Synthetic Rule Jumps House Hurdle, Senate Vote Next

The House passed a $1.5 trillion federal spending bill that includes language that gives the U.S. Food and Drug Administration power over synthetic nicotine. The bill now moves to the Senate and, if passed, will require a presidential signature to become law.

Not long after the 2,700-page spending bill was released early Wednesday and just hours before a scheduled vote, a number of Democrats privately registered their dismay with party leaders, raising the prospect that the entire package could collapse for lack of support. The dispute froze activity on the floor for hours as top Democrats rushed to salvage the spending measure, according to the New York Times.

By midafternoon, Speaker Nancy Pelosi of California notified Democrats in a brief letter that the coronavirus money would be dropped.

If the synthetic nicotine language remains in the bill and clears the Senate, Biden is expected to sign the measure. The rule will then become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).

If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”