No, the FDA doesn’t approve cigarettes or other tobacco products

On Aug. 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine. It is now the first COVID-19 vaccine to be granted full FDA approval and it also received the agency’s fastest vaccine approval ever.

Before Pfizer’s COVID-19 vaccine received FDA approval, many people who were hesitant to get vaccinated claimed, "it's not approved by the FDA." After the vaccine was approved, skeptics on social media, like comedian and rapper Lil Duval, began sharing a new claim: “The FDA has approved cigarettes.” 

VERIFY viewer Chuck says he’s seen those claims on Facebook and told our team the individuals posting them are using it as an excuse to not get the COVID-19 vaccine. He wants to know if cigarettes are really approved by the FDA. 

THE QUESTION

Does the FDA approve cigarettes or other tobacco products?

THE SOURCES

• U.S. Food and Drug Administration (FDA)
• Sara Tucker, Partner at Womble Bond Dickinson

THE ANSWER

No, the FDA doesn’t approve cigarettes or other tobacco products.

WHAT WE FOUND

The FDA says on its website that it does not approve tobacco products. However, under the Family Smoking Prevention and Tobacco Control Act, which was signed into law in June 2009, the FDA was granted the broad authority to regulate the manufacture, marketing, sale and distribution of tobacco products. 

According to the FDA, the agency develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act (FD&C Act) or other laws, including the Tobacco Control Act. FDA regulations have the full force of law.

“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. Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole,” said the FDA. 

In the United States, tobacco companies must receive a written order from the FDA to legally sell or distribute a new tobacco product. Three pathways are available to bring a tobacco product to market: premarket tobacco applications, substantial equivalence applications, or exemption from substantial equivalence.

The FDA says a marketing order does not indicate that the tobacco product is either safe or “approved.” Instead, it means that the manufacturer has complied with the requirements under the law to bring its product to market.

Sara Tucker is a partner at Womble Bond Dickinson in Atlanta who specializes in FDA regulatory and product liability litigation. She tells VERIFY the FDA’s Center for Tobacco Products (CTP) looks at whether or not tobacco products have the ingredients in them that the manufacturer claims they have and also checks to see if the products have any additives that have been deemed harmful.

“What FDA is going to be looking at in terms of a cigarette is very different than what FDA is going to be looking at in terms of a pharmaceutical product or a medical device implanted in your body. That's a really different set of regulations than what pertains to tobacco companies,” said Tucker. 

She says FDA regulations on tobacco products are publicly available on the agency’s website.

“If you want to see the statute that things are based on, you can click on it and they'll show you. [FDA] really explain exactly what their role is versus what their role is not,” said Tucker. 

Wondering what else is and isn’t FDA approved? Consumers can access a list on the FDA’s website.  

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