The push for regulation of premium cigars by the FDA becoming a reality.  The White House Office of Management and Budget (OMB) and Office of Information and Regulatory Affairs (OIRA) has released their latest version of the proposed regulatory agenda.  According to a communication by the International Premium Cigar and Pipe Retailers (IPCPR), this is being called “the most detailed release we have seen in recent years”.

The announcement was published and in the proposal it is stated that the proposed rule would generate some immediate quantifiable benefits by dissuading smokers of small and large cigars,” and “it would impose costs in the form of registration, submission, labeling, and other requirements.”

Last month, the push the regulatory agenda moved to the OMB to assess the economic impacts the industry. The IPCPR notes that for the first time, OIRA recognizes that proposed legislation should apply to tobacco products.  In a communication by the IPCPR:

Following a year of meetings and information sharing with the Food and Drug Administration (FDA) Center for Tobacco Products (CTP), IPCPR has learned that the process to federally regulate cigars has moved into the next phase. The proposed rule on regulating cigars has moved from the Department of Health and Human Services (HHS) to the OMB for review. This agency will analyze the rule and determine its economic impact on the industry before it is released for public comment.  It is critical that you are prepared for public comment period to be sure the voice of the retail tobacconist is heard.


The regulatory agenda notes international trade considerations, as the majority of premium cigars are imported. However, it also instructs agencies, when releasing the proposed rule, to consider Executive Order 13563 which states, “…each agency shall identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public.” Also, for the first time, OIRA recognizes that proposed regulations should apply to tobacco products, “if FDA determines that such regulation would be appropriate for the protection of the public health.” These potential regulations will greatly affect how your small business operates.

OIRA also indicates that FDA has many options when considering regulations on different classes of tobacco products. These options include, but are not limited to, “deeming only, but exempt newly-deemed products from certain requirements” and exempting “certain classes of products from certain requirements.”

As many know, the cigar industry is lobbying hard for bills S 772 and HR 792.  This would give premium cigars an exemption under such proposed rules.