Tobacco-Related Health Fraud
All tobacco products are harmful to your health, despite what they taste, smell, or look like.1 Claiming less harm or reduced risk of disease from using tobacco products can mislead consumers to think that these products are safe to use. FDA considers these kinds of unauthorized claims to be health fraud.
Explicit or implied claims of reduced harm or the risk of tobacco-related disease can only be made after scientific evidence to support those claims has been submitted to FDA, and FDA has issued an order permitting their marketing use. These requirements were put in place so that American tobacco consumers are not misled about the harms of tobacco products. See Modified Risk Orders for a list of tobacco products that have met the requirements permitting them to make claims of reduced risk or harm to users and nonusers.
What is Tobacco-Related Health Fraud?
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False or misleading claims in the promotion, labeling, advertising, distribution or sale of tobacco products, including suggestions that a tobacco product is safer, less harmful, contains a reduced level or is free of a harmful substance, or presents a lower risk of tobacco-related disease compared to other tobacco products.
Examples of Tobacco-Related Health Fraud
FDA has issued a number of warning letters for illegally marketing tobacco products and using claims or descriptions that may mislead consumers by suggesting reduced harm or risk in using a tobacco product. The letters cited several, specific examples of tobacco-related health fraud including:
- Marketing, advertising or promotional claims that suggest the product is safer, healthier or less risky to use, like:
- “Safe Smoke Filter”
- “Less Toxic”
- Labels, internet sites, or other promotions that describe a tobacco product as “Light,” “Low,” or “Mild”
- Letters, presentations, or other actions directed to consumers indicating FDA approval or authorization is assured or imminent.
Health Fraud Example 1
Health Fraud Example 1: The fictional ABC Cigarette promotion describes their product as "light," and claims that the filter "removes seven times more tar and nicotine." These claims may be misleading, suggesting a reduced harm. Both of these claims require scientific evidence and an order from FDA before they can be used.
Health Fraud Example 2
Health Fraud Example 2: While the fictional XYZ brand of smokeless tobacco displays the required warning statement, the label also states that XYZ brand is a "less toxic product." This is an example of health fraud unless this claim was submitted to FDA with supporting scientific evidence and FDA issued an order.
If you see tobacco retailers market or promote their products as “light,” “low,” “mild” or somehow safer to consume, please report it immediately to:
- CTPcompliance@fda.hhs.gov or 1-877-287-1373 Option 3
- Report a Potential Tobacco Violation
Appropriate enforcement actions will be pursued to protect public health once violations are verified.
Detailed information related to any unexpected tobacco- or e-cigarette-related health or product issues can also be reported to the FDA via the online Safety Reporting Portal.
Related Regulatory, Guidance & Compliance Information
- Overview of the Family Smoking Prevention and Tobacco Control Act
- Guidance: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
- Warning Letters Sent from FDA about Tobacco-Related Health Fraud – select “Center for Tobacco Products” in the dropdown menu for “Issuing Office”
1. U.S. Department of Health and Human Services (USDHHS). How Tobacco Smoke Causes Disease. The Biology and Behavioral Basis for Smoking-Attributable Disease (Executive Summary). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.