FDA confirms that it plans to regulate e-cigarettes to praise of oncology groups
Oncology groups have praised the decision by the FDA to regulate electronic cigarettes and other devices that deliver nicotine electronically.
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The health risks and benefits of these previously unregulated items will be reviewed by the FDA so that safety concerns can be more fully understood.
Changes to the Rules
The amended rules will ban the sales of all tobacco products to people under the age of eighteen and in two years time, new products will be subject to more stringent standards regarding the product design, ingredients, appeal to young people and health risks. Manufacturers may wonder how long does it take to get an FDA 510k approved, and this may increase from the present situation that requires them to notify the FDA a minimum of 90 days in advance of their intention to market a medical device.
The new rules have been criticised by some proponents of e-cigarettes, who argue that the process is too onerous and costly. However, the time to market can be crucial for manufacturers and clearance can be obtained more quickly if companies such as www.fdathirdpartyreview.com are involved in the review as Accredited Persons.
Some experts feel that the new registration expense will have a beneficial effect on public health by forcing many e-cigarette manufacturers out of business. It is expected that the three largest tobacco companies in the US will be unaffected, since their financial resources are so much greater.
The UK Situation
Concerns about the safety of electronic cigarettes are prevalent in the UK. According to The Daily Telegraph, a new report has suggested that they may be much more dangerous to health than was previously thought and could have a similar effect on the arteries as regular smoking.
The Basis for the FDA’s Decision
A survey by the Center for Disease Control and the FDA showed a dramatic increase in the use of e-cigarettes from the 2011 level of 1.5 percent to 16 percent in 2015. Concerns regarding the use of these products by younger people and the fact that a survey by the National Institutes of Health found that they may lead to people smoking conventional tobacco products led to the decision to regulate.
Although the health effects of cigarette smoking are well documented, the safety of products such as e-cigarettes is yet to be established.