The US FDA is unable to process all PMTA applications by the mandated deadline. Anti-tobacco activists again call for ENDS to be regulated.
With a court-mandated deadline of September 9 to approve the millions of submitted premarket tobacco product applications (PMTAs) looming over it, the US Food and Drug Administration (FDA) is most likely not going to be able to review all of the applications received, a fact that the agency acknowledged previously.
But, in the last month before that deadline FDA was quite active, first issuing a refuse-to-file letter (RTF) to JD Nova Group on August 9 for 4.5 million of the company’s products, citing a lack of an adequate environmental assessment. This did not cover all of the product applications JD Nova submitted. Then, at the end of the month, FDA rejected 55,000 products from JD Nova, Great American Vapes, and Vapor Salon, issuing them marketing denial orders (MDOs) citing that the applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.” All these products that received either the RTF or MDO must now be removed from the US market.
While FDA grappled with the volume of PMTAs received by the September 9, 2020 deadline and continues to review around 2.5 million remaining applications, some prolific anti-tobacco organizations who are former supporters of the PMTA process and Tobacco Control Act that led to it seem to have changed their minds, wanting FDA to instead review electronic nicotine delivery systems (ENDS) as drugs rather than tobacco. Ironic, since FDA had previously tried to regulate tobacco as a medical product in 1996 and 2009 but federal courts intervened each time.
In a letter to acting FDA commissioner, Janet Woodcock, in April this year, these organizations said, “If any e-cigarette, . . . can be shown to be effective for smoking or tobacco cessation, its manufacturer should submit evidence of this therapeutic benefit to CDER [FDA’s Center for Drug Evaluation and Research],” even though according to Section 387a(a) of the TCA “tobacco products . . . shall be regulated by the [FDA] under this subchapter and shall not be subject to the provisions of subchapter V of the Food, Drug & Cosmetic Act , which the TCA amends].”
While FDA can regulate a tobacco product as a drug if the manufacturer makes therapeutic claims about the product, the agency clearly stated that “FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product . . . to bring a tobacco product within its drug and device authority,” basically crossing out the possibility of it regulating ENDS as a medical product.
So far, FDA seems to be following what former commissioner Scott Gottlieb and Center for Tobacco Products director Mitch Zeller said in 2017 when they announced FDA’s comprehensive plan for tobacco regulation, “FDA is committed to striking an appropriate balance between protecting the public and fostering innovation in less harmful nicotine delivery,” and reviewing PMTA applications with the concept of harm reduction in mind.