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February 6, 2020

FDA Statement on Enforcement of Guidance

Today, the FDA issued a statement regarding the agency’s Guidance Document prioritizing enforcement actions on certain flavored cartridge-based and pod-based electronic nicotine products. The entire statement of the FDA is shown below:

Last month, FDA announced the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes, on the market without premarket authorization. Beginning today, the agency intends to prioritize enforcement against certain illegally marketed flavored ecigarette products, focusing on products that are particularly popular with youth and are easily accessible or marketed to them – such as flavored, cartridge-based e-cigarette products (other than tobacco and menthol). Importantly, this policy is designed to be flexible, enabling the agency to focus its priorities as warranted to address youth use. If FDA sees a product that is targeted to kids, the agency will not hesitate to target that product. For example, FDA will take action against any product—regardless of whether a product is cartridge-based, disposable, or flavored—if it is targeted to minors, its marketing is likely to promote youth use, or if the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access. Additionally, FDA intends to issue an import alert in the near future and refuse admission of certain unauthorized e-cigarette products that are imported or offered for import into the United States where warranted and as informed by the agency’s enforcement priorities. While FDA expects that responsible members of industry will cease the manufacture, distribution, and sale of unauthorized e-cigarette products, the public may continue to see some of the types of products outlined in the priorities on the market as the agency works to hold manufacturers and retailers—both in brick-and-mortar stores and online—accountable. For example, FDA will be initiating inspections and surveillance of manufacturers and retailers. Under the policy, companies that continue to manufacture, distribute, and sell unauthorized flavored cartridge-based ecigarettes (other than tobacco or menthol) risk FDA compliance and enforcement actions ranging from warning letters to injunction, seizure, and/or civil money penalty actions where warranted. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.

FDA’s enforcement priorities are not a “ban” on flavored or cartridge-based ENDS. FDA has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. Manufacturers that wish to market any of these products—including flavored e-cigarettes or e-liquids—need to submit an application to FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health. If a company can demonstrate to FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the agency would authorize that product for sale. Additionally, manufacturers of all deemed new tobacco products will still be required to submit marketing applications for their products by May 12, 2020. After May 12, FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application. For ENDS products other than those in the three groups described above, if premarket applications are submitted by that date, FDA intends to continue to exercise enforcement discretion for up to one year pending FDA review of the applications, unless there is a negative action by FDA on such application or the product is

CDC Confirms Black Markets, not "Vaping," Caused Outbreak

Michelle Minton • January 16, 2020

• January 16, 2020

new report from the U.S. Centers for Disease Control and Prevention (CDC) puts the final nail in the coffin of the idea that the spate of lung injuries that occurred beginning last summer were caused by “vaping.” The CDC admitted this week that the injuries appear to be exclusively linked to marijuana vapes—not nicotine e-cigarettes, most of which were purchased on the black market, a fact that CEI knew nearly six months ago.

According to the latest CDC findings, only one in six of the patients with the vaping-related lung injuries reported purchasing THC vapes from commercial sources. Some news outlets have interpreted this to mean that approximately 16 percent of the cases involved legally purchased cannabis vapes. But, as Jacob Sullum at Reason points out, this is incorrect. The CDC’s definition of “commercial” includes not only licensed dispensaries, but also pop-up shops, which are decidedly illegal in states with legal marijuana. Furthermore, the definition includes “stores,” without clarifying what this means. It is possible “store” includes bodegas and corner shops, which have been known to sell illegal drugs.

Thus, excluding the 3 percent of consumers who bought their THC at pop-up shops and the 2 percent who purchased them at “stores” other than dispensaries, only 11 percent of the cases reported buying their products at commercial outlets. Even that figure may be inflated, as it only reflects behavior reported by patients who may, for whatever reason, choose not to report purchasing or using cannabis products obtained from non-commercial sources.

As Sullum notes, it is still entirely possible that some of the cases were caused by legally purchased cannabis at licensed outlets. The manufacturers of cannabis products or components may have unkowingly adulterated their products with the ingredient or ingredients that caused the lung injuries. They should be held accountable for this, as all legal purveyors would be. But that does not mean that cannabis vapes—certainly not vaping as an entire category—is dangerously underregulated. Even sellers of vegetables sometimes err, causing widespread outbreaks of dangerous food-borne pathogens. The response in those cases is neither panic nor a leap to ban all lettuce. It merely calls for better standards and, perhaps, different types of oversight.

Instead of such a measured response to improve consumer safety, the outbreak of “vaping-linked” lung injuries prompted hysteria, leading to passage of bans on nicotine e-cigarettes—not even responsible for the outbreak—and a federal prohibition on all flavored e-cigarettes (excluding only tobacco and menthol.) These bans were pushed by dogmatic anti-tobacco interests, who exploited the early confusion over the outbreak.

The evidence that black market cannabis—not nicotine—vapes were the cause of the illnesses led the CDC this week to finally drop its long-standing unhelpful recommendation that people avoid all e-cigarette and vaping products. But, this concession has done little to slow the march toward a new drug war on e-cigarettes. Even this latest confession from CDC, is unlikely to cause any reversals in state or federal policy on e-cigarettes.

Instead of instituting better safety regulations and incentivizing consumers to purchase products legally, U.S. lawmakers have chosen to embrace prohibition, once again. As I wrote in July, this will do nothing to prevent future outbreaks caused by black market products. In fact, by creating an even larger black market, including not only cannabis, but also nicotine e-cigarettes, bans all but guarantee that future outbreaks will be more frequent and widespread.

(This post was updated on January 21, 2020.)