As detailed on this blog, the Food and Drug Administration (“FDA”) previously gave notice that it would publish its long-awaited e-cig regulations in April 2013. Despite those representations and the urging of several U.S. Senators, the FDA has still not issued the proposed e-cig regulations or published the promised list of dangerous chemicals found in e-cigs. In the interim, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that it will begin regulating e-cigs as medicine.
Details of UK E-Cig Regulations
While not placing an outright ban on e-cigs and continuing to allow them to be sold in convenience stores, the MHRA announced last week 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 the 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 offered, 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 several 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 the 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.
UK E-Cig Regulations’ Impact on the FDA
Like the FDA, the MHRA has received pressure to adopt e-cig regulations. With the MHRA’s announcement of last week, the spotlight should again shift back to the FDA. As previously articulated, the FDA attempted to regulate e-cigs as drugs or drug delivery systems, but was thwarted by a U.S. District Court for the District of Columbia decision, which stated that because the nicotine contained in e-cigs is derived from tobacco, the FDA may only regulate e-cigs as tobacco products.
No official statement from the FDA has been released as of yet, but given the prior legal precedent at issue, it is unlikely that the FDA will follow the MHRA’s lead and regulate e-cigs as medicine.
The development of the MHRA’s new e-cig regulations should be of interest to anyone involved in the e-cigarette industry and those interested in product marketing in general.