Industry group offers additional clarity on resource
Thomas A. Briant
MINNEAPOLIS — Feb. 15, 2007, is an important date in the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed to authorize the U.S. Food and Drug Administration (FDA) to regulate tobacco products. That date is known as the “predicate date” or “grandfather date.” Every tobacco product that was on the market as of Feb. 15, 2007, is grandfathered, which means that special applications do not need to be filed with the FDA to keep those products on the market.
Just last week, the FDA announced that it has included on its website a searchable database to determine whether a tobacco product is grandfathered. Click here to access that database. To use it, type in the tobacco product name, the name of the manufacturer, select the product category from the drop-down list and then click the search button. The search results will inform you if the product is grandfathered.
However, there is some confusion about the completeness and accuracy of the FDA’s grandfathered database. The Coalition of Independent Tobacco Manufacturers of America (CITMA), Richmond, Va., has issued a letter to its members outlining the issues with the FDA grandfathered database and allowed NATO to disseminate the letter.
Specifically, the CITMA letter indicates that a FDA grandfather determination is not required to sell a grandfathered tobacco product and this has resulted in some grandfathered tobacco products not being included in the database. This means the FDA database only includes those tobacco products that were the subject of a voluntary grandfather-determination request submitted to the agency by a manufacturer. In other words, the database does not include those grandfathered tobacco products for which a voluntary grandfather-status application was not submitted. Also, CITMA indicates that the grandfathered database does not include those tobacco products that receive grandfather status through a substantial-equivalency application submitted to the FDA by a manufacturer.
In its letter, CITMA reports that the coalition has requested the FDA to issue a statement clarifying that the grandfathered database does not include all legally marketed, grandfathered tobacco products.