A White House office deleted language in the most recent Food and Drug Administration‘s (FDA) tobacco regulation that would restrict flavored electronic cigarettes from the market until they were authorized by the FDA. On May 5, the FDA announced their final rule extending their tobacco authority to e-cigarettes, pipe tobacco, cigars, and hookah. The rule is to go into effect in early August. Under the new rule, companies must seek marketing authorization for any tobacco product introduced after Feb. 15, 2007. Additionally, the rule will give 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.
As submitted by the FDA to the White House Office of Management and Budget (OMB), the rule gave a grace period for flavored products of only 90 days after the rule became effective. Public health advocates have long called for flavored tobacco products to be banned, saying flavors such as bazooka Joe Bubble Gum and Cotton Candy are designed to appeal to children. 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, stated the OMB:
does not comment on changes made during the interagency review process.
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 they said the move was important because tobacco products with characterizing flavors, including menthol but excluding tobacco flavor, were attractive to young people.
FDA made an overwhelming scientific case to OMB. For reasons that are not articulated, those people substituted their own judgment.
We are deeply troubled that these important safeguards were stripped in this way when FDA repeatedly demonstrated that the science shows flavored products appeal to youth and young adults.
Proponents of e-cigarettes 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.