The U.S. Food and Drug Administration (FDA) is proposing a rule to extend its authority to cover additional tobacco products, including electronic cigarettes (e-cigarettes).
Products that would be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvables not already under the FDA's authority, according to the agency. The FDA's current regulation extends to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
Under the proposed rule, makers of newly deemed tobacco products would be required to do the following:
- 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.
- Not distribute free samples.
The following provisions would apply to newly "deemed" tobacco products:
- 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.
The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply.
Products that are marketed for therapeutic purposes will continue to be regulated as medical products.
The proposed rule will be available for public comment for 75 days.
