FDA Issues Warning Letters to Three Tobacco Manufacturers for the Use of "Additive-Free" and/or "Natural" Claims on Cigarette Labeling
Six years ago, Congress gave the FDA the responsibility to oversee the manufacture, marketing, distribution, and sale of tobacco products. A rigorous compliance and enforcement program has helped the FDA monitor regulated industry's compliance with the laws designed to protect the public health generally and to reduce tobacco use by minors.
The FDA is announcing today that through ongoing surveillance efforts, we are issuing warning letters to three cigarette manufacturers, who describe their cigarettes on product labeling as "additive free" and/or "natural." The warning letters are for violations of Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has determined that these products, described as "natural" and "additive-free" on their labeling, need a modified risk tobacco product (MRTP) order from the agency before they can be legally introduced as such into interstate commerce.
MRTPs can only be introduced into interstate commerce after scientific evidence to support them has been submitted to the FDA, and the FDA has issued an order permitting their marketing. To date, the FDA has not issued any orders that would permit label claims of reduced risk or harm to users and nonusers. These requirements were put in place so that American tobacco consumers are not misled about the harms of tobacco products.
Manufacturers must ensure their tobacco products and all related labeling and/or advertising comply with the FD&C Act and the FDA's implementing regulations. Failure to obey federal tobacco laws may result in the FDA initiating action, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction.
A manufacturer that seeks to claim that a product poses fewer risks than other tobacco products may submit a MRTP application to the FDA with scientific evidence to support that claim.