White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs
On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA’s original proposal.
If the proposed rule became final – e-cigarettes (and the other products “deemed” tobacco products) would have been subject to:
(1) Enforcement action against products determined to be adulterated and misbranded;
(2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products;
(3) required registration and product listing for all tobacco products;
(4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use;
(5) prohibition on the distribution of free samples;
(6) premarket review requirements;
(7) Requirement for a minimum age of purchase; (what this will do to online sales was yet to be determined)
(8) health warnings for product packages and advertisements; and
(9) prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.
After analyzing the proposed rule and its potential economic effects, the White House’s Office of Management and […]