Category — FDA
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.
December 5, 2014 Comments Off
Congressional Letter Casts Doubts on Applicability of 2007 Grandfather Date for Recently Deemed Tobacco Products
On November 24, the Speaker of the House John Boehner, House Majority Leader Kevin McCarthy, and Fred Upton, the Chairman of the Energy and Commerce Committee, wrote to the Secretary of the Department of Health and Human Services challenging the proposed “grandfather” date for premarket review of the newly “deemed” tobacco products. According to the proposed regulation, the grandfather date for purposes of premarket review of e-cigarettes, cigars and pipe tobacco would remain at February 15, 2007 – which is the date for other currently regulated tobacco products such as cigarettes, smokeless, and roll-your-own tobacco. These products have been regulated since the Tobacco Control Act was enacted in 2009. [Read more →]
December 3, 2014 Comments Off
In a notice to be published September 17th in the Federal Register, the FDA Center for Tobacco Products announced that it will conduct a public workshop to discuss e-cigarettes, including product science, packaging and labeling, risks and benefits of product characteristics, strategies to mitigate consumer risks, and methods for evaluating product performance. The notice further indicates that the FDA intends to conduct future workshops addressing both individual- and population-level health impacts of e-cigarettes. The workshops will be held on December 10 and 11, 2014 in Silver Spring, Maryland. [Read more →]
September 16, 2014 Comments Off
The Food and Drug Administration’s (“FDA”) proposed deeming regulations raise concerns for cigar manufacturers with product labels that include descriptors such as “light,” “mild,” “medium” or “low.” In 2009, the Tobacco Control Act banned these descriptors for cigarettes. The stated rationale for the ban was the assertion that many consumers believed that descriptors such as “light” or “mild” meant that certain cigarettes were less harmful than other cigarettes. [Read more →]
August 14, 2014 Comments Off
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a July 7th Reuters article titled “INSIGHT – As millions vape, e-cigarette researchers count puffs, scour Facebook.” [Read more →]
July 8, 2014 Comments Off
Earlier this week, the Tobacco Merchants Association hosted a conference on the FDA’s proposed tobacco product deeming regulations, which would subject a host of new products — including e-cigarettes, cigars and pipe tobacco — to the FDA’s regulatory authority. The Troutman Sanders tobacco team participated in the discussion regarding how the industry can best contribute to the ongoing debate as to how these products should be regulated, if at all. [Read more →]
June 19, 2014 Comments Off
The FDA’s proposed deeming regulations call for testing of harmful and potentially harmful constituents in electronic cigarettes. Those requirements would not be triggered until three years after the regulations become effective, and in the meantime the FDA presumably would need to establish protocols for e-cigarette testing and a list of constituents to be reported. [Read more →]
May 10, 2014 Comments Off
The Troutman Sanders tobacco practice has been quoted in two recent articles regarding the FDA’s recent move to extend regulatory oversight to e-cigarettes, cigars, pipe tobacco and other tobacco products. [Read more →]
April 25, 2014 Comments Off
The FDA issued proposed regulations yesterday that would extend the FDA’s regulatory authority under the Tobacco Control Act to all tobacco products, including e-cigarettes, cigars and pipe tobacco. It is important to note that this is a proposal only, and the regulations could become more reasonable or more onerous after a public comment period. [Read more →]
April 25, 2014 Comments Off
FDA’s proposed deeming regulation issued earlier today would cover a variety of products that meet the statutory definition of a “tobacco product,” including electronic cigarettes, cigars and pipe tobacco. This blog entry discusses three provisions that would apply to the tobacco products “deemed” to be subject to FDA regulation. [Read more →]
April 24, 2014 Comments Off