|
|
US: First Cigar Brands Receives FDA Grandfather Status Source from: halfwheel.com 04/26/2017  When the U.S. Food & Drug Administration (FDA) published its most recent list of grandfathered tobacco products on Friday, two new companies had made the list, the first premium cigars to do so: Altadis U.S.A. and Ortega Premium Cigars, Inc. There are 105 approved cigars, but most of the initial approvals are of smaller, flavored cigars. Grandfathered products are those that were being marketed as of Feb. 15, 2007. In addition, FDA requires the products must have remained on the market since the 2007 date. While FDA has suggestions how to prove a product is worth of grandfathered status, however there’s no formal application companies fill out. Rather they are asked to provide documentation that supports a product’s grandfather status. Products that are grandfathered are still subject to some FDA regulations, namely warning labels and a ban on free samples. However, grandfathered products avoid the process of substantial equivalence which is expected to cost at least thousands of dollars, though final costs are not determined and are likely to vary from sku to sku. FDA has previously estimated that up to 60 percent of cigars will be grandfathered. Altadis U.S.A.’s approved cigars are: Don Mateo Natural No.5 The company applied for submission on Nov. 2, FDA received the application on Nov. 7 and made a decision April 4. Ortega applied for eight applications on REO and VIBE: REO Chairman FDA says those applications were submitted on Sept. 2, received on Sept. 2 and decided on April 4. The two Ortega brands are somewhat interesting as they were discontinued for a fair amount of years. A 2010 Smokeshop article mentioned the brands had been discontinued for "several" years. In 2015, Ortega announced that he was "working with some great blends to bring back (two) blasts from the past." Enditem
Related Updates |