FDA tiptoes toward enforcement of rules prohibiting unauthorized ecigs

It is currently illegal to sell almost every e-cigarette on the market. (The exceptions are a few e-cigarettes produced by RJ Reynolds, NJOY and Logic Technologies.) But FDA has been very slow to take strong formal enforcement actions.

As of October 2022, FDA, working through the Department of Justice, had sought injunctions against 6 small-time manufacturers “for continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law” to compel them to stop. In February 2023, FDA, again working with DOJ, filed “civil money penalty complaints” against four manufacturers who had continued to sell e-cigarettes after being sent warning letters. (Since January, 2023 a total of 29 civil money complaints have been issued.) FDA announced, “Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.”

While technically correct, the reality is that the FDA could have levied much larger fines — $1.2 million — had it charged multiple violations at the same time. As a lawyer for the Campaign for Tobacco Free Kids wrote FDA Center for Tobacco Products Director Brian King on June 30, 2023:

We urge FDA to hold manufacturers accountable for making or selling illegal e-cigarette products by asserting, and seeking the statutory maximum for, multiple violations of the Family Smoking Prevention and Tobacco Control Act (“TCA”). This would be a change from what we understand to be the current policy of charging manufacturers or sellers with a single violation. …

In its February 22 press release, FDA stated that it was pursuing the “statutory maximum allowed by law.” We agree that these circumstances merit the maximum penalty. However, the Agency charged each of the four manufacturers with only a single violation of the TCA, seeking only $19,192—the maximum penalty for a single violation—from each company. We are concerned that seeking a total of only $19,192 from a manufacturer for marketing perhaps thousands of violative products will do little to deter wrongdoers and pressure e-cigarette manufacturers into compliance. In fact, as we explain below, the Agency has authority to charge a manufacturer with multiple violations, up to $1.2 million in a single proceeding. Moreover, under the statute, the Agency may initiate multiple proceedings against a manufacturer that has repeatedly violated the law, as many e-cigarette product manufacturers have.

The plain language of the TCA states that FDA may seek CMPs for multiple violations in a single action. This is consistent with how FDA historically has interpreted the statute.

TFK asked for a meeting to discuss these issues.

The fact that FDA has moved beyond warning letters is, of course, a good thing. The fact that they are only seeking nominal fines means continuing to flaunt the law is just a minor cost of doing business. Even $1.2 million is not that much money for a major company, but it is certainly more than $19,192.

And, of course, FDA has not gone after any of the big boys.

As of September 14, 2023, FDA has not responded to TFK.