White House cut FDA flavor ban hopes
U.S. Food and Drug Administration (FDA) attempts to restrict flavors in vapor products were squashed by the Office of Management and Budget (OMB). The regulatory arm of the White House deleted language in a recently introduced “deeming rule” that would have removed flavored e-cigarettes from the market until they had been authorized by the FDA, an edited version of the document shows, according to a story by Reuters.
As submitted by the FDA to the OMB, the rule gave a grace period for flavored products of only 90 days after the rule became effective. Proponents of vapor say the products can help people quit smoking and that flavors are a crucial element of what makes them attractive to adults seeking to quit. The FDA said in its original rule that evidence supporting such claims “is thus far largely anecdotal.” The rule requiring the ban was removed by the OMB,
The FDA provided pages of data and scientific studies in support of its plan, noting “a dramatic rise in youth and young adult use of typically flavored tobacco products, like e-cigarettes and waterpipe tobacco, and continued youth and young adult use of cigars.” The OMB deleted both the FDA’s planned policy and the rationale for the policy. A White House spokeswoman, Emily Cain, said the OMB “does not comment on changes made during the interagency review process.” The FDA also does not comment, FDA spokesman Michael Felberbaum said.
In its originally submitted rule, the FDA said it recognized that numerous flavored products would come off the market within 180 days of the rule’s publication “and that this will significantly impact the availability of flavored tobacco products at least in the short term.” But it said the move was important because tobacco products with characterizing flavors, including menthol but excluding tobacco flavor, were attractive to young people.
On May 5, the FDA announced a final rule extending its tobacco authority to include e-cigarettes, pipe tobacco, cigars and hookah. The rule becomes effective in early August. Under the rule, companies must seek marketing authorization for any tobacco product introduced after Feb. 15, 2007. The rule gives manufacturers a grace period of up to two years to submit marketing applications, during which they can continue to sell their products. They can sell them for an additional year while the FDA completes its review.
