Senator Durbin is right to critique the FDA’s speed and enforcement of ENDS product reviews

Last month, Senator Dick Durbin (D-IL) sent a scathing letter to the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) on the one year anniversary of a court-ordered deadline for the FDA to finish reviewing e-cigarette applications for Electronic Nicotine Delivery System (ENDS) products. The letter highlights several ongoing problems at the federal agency when it comes to maximizing time and efficiency and enforcing established rules.

In the letter, Durbin carefully articulates how the FDA’s failure to meet important deadlines, such as for the Premarket Tobacco Product Applications (PMTAs) pathways program, endangers public health by allowing unapproved products to remain on the market until after agency reviews are complete. He notes that at present, the FDA is only about halfway through the application process and does not expect to complete it until the end of June 2023. That date is nearly two years past the agency deadline and almost three years past the deadline for manufacturers.

Durbin also reveals “deep concerns” about the agency’s willingness to tackle issues of non-compliance. While some manufacturers are still awaiting FDA application approvals, many are not. In a striking number of cases, manufacturers have continued to sell ENDS products despite having already received denial orders. 

In a recent STAT News investigation that examined 120 denial orders issued to manufacturers between August 2021 and May 2022, the health news organization found that 139 of 274 banned products were still being sold on the market. Yet the FDA has shown little appetite for going after these bad actors.

This behavior is deeply concerning because, as Durbin himself points out, Congress has granted the FDA “sweeping legal authority” to take action against companies that willingly flaunt their disobedience of agency orders. In addition to having the authority to conduct Compliance Check Inspections and send “Warning Letters” to non-compliant businesses, the Tobacco Control Act (TCA) empowers the FDA to initiate legal proceedings against these businesses. This power includes issuing monetary penalties known as Civil Money Penalty (CMP) Complaints. The FDA also has the authority to remove products from the market, but it almost never does.

According to the most recent data available on the FDA’s “Compliance Actions” dashboard, letters of warning were the only method of enforcement the agency employed. Between 2010 and 2022 alone, the agency issued 116,198 “warning letters” to non-compliant businesses. In contrast, the agency issued zero injunctions and zero product seizures. With consequences like these, one can hardly wonder why so many businesses continue to skirt FDA rules.

This situation is a shame since the FDA has a key role to play in evaluating product quality and determining whether a product meets U.S. safety standards. Consumers deserve to know that the products they purchase have been tested. Research tells us that most Americans are not aware of the contents of many e-cigarette products, particularly those that are disposable and have been manufactured overseas. 

The lack of enforcement by the FDA is unfair to any e-cigarette manufacturer who plays by the rules. If untested products from competitor manufacturers are allowed to remain on store shelves, then little incentive exists for good behavior. Swift action against non-compliant actors is a necessity for both consumers and law-abiding businesses. 

Not everything in Durbin’s letter to the FDA is correct. For instance, not all e-cigarette products are equally harmful. Properly vetted vape products can offer consumers an alternative to traditional combustible cigarette, which contain greater amounts of dangerous chemicals and carcinogens. Moreover, these products have been shown to play an important role in harm reduction and cessation treatments.

However, Durbin is absolutely correct that the FDA needs to improve both its speed of operation and enforcement practices. Sending angry warning letters to repeat offenders is simply not enough. The agency must begin issuing real monetary penalties to non-compliant actors and remove untested products from store shelves whenever and wherever they appear. Actions such as these will go a long way toward showing consumers and product manufacturers that the agency is serious about protecting public health. 

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