The changing face of regulation
In recent years, there has been significant international growth for products that deliver nicotine without the requirement to burn tobacco. As a result, there has also been a significant and varied increase in regulation, leading to a marked difference between the way nicotine and tobacco-containing products are regulated and perceived across the globe.
Through its team of regulatory experts, Nerudia supports and guides companies operating in this environment through the entire regulatory process; from design to post-launch obligations.
FDA’s Premarket Tobacco Product Application (PMTA) Tobacco Strategy
On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced that it will be refocussing the Agency’s implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule.
The FDA confirmed that it will be extending the deadline for required applications for non-combustible products, such as e-vapor and e-liquid products, to August 8 2022. The deadline for applications for newly-regulated combustible products such as cigars, pipe tobacco and hookah tobacco has also been extended; in this case to August 8 2021.
Why has the FDA extended the deadline?
Justifying the aforementioned extensions, Scott Gottlieb, M.D., Commissioner of Food and Drug Administration, stated “we need to take a fresh look at nicotine itself, and how the addiction that it causes relates to the potential harm of its delivery mechanism. To succeed, the FDA must be strategic about how it uses its tobacco and drug authorities and are looking for participants from all sectors in the ongoing harm reduction debate to take a step back and work together to reach greater common ground.”
An opportunity to innovate
Despite the deadline extensions, companies selling Electronic Nicotine Delivery Systems (ENDS) can still make new PMTA applications, so the announcement does not represent a ban on innovation. This “disruptive” industry is still at the beginning of its technological journey and to continue to grow and differentiate it must also continue to innovate. The deadline extension allows ENDS companies the opportunity to direct their investment in to developing and submitting new innovative products, as well as producing quality dossiers with the highest possibility of authorisation. Once authorised, these products may then have the potential to act as predicates for a substantial equivalence process, or even to generate data supporting a Modified Risk Tobacco Product (MRTP) application.
An opportunity to generate credible science and evidence
For those ENDS companies not wishing to submit proactive innovative applications, the deadline extension offers the opportunity to generate science and evidence around their existing products and consumer usage. Companies could also use the additional time to generate long-term stability data and publish studies supportive of a continuum of risk, with educational programmes aimed at creating a more credible and scientifically-supported category in the eyes of the regulators, public health authorities and the general population.
What if the industry does nothing?
Companies that wait for the new deadline before submitting may find that the market has moved on, and consumers no longer desire or find satisfaction in what would effectively be five-year-old products and technologies post-2022 (whether they are FDA authorised or not).
Nerudia are here to support, guide and develop
Nerudia is built upon the pillars of Consultancy & Compliance, Manufacturing and Innovation, providing the tools, knowledge and experience to guide and support companies through these challenging regulatory and competitive environments. Contact us for more information on how we can help your business.
Senior Consultancy & Compliance Officer