Regulation of E-Cigarettes in North America
- September 29, 2015
- Posted by: AXSource
- Category: Blog, Regulatory and Quality
Electronic cigarettes, also known as e-cigarettes, consist of a battery-powered delivery system to heat or vaporize “e-liquid” or “e-juice,” a liquid chemical mixture comprised of nicotine, propylene glycol, flavor and other chemicals into an aerosol that is inhaled by the user. This is referred to as “vaping’. In recent months, a number of electronic cigarettes, cigars and pipes as well as cartridges of nicotine solutions and related products have been marketed in North America, and through the Internet. Currently, there is a public debate concerning e-cigarettes and regulatory agencies like Health Canada and the U.S. Food and Drug Administration (FDA) are caught in between.
Nicotine is a highly addictive and toxic substance that is hazardous to the health and safety of certain segments of the population such as children, youth, pregnant women, nursing mothers, people with heart conditions, and the elderly. Some e-cigarettes are labeled and marketed as nicotine free. However, testing has revealed e-cigarettes labeled to be nicotine free do in fact contain nicotine. Propylene glycol is also a known irritant. E-cigarettes have been found to have heavy metals at levels exceeding conventional cigarettes and contain rubber and ceramics that can be vaporized to cause adverse health effects. Batteries have been known to explode occasionally and toxins in e-cigarettes can exceed their levels in conventional cigarettes.
Most e-cigarettes are manufactured to resemble and provide a simulated smoking experience as conventional cigarettes, cigars, or pipes. Some resemble everyday items such as pens and USB memory sticks. E-cigarettes are relatively new products and so scientific evidence on long term public health impact is lacking and there is conflicting evidence as to their potential for smoking cessation health benefit claims. While some research shows e-cigarettes to be useful in quit attempts, other studies show that smokers are unsatisfied with the new devices and return to smoking tobacco cigarettes or maintain dual use of e-cigarettes and conventional cigarettes. North American regulatory agencies like Health Canada and the U.S. Food and Drug Administration (FDA) are therefore attempting to regulate e-cigarettes when intended for recreational and health indications.
Regulation of E-Cigarettes in Canada
Electronic cigarette products without nicotine and without health claims can legally be imported and sold in Canada, provided they meet the general safety requirements of the Canada Consumer Product Safety Act. However, electronic cigarettes, cigars, cigarillos and pipes, as well as cartridges of nicotine solutions and related products with nicotine and/or health claims fall within the scope of the Food and Drugs Act and require Health Canada market authorization prior to being imported, advertised or sold in Canada. To date, no electronic cigarettes with nicotine and/or health claims have been authorized by Health Canada as their safety, quality, and efficacy remain unknown. Health Canada therefore advises Canadians not to purchase or use electronic cigarettes.
The Tobacco Act governs the manufacture, sale, labelling and promotion of conventional tobacco products. With respect to e-cigarettes, Canada’s House of Commons Standing Committee on Health, in March 2015, released a Parliamentary Report that issued 14 recommendations, including the need for an e-cigarette regulatory framework relative to other tobacco and nicotine products, measures in relation to product standards, market and sale, and increased research in Canada.
Meanwhile, Health Canada advises that electronic smoking products, including their nicotine cartridges, be kept out of the reach of children at all times, given the risk of choking or nicotine poisoning. Canadians who have used e-cigarette products and are concerned about their health are advised to consult with their healthcare practitioner.
Complaints involving electronic smoking products can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by contacting a Health Products and Food Branch Inspectorate Regional Operational Centre.
Regulation of E-Cigarettes in USA
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed by the President in 2009, created the U.S. Food and Drug Administration (FDA) Center for Tobacco Products and gave FDA oversight over the manufacture, distribution, and marketing of tobacco products. Products made or derived from tobacco can be regulated under the Food, Drug & Cosmetic Act’s (FDCA) “tobacco product” authorities unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. Thus, currently, the FDA Center for Tobacco Products (CTP) regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco while the FDA Center for Drug Evaluation and Research (CDER) regulates e-cigarettes marketed for therapeutic purposes.
The Food, Drug & Cosmetic Act (FDCA) permits FDA to issue regulations to subject other products that meet the definition of “tobacco product” to the Agency’s “tobacco product” authorities under the FDCA. FDA has issued a proposed rule, Tobacco Products Deemed To Be Subject to the Food, Drug & Cosmetic Act (Deeming), that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FDCA to cover additional products that meet the statutory definition of “tobacco product” in Section 201(rr) of the FDCA. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” nicotine gels, and waterpipe (hookah) tobacco. Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death.
The proposed deeming action differs from most public health regulations in that it is an enabling regulation. In other words, in addition to directly applying the substantive requirements of chapter IX of the FD&C Act and its implementing regulations to proposed deemed tobacco products, it enables FDA to issue further public health regulations related to such products. The proposed rule would enable FDA to explore whether electronic cigarettes pose different levels of risk, and would help the Agency develop policies to improve public health. FDA expects that the proposed deeming action will enable them to collect vital ingredient and health information and propose further regulatory action as appropriate.
Highlights of the Deeming Proposed Rule
Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:
- Register with FDA and report product and ingredient listings
- Only market new tobacco products after FDA review
- Only make claims of reduced risk if FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole
- Not distribute free samples
In addition, under the proposed rule, the following items would apply to newly deemed covered tobacco products:
- Minimum age and identification restrictions to prevent sales to underage youth
- Requirements to include health warnings
- Prohibition of vending machine sales, unless in a facility that never admits youth
The term “covered tobacco products” is defined here as those products deemed to be subject to the Food, Drug, and Cosmetic Act under section 1100.2 of title 21 of the Code of Federal Regulations (CFR), other than a component or part that does not contain tobacco or nicotine.
In conclusion, e-cigarette regulation is coming to North America. AXSource consultants can support e-cigarette manufacturers with their compliance needs.