SYNTHETIC NICOTINE REGULATION IN OMNIBUS BILL

It is expected that the Senate will approve the 2022 Omnibus budget bill and, with it, an amendment to the rider of legislation that broadens smoking products’ definition to encompass nicotine-free ones.

The purpose of this Omnibus bill is to distribute federal funds primarily; smaller legislations are added in the hopes of having it passed once the larger Omnibus bill is passed. Since this Omnibus bill was a massive measure that Congress was under pressure to pass within a short timeframe sma, later statements were inserted to ensure that the Omnibus bill passed without allowing citizens to reach out to their representatives to voice their opinions on the provisions of the bill.

When President Biden adopts this bill, nicotine-free tobacco products depend on PMTA approval. They will not be granted the year-long grace period initially given to nicotine-based products.

The bill’s language is identical to HR6286, which initially introduced the idea of expanding the definition of tobacco products into a law. Most of the provisions of HR6286 were merely added to the omnibus bill.

The law becomes effective 30 days after its approval. After that, manufacturers will have up to 60 days to submit the PMTA to market their product, except if the FDA has rejected a synthetic equivalent of that product. If the FDA has previously refused to approve the non-synthetic version of a product, then the products will be susceptible to being regulated as soon as the law becomes law.

Tobacco companies generally support this policy. Making synthetic nicotine a tobacco product usually will affect smaller vape manufacturers. Several smaller companies have shifted to producing synthetic nicotine to stay afloat as the various legal battles surrounding PMTA PMTA procedures are currently being waged. This could hurt smaller businesses and reduce competition for products like IQOS. It will be an era of many modifications in the vape market.

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