Reduced-risk products: how do regulators cope with technological developments?

by:
Gurhan Coban – External Opinion Leader

Not surprisingly, technological developments within the Tobacco industry are becoming increasingly challenging for regulatory authorities.
The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” With this definition, the area of action for producers is extremely wide, and leads to millions of premarket product applications, with new technologies, safe or not, constantly coming out.
Nowadays, new tobacco products must be reviewed and obtain a marketing order by the FDA before being marketed to consumers. The same goes for Modified Risk Tobacco Product (MRTP), introduced in 2019 with the first MRTP approved (Snus), that can be marketed as MRTP only if the evidence provided within the application meets the requirements of Section 911 of the FD&C Act. These evidences have to prove a reduced risk for the consumer, that could be a lower exposure to chemicals or a lower risk to disease.
Companies are also required, once they get the approval from FDA, to conduct post market surveillance and studies, that have to be submitted yearly to the FDA, that will monitor the product and can withdraw the approval.

E-Cigarettes and Synthetic Nicotine

In 2016 the FDA extended the law for tobacco products to E-Cigarettes too, making producers have to file the same application as for other tobacco products. To avoid submitting applications to the FDA, or after they got a reject, many companies have started using or producing synthetic nicotine instead of the natural one. Since it’s not derived from tobacco, the topic has raised many regulatory problems because the new product can’t be regulated as an MRTP or as a Tobacco product, remaining in a regulatory borderline area that ensure producers access to the market without any regulatory control. However, tobacco companies shall be advised to be careful of working at the edge of regulations, hence in return they might get a set of regulations which are more stringent and makes the production process quite unprofitable.
Right now the MRTP market is in a phase of continuous change, with companies coming up with more and more innovative products that lengthen the borders of regulations; the synthetic nicotine case shows how important is for regulatory authorities to act in advance to new product and technologies and be a step ahead of companies, in order to ensure control over the market and avoid misregulation or no regulation areas.

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