from others they regulate. I’m thankful to the FDA for this chance and you better believe IPCPR is going to make the most of it on behalf of all of our great retailers.”
What does the ANPRM ask for?
The FDA is requesting data and feedback from the public on three specific issues relating to premium cigars.
- Proposed definitions of premium products,
- Their patterns of use compared to other cigars and tobacco products, and
- What public health considerations are related to premium cigars.
Hasn’t the FDA requested similar data in the past?
Yes. During the rulemaking process in 2014 and during consideraiton of the “option-2” definition of premium cigars in the proposed deeming rule, FDA solicited similar information from industry. However, even the FDA has acknowledged a host of new information and studies have since been published that provide more data specifically to these questions. Moreover, the previous rulemaking process was completed by the prior administration. This administration has demonstrated a continued commitment to examining and easing the regulatory burden placed on Americans wherever possible.
So the FDA is going to change its regulations on premium cigars?
Not so fast – the ANPRM is a process through which the FDA requests information to inform what, if any, regulatory actions they take. The agency could decide it does not see sufficient evidence to make any changes and ultimately leave its current requirements in place. IPCPR, along with the rest of the industry hopes to present a sufficient case where they recognize the need to make a change.
Who can submit comments and when are they due?
Anyone can submit comments during this process. IPCPR will be sure to submit comments and looks forward to communicating the content of those comments out to our retailers. Comments are due June, 25th and can be submitted here.
For questions about the premium cigar ANPRM or any issues concerning FDA regulations, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at firstname.lastname@example.org.