E-cigarette or drug delivery device? Questions about safety, usage and future implications of new nicotine delivery products

ScienceDaily (July 21, 2011) — Devices marketed as "electronic cigarettes" are in reality crude drug delivery systems for refined nicotine, posing unknown risks with little new benefits to smokers, according to tobacco control experts.

In a "Perspective" published in the New England Journal of Medicine, researchers from the Legacy's Steven A. Schroeder National Institute for Tobacco Research and Policy Studies explore the current regulatory climate around electronic cigarettes ("e-cigarettes") and their safety. The authors, Nathan K. Cobb, MD, a pulmonologist and assistant professor at Georgetown University Medical Center, and David B. Abrams, PhD, executive director of the Schroeder Institute, also question future implications for physicians, policy makers and e-cigarette users.

E-cigarettes are constructed to mimic real cigarettes in size and appearance, but contain no tobacco and are not cigarettes at all. In reality they are delivery devices for refined nicotine, having more in common with inhalers used to treat asthma or other delivery devices for both approved and illicit drugs. Though individual brands vary in construction, the products generally produce a propylene glycol mist containing nicotine along with flavorings and other chemicals.

Currently, three interrelated products are being sold: the delivery device itself; cartridges that can contain up to 20 mg of nicotine; and refill kits that allow consumers to fill used cartridges with replacement nicotine solution. Some refill bottles, easily obtained over the Internet, contain enough nicotine to kill an adult if accidentally ingested.

The U.S. Food and Drug Administration (FDA) announced April 25, 2011, that it would regulate e-cigarettes as "tobacco products" and not as "drug-delivery devices." That action came after federal courts blocked the agency from regulating the products as drug-delivery devices. The courts maintained that, under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), the FDA must regulate as tobacco products any product that contains nicotine from tobacco and that makes no claims to be therapeutic. These decisions together, the authors note, "upend[ed] the status quo" by having the effect of allowing the sale of unregulated refined nicotine directly to consumers, unless and until the FDA takes further action.

"The court's decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health. It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers," said Cobb. "It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose."

While most devices and nicotine fluids are produced by small manufacturers, Cobb and Abrams note that the fact that leading cigarette manufacturers Philip Morris International and British American Tobacco recently purchased sophisticated nicotine inhaler technologies may be an indication that both companies are developing next generation nicotine delivery devices of their own.

Abrams, a professor at Johns Hopkins Bloomberg School of Public Health added "Any refined nicotine product, whether used for smoking cessation and tested and approved by the FDA (like the Nicotrol inhaler) or a new product designed for 'reduced or modified' risk, can and must be tested and strictly regulated before being introduced to the market."

The authors argue that a comprehensive approach to regulating products containing refined nicotine is needed to protect the public's health and should involve Congress, the courts and the FDA.

In this piece, Cobb and Abrams discuss several safety concerns:

Testing of cartridges reveals poor quality control, variability in nicotine content among brands, and deviations between label claims and cartridge content.The devices do not reliably deliver nicotine, and have not been sufficiently evaluated in scientific studies the way the FDA requires of other drugs and devices used for smoking cessation. Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective due to the fluctuating nicotine content and unpredictable delivery.Manufacturers sell cartridges with a range of up to 20 milligrams of nicotine. However, refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses. In fact, the devices are not limited to delivering nicotine. The paper notes that instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet.The safety of inhaling propylene glycol over an extended period of time has not been studied in humans.E-cigarettes may serve as a "bridge product" that smokers use in places where traditional tobacco smoking is prohibited, thus perpetuating their addiction and use of real cigarettes. Additionally, they may be used as a 'starter' product for young people considering smoking, especially since the cartridges can be purchased over the Internet with tempting flavoring like grape and chocolate.

In their conclusion, Cobb and Abrams counter the argument made by e-cigarette advocates that taking the devices off the market could mean current users would be forced to return to traditional tobacco products. Instead, the two researchers point to the multiple pharmaceutical-grade nicotine products on the market that have been regulated, approved and deemed safe and effective by the FDA, including patches, gums, lozenges, nasal sprays and even an FDA-approved inhaler. The two researchers also state that current users should pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines, and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Georgetown University Medical Center, via EurekAlert!, a service of AAAS.

Journal Reference:

Nathan K. Cobb, David B. Abrams. E-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products. New England Journal of Medicine, 2011; 365 (3): 193 DOI: 10.1056/NEJMp1105249

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

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Food coloring and ADHD: No known link, but wider safety issues remain, researcher says

ScienceDaily (June 14, 2011) — When University of Maryland psychologist Andrea Chronis-Tuscano testified before a U.S. Food and Drug Administration (FDA) hearing last March, it changed her mind about possible risks of artificial food coloring for children, and drove her to look more closely at the products in her own pantry that she feeds her kids.

Chronis-Tuscano walked in to the meeting certain that NO convincing scientific evidence supports the idea that food coloring additives cause Attention-Deficit/Hyperactivity Disorder, or ADHD -- nor that strict diets eliminating dyes effectively treat the condition.

While the testimony from other experts did NOT shake that assessment, it did raise concerns for her about the lack of research on the overall safety of food dyes for children.

"The testimony I heard presents significant questions for me -- issues that have not been adequately studied by scientists," says Chronis-Tuscano, a mother of young children, an associate professor of psychology and director of the University of Maryland ADHD Program.

"Beginning in the womb, developing brains are particularly sensitive to toxins," Chrois-Tuscano explains. "It's important to get better information about how much of these substances American children consume, and whether these levels are dangerous.

"Given the lack of hard evidence, I am not convinced that food coloring additives are dangerous, but I am also not convinced that they are not. It is certainly possible that some small subset of children have a unique sensitivity to these substances.

"The issue shouldn't end here. We need better answers about the effects of these additives on our nation's children," she concludes.

The debate over a possible link between food additives and a range of childhood behavioral issues, such as ADHD, has persisted for decades, spurred on by parents' desire to find a remedy that does not involve powerful medications.

"This debate has itself been colored by weak science and strong emotional beliefs," Chronis-Tuscano says.

"My concern as a clinician is that the belief held by many parents that diets eliminating all food additives can cure ADHD often delays or prevents them from getting treatments for their children that are backed by strong scientific evidence -- behavior therapy, stimulant medication, or their combination. The earlier such treatment begins the better. Going down the wrong path wastes resources and, most critically, precious time in the life of a child."

A complete copy of Chronis-Tuscano's account is available at: http://newsdesk.umd.edu/vibrant/chronis_additives.cfm

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by University of Maryland.

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here