The Food and Drug Administration’s response to a legal challenge on its electronic cigarette regulations is that all such products “present significant risks to the public health,” even when nicotine-free liquids are consumed.
Nicopure Labs LLC of Tampa, Fla., became on May 10 the first liquid nicotine manufacturer to file a federal lawsuit against the FDA for the controversial smokeless tobacco rules that went into effect Aug. 8.
The company said the regulations “would subject electronic cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act” approved by Congress.
Nicopure, which is not affiliated with any tobacco company, operates a 110,000-square-foot manufacturing and distribution center in Gainesville, Fla.
The question at hand is whether e-cigs and vaporizers, when used with nicotine-free liquids, are tobacco products, as claimed by the FDA.
Nicopure began operations in 2009, nearly two years after the FDA set a predicate date of Feb. 15, 2007, for smokeless products to be similar enough to existing products to be grandfathered. Nearly all e-cig products were introduced after that date.
Nicopure contends the FDA’s rulemaking process violates the Administrative Procedure Act, and that the deeming rule violates the First Amendment of the U.S. Constitution.
Since unveiling the regulations May 5, FDA officials have downplayed scientific studies that show e-cigs and vaporizers have the potential to be 95 percent less harmful than traditional cigarettes, while claiming “there is ample evidence” to support its public health harm claims.
“Although the FDA recognized that completely switching to e-cigarettes may reduce the risk of tobacco-related disease for individuals currently smoking conventional cigarettes, it found that e-cigarettes still pose a number of significant health and safety risks,” the FDA said in its response filed Wednesday.
“Nicopure does not disclose its actual ingredients for its e-liquids, so what consumers are really inhaling is largely unknown.”
The FDA claims that because most e-liquids are used in refillable devices, even if the original liquid used contained no nicotine, there is no guarantee that subsequent e-liquid use will be nicotine free.
The FDA claims Nicopure has shown no proof of being harmed by the new regulations because it did not assert that its nicotine-free e-liquids are intended to be mixed with liquid nicotine.
“The only nicotine-free e-liquids that the rule brings under the FDA’s regulatory authority are those that are made or derived from a tobacco product, or that otherwise meet the definition of a ‘component’ or ‘part.’”
The FDA says the regulations’ free sample ban “regulates conduct, not speech,” and its deeming regulations “are modeled after the premarket review of therapeutic drugs under the Federal Food, Drug and Cosmetic Act.”
The agency said that compared with two traditional cigarette flavors — tobacco and menthol — there are up to 8,000 different e-liquid flavorings, many of which are fruit and candy styles that it claims appeals to youths.
Several anti-smoking advocates have pushed back against the FDA stance on e-cigs.
“At the same time that England and France are making great strides in distributing truthful information about vaping to the public, the FDA is ramping up the rhetoric and relying on easily debunked junk science,” said Gregory Conley, president of the American Vaping Association.
Conley claims that Mitch Zeller, a former pharmaceutical lobbyist who runs the FDA’s Center for Tobacco Products, wants to destroy the vapor products industry.
Advocates have said some pharmaceutical companies have pushed the FDA to tighten e-cig and vaporizer regulations because they don’t want competition for their nicotine-cessation products, which have a mixed track record for results.
“(Zeller) recognizes that unless you decimate nicotine-free e-liquids and open vapor system devices, there is no possible way for the agency to truly kill the industry,” Conley said.
Jacob Sullum, senior editor of Reason magazine — billed as for “free minds and free markets” — said the FDA response “further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine.”
“Are e-liquids not subject to the FDA’s burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative?” Sullum asked.
“No, because the FDA’s definition of tobacco product does not require nicotine or any other tobacco derivative.
“Does that mean a nicotine-free e-liquid is a ‘component’ or ‘part’ of a tobacco product, i.e., the vaporizer?
“The FDA can’t or won’t give a straight answer to that question.”