The following table compares the high-level options for a regulatory vehicle for emerging tobacco and nicotine-delivery products. Table 13: Comparison of options for a regulatory vehicle for emerging tobacco and nicotine-delivery products Options Option 1: status quo Products unlawful under SFEA; decisions taken and Act amended on case-by-case basis Option 2: Rely on existing consumer protection legislation Option 3: Include within the of the Psychoactive Substances Act Option 4: Incorporate a new regulatory framework under the SFEA Option 5: Develop bespoke legislation Pros High of scrutiny and decision-making Low cost for business and government High regulatory hurdle in Act is appropriate for products at the high-risk end of the spectrum Opportunity to build on ecigarettes framework (at end of spectrum) Emerging tobacco and nicotine-delivery products fits best with legislation regulating existing tobacco products Existing legislative vehicle on 2017 legislation programme to amend SFEA Opportunity to develop bespoke purpose, principles and modern risk-based regulatory framework best suited to emerging tobacco and nicotine-delivery products Cons Slow process – regulatory change lags considerably behind shifting evidence and public expectations Not sufficiently robust to manage the safety risks associated with emerging tobacco and products No existing safety standards for emerging tobacco and nicotine-delivery products could be adopted Enforcement is passive, in response to complaints and failures High regulatory hurdle inappropriate for products at the low-risk end of the spectrum Relatively high costs to business and government associate with approving products Would require a legislative amendment to bring nicotine into scope of the Act May be philosophically at odds with traditional approach to tobacco control, which has focused on an end-game (harm reduction is not a principle that has been used) Time and cost in developing a new Act Would need to interface smoothly with SFEA
United Kingdom Revised European (EU) Tobacco Products Directive sets out new regulations which include nicotine ecigarettes. EU rules don’t apply to therapeutic products, which are regulated under national rules (Medicines and Healthcare Products Regulatory Authority has approved a novel nicotine inhaler called Voke and an ecigarette called evoke). Member states can decide how to regulate non-nicotine ecigarettes. As per EU directive: prohibits of nicotine ecigarettes to under 18s. Not included in EU directive. No prohibition – Public Health England has issued guidance to assist businesses and employers determine their own vaping policies. As per EU directive: forms of sponsorship and advertising prohibited; other forms of advertising allowed, eg, cinemas, local buses. However, the Scottish Government has legislated for comprehensive advertising restrictions for nicotine and non-nicotine ecigarettes, except at point-of-sale. As per EU directive; controls include: nicotine concentration no higher than 20 mg/ml volume limitations on nicotine eliquid containers labelling requirements health warning re addictiveness of nicotine licensing of flavours standards to be met for devices and liquids, including child-resistant closures products must be notified 6 months to marketing. Canada Ecigarettes containing nicotine are regulated as drugs/drug devices under the Food and Drugs Act. Nicotine ecigarettes require market authorisation from Health Canada before they can be imported, marketed or sold (to date no product has been approved). Non-nicotine ecigarettes that do not make health claims are legal and are regulated at the provincial level. The majority of provinces prohibit ecigarette sales to under-19s (one province has an under-18 ban). The majority of provinces prohibit vaping in enclosed workplaces and public places, similar to smoking. The majority of provinces have taken some sort of legislative approach and many of these appear to be in the process of making regulations. Most have some sort of restriction, eg: general ban on promotion at retail, but availability and price information allowed exemptions for vape shops prohibition where accessible by minors prohibition if visible from outside. Several provinces have regulation-making powers: related to labelling, eg, for health warnings to determine unit quantities to ban flavours. One state has powers to determine product standards. No regulations are yet in
United States US Food and Drug Administration is implementing product safety regulations for nicotine ecigarettes. Sale of nicotine ecigarettes prohibited to under-18s. Non-nicotine ecigarette laws differ from state to state. Vaping in smokefree areas differs from state to state. Differs from state to state. Federal prohibition on distributing samples New regulations include: manufacturer registration ingredients listing pre-market review and authorisation of products health warnings on packaging and advertisements ban on distributing free samples.