Cigarmakers seeking approval under the U.S. Food and Drug Administration's new premium cigar regulations are getting a bit of extra breathing room.
The FDA recently issued an extension for newly-regulated tobacco manufacturers, pushing back the agency's registration deadline to June 30, 2017. FDA registration requires tobacco manufacturers to re-register with the agency by December 31 of each year, but for this first year, the agency is extending the deadline by six months. The extension, however, only applies to manufacturers that released premium cigars prior to August 8, 2016—the date in which the agency began regulating the cigar industry. Cigarmakers who released blends after August 8 will not receive the six-month extension and are required to complete registration prior to introducing new blends to the market.
In an updated version of the FDA's industry guidance, called "Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments," the agency states that additional time will "allow for submission of higher quality information" from manufacturers.
The revised section acknowledges that some manufacturers of newly deemed products may require additional time to complete the forms accurately, especially if the products require multiple submissions.
According to Section 905(i) of the Family Smoking Prevention and Tobacco Control Act, manufacturers registered with the FDA must include a Product List that details "all tobacco products which are being manufactured, prepared, compounded or processed by that person for commercial distribution." The Product List must also be accompanied by:
- A reference from the FDA authorizing the marketing of the tobacco product
- A copy of the labeling found on the packaging of the tobacco product
- A sample of the advertising for the tobacco product
Registration also requires manufacturers to submit biannual reports for cigars that have not been included on previous lists disclosed to the FDA. The reports must include cigars that are being introduced or reintroduced to the market, as well as those that have been altered or discontinued.
While manufacturers who released blends before August 8 will benefit from the extension, the FDA has a separate deadline for submission of ingredient information: August 8, 2017 for "small-scale tobacco manufacturers," which includes cigarmakers with 150 or less full-time employees and an annual revenue of $5 million or less. For larger companies, the ingredients deadline is February 8, 2017.
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