Fact Check: Cigarettes Are NOT 'FDA Approved'

Fact Check

  • by: Marlo Lee
Fact Check: Cigarettes Are NOT 'FDA Approved' Legal Vending

Are cigarettes approved by the FDA? No, that's not true: The Food and Drug Administration does not "approve" tobacco products, but it does regulate the manufacturing, marketing and distribution of tobacco products. There is a difference between regulating a product and approving it for use.

The claim appeared in a Facebook post (archived here), published on August 24, 2021, with text reading:

Friendly reminder: Cigarettes are FDA approved.

This is what the post looked like on Facebook at the time of writing:

Facebook screenshot

(Source: Facebook screenshot taken on Wed Aug 25 17:55:17 2021 UTC)

The FDA has a page on its website about the agency's Center for Tobacco Products (CTP) answering commonly asked questions. The site says this about the relationship between the FDA and tobacco products:

FDA does not 'approve' tobacco products, but the Family Smoking Prevention and Tobacco Control Act provides legal ways for new tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, we will issue a written notification permitting the marketing of the new tobacco product. Tobacco manufacturers may use one of the three Pathways to Market to seek to legally market new tobacco products. These include:

  • Premarket tobacco products--This pathway requires the applicant to demonstrate that FDA permitting the marketing of the new tobacco product would be appropriate for the protection of the public health.
  • Substantial equivalence--This pathway may be appropriate for a new tobacco product that demonstrates it has the same characteristics as a predicate tobacco product, or has different characteristics, but does not raise different questions of public health from a predicate product.
  • Exemption from substantial equivalence--This pathway may be appropriate for new tobacco products with certain minor modifications to additives of a legally marketed tobacco product.

The Family Smoking Prevention and Tobacco Control Act, signed into law on June 22, 2009, gave the FDA authority to regulate the manufacturing, marketing and distribution of tobacco products.

The Center for Tobacco Products exercises that authority. According to its "What CTP Does" page, it protects youth, provides information to help educate tobacco consumers, ensures compliance with the law, reviews new products and product changes, and leads cutting-edge research.

Nether the CTP, as part of the FDA, nor the FDA "approves" any tobacco products, including cigarettes.

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Marlo Lee is a fact checker at Lead Stories. She is a graduate of Howard University with a B.S. in Biology. Her interest in fact checking started in college, when she realized how important it became in American politics. She lives in Maryland.

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