FDA Decision to Leave Thousands of Tobacco Products on Market without Review Raises Troubling Questions

WASHINGTON, D.C. – The Family Smoking Prevention and Tobacco Control Act requires the U.S. Food and Drug Administration to review new or changed tobacco products to evaluate their impact on public health. This provision of the law was intended to end the tobacco industry’s long history of manipulating their products to make them more appealing and more addictive and ensure that the introduction of any new or changed products is consistent with the law’s goal of reducing the death and disease caused by tobacco use.

Under the Tobacco Control Act, tobacco products introduced between February 15, 2007, and March 22, 2011, could remain on the market if the manufacturer filed an application claiming the product was substantially equivalent to a product on the market before February 15, 2007. These applications still had to undergo FDA review and the FDA could remove products from the market that it determines are not substantially equivalent. As of March 2011, the deadline for tobacco companies to submit such applications, the FDA had received applications for approximately 3,600 products.

Yesterday the FDA announced that, after more than seven years, the agency had still not yet reviewed 2,500 applications – almost 70 percent of the applications initially filed. Without clearly setting forth the criteria used, the FDA announced that it no longer planned to review approximately 1,500 applications that it decided “had a lower potential” to raise “different questions of public health.”

To illustrate one type of tobacco product application among those that the FDA will no longer review, the agency gave an example of a case in which a tobacco manufacturer claimed that the only change made to its product was a “switch to fire standard compliant cigarette paper.” But the FDA didn’t say how many of the 1,500 products fell into this category, nor did it indicate if the agency relied entirely on unverified assertions by tobacco manufacturers in making these determinations.

Without more information, it is impossible to know whether the FDA’s decision puts the public at greater risk. Regardless, it is troubling that at least 2,500 tobacco products have remained on the market for more than seven years without even being reviewed by the FDA.

We urge the FDA to release information about the criteria used for its decision not to review the 1,500 products it removed from its queue; identify the categories of products that will avoid review; quantify the number of products that fall into each category; and explain whether claims made by the tobacco manufacturers for each product were independently verified by the agency. This level of transparency is essential for the public to assess the public health implications of FDA’s new policy.