FDA Proposes Long-Awaited E-cigarette Regulations

On April 24, the FDA proposed long-awaited rules that would extend the agency's authority over e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah, and other dissolvable tobacco products that are currently unregulated.  The proposed rules prohibit sales to children, require health warnings, and prohibit vending machine sales.  The rules would also require makers of the newly regulated tobacco products to:

• 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 scientific evidence that marketing the product will benefit public health as a whole; and 
• Not distribute free samples.

  The  proposed rule is available for public comment for 75 days.  Related article:  Legal News: Proposed Class Action Highlights Dancers of E-cigarettes and Need for FDA Regulation, MedWarn, March 21, 2014.

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