The Story Behind the Policy

The FDA recently approved flavored vapes and nicotine pouches. What has gone unexamined: the people whose job it is to enforce vaping regulations didn't know it was happening.

According to AP Health Writer Matthew Perrone, two FDA staffers — speaking anonymously because their jobs depend on it — confirmed that senior officials in the FDA's tobacco center were not consulted on the new guidelines. They found out the night before the document went public.

A Six-Page Memo That Changed Everything

The policy in question is a six-page memo posted online earlier this month. According to AP News, it allows companies to launch certain nicotine-based products before they've been fully vetted by regulators.

This breaks with longstanding FDA policy, which requires scientific verification of health benefits for smokers before any new product hits the market.

It also bypassed a federally required public comment period. The FDA published the final policy without the legally standard process for public input and revision.

Hours-long internal meetings have since been held at the agency trying to figure out how to implement a memo that appeared out of nowhere, according to AP reporting.

Who Ordered This?

Mitch Zeller, who ran FDA's tobacco division until 2022, told AP News: "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."

Andrew Nixon, spokesperson for Health and Human Services, issued a statement saying the approach "strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers." He did not address who authorized the guidance or how it came about, according to WRAL's reporting of the AP story.

Former FDA Commissioner Marty Makary — who resigned last week — did not return messages seeking comment, per AP News. Makary resigned after the memo was posted but before this story broke.

The guidance was published after months of complaints about Makary from industry lobbyists close to the White House. Industry complaints preceded the policy change, which preceded Makary's departure.

The Specific Products

The manufacturer behind two of the newly approved products is Glass Inc., based out of Los Angeles, according to Dr. Scott Hadland, Chief of Adolescent Medicine at Mass General Brigham for Children. The two products are called Gold (mango flavored) and Sapphire (blueberry flavored).

The FDA approved them for smoking cessation in adults.

The American Academy of Pediatrics wants the FDA to reconsider. Dr. Hadland told WISN their concern is straightforward: flavors are what attract teenagers. The vast majority of teens who vape cite flavoring as the reason they started.

Teen Vaping Is Declining

Dr. Hadland cited the most recent national data from 2024: 1.6 million middle and high school students reported vaping — down from 2.1 million the year before. That's a drop of 500,000 kids in one year, per WISN.

Vaping among teens is at an all-time low.

What the Coverage Is Missing

Left-leaning outlets have framed this primarily as a youth health crisis. The broader issue is process: a federal regulatory agency published a major policy change, bypassing legally required public comment, without consulting the experts responsible for enforcement, and no one will name who authorized it.

That is a breakdown in how federal regulation functions. A federal agency where unnamed forces can override staff experts and skip public comment isn't deregulation. It's a process without oversight.

What This Means for You

If you're an adult smoker trying to quit, these products may genuinely help — the science on e-cigarettes versus combustible tobacco is reasonably well established. That part of the policy has a basis.

But if the FDA can be redirected overnight by unnamed people, skipping legal process, then the agency's credibility depends on knowing who makes major decisions and why.

The FDA's credibility is what stands between 330 million people and whatever a well-connected lobbyist wants on the market next week.

We still don't know who ordered this.