FDA Announces Grandfathered Product Database

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The U.S. Food & Drug Administration (FDA) has announced the creation of a grandfathered submissions database, a new tool that—as the name implies—will show a list of grandfathered products.

In order for products to be given grandfathered status under the deeming regulations, a company must prove that product was for sale as of Feb. 15, 2007 and that it has been actively sold since that date.

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In a complete form, a grandfathered database could be used by other manufacturers to help establish substantial equivalence arguments for non-grandfathered products. However, FDA’s database will be far from complete.

First, companies aren’t required to submit for grandfather status to FDA. They could be required to validate a product’s grandfather status if FDA investigates that particular product, but FDA acknowledges that companies are not compelled to apply for grandfather status.

In addition, the database will not include any products that are deemed grandfathered after a substantial equivalence application is made. The likelihood of this happening seems somewhat slim, but it will still mean that even products FDA validates as grandfathered might not be listed.

Finally, the agency says that it will be updated “periodically,” something that will also likely impact the completeness.

As of now, the database’s cigar filings are largely little and flavored cigars.

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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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