The World Health Organization’s Take on E-Cigs and the FDA Regulations

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1063679_75653222Amidst the publication of the Federal Drug Administration’s (“FDA”) draft e-cig regulations and  New York CityChicago and Los Angeles banning the indoor use of e-cigs, the World Health Organization (“WHO”) chimed in this week voicing its approval of the United States’ proposed treatment of e-cigs.

New FDA E-Cig Regulations

Under the FDA’s proposed e-cig regulations, the FDA will require that e-cig manufacturers provide the agency with a detailed description of its manufacturing processes and ingredient lists, substantiated with verifiable scientific data.  E-cig manufacturing facilities will also be subject to FDA inspections.  The draft regulations also include a nationwide minimum age requirement in order to purchase and use e-cigs.  If the draft regulations are passed, no one under the age of 18 will be able to legally purchase e-cigs.  Please note that the same age standard would also apply to tobacco accessories, such as filters, rolling papers, tobacco flavorings, hookah coals, etc.

There are currently no marketing restrictions contained in the FDA’s proposed e-cig regulations.  However, due to the letters and comments received by the FDA that demand the addition of marketing restrictions, including a petition signed by 29 attorneys general,  there will likely be marketing and possibly location-based restrictions included in the final FDA regulations.

Details of UK E-Cig Regulations

While not placing an outright ban on e-cigs, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) announced earlier this year that it will pass e-cig regulations beginning in 2016, that will essentially treat e-cigs as non-prescription medicines.  The MHRA stated that the reasoning behind implementing e-cig regulations is an attempt to improve the quality of e-cigs offered for sale on the market.  There are currently more than 45 different brands of e-cigs available, with that number increasing rapidly.  Unsurprisingly, some brands are of better quality than others and the MHRA has found varying levels of nicotine and contaminants in the various brands offered for sale.

Under the MHRA’s e-cig regulations, e-cig manufacturers will have to conduct clinical trials and prove to the MHRA that their products are compliant with its e-cig regulations and provide consistent levels of nicotine.  Manufacturers of e-cig products that are deemed acceptable will be issued licenses to distribute their products.

WHO Response

The WHO is a United Nation’s agency that makes recommendations and issues reports on issues that affect global health and well-being.  According to a report issued earlier this week, the WHO urges countries to adopt global guidelines that will end the indoor use of e-cigs.  The studies commissioned by the WHO have found that exhaled e-cig vapor may contain trace amounts of toxic chemicals and nicotine, which could harm third party bystanders.

Moreover, and consistent with the petition of the state attorneys general, the WHO calls for a ban on marketing practices that could encourage children and non-smokers to use e-cigs.  The WHO report specifically references the use of fruit, candy or alcoholic-drink style flavors in marketing campaigns that target children and minors.

It should be noted that the report issued by the WHO is only meant to serve as a regulatory guideline for policy makers.  Governmental agencies are under no obligation to consider or even review the restrictive recommendations set forth by the WHO.

The development of the FDA’s new e-cigarette regulations and those of international governments should be of interest to anyone involved in the e-cigarette industry.

If you are interested in learning more about this topic or pursuing a venture in this area, please e-mail us at info@kleinmoynihan.com, or call us at (212) 246-0900.

The material contained herein is provided for informational purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney.  Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.

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David O. Klein

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David Klein is one of the most recognized attorneys in the telemarketing, technology, Internet marketing, sweepstakes and telecommunications fields. Skilled at counseling clients on a broad range of technology-related matters, David Klein has substantial experience in negotiating and drafting complex licensing, marketing and Internet agreements.

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