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FDA issues guidance confirming deeming rule delays

11 May 2017. The Food and Drug Administration (FDA) confirmed it has pushed back all deadlines that fall on or after May 10 for tobacco products covered under the deeming rule that went into effect last August.

Deadlines for vaping, shisha, pipe tobacco and cigars will be pushed back 30 days, FDA said in a guidance that confirmed earlier press reports. Makers of cigarettes and hand-rolled tobacco also will receive a 90-day reprieve on printing addictiveness warnings, the agency said.

Among the deadlines affected are those for cigar warning label plans, registration and listing, ingredient listing, health documents for small-scale manufacturers, Substantial Equivalence exemption requests, Substantial Equivalence reports, Premarket Tobacco Product Applications (PMTAs), and Harmful and Potentially Harmful Constituent (HPHC) reports, FDA said.

The guidance may be accessed at: