FDA announce proposal to regulate e-cigarettes
The US Food and Drug Administration have announced a proposal to extend current tobacco regulation to include e-cigarettes. The proposals will mean that minors under the age of 18 will not be able to purchase them.
The e-cigarette industry has come under major scrutiny in recent months after concerns have been raised regarding the health implications of the devices.
Traditionally marketed as smoking cessation aids, studies have suggested that e-cigarettes may actually encourage conventional cigarette smoking, particularly in adolescents who are prime users of the devices.
A study from the Centers for Disease Control and Prevention (CDC) reveals that e-cigarette use more than doubled among middle and high school students between 2011 and 2012, from 4.7% to 10%.
In addition, research has indicated that the vapors produced by e-cigarettes may cause damage to the lungs - an effect commonly associated with traditional cigarettes. A more recent study from the CDC reveals that the number of e-cigarette-related calls to US poison centers have soared.
Such concerns have led to calls for the devices to be regulated - a topic that was discussed in a recent spotlight feature from Medical News Today. Now, it seems that the Food and Drug Administration (FDA) have listened to these calls.
Proposed age and marketing restrictions
At present, only e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research (CDER), while the FDA Center for Tobacco Products (CTP) regulates conventional cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.
Under the new proposal, youths under the age of 18 will be banned from buying e-cigarettes.
Now, the FDA plan to extend such regulations to include e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco and dissolvables that are not already regulated.
The new proposition would mean that minimum age and identification restrictions would be applied to the purchase of these products - an individual will need to be aged 18 or over to buy them.
The products will also be required to include health warnings, and a prohibition will be placed on vending machine sales unless the machine is in a facility that does not admit persons under the age of 18.
The manufacturers of these newly deemed tobacco products will not be banned from marketing them, but they will be required to:
- Register with the FDA and disclose product and ingredient listings of their products
- Only market their products after they have been reviewed by the FDA
- Only make direct and implied claims of reduced risk if the FDA confirms there is sufficient scientific evidence to support them and that marketing the product with benefit overall public health, and
- Not distribute free samples of their products.
Commenting on the new proposal, FDA commissioner Dr. Margaret A. Hamburg says:
"Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products.
Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."
Mitch Zeller, director of the CTP at the FDA, notes that tobacco-related disease and death is one of the most "critical" public health challenges that the FDA face.
"The proposed rule would give the FDA additional tools to protect the public health in today's rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims," he adds.
The FDA are taking public comments for the proposed rule for 75 days. In particular, they are looking for comments as to whether all cigars should be subject to regulation, and views as to how products that do not involve burning of tobacco - such as e-cigarettes - should be regulated.
But in a statement from the American Association for Cancer Research (AACR), chief executive Dr. Margaret Foti says it is "imperative" that the FDA regulate all tobacco products, including e-cigarettes and cigars.
"We do not know the nature of the long-term health consequences of these devices or what effect they will have on smoking continuation or uptake by adults and youth," adds chair of the AACR Tobacco and Cancer Subcommittee, Dr. Roy S. Herbst. "Therefore, FDA regulation of these products is appropriate and welcomed by the AACR."
Written by Honor Whiteman
Copyright: Medical News Today
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