The finalized version of FDA’s Deeming Rule has been released in a 499-page document.
Two years, it is the time industry and advocacy groups had to wait until the Food and Drug Administration (FDA) released its finalised Deeming Rule that gives it authority over the tobacco products currently not under its regulatory control.
The Tobacco Control Act (TCD) empowers the US Food and Drug Administration to regulate other tobacco products by issuing regulations or rules. A federal court, in 2010, ruled that e-cigarettes couldn’t be regulated as drug/device but had to be regulated as tobacco products, under the TCA.
The proposed regulation (i.e. the Deeming Rule) was published by FDA in April 2014 and was followed by a period for comments until August 2014, recalled Patricia Kovacevic, Nicopure’s General Counsel, in a webminar.
At the end of consultation and after the FDA has reviewed all the comments, a final rule was prepared and passed the Office of Management and Budget economic impact assessment (OMB).
- FDA contemplated a compliance period of 24 months after the effective date of the final rule for the submission of applications for all newly deemed, new tobacco products under all three marketing pathways.
- FDA has determined that it lacks authority to change the grandfather date, which is set by statute.
90 days from May 10th the market freezes. Then two years after that, 99% of products will end up banned. https://t.co/0Yzdt12aml
— Gregory Conley (@GregTHR) May 5, 2016
FDA E-Cigarette Deeming Regulations are a Disaster for Public Health https://t.co/AtsfDYSvSc
— Michael Siegel (@mbsiegel) May 5, 2016
No change in the grandfather (or predicate) date: February 15, 2007
The retroactive premarket review of any e-cigarette or vaping product on the market after 2007 was expected to send back to the job market thousands of manufacturers who created their own business while benefitting to tobacco giants.
The House Appropriations Committee voted in favor of an amendment, the Cole&Bishop bipartisan amendment, that would modernize the predicate date for vapor products and stop the FDA from banning 99%-plus of vapor products on the market.
Nevertheless, FDA has determined that it lacks authority to change the grandfather date, which is set by statute.
The February 15, 2007, date is unfair to the manufacturers of the newly deemed tobacco products (particularly e-cigarettes) because they were not on notice of pending regulation and they contended that “all newly deemed products will be forced from the market.” In response, FDA argues that some newly deemed products will qualify as “grandfathered” products under the statute and any that are not grandfathered will be able to apply for premarket authorization.
“Therefore, manufacturers of the newly deemed products have been on notice for more than 4 years that these products could and likely would be regulated. “-p 76.
For products that meet the statutory definition of “tobacco products”:
- Enforcement action against products determined to be adulterated or misbranded (other than enforcement actions based on lack of a marketing authorization during an applicable compliance period);
- Required submission of ingredient listing and reporting of HPHCs;
- Required registration of tobacco product manufacturing establishments and product listing;
- Prohibition against sale and distribution of products with modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order authorizing their marketing;
- Prohibition on the distribution of free samples (same as cigarettes); and
- Premarket review requirements.
Restrictions for covered tobacco products:
- Requirement for a minimum age of purchase;
- requirement for health warnings for product packages and advertisements (which FDA is also applying to cigarette tobacco and roll-your-own tobacco); and
- prohibition of vending machine sales of such products, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.
The deeming provisions and minimum age and identification and vending machine restrictions are effective 90 days from the date of publication of the final rule.
The health warning requirements are effective 24 months from the date of publication of the final rule, with an additional 30-day period in which a manufacturer may continue to introduce into interstate commerce existing inventory manufactured before the effective date that does not contain the required warning statements on packaging.