Posted September 19th, 2019 in Top Stories, Legal Insights
Vaping Deaths: What Manufacturers and Retailers Need to Know about Current Laws and Regulations
In recent weeks, the news has been full of stories of vaping-related illnesses and deaths. An eighth person has now died from a vaping-related illness, and reports state that hundreds more have been sickened with severe respiratory illnesses. Health officials and researchers have not yet determined an exact cause of these illnesses and are warning users to stop vaping altogether given the uncertainty regarding its long-term health effects. In response, the Trump administration has announced that it is taking steps to ban flavored e-cigarettes to counter the appeal of vaping to teens and young adults. And state governments are also stepping in to impose their own regulations and restrictions on the sale and use of vaping and e-cigarette products.
With the regulatory landscape changing rapidly, manufacturers, distributors, and retailers of vaping and e-cigarette products must be aware of what laws and regulations govern these products, and should take proactive steps to mitigate their legal risks.
The Regulatory Landscape
E-cigarette products are regulated by the FDA. The FDA, however, was slow to react to the rapid rise in e-cigarettes and is still working to catch up to the state of the industry, leaving the regulatory landscape in flux. Although e-cigarettes have been on the market in the U.S. since the mid-2000s, it was not until 2016 that the FDA issued a “deeming rule,” which deemed e-cigarettes to be “tobacco products” subject to the FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act. Under the FDA’s deeming action and authority, it put in place similar rules already applicable to traditional tobacco products, including banning e-cigarette sales to minors, requiring photo ID for purchases, limiting advertising, and prohibiting advertising of e-cigarette products as safer than traditional tobacco products.
Since 2016, the FDA has also been working to create and implement a regulatory framework for e-cigarette products. Because e-cigarettes were already on the market, the FDA initially gave the industry two years, until 2018, to submit applications to receive approval to continue to market their e-cigarette products. In 2017, however, the FDA pushed back that deadline to 2022 to allow additional time to study the issue, permitting companies to continue to market their products in the meantime. The FDA also issued draft guidance to the industry, which focused primarily on combatting practices and products that promoted use of vaping among minors, but stopped short of banning any particular e-cigarette products.
Given the FDA’s delay of the application deadline, various health groups challenged the FDA’s actions as too tepid a response to what they believed was a public health emergency. In July 2019, a federal court in Maryland ruled that the FDA abdicated its statutory duty to review and regulate these products by giving the industry over five years to submit applications and permitting continuing sales in the interim. The court ordered that companies must submit premarket applications to the FDA by May 2020 and gave the FDA a one-year deadline for approval or denial of such applications. As it stands, companies now have until May 2020 to submit their applications for marketing authorization of e-cigarette products, and may continue to sell such products for up to one year while an application is pending. Various states and cities have also stepped in to regulate e-cigarette products, most commonly with respect to sales and marketing practices aimed at minors. However, some have enacted regulations that prohibit these products altogether. San Francisco, for example, has adopted an ordinance prohibiting the sale of e-cigarettes that have not yet undergone premarket approval from the FDA. Other states are seeking to implement their own bans of flavored e-cigarettes.
Alongside this patchwork of FDA and state and local regulations, e-cigarette products can also fall under the purview of the Consumer Product Safety Commission (CPSC). Although the FDA’s deeming rule purports to give the FDA authority over all e-cigarette products, including all components and parts of those products, the CPSC has also exercised overlapping authority with respect to some aspects of e-cigarette products. For example, the CPSC has taken enforcement action against e-liquid makers and retailers for selling liquid nicotine containers that do not comply with child-resistant packaging requirements of the Child Nicotine Poisoning Prevention Act. The CPSC has also overseen product recalls of vaping devices for fire and explosion hazards.
The current vaping-related illness crisis is pushing lawmakers and regulators to take further action against e-cigarette products, and the industry must be prepared to react to the fast-changing landscape. Because health officials and investigators have not yet determined a cause of these illnesses and have stated that it could be caused by ingredients or contaminants in the e-liquids, or by the vaping device itself, it is important that product manufacturers take proactive steps now to mitigate their risks and anticipate future legal challenges. Some actions e-cigarette and e-liquid manufacturers should take include:
- Develop and implement plans for good manufacturing practices to ensure safe, consistent, and quality products.
- Review contracts with component suppliers, distributors, and retailers, and ensure risks are appropriately allocated.
- Track and document changes to ingredients, materials, components, and testing procedures.
- Investigate and warn against counterfeit products and replica packaging.
- Document and investigate consumer complaints, incident reports, and injury claims.
- Always remember that any compliance plan is only as effective as its implementation.