Wednesday 01 Oct 2014

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FDA asked to extend its jurisdiction to all tobacco products

Published: 2:49 pm CDT, June 19, 2014

With the 5th anniversary of the landmark tobacco law looming, the American Heart Association called on the Food and Drug Administration to do much more.

Nine public health groups joined in a public statement on Thursday asking the FDA to extend its jurisdiction, with no exception, to all tobacco products, including e-cigarettes; create first-ever product standards to reduce addictiveness and toxicity of tobacco; and push through legal challenges to require large graphic warning labels.

Tobacco use is the leading preventable cause of death in the United States and a major risk factor for cardiovascular disease – the nation’s No. 1 killer.

“As opposed to many of the problems we deal with in heart disease and stroke, where research is ongoing, in this situation we know what we need to do and what works,” said Dr. Elliott Antman, president-elect of the American Heart Association.

“It’s very important the FDA take a firm stance on tobacco products, that they set standards to reduce their toxicity and addictiveness,” said Antman, who is a professor of medicine and associate dean for Clinical/Translational Research at Harvard Medical School. He also is a senior physician in the Cardiovascular Division of the Brigham and Women’s Hospital in Boston.

President Obama signed the Family Smoking Prevention and Tobacco Control Act into law on June 22, 2009, which for the first time granted the FDA the authority to regulate the manufacture, distribution, sale, labeling, advertising, and promotion of tobacco products to protect public health. It gave the agency jurisdiction over cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

In April, the FDA proposed new rules to ban the sale of electronic cigarettes to minors and require health warnings on nicotine-delivery devices. Newly deemed “products” would include electronic cigarettes, cigars, pipe tobacco, gels and waterpipe tobacco.

That public comment period ends in July, and then the rule undergoes agency changes, a process which could take months.

But the American Heart Association and other groups are asking the FDA to issue, before April 25, 2015, a “complete, effective final rule with no exceptions and address critically important issues not addressed in the proposed rule, such as marketing and flavorings that appeal to kids. The FDA should take even faster action to require child-proof packaging on nicotine-containing liquids to address the skyrocketing number of calls to poison control centers related to the nicotine liquids used in e-cigarettes.”

Battery-powered e-cigarettes, which deliver a nicotine-containing aerosol popularly called “vapor,” were first introduced in 2008. These devices come in kid-friendly flavors, such as chocolate or mint. A Centers for Disease Control and Prevention study found the number of middle and high school students who tried e-cigarettes doubled from 2011 to 2012.

“The e-cigarette is an important and quickly evolving issue,” Antman said. “The AHA is very concerned about the risk to our youth who may make their entree into tobacco addiction by a first exposure to e-cigarettes. Each day, 3,200 teens smoke their first cigarette. … We also know by smoking 15 to 20 cigarettes a day, you may die 10 years earlier than your counterparts who do not smoke.”

Once the final rule is complete, the FDA can use powerful regulatory tools – such as age restrictions and scientific review of new tobacco products and claims.

Another area still to be mapped out is warning labels. The 2009 law allows for graphic warnings covering the top 50 percent of the front and back of cigarette packs. Nine labels that originally were to appear on store shelves in 2012 would have represented the biggest change in cigarette packs in the U.S. in 25 years.

But a federal appellate court blocked the specific labels the FDA initially developed. A separate appellate court upheld the law’s underlying requirement. And now the health groups on Thursday said the FDA needs to quickly issue new warnings that comply with the law.

“The U.S. needs to update its woefully outdated and nearly invisible cigarette warnings and catch up with the more than 60 countries that now require graphic warnings,” the groups said. Antman advocates that doctors shouldn’t wait for labels when they counsel patients on the dangers of using cigarettes.

The AHA has been advocating for more than a decade that the FDA be able to regulate tobacco, he said.  “As a country we have made great strides since 1964 in reducing tobacco but it is by no means time to declare victory,” he said. “Failing to prevent preventable deaths is an abdication of our responsibility as a society.”

The groups calling on the FDA and the Obama administration to act, include:

The American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Americans for Nonsmokers’ Rights, Campaign for Tobacco-Free Kids, Legacy, National African American Tobacco Prevention Network, Smoking Cessation Leadership Center, and Tobacco Control Legal Consortium.