AHA to FDA: Take a tough stance with e-cigarette regulations

E-cigarettes should fall under the same regulatory rules as tobacco products, stated the American Heart Association (AHA) in a position paper. The AHA called for strong laws and strategies to dissuade children from using these products, the lead author told Cardiovascular Business.

The position paper clarifies the AHA stance on e-cigarettes, cigars and other tobacco products not currently regulated under the same laws as cigarettes. It was written in response to the FDA’s proposed rules, which call for regulating these products as an extension of the Family Smoking Prevention and Tobacco Control Act. The paper was published online Aug. 24 in Circulation.

Aruni Bhatnagar, PhD, chair of cardiovascular medicine at the University of Louisville in Kentucky, said in an interview, “The position of the association is that e-cigarettes are tobacco products and that they should be regulated under stated federal laws that apply to these products. Strong new laws and regulations are needed to regulate the sale and marketing of e-cigarettes, especially to children and youth.”

Other cardiovascular organizations also have weighed in on the issue. The American College of Cardiology (ACC), for instance, called the FDA’s initiative “groundbreaking in many ways” but concluded it fell short. The ACC recommended banning Internet sales, prohibiting characterizing flavors, limiting marketing to children and adding childproof packaging to liquid nicotine products, among other restrictions.  

In the AHA paper, the team of experts led by Bhatnagar discussed the nature of these currently unregulated products and sought to guide the laws being written. “The overarching aim of the AHA is to support evidence-based policy. So we sought the opinion of the experts to understand and to get their view on how we ought to proceed,” Bhatnagar said.

As stated in the paper, e-cigarettes can contain a range of strengths of nicotine and other chemicals, including flavorants. One of the concerns expressed by the AHA through the paper and further emphasized by Bhatnagar was that flavors are part of what makes this product attractive to children and young people. The AHA argued that the same laws that keep traditional cigarettes from being sold, marketed and made accessible to children apply, including keeping these products from being given appealing flavors and packaging.

One tactic recommended was through taxation, bringing the price point for e-cigarettes up high enough that price sensitive individuals, such as adolescents and teenagers, are less able to afford them, while keeping the price below that of traditional combustible cigarettes to allow e-cigarettes as option for current smokers who are looking to switch over.

The AHA did not recommend dual use of combustible and e-cigarettes.

While there is not as much research in the use of e-cigarettes as an a effective smoking cessation tool as opposed to other nicotine replacement therapies, the AHA made a series of recommendations for physicians.

One small, but very important step, Bhatnagar stated, is “how physicians should address this issue of e-smoking with their patients. They need to include e-cigarette questions as part of the normal physical exam.”

While the AHA would recommend full smoking cessation, the society noted that if an individual is unable to quit or is averse to other therapies, physicians could discuss e-cigarettes provided two things: “One, that they would set a date when they would completely quit, and two, that they would not indulge in protracted dual use, where they would be using both the cigarettes and e-cigarettes,” said Bhatnagar.

The question of taxation and the position on smoking cessation were extensively debated by the AHA panel. One area they didn’t argue about, according to Bhatnagar, was that more studies were needed on the health risks of e-cigarettes and how much reduction in risk over combustible cigarettes e-cigarettes have. 

Among the questions posed by the AHA for researchers is how much of a health risk individuals are placing on themselves and others when using e-cigarettes. Bhatnagar noted there is some evidence that cardiovascular burdens increased with each “hit” of nicotine taken through one of these devices. “The studies so far have been rather small,” Bhatnagar noted.

However, in patients with atrial fibrillation, MI and stroke, survival improvements have been seen when use of other tobacco and nicotine products ceased.

The FDA has funded a number of centers to study the effects of e-cigarettes on short-term health, including through the AHA. However, both short- and long-term studies are needed to ensure a better understanding of the full potential impacts of these products on public health, particularly at the varied levels of nicotine and other additives currently being used.