FACT CHECK: Does The FDA Approve Cigarettes?
An image shared on Facebook over 200 times claims cigarettes are approved by the Food and Drug Administration (FDA).
The FDA does not approve tobacco products. It regulates their manufacture, distribution and marketing.
Posts claiming cigarettes are FDA-approved cropped up on Facebook after the FDA announced Aug. 23 that it had approved the Pfizer-BioNTech COVID-19 vaccine for people ages 16 and older. (RELATED: Viral Post Claims The FDA Did Not Approve The Pfizer COVID-19 Vaccine)
The FDA is “responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation,” according to a page on its website. However, the agency does not grant approval to cigarettes.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA has the authority to “regulate the manufacture, distribution, and marketing of tobacco products.” Regulation and approval are not the same thing. The FDA explicitly states on its website that it “doesn’t approve tobacco products.”
“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 FDA explains. “Instead, the FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.”
Manufacturers “must receive a written order from FDA” to legally sell or distribute a tobacco product, according to the agency’s website. The FDA notes that such a marketing order “does not indicate that the tobacco product is either safe or ‘approved'” but rather that the manufacturer “has complied with the requirements under the law to bring its product to market.”
Sarah Tucker, a partner specializing in FDA regulation and product liability at the law firm Womble Bond Dickinson, explained to ABC 10’s Verify that there are different regulations for medical products and tobacco products, saying, “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.”
The FDA’s Center for Tobacco Control has the legal authority to “require tobacco product manufacturers register with FDA,” “establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness,” “establish limits on sale and distribution of tobacco products” and “require premarket review for new and modified risk tobacco products to protect the public health,” according to the FDA website.
Vaccines like the Pfizer-BioNTech COVID-19 vaccine go through a multi-step approval process that includes conducting clinical trials, filling out a Biologics License Application and presenting findings to the FDA’s Vaccines and Related Biological Products Advisory Committee, according to the Centers for Disease Control and Prevention. Pfizer told the Associated Press that the process of getting its COVID-19 vaccine approved required a 360,000-page application along with inspections.