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FDA Finalizes Rules For Premarket Review—Premium Sector Still Exempt

Jan 20, 2021 | By Gregory Mottola
FDA Finalizes Rules For Premarket Review—Premium Sector Still Exempt

In an effort to clarify the sometimes convoluted application process for new tobacco products, the U.S. Food & Drug Administration, which regulates the sale of tobacco, has finalized its foundational rules for its premarket review process, meaning that there should be greater clarity, detail and information regarding the requirements for pathways to market. However, a court ruling from August of 2020 currently exempts the premium cigar industry from the regulation.

The two major pathways to market for new cigars and other tobacco products are either a premarket tobacco product application (PMTA) or substantial equivalence (SE). The FDA believes that the application process for either pathway is now more effective and efficient, providing more details and insight as to the necessary steps required by a manufacturer looking to introduce new tobacco products to the market.

“The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA commissioner Stephen M. Hahn, M.D. in a statement released yesterday.

The final rules will be effective 30 days after publication in the Federal Register, but in the organization’s official statement, the FDA added that it’s currently prohibited from enforcing these premarket requirements for premium cigars. This exemption is due to a court ruling handed down by Judge Mehta last summer granting some regulatory relief to the premium cigar industry.

“Because of a pending lawsuit, this premarket approval process does not apply to handmade cigars unless they are flavored,” said Drew Newman, general counsel for J.C. Newman Cigar Co., adding that the cigar industry’s lawsuit against the FDA is still ongoing. “Yesterday’s announcement is not permanent relief for premium cigars, however, it is a good step forward.”

Newman also points out that the FDA has codified the definition of a premium cigar into law for the first time.

The FDA began regulating the premium cigar industry more than four years ago when it published its Final Deeming Rule in May of 2016.

FDA

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