Fact check: Pfizer's coronavirus vaccine is FDA-approved; cigarettes are not

Devon Link

The claim: The Food and Drug Administration approved cigarettes

On Aug. 23, the U.S. Food and Drug Administration fully approved the Pfizer-BioNTech COVID-19 vaccine. The move opened the doors for companies, schools and governments to announce vaccination mandates.

In the following days, anti-vaccine advocates wrongly claimed the FDA approval meant "nothing" since the agency also approved tobacco products.

“Just so everyone is clear.. FDA also approved cigarettes,” reads text in an image shared to Facebook Aug. 24.

“Friendly reminder: Cigarettes are FDA approved,” another Aug. 24 post says. 

But the FDA hasn’t approved cigarettes or any other tobacco products. And it doesn't have the authority to ban them.

Fact check:FDA has fully approved Pfizer's coronavirus vaccine

The agency regulates how tobacco products can be manufactured, marketed and distributed. These regulations are different from the pre-market approval process the Pfizer vaccine had to go through.

USA TODAY reached out to several social media users who shared the claim for comment.

FDA doesn't approve tobacco products

The FDA is charged with ensuring food, drugs, cosmetics and other products are safe for consumers. The agency regulates tobacco products, but it doesn't approve them the same way it does drugs and biologics, which include vaccines.

Since tobacco products are inherently dangerous, the FDA does not approve them.

Fact check:Comparing Pfizer vaccine approval to cigarettes, alcohol is wrong

“There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products,” the agency says on its website. “Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.”

To legally sell and distribute tobacco products in the U.S., manufacturers must apply for a marketing order that indicates the product complies with the law. The FDA does not have the authority to ban tobacco products.

Vaccines face more scrutiny, need pre-market approval

Unlike tobacco products, the FDA must approve vaccines before they are distributed to the public.

That was the case with Pfizer's vaccine, which was tested in several clinical trials with tens of thousands of recipients before receiving FDA approval. 

Dr. Yomaris Pena extracts the last bit of Pfizer-BioNTech COVID-19 vaccine at the Corsi Houses in New York

On Dec. 11, the FDA approved the vaccine for emergency use in individuals 16 and older. The FDA grants emergency use authorizations to medical products if the Health and Human Services secretary declares a public health emergency and the product's benefits outweigh its potential risks. 

On May 10, the Pfizer vaccine's emergency use authorization was extended to those ages 12 to 15.

As part of the official FDA approval process, Pfizer had to submit a comprehensive biological license application that the agency used to evaluate data on the vaccine’s safety and efficacy. The 340,000-page application added to data previously submitted and reviewed in the emergency use application.

The license application reviewed data on the vaccine’s effects on 44,000 trial participants over several months. The trial results indicated the vaccine was 91% effective in protecting against COVID-19. 

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“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in an Aug. 23 statement.

Our rating: False

The claim that the FDA approved cigarettes is FALSE because it is not supported by our research. The FDA does not approve tobacco products. Instead, it regulates their distribution and sale to reduce harm. The FDA’s tobacco regulations are different than the approval process vaccines like Pfizer’s must go through to gain official approval. The FDA does not have the authority to ban cigarettes.

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Our fact-check work is supported in part by a grant from Facebook.