Plumes of Praise, Puffs of Pain

FDA's proposed OTP deeming regs receive mixed reaction

Published in CSP Daily News

By  Mitch Morrison, Vice President & Group Editor
Melissa Vonder Haar, Tobacco Editor

While Altria stood virtually alone five years ago in its support of FDA, the majority of major tobacco brands on Thursday extended cautious support of the agency's bid to provide a regulatory framework around the unwieldy e-cig world that government officials publicly described as the "wild, wild West."

Much of the mainstream opposition to both online and brick-and-mortar retail sales to minors and requirements for labeling and listing of ingredients is anchored in the need for the nascent e-cig segment to establish credibility among consumers and merchants--that these e-cig and vaping companies are responsible partners, and that their products are safe and performance is predictable.

"I would consider the deeming regulations extremely favorable for the END (electronic nicotine devices) industry as a whole," said Greg Doyle, COO of Metro e-cig maker Nicotek. "The industry is receiving immeasurable credibility and exposure from a consumer standpoint."

Two leading e-cig companies likewise praised the FDA for not overreaching.

"By resisting calls to regulate ahead of--and indeed in opposition to--the science and data, today the FDA has brought NJOY a giant step closer to achieving its corporate mission of obsoleting cigarettes," said NJOY president and CEO Craig Weiss. "There are encouraging signs that 10 years from now, this date will be remembered as the beginning of the end of the tobacco epidemic." 

Tony Gaines, chief customer office at Logic, describes the FDA's proposal as "much lighter than expected."

He added, "We at Logic already have this in place so business as usual for a leading brand."

FDA Missteps

While the agency's proposal seems to give e-cigs greater latitude than its combustible counterparts, some e-cigs were in a huff over the news.

"All in all, the deeming regulations are a disaster," blogged Dr. Michael Siegel, a professor at Boston University's School of Health who previously worked at the Office on Smoking & Health at the Centers for Disease Control & Prevention (CDC).

Although he credited FDA for holding off on an e-cig assault by permitting flavors and advertising, Siegel lambasted the call mandating pre-approval (or substantial equivalence [SE] determination) for all new e-cig products.