Analysis: differences between EU and US tobacco product and e-cig regulation SRNT Florence 8 March 2017 Deborah Arnott Chief Executive Action on Smoking and Health

Conflict of Interest ASH is a public health charity set up by the Royal College of Physicians in 1971 to advocate for policy measures to reduce the harm caused by tobacco.  Funded primarily by the British Heart Foundation and Cancer Research UK. Has received project funding from the Department of Health in England to support tobacco control. ASH does not accept commercial funding In particular ASH does not have any direct or indirect links to, or receive funding from, the tobacco industry.

What this presentation covers Summary of US regulatory system Comparison US and EU Conclusions US population around 320 million (2014), 50 states

US tobacco regulatory system Family Smoking Prevention & Tobacco Control Act 2009 FDA Centre for Tobacco Products set up and given authority to regulate tobacco products intended for human consumption to reduce harm across the population Costs of regulation paid for by the industry

Industry pays for regulation User fees pay for costs of FDA related tobacco regulation Section 919 of the Family Smoking Prevention & TC Act sets out annual totals 2009 = US$ 85 million (fiscal year Oct-Sept) 2016 = US$ 599 million 2017 = US$ 635 million 2018 = US$ 672 million 2019 onwards = $712 million Allocated on basis of sales Federal fiscal year (Oct-Sept) and collected quarterly

Key Provisions of the 2009 Act (1) Bans candy and fruit-flavored cigarettes that appeal to children (in force 2009) Cracks down on cigarette marketing and sales to children (following measures in force 2010) national minimum age of sale = 18 free samples and self-service displays banned prohibits brand sponsorships of athletic and musical events; and strengthens enforcement and penalties. Prohibits Deceptive Cigarette Labels "Light" and "Low-Tar" (in force 2010)

Key Provisions of the 2009 Act (2) Requires bigger, bolder health warnings, including graphic warnings on cigarettes FDA published 9 final graphic warnings required on all US cigarette packs and ads from Sept. 2012 in June 2011   cigarette companies successfully challenged the specific proposed warnings as a violation of the companies’ First Amendment rights.  FDA said would develop new proposed graphic warnings that would survive constitutional challenge.  To date FDA still has not issued a new set of graphic health warnings

Key Provisions of the 2009 Act (3) Before cigarette companies can market products as safer, requires them to support their claims and show a public health benefit from making them. Requires tobacco companies to disclose to FDA information about their products, including harmful ingredients. Products on market at 15 Feb 2007 ‘grandfathered’ in – all new products after that require premarket review

Key Provisions of the 2009 Act (4) Allows FDA to order reduction or elimination of harmful ingredients and additives in tobacco products to protect public health. Gives FDA authority to issue a rule “deeming” other tobacco products subject to FDA regulation

Electronic cigarettes The FDA originally planned to regulate e-cigarettes under the Food, Drug, and Cosmetics Act as a ‘combination drug-device product that requires pre-approval, registration, and listing with the FDA’ The US Court of Appeals (DC) held that, in the absence of a therapeutic claim, e-cigarettes and other products made or derived from tobacco could only be regulated under the tobacco provisions of the 2009 Tobacco Act FDA accepted the judgement

Deeming in 2016 On 5 May 2016 FDA finalized a rule that “deems” the following products to be subject to FDA’s tobacco product authorities, including: ENDS (e-cigarettes, e-cigars, vape pens, etc) All cigars Pipe tobacco Nicotine gels Waterpipe (hookah) Dissolvables not already under the FDA’s authority Future tobacco products

Impact of deeming FD&C Act provisions for “tobacco products” automatically apply to newly-regulated products Registering manufacturing establishments and providing product listings to FDA Reporting ingredients and harmful and potentially harmful constituents Requiring premarket review and market authorization of new tobacco products Health warnings on product packages and advertisements Not selling tobacco products that make modified risk tobacco claims (including “light,” “low,” or “mild”) unless authorized by FDA No distribution of free samples

Impact on e-cigs Pre-market review Health warnings Newly-regulated tobacco products subject to premarket review unless they were commercially marketed as of 2/15/2007 Product category only on market around 2007 so most products will require premarket review Health warnings As of May 2018 30% of principal display panels must have warning: “This product contains nicotine. Nicotine is an addictive chemical.”

