Harkin, Six Senate Democrats Call on FDA to Regulate E-Cigarettes and Other Nicotine Delivery Products

WASHINGTON, D.C.—Amidst mounting evidence that the emerging market of new nicotine delivery products poses serious public health and consumer protection issues, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, joined six of his fellow senators today in calling on the Food and Drug Administration (FDA) to move quickly to regulate the rapidly evolving market of e-cigarettes and other nicotine products, saying: “It's time for the FDA to stop the sale of these candy-flavored poisons to our children.”

Joining Harkin on today’s letter were U.S. Senators Dick Durbin (D-IL), Barbara Boxer (D-CA), Richard Blumenthal (D-CT), Ed Markey (D-MA), Jack Reed (D-RI) and Jeff Merkley (D-OR).

A New York Times report found a dramatic increase in accidental nicotine poisonings, notably among children.  The article cited the National Poison Data Systems which recorded 1,351 accidental nicotine poisonings from electronic devices in 2013 - a 300% increase from 2012.  Of the cases in 2013, 365 were referred to hospitals, triple the previous year’s number. In addition to health risks posed by the nicotine in these products, the New York Times article cites quality control and manufacturing dangers.

“Yesterday’s New York Times describes the dangerous emergence of liquid nicotine products, raising serious public health and consumer protection concerns about the rapidly evolving market for new and unregulated nicotine delivery products,” the senators wrote. “These nicotine products are readily available in stores and online, where they can be sold to youth and adults who do not understand the associated health risks…As the [FDA] asserts regulatory authority over tobacco products, it is critical that the agency’s regulatory oversight keeps pace with these new nicotine delivery products.”

Electronic cigarettes, also called e-cigarettes and e-cigs, are battery-operated products that simulate traditional cigarettes by converting liquid in cartridges typically filled with addictive nicotine, other additives, and flavorings into vapor inhaled by the user. Currently, e-cigarettes and liquid nicotine are not subject to federal laws and regulations that apply to traditional cigarettes, including a ban on marketing to youth. Unlike traditional tobacco products, these products can be legally sold to children and are not subject to age verification laws.

“In spite of the growing popularity of nicotine delivery products, decades of research shows that exposure to nicotine increases risk of addiction and has adverse health consequences,” wrote the senators.  “Unlike traditional cigarettes and tobacco products, these novel nicotine products are not subject to federal regulations that prohibit sale to minors, restrict marketing to youth, ban products in candy and fruit flavors, and regulate manufacturing practices and ingredients.  In the absence of federal oversight, these products are taking advantage of the regulatory vacuum to market nicotine products to youth and risk addicting a new generation to nicotine.”

Last month, Senators Harkin, Boxer, Durbin, Blumenthal and Markey introduced the Protecting Children from Electronic Cigarette Advertising Act which would prohibit the marketing of e-cigarettes to children and teens.  Despite claims from some e-cigarette makers that they do not market their products to children, e-cigarette manufacturers have adopted marketing practices similar to those long used by the tobacco industry to market regular cigarettes to youth – including flavoring their products in candy or fruit flavors that appeal to children, and sponsoring youth-oriented concerts and sporting events in order to market their products to teens.

The Protecting Children from Electronic Cigarette Advertising Act would permit the Federal Trade Commission (FTC) to determine what constitutes marketing e-cigarettes to children, and would allow the FTC to work with states attorneys general to enforce the ban.

According to the National Youth Tobacco Survey, 1.8 million middle and high school students said they tried e-cigarettes in 2012, and a study released by the Centers for Disease Control and Prevention found that the percentage of high school students who had tried them had more than doubled in just one year – indicating that e-cigarette companies could be targeting youth through advertisements. More than 76 percent of those users said they also smoked conventional cigarettes, suggesting that for many young people, e-cigarettes could be a gateway to nicotine addiction and smoking of conventional cigarettes.

In December, Senators Harkin, Durbin, Boxer, Blumenthal, Markey, and U.S. Senator Sherrod Brown (D-OH) sent a letter urging the FTC to investigate the marketing practices of e-cigarette manufacturers.

The text of today’s letter is below:

The Honorable Margaret Hamburg

Commissioner

U.S.  Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

Yesterday’s New York Times describes the dangerous emergence of liquid nicotine products, raising serious public health and consumer protection concerns about the rapidly evolving market for new and unregulated nicotine delivery products.  As the Food and Drug Administration (FDA) asserts regulatory authority over tobacco products, it is critical that the agency’s regulatory oversight keeps pace with these new nicotine delivery products.

As a result of the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has made commendable efforts to enhance the regulation of cigarettes and smokeless tobacco products.  However, over the years we have seen the emergence of new nicotine products, such as e-cigarettes, hookah pens, dissolvable nicotine orbs and strips, and liquid nicotine products, also called e-liquids, which are marketed to appeal to children with bright colors and flavors like cherry and bubble gum.  Unlike traditional cigarettes and tobacco products, these novel nicotine products are not subject to federal regulations that prohibit sale to minors, restrict marketing to youth, ban products in candy and fruit flavors, and regulate manufacturing practices and ingredients.  In the absence of federal oversight, these products are taking advantage of the regulatory vacuum to market nicotine products to youth and risk addicting a new generation to nicotine.

In spite of the growing popularity of nicotine delivery products, decades of research shows that exposure to nicotine increases risk of addiction and has adverse health consequences.   The 1988 U.S. Surgeon General’s Report, The Health Consequences of Smoking: Nicotine Addiction, states that “nicotine is a psychoactive drug with actions that reinforce the use of tobacco…and that causes addiction.”  The report goes on to say that, “the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.” Furthermore, nicotine exposure during adolescence can have important health consequences.  The 2014 Surgeon General Report found that nicotine exposure during adolescence, a critical window for brain development, may have lasting adverse consequences.

These nicotine products are readily available in stores and online, where they can be sold to youth and adults who do not understand the associated health risks.  The New York Times article reports that, “accidental poisonings, notably among children, are soaring.”  According to National Poison Data Systems, accidental e-liquid poisonings in the U.S. have skyrocketed “to 1,351 in 2013, a 300 percent increase from 2012…. Of the cases in 2013, 365 were referred to hospitals, triple the previous year’s number.” According to Dr. Lee Cantrell, Director of the San Diego Division of the California Poison Control, the dose of nicotine in some e-liquids is lethal enough to kill, “Not just a kid. One tablespoon could kill an adult.”

In addition to health risk posed by the nicotine in these products, the New York Times article cites quality control and manufacturing dangers.  The article reports that, “[e-liquids] are mixed on factory floors and in back room shops.”  These concerns are supported by a 2009 analysis FDA conducted on a sample of e-cigarettes.  The analysis found significant quality control issues, such as the presence of carcinogens and toxic chemicals, including diethylene glycol, an ingredient commonly found in antifreeze.  FDA also found that different samples of the same product emitted markedly different nicotine levels, indicating that some manufacturers are using substandard or non-existent quality control measures.  This analysis substantiates concerns regarding the safety of e-cigarettes, both for current users and for bystanders exposed to their vapor. 

The emerging market of new nicotine delivery products raises serious public health and consumer protection concerns.  It's time for the FDA to stop the sale of these candy-flavored poisons to our children.  We urge FDA to move quickly in developing a regulatory structure to minimize the harm to public health not only of traditional tobacco products, but also the rapidly evolving market of nicotine products.

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