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US – [Concluded] Stop a Synthetic Nicotine Ban!
03/15/22 – President Biden officially signed the bill into law.
03/10/22 – Passed Senate, H.R. 2471, the “Consolidated Appropriations Act of 2022,” also known as the Omnibus Budget bill, by a vote of 68-31.
03/09/22 – Overnight, the US House of Representatives passed the 2022 Omnibus Spending package with a defacto ban on synthetic nicotine included. The budget bill is moving to the Senate for final consideration.
03/08/22 – Rider including an amendment to include synthetic nicotine in FDA’s tobacco authorities is being debated as part of the 2022 Omnibus Budget Bill.
Thursday night, March 10, the US Senate passed H.R. 2471, the “Consolidated Appropriations Act of 2022,” also known as the Omnibus Budget bill, by a vote of 68-31. The vote took place nearly a day earlier than anticipated and easily garnered the 60-vote threshold with the promise of spring break on the other side. The rider to grant FDA regulatory authority over synthetic nicotine is included in the final bill passed by the senate.
The omnibus budget bill was signed into law by President Biden on March 15, 2022.
When President Biden signs the budget bill (enactment) it starts the clock on the following schedule of effective date and deadlines:
- 30 days from enactment – Effective Date
- 30 days from effective date – For products marketed on or before April 10, 2022, PMTA applications are due in order to remain on the market.
- 90 days from effective date – Deadline for FDA to issue marketing orders (PMTA approval) for products to stay on the market.
- Urge your senators to oppose new regulations on synthetic nicotine that are included in the 2022 Omnibus Budget bill.
- The synthetic nicotine rider in the Omnibus does not give manufacturers the time necessary to complete and submit product applications making this language a defacto ban on on synthetic nicotine.
- FDA’s regulation of new and lower-risk nicotine products is a disaster. Rather than protecting consumers, FDA is making it more dificult for people to switch to smoke-free products.
- Giving FDA authority to ban synthetic nicotine as if it were a tobacco product will further fuel a growing, unregulated underground market where consumers have no assurances of product quality and no legal recourse for incidents involving fraud or injury.