FDA Extends Deeming Regulation Comment Period 30 Days

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The U.S. Food and Drug Administration (FDA) has announced a 30-day extension to the public comment period regarding the proposed regulation of cigars, e-cigarettes and pipe and shisha tobacco. The new deadline for public comment is now Aug. 8, 2014.

An announcement from FDA did not explain the reasons behind the extensions.

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FDA has published a notice in the Federal Register announcing a 30-day extension of the comment period for the proposed rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. The proposed rule, which appeared in the Federal Register of April 25, 2014, is seeking comments on FDA’s regulatory approach to electronic cigarettes and other tobacco products, proposed options for the regulation of cigars, pathways to market for proposed deemed tobacco products, and compliance dates for certain provisions, among other issues.  The comment period will now close on August 8, 2014.

In April, FDA formally announced its intention to regulate the aforementioned tobacco products. These new regulations would require approval, new warning labels and a ban on sampling—all of which would dramatically raise the price of those products, as well as significantly hinder the ability to introduce new products.

FDA has asked for public comment on a variety of issues, notably whether “premium cigars” should be exempt from its regulation. Under Option 1, cigars would not be exempt, under Option 2 “premium cigars” would be exempt. There is also public comment requested over what defines a “premium cigar.”

The FDA’s own estimates indicate that regulation could cut the handmade cigar business in half and cost the industry upwards of $300 million in the next two decades. 

It is expected that an additional request for an extension will be filed. The International Premium Cigar & Pipe Retailers Association (IPCPR) was originally seeking a 75-day extension.

For details on how to submit your comments to FDA, click here. For more information about FDA regulation, please visit halfwheel.com/fda.

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Charlie Minato
About the author

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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