FDA Imposes Deadline on Synthetic Nicotine Products

On Wednesday, the FDA Tobacco Products Center faced a deadline to take action on popular synthetic nicotine products. However, the agency did not take the strong action that lawmakers and anti-tobacco advocates had requested.

Electronic cigarette companies must submit their pre-market applications before May 14th in order to maintain their products on the market. Products that use synthetic nicotine in electronic cigarettes without FDA authorization must be removed from shelves before July 13th. On Wednesday, the FDA announced its so-called "first two warning letters" to manufacturers who have been illegally selling non-tobacco nicotine electronic cigarette products without authorization.

Synthetic nicotine is an attempt by the industry to evade FDA oversight by manufacturing nicotine in labs rather than sourcing it from tobacco, effectively putting it out of the agency's jurisdiction. However, the FDA stated before the law came into effect in April that the national spending package announced in March "clearly indicates that the FDA can regulate all tobacco products containing nicotine.

According to the FDA, letters were sent to AZ Swagg Sauce LLC and Electric Smoke Vapor House, which together have 10,000 products. The agency stated that both companies did not submit premarket applications by the deadline. Under the law, anyone manufacturing or selling "non-tobacco nicotine" must comply with FDA regulations, which include the requirement for FDA authorization, no sales to individuals under the age of 21, and no claims that their products are less harmful than cigarettes.

The US Food and Drug Administration (FDA) announced on Wednesday that it has sent 107 warning letters to retailers in the past two weeks, demanding that they refrain from selling synthetic nicotine products to minors.

According to Brian King, director of the Center for Tobacco Products, the FDA has been actively implementing key new laws regulating non-tobacco nicotine products since their passage. The warning letters announced today are just the beginning of our efforts to ensure compliance and enforcement. Over the coming weeks, we will continue to investigate companies that may be illegally marketing, selling, or distributing non-tobacco nicotine products and take appropriate action.

Starting Wednesday, any new synthetic nicotine products that have not been authorized for market by the FDA cannot be legally sold. The US Food and Drug Administration (FDA) has reported that it is currently processing over one million applications for synthetic nicotine products submitted by more than 200 manufacturers.

Anti-tobacco advocates say that the FDA's actions are insufficient.

This is not even a step forward, it's just them lifting their foot," said Erika Sward, National Assistant Vice President of Public Affairs for the American Lung Association. Taking action against retailers does not cut off the head of the beast.

Sward stated that all products should be taken down by Thursday with no reason for retention.

The FDA has not taken action against the popular disposable brand, Puff Bar, which offers a variety of flavors including mango, strawberry banana, and peach ice. The product has become a favorite among students in 2021, with over a quarter of high school students claiming Puff Bar as their go-to brand.

According to Sward, the deadline is crucial because it involves the most popular products and brands among children, including Puff Bar. "If the FDA is really going to take action to protect children, Puff Bar needs to be the starting point. We fully expect and hope to see Puff Bar removed from the market. I think it's clear that this is what Congress wants.

Puff Bar did not respond to this.

Republican Senator Susan Collins of Maine and Democratic Senator Dick Durbin of Illinois wrote a letter to the FDA, urging the agency to complete its work before the deadline. On Wednesday, Durbin criticized the agency in the Senate.

The FDA should protect all Americans, especially our children. I call on the FDA to ultimately regain their senses. Stand on the side of public safety, stand on the side of children, not on the side of tobacco companies. The FDA's legal department's actions are unimaginable. This is unsafe for the United States. This is unsafe for our future," he said.

The anti-tobacco organization expressed disappointment with the FDA's inaction.

Harold Wimmer, the President and CEO of the American Lung Association, stated that in March, Congress gave the FDA a clear deadline to regulate tobacco products made with synthetic nicotine. The law requires the FDA to take action and immediately remove these products from the market, using the necessary tools at their disposal.

In May, the FDA announced that it will not complete the review of all pre-market applications for electronic cigarette companies before June 2023, despite a court order to make a decision by that time. This marks a delay of nearly two years.

According to a national survey on youth tobacco use, over two million middle and high school students used e-cigarettes in 2021.

Wimmer stated, "The FDA's ongoing delay is putting more children at risk of addiction to these products. We urge the FDA to swiftly remove all synthetic nicotine products from the market and take strict enforcement measures.

Last week, after a temporary administrative halt was put in place by the US Appeals Court on June 24, the FDA announced that it was suspending its order to remove all Juul Labs' electronic cigarette products from store shelves. The agency cited "scientific issues" and stated that further review was warranted. Anti-tobacco organizations criticized the agency for making ambiguous statements.

The Biden administration has taken steps to curb smoking. In June, it announced plans to develop a proposed regulation that would establish a maximum nicotine level in cigarettes and other tobacco products.

In April, the FDA proposed a rule to ban menthol cigarettes and flavored cigars. A public hearing was held on this topic earlier this summer, and the agency is currently reviewing comments to ultimately determine the rule. However, tobacco companies are expected to file lawsuits in order to prevent the rule from going into effect.

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