Last week, the Office of Management and Budget (OMB) updated its regulatory calendar, including a small update to the U.S. Food & Drug Administration’s (FDA) planned regulations of tobacco products under the Family Smoking and Tobacco Control Act. Post update, the proposed rule now lists a date of “06/00/2015” for “Final Action.” Many have taken to accepting as a deadline on when the FDA must act regarding the proposed regulation of premium cigars, something that isn’t really true.
While it very well me be the case that we find out some time in June 2015, there’s no actual deadline.[ref]It should also be pointed out, it’s not even an FDA final rule, rather, an OMB calendar.[/ref]
Twice per year, federal agencies are required to publish a “rule making agenda” as required by the Regulatory Flexibility Act. And while these agencies are required to provide dates for things like final actions, it’s a non-binding update. There is no rule that requires the Office of Management & Budget (OMB) or FDA to act in or by June.
In fact, OMB could decided to push back the final rule again in May 2015 when the next semi-annual update is required. Alternatively it could go through June without any sort of final action. Legislative sources told halfwheel that early on in the Obama administration these dates were “treated as gospel,” but within the last few years they’ve been completely ignored as there is no punishment for a federal agency going past the deadline.
Currently, FDA is still reviewing comments after it prepares responses it will decide whether it wants to update the proposed rule accordingly. It will then make its way over to OMB, where it will be modified before approval and publication.
The good news for cigar smokers is that OMB was rather cigar friendly this time a year ago. The original version of the proposed rule written by FDA included no exemption for premium cigars, rather a less strict version of rules. After spending a few months modify the legislation, OMB submitted language for a cigar exemption, as well as striking language that referenced studies focused on the negative effects of cigar smoking.
To learn more about the proposed regulation of premium cigars, please visit halfwheel.com/fda.