The FDA’s problem isn’t personnel — it’s enforcement

.

President Donald Trump’s FDA chief is out, but the reason behind it is not what many think. We must be careful not to learn the wrong lessons from Marty Makary’s resignation.

The narrative around the resignation of former Food and Drug Administration official Makary, as reported in the media, implies he was pushed out for refusing to approve fruit-flavored vapes. In reality, the FDA reversed its strict stance against the product last week, and Makary’s departure involved several unrelated factors that marked his tenure, including mass layoffs and policy disputes with lawmakers and Trump. The media’s increased focus on political speculation is irresponsible. It distracts from the real issue at hand: the agency’s failure to implement regulations on the flavored vapes already on the market.

The reversal doesn’t guarantee the safety of products for sale in gas stations, since many were already available before approval. Instead, it shows the FDA’s inconsistent regulatory process. If the FDA wants to protect the youth while maintaining legitimacy, it should focus on thorough product review, age-gated authorization, and demanding accountability from manufacturers, rather than allowing political speculation over Makary to obscure possible dangers to adolescents.

TOM COTTON WARNS FDA ABOUT CYBERSECURITY THREAT FROM CHINESE-MADE MEDICAL DEVICES

A pattern of weak enforcement by the FDA with illicit vape retailers is not new. That’s how illegal products became quickly available and prolific in the American market. Over 86% of the U.S. market hosts unregistered vape products today, directly undermining the FDA’s approval process, which typically requires a substantive evaluation of each product’s design, manufacturing, chemical ingredients, and health risks before sale.

Completely unregulated products present various risks to consumer safety and manufacturer liability. Unknown ingredients, possible contamination, and inconsistent levels of nicotine, combined with a lack of FDA oversight, endanger the health of a young customer base. Failing to inspect incoming products also allows more unsafe and unauthorized products to flood our markets, while undermining legitimate vape companies that do comply with review requirements. Black market vapes are also more likely to evade age restrictions and general quality control, causing ambiguity and preventing a clean, safe market.

Many illegal products are still on the market today and will likely remain unchecked due to the FDA’s relaxed enforcement. There are currently thousands of flavored vape products in the market, with a majority being cheap, unregulated disposables from China, while only 45 are FDA-approved. The oversight, paired with a reported lack of proper identification by shops, is making it progressively more difficult to reduce risks to adolescents consuming the liquid, with 1.63 million middle and high school students claiming to own a vape in 2025.

The FDA must step up and do its job: remove illicit products from the market and approve safe alternatives instead. A failure to achieve this basic duty is Makary’s legacy.

Thorough product review and age-gated authorization are crucial in vape production and distribution, but manufacturer accountability is another important element. The United States recently seized $175 million worth of illegal e-cigarettes shipped from China, underscoring the importance of targeting the head of the supply chain and possibly saving many from more hazardous illegal products.

NEW ELI LILLY WEIGHT LOSS DRUG HAS DRAMATIC EFFECTS IN CLINICAL TRIAL

Enforced accountability at the manufacturing stage is essential for cultivating public trust and consumer safety. The FDA’s new enforcement guidance does the opposite. It allows illegal vapes to stay in the market while products are processed, which could take up to five years due to a backlog of applications.

The sensationalist speculation about Makary’s departure from the FDA deflects from the agency’s deep-rooted administrative failures, which predate his tenure and allowed thousands of dangerous and unauthorized vaping products to proliferate in the U.S. with little effective enforcement.

Lora Karch is an independent policy writer with Young Voices, passionate about individual liberties. Her work has appeared in The National Interest, Reason, The Libertarian Institute, RealClearWorld, Times of Israel, and more. You can follow her for more of her work on X: @LoraKarch

Related Content