The House Appropriations Committee recently approved funding language that would exempt traditional large and premium cigars from FDA regulation and substantially lessen the regulatory burden on vapor products.
With respect to premium cigars, the approved language would strip funding from the FDA to enforce the so-called “deeming regulations” (which apparently will be released soon) with respect to cigars that: (1) are wrapped and bunched with 100% tobacco; (2) weigh at least 6 pounds per 1,000; (3) have no filter; and (4) are either hand-made or produced with limited machinery.
With respect to all other products, the approved language would strip funding from the FDA to enforce premarket review requirements on any newly-deemed products unless the grandfather date is shifted from February 15, 2007 to the effective date of the regulations. Products introduced after the effective date of the regulations, but before 21 months after the effective date, could be provisionally marketed unless and until the FDA rejects a premarket review application.
The Appropriations Committee language also has special provisions for vapor products:
- A requirement to establish product standards for batteries.
- A requirement to advertise only in adult publications.
- A prohibition on self-service sales.
- Special labeling requirements.
- Retail establishment registration
The Appropriations Committee language comes in advance of the anticipated release of the deeming regulations.