US: FDA Extends Comment Period on E-Cig Regulations

Source from:  Winston-Salem (NC) Journal  06/23/2014

The Food and Drug Administration said Friday it is extending by 30 days the public comment period for how it should regulate electronic cigarettes and other tobacco products.

Comments now will be accepted until Aug. 8.

The FDA also is requesting comments on potential options for regulating cigars, pathways to market for proposed new tobacco products, and compliance dates for certain regulatory provisions.

"Completing this rulemaking is a very high priority" for the FDA and the U.S. Department of Health and Human Services, the agency said in its statement.

The FDA released April 24 its long-awaited proposal on regulating e-cigs and other tobacco products not already under its oversight. Congress gave the FDA oversight over the industry in 2009.

At that time, the FDA set a 75-day public-comment period. Although FDA officials did not provide a timeline for implementing approval regulations, analysts say it could take as long as two years.

E-cigs are battery-powered devices that heat a liquid nicotine solution in a disposable cartridge and create a vapor that is inhaled. Vapor products can feature a liquid capsule that is inserted into a cartridge. Vapors offer consumers a wider variety of flavors.

Among the main FDA recommendations are a ban on sales to underage youths, requiring health warning labels, FDA review of existing and future products, and no more free samples.

However, the FDA did not call for an outright ban of e-cigs, which some anti-tobacco advocates had pushed for. The FDA did not curtail Internet sales or current marketing efforts that include television and social media.

Analysts said the surge in popularity in e-cigs over the past six years likely eliminated banning as an option, barring new scientific proof of increased consumer danger from inhaling the vapor produced from an e-cig. E-cig manufacturers and marketers warned about an unregulated black market surfacing upon a ban.

Other tobacco products subject to the regulations are cigars, pipe tobacco, nicotine gels, water-pipe or hookah tobacco, and dissolvable products, such as film strips, chew sticks and orbs sold by R.J. Reynolds Tobacco Co.

Wells Fargo Securities analyst Bonnie Herzog estimated there was $2 billion in overall e-cig revenue last year. She projects up to $10 billion by 2017.

The FDA also, at least for now, is not recommending curtailing flavorings, a move opposed by anti-tobacco advocates who claim candy and fruit flavors make e-cigs more attractive to youths. The agency said it could propose more regulations once standards are approved.

R.J. Reynolds Vapor Co. and Altria Group Inc. offer only traditional and menthol flavorings in e-cigs. Lorillard Inc.'s blu eCigs offer those along with vanilla, cherry crush, java jolt, pina colada and peach schnapps. Enditem