FDA proposes e-cigarette regulations
The FDA issued a proposed rule Thursday that would broaden its authority to regulate electronic cigarettes.
April 24, 2014
The FDA issued a proposed rule Thursday that would broaden its authority to regulate electronic cigarettes.
Along with e-cigarettes, other new categories to be regulated under the proposal are those that meet the statutory definition of tobacco products: products containing nicotine made or derived from tobacco. These include cigars, pipe tobacco, nicotine gels and waterpipe (or hookah) tobacco.
The proposed rule would mean that manufacturers of these products would need to follow requirements similar to currently regulated tobacco products like cigarettes and cigarette tobacco.
Among them:
Prohibit sales to those under the age of 18 (the proposed law preserves states' rights to set a higher minimum age than the federal age of 18, if they wish).
Register with the FDA and report product and ingredient listings.
Only market new tobacco products after FDA review.
Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
No free samples.
Minimum age and identification restrictions to prevent sales to underage youth.
Requirements to include health warnings.
Prohibition of vending machine sales, unless in a facility that never admits youth.