On Thursday May 5, 2016, The United States, Food and Drug administration (FDA) in its latest press release issued a rule stating the regulation of all the tobacco products including e-cigarettes and cigars by the authority itself. The authority has extended its jurisdiction in order to prevent the American public from the harmful effects of tobacco and its latest products like e- cigarettes. The implementation of this rule will result in the overall health benefits for the public.
“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said Health and Human Services Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”
This rule now restricts the sale of e-cigarettes to the people of less than 18 years of age. Previously a rule like this does not exist. The FDA will now overview all the e-cigarettes manufactured and marketed by different companies. The companies now have to get their tobacco products registered and approved by FDA. Similarly it also restricts the retailer from selling the electronic tobacco products to the underage people. These products can now be sold only after the verification of the buyer’s age after its photo identification. Similarly, free distribution of sample is also not allowed.
This rule will now help the FDA in prevention of the misleading claims that electronic tobacco product manufacturers make for the marking and selling of their products. The rule will be effective within ninety days from its release. This rule also requires that the manufacturers of these products should demonstrate the safety and efficacy of their newly registered products in order to get the authorization from FDA. This will result in an increased ability to analyze the important risk factors associated with tobacco related e-products such as health hazards, design of the product and their constituents. After a company files an application for its tobacco product approval, it can continue selling its product for two years while FDA reviews its application. After this period, the further selling of the product will be subjected to the issuance of the market authorization by FDA for that particular product. The requirements for the application will include registration of the manufacturing facilities, ingredients and their provision of information related to their harmful effects, pre- and post-marketing survey of newly authorized tobacco products, placing warning labels on the products and not selling the products labeled as mild, light or low unless approved by the authority.
The multi-billion dollar e-cigarette industry will be hampered by this rule to a maximum extent. This industry is progressing leaps and bounds and currently no rule was in place to regulate its activity. The industry claims itself to be an alternative to the conventional cigarettes. All of the current e-cigarettes brands would now be reviewed by the FDA for their safety and potential health related problems. As the results of this review process their sale to the public would be restricted and new health warnings would be issued for the public.
The Vaping Industry did not welcome this rule whole heartedly and considers that the review process might not be cost effective and can be time consuming. Smaller industries will be affected by this process and they may face financial loses, which will ultimately lead to their closure.
“The regulations will cause a modern-day prohibition of products that are recognized worldwide as far less hazardous than cigarettes,” said Gregory Conley, the President of the American Vaping Association. “If the FDA’s rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years”.
The e-cigarettes are the electronic devices that use batteries for their operation and they convert the nicotine directly to the inhalable vapors form. The drug nicotine may cause addiction but the production of harmful chemicals like tar and other gases can be prevented. These harmful chemicals are hazardous to health and they are produced by the burning of tobacco.
According to Wells Fargo, an American multinational banking and financial services provider company, in 2015, a sale of worth US $ 3.5 billion was recorded in U.S. The e-cigarette companies are experiencing a competition by the traditional tobacco companies. To promote the sale of their products they can be indulged into the use negative tactics for their publicity. These tactics may include over-rating of the safety and cost effectiveness of their electronic cigarette devices. As a result many underage children can be attracted and indulged into smoking.
Apart from the reservations from the e-cigarette manufacturers the implementation of this rule is welcomed by the healthcare professionals and general public in order to prevent and reduce the smoking trends in children and non-smokers.