U.K. E-Cigarettes Can Make Smoking Alternative Claim, But Not Healthier

NJOY ads “implied that the product was favorable to smoking tobacco cigarettes,” but “there may be a number of reasons why a friend might suggest the product as an alternative to smoking tobacco cigarettes,” U.K. advertising watchdog says.

Electronic cigarettes marketed in the U.K. can make a claim as alternatives to smoking, but not a healthier one, the country’s advertising watchdog says with less than two years to go before all e-cigarettes will need clearance as nonprescription medicinal products to remain available.

Electronic cigarettes marketed in the U.K. must be cleared as nonprescription medicinal products to remain available starting in 2016, but in the interim the country’s advertising watchdog says advertising can promote the products as alternatives to smoking, though not a healthier one.

The Advertising Standards Authority in a July 16 ruling said two TV ads for NJOY Innovations Ltd. e-cigarettes did not violate U.K. advertising regulations by stating, “Friends don't let friends smoke. Give them an NJOY King electronic cigarette.”

ASA, the U.K.’s independent regulator for advertising, said the audio, visuals and on-screen text in the ads did not contain express health claims for the product, and “no express claims [were] made stating that smoking the product was healthier than smoking tobacco cigarettes.”

The agency allowed that the advertising “implied that the product was favorable to smoking tobacco cigarettes,” but said “we considered that there may be a number of reasons why a friend might suggest the product as an alternative to smoking tobacco cigarettes.”

ASA said the ad suggested the product as an alternative to smoking tobacco cigarettes and did not imply, as a complaint challenged, that using the product was healthier than smoking tobacco cigarettes.

The agency “did not consider we needed to see evidence that smoking the product was healthier than smoking tobacco cigarettes and we concluded the ads were not misleading,” according to the ruling.

Satisfaction Not A Health Claim

NJOY Innovations, a London subsidiary of U.S. firm Sottera Inc., argued in its response to ASA that its ads emphasized NJOY products are "made to satisfy" and the phrase is not a scientific or health claim, “but rather a feel good line.”

Additionally, without references to health benefits or concerns about either NJOY or combustible cigarettes in the ads, the firm “did not believe the concepts of satisfaction and health were comparable.”

NJOY advised ASA it worked with Clearcast, the U.K. commercial broadcasters’ organization that makes pre-market evaluations of ads, to ensure the ads did not breach the Broadcast Committee of Advertising Practice Code.

Clearcast, also responding to ASA, said the ads presented smoking tobacco “in a negative light and presented the product as an alternative only.”

The broadcasters’ group “believed that this was acceptable under the BCAP Code and in line with previous published ASA adjudications,” according to the ruling.

Clearcast also argued said there are “many reasons” why a consumer would use the product rather than smoke tobacco cigarettes and “why a friend might make that suggestion.” The reasons could include the comparable cost of NJOY with tobacco cigarettes, being allowed use the product inside some venues and public spaces or the lack of smoke smell and residue from using an e-cigarette.

The group believed that both ads presented the product as an alternative only and did not imply that the product was a safer or a healthier alternative to smoking tobacco cigarettes.

E-Cig Clock Ticking In U.K.

While NJOY can continue using its “friends don't let friends smoke” advertising, it and other firms marketing e-cigarettes in the U.K. have until June 2016 to either receive a medicinal product marketing authorization from the country’s health care regulator, or pull their products from the market (Also see "U.K. Packages All Electronic Cigarettes Under Medical Regulation" - Pink Sheet, 17 Jun, 2013.).

The U.K. Medicines and Healthcare products Regulatory Agency in June 2013 announced it will regulate e-cigarettes as nonprescription medicines beginning in 2016 regardless of whether they make drug claims. MHRA said delaying enforcement gives manufacturers time to comply with the safety, quality and efficacy requirements of a medicine.

The agency said the quality of e-cigarettes and other non-tobacco, nicotine-containing products not licensed as drugs “can vary considerably.”

Following the MHRA announcement, the Action on Smoking and Health advocacy group in the U.K. noted that e-cigarette firms that gain licensing will be able to market their products like other nonprescription medicines, which are available in the country both over the counter and in pharmacy-only sales.

For a licensed e-cigarette in the U.K., advertising would include TV ads similar to those for nicotine replacement therapy products, which must explicitly state the product is licensed to reduce smoking with a view to aiding cessation, ASH said.

MHRA also said it would ask the European Union to recognize nicotine-containing products as medicines. The European Parliament, however, in February approved legislation to make e-cigarettes subject to tobacco product regulations, including ad restrictions, unless a product makes a drug claim.

The EU proposal says e-cigarettes under tobacco regulation should contain no more than 30mg/ml of nicotine, carry health warnings and not be sold to any minors. Manufacturers also would have to supply regulators in EU member countries with a list of ingredients the products contain.

“Essentially, if you don’t have too much nicotine in your juice, then in the EU you can be regulated as a tobacco product,” said Joe Gitchell, who consults with firms including NJoy as president of Bethesda, Md.-based Pinney Associates.

As an EU member, the U.K. could stick with its plan to require medicinal product approvals for all e-cigarettes marketed in the country or use the EU’s two-tier approach. E-cigarette marketers are pushing MHRA to adopt the EU approach, but the agency so far has not changed its plan.

The European approach is similar to the proposed regulation FDA published in April 2014 to add to its tobacco market oversight e-cigarettes and other products not already regulated. The proposed rule would allow e-cigarettes and other products newly deemed as FDA-regulated to remain available for sale without approval by the agency until two years after the proposal becomes a final rule (Also see "Electronic Cigarettes Granted Two-Year Grace Period Under Proposed FDA Rule" - Pink Sheet, 24 Apr, 2014.).

FDA’s drug center already requires pre-market approval for any e-cigarette making a health claim, and so far none are approved. The agency’s tobacco center regulates whether tobacco or nicotine products are promoted as modified risks compared to traditional combustible tobacco products, and so far no modified risk claims are approved.

The agency initially moved to force all e-cigarettes from the market as unapproved medical drugs or devices before federal courts ruled for manufacturers and said FDA must regulate the products under its tobacco oversight authority unless a health claim is made. However, with the deeming reg pending, FDA’s tobacco oversight currently is limited to conventional and roll-your-own cigarettes and smokeless tobacco (Also see "Classifying E-Cigarettes As Tobacco Snuffs Out Cessation Utility – FDA" - Pink Sheet, 10 Jan, 2011.).

The proposed rule deems cigars, pipe tobacco and e-cigarettes and other novel nicotine delivery products as subject to FDA’s tobacco authority. The end of the comment period for the proposal was extended a month to Aug. 8.

FDA in 2012 began spending $270 million over five years on 48 research projects on determining potential risks of e-cigarettes.