FDA Inability to Police Vapes Criticized at Hearing

Both Republicans and a Democrat on the committee criticized the agency's efforts to keep unauthorized vaping products off the market, saying that it's too focused on small vape shops, doesn't tackle large manufacturers (who are mostly in China) and distributors enough, and isn't effective in curbing the supply.

Only 11% of vapes for sale in the U.S. are authorized by the FDA.

Center for Tobacco Products Director Brian King said during a Sept. 10 hearing that the millions of applications that the FDA hasn't approved didn't submit adequate science to show that their products were more likely to help smokers switch to vaping rather than lure teens or tweens into nicotine addiction.

King also told the subcommittee that the FDA has taken action against importers. In his opening statement, he said, "FDA also works with CBP, and the U.S. Postal Service at the International Mail Facilities, to screen FDA-regulated products at entry for compliance with applicable requirements. Many e-cigarette products offered for import are not properly declared. CBP has authority to administratively seize products that are smuggled or clandestinely imported."

He said a joint operation with CBP at Los Angeles International Airport "resulted in the administrative seizure of approximately 1.4 million units of unauthorized e-cigarette products, including Elf Bar, one of the most used products among youth, with an estimated retail value of more than $18 million. Many of these products were intentionally mis-declared as various items such as toys or shoes and listed with incorrect values."

A press release about the action last year said the vapes were in 41 shipments sent over three days to LAX.

In June, the FDA and CBP seized 179 boxes of vaping products that were mislabeled as other items that arrived at the Chicago port of entry from China; they contained 53,700 items, valued at $1 million.

Although some of these shipments were fraudulently labeled, there is no requirement that importers of e-cigarettes verify that the products have been cleared by the FDA. The agency is accepting comments now on a proposed rule that would require shipments containing vapes or vaping liquids to submit into ACE the tracking number associated with their request to market their goods (see 2408150025).

If that was required, FDA would be able to automate its rejection of unauthorized vapes. "Lowering instances of manual review by FDA of entries containing [electronic cigarette] products ... will protect the public health by conserving Agency resources and more quickly identifying ... products that do not have marketing authorization and which may be associated with a greater public health risk," the FDA wrote in its proposed rule.

King argued that Congress needs to rewrite the user fee law for cigarettes, because vapes and vaping liquid are not covered by the user fees, and the fees are capped at $712 million. King said the FDA needs an additional $114 million annually in fees to manage its oversight, enforcement and education missions.

Subcommittee Chairman Brett Guthrie, R-Ky., said he does not believe the Tobacco Center's "failure to authorize tobacco harm reduction products" is a problem of lack of resources, but instead, shows poor priorities and culture.

Rep. Jennifer McClellan, D-Va., has introduced a bill that would apply the fees to vapes and end the fee cap.

Rep. Richard Hudson, R-N.C., told King that he was able to quit smoking cigarettes, which he had done for almost 40 years, by using alternative nicotine delivery systems, and complained that the FDA has not approved any nicotine pouches (similar to oral tobacco, but just with nicotine powder).

Hudson scoffed at King's argument that the agency is acting against importers, given that the $18 million action is less than one-tenth of 1% of the $2.4 billion vapes market in the U.S.

Rep. Lori Trahan, D-Mass., complained that even though it's illegal to sell flavored vapes in Massachusetts, they're still available.

King said the volume of contraband cannot be stopped with the resources his center has.

However, full Committee Chair Rep. Cathy McMorris Rodgers, R-Wash., told King that the FDA has done a good job in educating teens about the dangers of vaping, and she believes the data that teen vaping is down, as she's hearing less about the problem from her constituents. But she said she has been hearing problems about candy containing CBD or THC, chemicals in cannabis.

Jim Jones, deputy commissioner for human foods at the FDA, the other witness at the subcommittee hearing, said they have taken action against CBD in foods, but also suggested that parents report the goods to local law enforcement.

Rep. Morgan Griffith, R-Va., said that local police have no authority to pull goods that say "THC" on the package, because that being on the label doesn't make it so. In order to prove the food was adulterated with cannabis, the food would have to go to overworked forensic labs. "That dog won't hunt," he said.

Guthrie, ahead of the hearing, had said they might discuss tobacco fees legislation, a bill on food traceability, a bill changing the requirements for orange juice, a bill on shrimp inspections, on honey identification, and on prohibiting soy or other plant milks from calling themselves "milk," among others. The last bill drew most of the questions.

Ranking member Anna Eshoo, D-Calif., said in her opening statement that the FDA is taking too long to promulgate rules on non-dairy milk, orange juice and honey, and she said she hopes they will act so that Congress won't have to pass legislation to force their hands.

Several members from Florida complained that domestic orange growers cannot sell their juice because Florida trees no longer produce fruit with a high enough sugar concentration, so juice companies have to import foreign OJ to blend with Florida juice to be allowed to market the juice as orange juice.

Rep. Buddy Carter, R-Ga., said the Laws Ensuring Safe Shrimp Act is needed to require inspection of seafood entering the U.S. so that it is free of illegal antibiotics, and wasn't captured in illegal fishing operations.

"I'm not trying to do away with competition," Carter said. "We need this industry to survive."

Jones said that the FDA has spent $7 million to enhance its shrimp import program, and that the FDA has been working with the governments of the countries that host major exporters to increase "the likelihood safety standards are being adopted."