An article by the Troutman Sanders Tobacco practice appears in the October issue of Smokeshop Magazine. The article, titled “Premium Cigars Face Regulations Strangulation under FDA”, discusses the anticipated impact of FDA’s pre-market review requirements on the premium cigar market.
The article discusses the unique challenges faced by the premium cigar industry under the current premarket review scheme due to the fact that cigars are “artisanal and not homogeneous” and that there is the possibility for a many similar products with only slight variations. Under the current FDA policy, even slight changes would be enough to trigger the need for a new product application. This requirement will impede manufacturers from improving their products in ways such as sourcing better materials or improving their packaging, as either of those changes would apparently result in the need for premarket review.
Additionally, the grandfather date of February 15, 2007 poses another challenge – cigars that are unable to be proven as being sold “in market” before this date would automatically be subject to premarket review. Manufacturers that either added products after this date, or were not in business before this date, would have to undertake the costly task of acquiring data and product specifications from a pre-February 15, 2007 product to serve as a “predicate” product, as is required for the submission of a Substantial Equivalence report. Submission of this report would allow for the continued to manufacture of the cigar until the FDA either approves or denies the application.
Cigar manufactures can take steps now to lessen the potential impact on their businesses. Feel free to contact us for help in this area.
The full text of the article can be found here.