The latest: The Food and Drug Administration (FDA) issued warning letters to 8 retailers for selling unauthorized tobacco products, including nicotine pouches and dissolvable tobacco products, that have labeling, advertising, and/or design features that cause the products to imitate candy, breath strips, and cough drops.
- Why it’s important: Products that look like everyday items can accidentally be ingested by young children and may appeal to children looking to hide the products from parents, teachers, or other adults.
But meanwhile: More details have come out about FDA’s decision to approve the first flavored vaping products and stop enforcing against some unauthorized flavored vapes. And some members of Congress have questioned health officials and voiced frustration with the move.
- Big Tobacco donations: Reynolds American donated $5 million to a super PAC backed by President Trump last month, about one week before the administration rolled out the new policy. Two days after the donation top executives and lobbyists had lunch with Trump at his golf club in Florida and expressed dissatisfaction with the way FDA was regulating the industry. Trump interrupted the conversation to call then-FDA Commissioner Makary, Department of Health and Human Services Secretary Kennedy, and Centers for Medicare and Medicaid Services Administrator Oz, complaining about FDA’s regulation of e-cigarettes. Less than one week later, FDA issued the new guidance, which bypassed the regular rulemaking process. There is no definitive evidence linking the guidance to the donation, lunch, or specific lobbying, but the episode represents a victory for industry. Reynolds has also donated to a separate super PAC backing Trump’s campaign and to the effort to raise funds to build a White House ballroom.
- FDA officials blindsided: Senior officials in FDA’s tobacco center were blindsided by the recent guidance. Some FDA officials tasked with enforcing vaping regulations were not consulted on the changes and only learned of them the night before the document was published. This sparked internal confusion about how the policy came about and who authorized it. It is highly unusual for FDA to draft new policies without input from the staffers who oversee them. The guidelines also bypassed a federally required public comment period.
- Response in Congress: At a Senate Appropriations Health Subcommittee hearing, health officials struggled to defend the policy. NIH Director Bhattacharya would not say whether he approved of FDA’s authorization of fruit-flavored vapes. When questioned by Sen. Durbin on the FDA authorizations, Bhattacharya said he thinks “vaping for kids is a dangerous thing,” but the NIH’s role “isn’t to set policy” but rather to research how to address health problems. Durbin asked Bhattacharya if the administration’s decision makes sense to him, and Bhattacharya replied, “Having kids have more access to vaping does not make sense to me.” Durbin also sent a letter to HHS Secretary Kennedy to push back on the decision to ease regulations on flavored vaping products and authored an article in STAT outlining how the moves will help Big Tobacco and hurt young people.