Deemed products – implementation dates 8 August 2016 - No new products (or changes to existing products) can be introduced to the market before authorised by FDA through a “marketing order” using the SE or PMTA pathways 8 August 2017 - Substantial Equivalence Exemption Requests due. Filed products can remain on market for one further year. 8 August 2018 - Premarket Tobacco Applications (PMTA) are due for all products that were on the market as of August 8th, 2016. Filed products can remain on market for one further year.

EU-US differences: key areas Funding Health warnings Prohibition of flavourings Smokeless tobacco Novel products: notification versus authorisation

EU-US: Funding US user fee = FDA has substantial funding to pay for regulation and evaluation EU – no such system. MS can require tobacco firms to pay for costs of licensing but not full costs of regulatory process

EU-US: Health warnings Cigarette health warnings still as they were in the 1980s 4 rotated text warnings no location specified so put on side of pack By May 2018 text warnings 30% principal display panels EU 65% pictorial warnings principal display panels Member States can introduce “plain” packaging - only branding name in standard font e.g. UK, France others on the way

EU-US: flavouring prohibition Sale of cigarettes and handrolled tobacco with ‘characterising flavourings’ prohibited from May 2017 menthol banned from 2020 US banned flavourings in cigarettes from 2009 Menthol given exemption Menthol ban still under consideration no plans as yet

EU-US: notification vs authorisation Products on market before Feb 2007 grandfathered in All new products require pre-market authorisation Stringent process takes considerable time EU New products require notification 6 months in advance NOT authorisation [unless required by Member State] Existing products also require notification

EU-US: smokeless tobacco Oral snuff illegal, traditional chewed products legal Opt out for Sweden where snus traditional product US 8 Swedish match products given ‘pre-market authorisation’ Currently consulting on standard for nitrosamine limit for SLT BUT Modified risk application from Swedish Match: action deferred [warning would have changed from "This product is not a safe alternative to smoking" to "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.“]

EU-US: e-cig regulation Products have to be notified E-cigs have to meet generic standards rather than individual authorisation e.g. size of tank, size of refill US Novel products introduced after Feb 2007 have to be authorised including e-cigs Only exemption if can prove they are substantially equivalent to products already on the market

Notification versus authorisation in the UK Tobacco Products Directive regulation of electronic cigarettes MHRA licenced Nicotine Containing Products (NCPs) including e-cigs Products not available on prescription Products available on prescription 20% sales tax in UK 5% sales tax allowed for OTC (over the counter) nicotine replacement therapy Cross border advertising banned; up to Member States to decide on domestic advertising (billboards, Point of Sale, buses etc.) Advertising allowed – under OTC rules so no celebrity endorsement or free samples and must be targeted at adult smokers etc. Products widely available Products available on general sale (GSL) Can’t make health claims Can make health claims Upper limits for nicotine content of 20mg/ml fully in force by 20 May 2017. MHRA regulation is flexible; there are no upper limits. 30% health warning on packs about nicotine on front and back of packs No health warnings on packs Member States retain powers e.g. on flavours, domestic advertising. Flavours require a marketing authorisation Age of sale of 18 for nicotine products. Age of sale 18 for electronic cigarettes.

So far – no licensed products on market Tobacco Products Directive regulation of electronic cigarettes MHRA licenced Nicotine Containing Products (NCPs) including e-cigs Products not available on prescription Products available on prescription 20% sales tax in UK 5% sales tax allowed for OTC (over the counter) nicotine replacement therapy Cross border advertising banned; up to Member States to decide on domestic advertising (billboards, Point of Sale, buses etc.) Advertising allowed – under OTC rules so no celebrity endorsement or free samples and must be targeted at adult smokers etc. Products widely available Products available on general sale (GSL) Can’t make health claims Can make health claims Upper limits for nicotine content of 20mg/ml fully in force by 20 May 2017. MHRA regulation is flexible; there are no upper limits. 30% health warning on packs about nicotine on front and back of packs No health warnings on packs Member States retain powers e.g. on flavours, domestic advertising. Flavours require a marketing authorisation Age of sale of 18 for nicotine products. Age of sale 18 for electronic cigarettes.

Conclusion BUT Many similarities on product regulation Biggest difference “grandfathering” and US requirement for products introduced after 15 Feb 2007 to be authorised UK medicines license much less onerous than FDA authorisation Yet only 2 products received license so far: none yet come to market BUT Alternative exists through TPD, so authorisation not essential What will happen in US?