1. 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

2. 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.

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

4. 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

5. 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

6. 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)

7. 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 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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 % of principal display panels must have warning: “This product contains nicotine. Nicotine is an addictive chemical.”

14. Deemed products – implementation dates
8 August 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 Substantial Equivalence Exemption Requests due. Filed products can remain on market for one further year.
8 August Premarket Tobacco Applications (PMTA) are due for all products that were on the market as of August 8th, Filed products can remain on market for one further year.

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

16. 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

17. 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

18. 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

19. 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

20. 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.“]

21. 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

22. 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.

23. 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.

24. 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?