P. Kovacevic: Insight into the FDA’s rulemaking process

On her Blog, Patricia Kovacevic is giving updates about the rulemaking process of the FDA's deeming rule. Patricia is a jurist specialized in international law and compliance for nicotine and tobacco products. Within Halo, she is in charge of efficient and cost-effective compliance with fast-changing regulatory frameworks.

A7mad-vp

December 8, 2015

The status of the vaping industry in the USA is pending on the FDA’s Deeming Rule, currently under review. A proposed rule was published in 2014 that imposes onerous requirements on the industry and one expects the final one to be very close to the initial proposition. Hence, as of October 19, 2015, this text is under review by the Office of Management and Budget (OMB). OMB is required to take meetings with industry in order to evaluate the economic impact on the rule before its publication.

Vaping products undergo similar requirements as tobacco

The deeming rule, if enacted, would extend several provisions of the federal Tobacco Control Act to these newly defined “tobacco products”. Some products would now be subject to the federal prohibition on sales to minors, the federal prohibition on free sampling, federal warning label requirements, and the requirement that tobacco manufacturers register with the FDA and seek the agency’s review of new tobacco products.

The Halo Company is one of the major manufacturer of e-liquids with the key product, Tribeca. The Halo Company, like any other manufacturer in the Vape Industry, is keeping track of the rulemaking process that will lead to the issuance of regulation affecting their market.

Even if the exact timing has not been revealed yet, the process is underway. Patricia Kovacevic recalls that the regulation of the vaping products is about to be implemented in the USA, that “the deeming rule is now at the Office of Management and Budget (OMB) for economic impact review” and that the OMB is now meeting stakeholders.

“My personal estimate is – not before January 1. It’s not a bet, though!” -P. Kovacevic, The Halo Company.

The OMB is planning plenary sessions with stakeholders beyond what appears to be a self-imposed deadline, on December 15, in response to many individual requests. The General Counsel and Chief Compliance Officer does not expect the rule to be published before January 1 in the Federal Register.

After the date of its publication, another thirty days will be required, approximately, for the rule to become effective.Therefore, stakeholders are stressed to file their comments before the date of its publication to give a chance for their demand to be considered. Beyond the official publication, a judicial review will be their last resort.

American vape shops endangered by the FDA’s upcoming regulation

“Essentially the FDA regulation is a guaranteed death knell for over 99% of the companies in the industry” -G. Conley, American Vaping Association

The requirement for tobacco manufacturers to register with the FDA may lead to the collapse of the American Vaping Industry. The approval process would require an extensive data collection for each item and a substantial cost that many small businesses wouldn’t be able to sustain. The retroactive premarket review of any e-cigarette or vaping product on the market after 2007 is expected to send back to the job market thousands of manufacturers who created their own business while benefitting to tobacco giants.

A similar situation is also expected in Europe, where TPD implementation is ongoing, accompanied by several prohibitions and a complex homologation procedure.