Lorillard Worried about FDA’s Delays on Handing Approval of New Brands
Probably disappointed with FDA’s delays in adopting new smoking products, Lorillard Tobacco Company has filed a petition calling that FDA implement enforcement caution to permit marketing of such products, as long as the producer has presented a report under Section 905 of the Tobacco Control Act before launching the product. Under the present Act, FDA gas the power to examine and approbate the so-called “new smoking products”, considered as products launched or changed after February 15. Producers offering new smoking products have two choices: 1) present a new cigarette application; or 2) present a report under the previously mentioned Act, demonstrating that the product is practically similar to an already existing product. Thus practically similar products are those that have same qualities, or where the diverse characteristics do not cause any health issues.
Cigarette producers launching new brands before March 22, 2011 should proceed to advertise the product without any FDA’s approval, so long as the maker presented an adequate report before March 22, 2011, unless FDA considers that the newest products are not similar. From the other side, for producers launching new brands after March 22, 2011, FDA takes the right that it should approbate the brand before it can be advertised and sold to consumers. Thus, a great number of tobacco producers rushed to introduce new products before March 22, 2011.
Lorillard’s citizen petition declares that FDA should examine the equivalence report within 80 days after submission. This position seems to correspond to the Section 910 of the Tobacco Control Act, which demands the submission of similar reports at about 80 days before the launch of new products into the market. The given petition also demands that, if FDA is not able to check the report within 80 days, it must permit the distribution of new tobacco products while FDA finishes its review. This seems to be a reasonable solution of the appeared problem as FDA currently faces a lack of additional resources to examine all demands in time.
Tobacco producers with new smokes awaiting FDA approbation, producers that have introduced changed to their products since March 2011 and those producers that are thinking to launch new brands will be waiting for the FDA’s response.
By Clark Moore, Staff Writer
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