FDA Vaping Rules vs. Europe Vaping Laws

The regulation of vaping devices and liquids is a topic of significant global debate. Different countries have various approaches, ranging from outright bans to partial restrictions and more permissive attitudes. The United States and countries across Europe illustrate how lawmakers attempt to control vaping without completely banning it. This article explores the implications of FDA vaping regulations in the US and the impact of European vaping laws.

FDA E-Cigarette Regulation: The Basics

Background

The FDA classifies e-cigarettes, liquids, and most other vaping products as "tobacco products" under US law. This classification brings them under the 2009 Family Smoking Prevention and Tobacco Control Act, initially designed to prevent the tobacco industry from suggesting that some cigarettes are safer than others. It also aimed to stop the introduction of new cigarettes to the market. Cigarettes available before February 15, 2007, were allowed to stay on the market.

To introduce a new tobacco product after this date, companies must demonstrate that it is "substantially equivalent" to something already on the market before that date or submit a new application. The primary option is a pre-market tobacco application, although in theory, a product could be proposed as a modified risk tobacco product, implying reduced risk.

Impact on Vaping

The FDA vaping regulations require e-cigarettes to meet stringent requirements. The 2007 date prevents them from receiving a "free pass" like traditional cigarettes and rules out any substantial equivalence claims, as there were hardly any e-cigarettes on the market in 2007.

A modified risk approach might seem appropriate for vaping, but it is unlikely to succeed. Swedish Match, which manufactures snus (a smokeless tobacco), faced significant opposition despite submitting over 100,000 pages of evidence. No vaping product has yet come close to this level of documentation.

Thus, the only viable option is the pre-market tobacco application, which is more challenging than it might sound. The application process is costly and requires substantial evidence, including laboratory studies on the products, and significant administrative costs.

Each application under the FDA vaping regulations is estimated to cost over 1 million dollars per product. Worse, a separate application is required for each product variation—vape manufacturers must submit one for each flavor and each nicotine strength. This process is expected to devastate the industry unless the February 2007 date is amended to something more reasonable.

Some e-cigarette companies may bear these costs, but the regulations favor tobacco companies involved in the industry, which have deeper pockets and more regulatory experience.

Europe Vaping Laws

European vaping laws are embodied in the Tobacco Products Directive (TPD) of the European Union. The EU vaping rules may not present the same high entry barriers as the FDA regulations, but there are still many similarities and some highly questionable restrictions.

Key Regulations

The most relevant parts of the TPD include:

• Notification Requirements: Manufacturers and importers of vaping products must notify authorities of their intention to market products, providing a full ingredients list, emissions data, and toxicological data.
• Size Restrictions: Tanks are limited to 2 ml, and e-liquid containers cannot exceed 10 ml.
• Nicotine Strength: The maximum nicotine strength allowed is 20 mg/ml.
• Additives: Additives like caffeine or vitamins are not permitted in e-liquids.
• Purity Standards: E-liquids must use high-purity ingredients.
• Consistency: Devices must provide a consistent dose of nicotine.
• Safety Features: E-liquids must be sold with child-proof caps and have leak-free filling mechanisms.
• Information Requirements: E-cigarette products must include an information card with usage instructions, addictiveness, toxicity, and more.
• Warnings: Packages must carry warnings about nicotine being a highly addictive substance.
• Marketing Restrictions: Most marketing in print, radio, and television, as well as sponsorships promoting vaping, is prohibited.

Impact on Businesses and Consumers

The registration and ingredient listing require substantial information gathering, which may be beyond the capacity of some small businesses. However, this is less severe than the FDA’s requirements, as there is no equivalent to the pre-market tobacco application.

For consumers, the restrictions on nicotine strength and the size of tanks and bottles are most problematic. Despite a general shift towards lower-nicotine e-juices, some smokers still benefit from stronger e-liquids, with 24 mg/ml once being common. Removing this option without justification is indefensible.

The limitations on e-juice bottle and tank sizes are particularly unjustifiable. These restrictions lead to unnecessary packaging and increase the frequency of tank refilling, raising the likelihood of spills.

UK Vaping Laws – What Happens After Brexit?

UK vaping laws, overseen by the Medicines and Healthcare Regulatory Authority (MHRA), align with the European vaping laws unless a bid to repeal the TPD is successful. If not, the TPD will be incorporated into UK law along with other EU legislation, pending potential future removal.

The MHRA vaping laws will essentially mirror those from the EU, but there is some flexibility in implementing restrictions. The UK generally adopts a pro-vaping stance, and the MHRA appears to be taking a minimalist approach to the TPD. While the future is uncertain with upcoming general elections, this trend is likely to continue.

However, EU member states and the UK could impose stricter measures than the minimum requirements of the European vaping laws, possibly including flavor bans to reduce vaping's appeal to teens. Although this approach is unlikely to have a positive impact, it does not mean some countries won’t attempt it when implementing the TPD within their own borders.

Conclusion: Europe Vaping Laws are Flawed; FDA Vaping Regulations are a Disaster

While both the EU and FDA approaches to regulating e-cigarettes have significant problems, the FDA's approach is far more detrimental. The FDA’s regulations have been likened to a “slow-motion ban” due to the insurmountable barriers they create for small and medium-sized businesses. In contrast, the European vaping laws, though overreaching and often illogical, do not erect barriers so significant that they prohibit market entry.

Perhaps Brexit will bring about changes in UK vaping laws that better reflect how these products should be regulated, but the current outlook remains bleak.