Makary Is Out. The Mess He Left Behind Isn't.

Former FDA Commissioner Marty Makary resigned from the agency last week, according to The Independent. His office is tied to a six-page memo that bypassed internal tobacco staff, skipped federally mandated public comment periods, and opened the door to a flood of new flavored nicotine products — all without the knowledge of the people whose job is to vet them.

He's gone. The policy is still in effect. The internal confusion at the FDA continues.

Two Specific Products. One Los Angeles Company. Zero Scientific Vetting.

The company at the center of this is Glass Inc., based out of Los Angeles, according to reporting from WXII and KETV. They got two flavored e-cigarette products approved under the new FDA framework — one called Gold (mango flavor) and one called Sapphire (blueberry flavor). Both were marketed as smoking cessation tools for adults.

Both are fruit-flavored. Both are now on the market.

The FDA's stated justification: the new guidelines allow certain nicotine-based products to enter the market without full regulatory scientific vetting, a direct reversal of the agency's decade-long standard requiring verified health benefits before authorization, according to The Independent.

The American Academy of Pediatrics Has Seen Enough

The American Academy of Pediatrics is now formally calling on the FDA to reconsider and reverse these approvals. Dr. Scott Hadland, Chief of Adolescent Medicine at Mass General Brigham for Children, explained the concern on WXII and KETV: flavoring is the primary driver of teen vaping adoption, and the vast majority of teenagers who vape report the flavors as a key reason.

"We just don't know what on balance is going to happen here," Hadland said. His worry isn't that adults can't benefit from vaping as a cessation tool. His concern is that those adult benefits will be outweighed by new teen users who find a way to get their hands on mango and blueberry vapes regardless of age restrictions.

Teen vaping hit 1.6 million students in 2024, down from 2.1 million the year prior, according to Hadland. That's a drop of half a million. The question now is whether approving more flavored products reverses this progress.

The FDA's Own Defense Doesn't Answer the Core Question

HHS spokesperson Andrew Nixon put out a statement saying the new approach "strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers," according to The Independent.

The statement does not explain who wrote the memo, who authorized it, or why FDA tobacco enforcement staff found out about it the night before it was published.

Nixon didn't address the guidance's origins. Makary didn't respond to comment requests. The agency is still holding extensive internal meetings to figure out how to implement a policy that landed in their laps without warning, according to The Independent.

The Lobbying Connection

This memo came after months of complaints about Makary from industry lobbyists with close ties to the White House, according to The Independent. Industry lobbyists complained about the FDA's top official. That official then published a policy favorable to the industry — without consulting his own staff — and subsequently resigned.

Mitch Zeller, who ran FDA tobacco regulation until his 2022 retirement, said directly: "It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway. And that goes to the ability of the public to have trust and faith in institutions like FDA," according to The Independent.

Zeller ran that office for years. When he says the process was compromised, he brings credibility to the claim.

What Mainstream Coverage Is Getting Wrong

Left-leaning outlets like AP News are leading with the process scandal — which is real and legitimate — but they're soft-pedaling the actual product approvals and the specific company involved.

Meanwhile, most coverage is missing this angle: this directly contradicts the Make America Healthy Again framework the current administration has championed. MAHA explicitly targets food dyes, additives, and products that harm children. Approving mango and blueberry vapes that the nation's top pediatrics organization says will reach teenagers — without scientific review — is inconsistent with that agenda.

What This Means for Regular People

Two flavored vapes are already on store shelves. More could follow under the same framework. Teen vaping numbers were finally moving in the right direction — 500,000 fewer kids vaping in a single year. That progress is now at risk.

The FDA has no credible answer for who authorized this. Its top official resigned. Its own staff was blindsided. The pediatrics community is formally demanding a reversal.

Somebody made this call. We still don't know who.