E-Cigarette Facing FDA Regulations?


The FDA wants to regulate the e-cigarette industry. A 2009 law granted authority to the agency to regulate cigarettes, smokeless tobacco and self-rolled tobacco. The law also granted the FDA power to regulate other tobacco products within its jurisdiction. Now the agency wants to expend those regulations to the e-cigarette industry. The FDA has submitted its regulation proposals to the White House Office of Management and Budget for approval.

Government jurisdiction would require e-cigarette companies to register with the FDA, pay fees, list product ingredients, obtain approval for new products, and restrict sales to minors both in brick and mortar establishments and the internet. Members of the White House’s Office of Management and Budget will review the impact of the regulation and make recommendations.

E-cigarettes were introduced to the U.S. market in 2007. They have a battery charge that heats a coil. The heated coil turns a mixture of propylene glycol and vegetable glycerin that are known as e-liquid or juice into a vapor cloud. No ash is produced.

Since the introduction of e-cigarettes, smoking rates among adults have fallen from 43 percent in 1965 to 18 percent. People using e-cigarettes find them less expensive than tobacco products and have help some quit smoking all together. Others prefer the product for recreational purposes.

Non-smokers confuse the vapor of e-cigarettes for smoke and insist that second hand nicotine vapor is no better than second hand smoke. Youths preferred the numerous flavors such as strawberry or peach. Between 2011 and 2012, the Centers for Disease Control and Prevention found the use of e-cigarettes among children had doubled. Since the product do not contain tobacco, they are not regulated by the FDA and subject to tobacco laws requiring proof of age.

Manufacturers such as Lorillard Inc, NJOY, and LOGIC Technology control 80 percent of the $1.5 billion industry and have requested exemptions. They claim FDA oversight would stifle innovations, hinder small business, and prevent smokers from curtailing their current intake of tobacco products.

Bryan Haynes, a lawyer and lobbyist for the Electronic Cigarette Industry Group, contends that since e-cigarettes lack tobacco and only deliver nicotine in a vapor form, FDA regulations would hamper further development. Currently, there are close to 4,000 applications for new or modified tobacco products awaiting FDA approval. The turnaround time for approval or denial can take years.

E-cigarettes are sold in a variety of locations from grocery stores to Walmart. The owners of NJOY and LOGIC Technology oppose TV advertising and public sponsorship of third parties. Both companies support age verification to prevent sales to minors. As an added precaution, LOGIC Technology only sells their brand in either tobacco or menthol flavors.

Restricting internet sales would hinder companies that have striven to create an online presence with their customers. According to Cynthia Cabrea of the Smoke Free Alternatives Trade Association, close to a quarter of e-cigarette sales derive from the internet.

Once the Obama Administration announces its proposed ruling, there will be a period for public comment. The White House is expected to approve the recommendations granting the FDA the regulation it wants over the e-cigarette industry.

By Brian T. Yates

Bloomberg Businessweek 
Discovery Fit & Health
Tampa Bay Times 

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