The FDA reportedly failed to perform a mandatory regulatory analysis of the new deeming regulations.
A formal request from NATO, the Pipe Tobacco Council and the International Premium Cigar and Pipe Retailers Association (IPCPR) has been submitted to the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products.
NATO reported that the request letter asks that the FDA conduct a regulatory analysis on the impact of the provisions in the new tobacco deeming regulations that regulate tobacco retailers as manufacturers if retailers purchase bulk pipe tobacco and subsequently sell small quantities to adult consumers and/or blend pipe tobaccos in-store. Such a regulatory analysis is required by the Federal Regulatory Flexibility Act, and the request letter also recommends that the FDA delay implementation of the deeming regulations that would regulate pipe tobacco retailers as manufacturers so that the Center for Tobacco Products would have time to complete the required analysis. The letter requested a delay of at least 120 days.
NATO reported that the Federal Regulatory Flexibility Act mandates that every federal agency prepare a regulatory flexibility analysis when that agency issues final regulations. Reportedly, these analysis factors were not completed by the FDA’s Center for Tobacco Products for the new deeming regulations. It is evident that the analysis was not completed because the agency stated that it was unable to determine the number of retail stores that sold pipe tobacco in small quantities or blended different pipe tobaccos together for sale.
According to the report from NATO, in order for the Center for Tobacco Products to comply with the Federal Regulatory Flexibility Act, the agency is must:
- Compile a description and estimate of the number of small retailers that will be impacted by the pipe retailer regulations,
- Draft a description of the reporting, recordkeeping and compliance requirements that retailers which sell pipe tobacco will need to comply with, and
- Explain the steps the FDA took to minimize the significant economic impact on small retailers including a statement of the reasons why the FDA did not accept the alternative to exempt retailers that blend less than 5,000 pounds of pipe tobacco annually from manufacturer regulatory requirements.
The FDA has been asked to respond to the formal request letter as soon as possible, since the deeming regulations are scheduled to go into effect on August 8, 2016, the.