In response to the e-cigarette epidemic and the vaping-related lung injury crisis, many local governments, states, and tribes have established sales prohibitions and emergency bans, and taken other actions removing these harmful products from the marketplace. Though federal action to do the same has moved at a near-glacial pace, federal regulators are now taking small steps to remove some e-cigarettes from the marketplace. Unfortunately, getting these products off the shelves is not the end of the public health response. That’s because once they can no longer be legally sold, they are likely to be considered hazardous waste under federal law. Therefore, retailers must comply with hazardous waste law when getting rid of unsold products when sales restrictions make their inventory unsellable.
Nicotine is a listed hazardous waste
Since 1980, nicotine has been a listed acute hazardous waste under federal law. Specifically, the Resource Conservation and Recovery Act (RCRA) mandates how hazardous wastes must be stored, transported, treated, destroyed, and disposed of. This means that nicotine e-liquid products that are in the hands of a business and intended to be discarded are subject to RCRA storage, transportation, treatment, and disposal requirements. As an “acute” hazardous waste, nicotine is a chemical product known to be dangerous even when properly managed and likely to cause death or serious injury even in low doses. Therefore, when businesses become unable to sell or otherwise legally use even very small amounts of e-liquid , they must treat it carefully and dispose of it properly.
Some states have already created guidance for vape shops and businesses in the e-liquid industry, some of which are likely to fall under the highest RCRA regulatory scrutiny because of the amount of nicotine they are storing and discarding. As more jurisdictions adopt tobacco product sales restrictions businesses like gas stations—which may not be familiar with RCRA’s requirements for storage and disposal of these dangerous chemicals and e-waste—will have to understand their responsibilities when it comes to proper nicotine and e-waste storage and disposal.
FDA e-cigarette sales prohibitions and premarket review
The FDA’s recent and upcoming actions intend to remove products from the market in stages. First, starting on February 6, 2020, a limited number of non-tobacco or menthol- flavored “cartridge and pod-based products” are no longer allowed to be sold in the U.S. While the FDA’s action was hardly comprehensive, it will impact businesses that now have tobacco products they cannot sell. In other words, thousands of businesses now possess hazardous waste, and may not understand the implications of holding these products for eventual disposal, nor how to properly dispose of them.
More comprehensively, a federal court has ordered the FDA to review all new tobacco products between May 12, 2020, and May 12, 2021. If a tobacco company that has been selling e-cigarettes does not apply for premarket review with the FDA by the May 12, 2020 deadline, the FDA has indicated its plan to require those products to be removed from market. And then for those products awaiting action on an application, as of May 12, 2021, any e-cigarette that has not received a marketing order from the FDA must not be sold in the U.S. As a result, there will likely be a glut of harmful e-cigarette products left in the hands of retailers over the course of the next thirteen months, raising the risk that they will be disposed of illegally and dangerously, in violation of RCRA and state laws.1
Penalties for noncompliance with RCRA
Retailers’ improper disposal of hazardous waste products is harmful to the environment. It can also lead to multi-million dollar fines for violations of hazardous waste law. As of February 2019, violations of RCRA hazardous waste requirements can incur civil penalties of up to $74,552 per day. In addition to EPA oversight, states that are delegated RCRA authority may enforce hazardous waste penalties, and some local agencies have authority to do so as well. Even storing someone else’s abandoned or unsellable e-cigarettes has resulted in tens of thousands of dollars in fines for some businesses.
Ensuring the continued protection of public health
The standards in RCRA applicable to nicotine waste are an important protection of human health and the environment. The FDA’s premarket review process, similarly, is intended to only permit the sale of new tobacco products appropriate for the protection of public health—meaning the products must cause no greater death and disease than those products already on the market. The fact that sales prohibitions result in potentially dangerous waste certainly does not mean that any jurisdiction should hesitate to prohibit the sale of tobacco products. On the contrary—such prohibitions are critical measures to protect public health. Furthermore, due to the FDA’s delayed enforcement against existing products, the problem of coping with this hazardous waste has shifted to our nation’s schools, sticking taxpayers with the bill for storage, transportation, and disposal. Sales restrictions effectively shift that burden back to tobacco-selling businesses, where it belongs, and ultimately, moves us further towards long-term protection of public health.
By Kyra Hill and Hudson Kingston, Public Health Law Center
March 27, 2020
1 In some states it might be possible to recycle products and thus keep them out of the waste stream, and in California retailers can return products to the original manufacturers as retrograde materials to avoid having to treat them as hazardous waste. All such alternative methods of handling the waste are subject to their own legal controls and safety procedures.