![]() ![]() The FDA has determined that these products, described as 'natural' and 'additive-free' on their labelling, need an FDA modified risk tobacco product order before they can be legally introduced as such into interstate commerce. Ltd.: Products – Nat Sherman cigarettes with the MRTP claim 'Natural' Santa Fe Natural Tobacco Company Inc.: Products – Natural American Spirit cigarettes with the MRTP claims 'Natural' and 'Additive-free' ITG Brands LLC: Products – Winston cigarettes with the MRTP claim 'Additive-free' The companies received warning letters for the following products and their related modified risk claims: To date, the FDA has not issued any orders permitting the introduction of modified risk tobacco products into interstate commerce. This includes products, the label, labelling, or advertising of which represents implicitly or explicitly that the product or its smoke does not contain or is free of a substance and/or that the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products.Ī manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (MRTP) application to the FDA with scientific evidence to support that claim. Under section 911(b)(1) of the FD&C Act, a “modified risk tobacco product” is “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” It also created a process for the FDA to evaluate requests from companies seeking to market their products as modified risk. The FD&C Act, amended by the Tobacco Control Act, gives the FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. ![]() “This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the US public from the harmful effects of tobacco use.” “The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like 'additive-free' and 'natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 to pursue regulatory action regarding the use of “additive-free” or “natural” claims on tobacco product labelling. The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). who describe their cigarettes on product labelling as 'additive-free' and/or 'natural.' The US Food and Drug Administration has issued warning letters to three tobacco manufacturers - ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. ![]()
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