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Why the June 2015 FDA Deadline Isn’t Really a Deadline

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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. 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 2016 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 ...

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