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FDA Issues Warnings to Tobacco Manufacturers Related to “Natural” Labeling

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On August 27, 2015 the Food and Drug Administration (“FDA”) issued warning letters to three tobacco companies regarding their labeling of cigarettes as “additive-free” and/or “natural.” This marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 to target this type of labeling on cigarettes.

The brands and manufactures are Natural American Spirit for Santa Fe Natural Tobacco Co., Winston for ITG Brands, and Nat Sherman for Sherman’s 1400 Broadway N.Y.C. Ltd. As reported by the Winston-Salem Journal, Santa Fe was bought by Reynolds in December 2001 and ITG Brands took ownership of Winston in June as part of a $7.1 billion transaction involving its parent company, Imperial Tobacco Group Plc, and Reynolds.

Pursuant to the FDA’s authority under the Family Smoking Prevention and Tobacco Control Act of 2009, a manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (“MRTP”) to the FDA with scientific evidence to support that claim. The companies received the warning letters for the following labels:

  • ITG Brands LLC: Winston cigarettes with the MRTP claim “additive-free”
  • Santa Fe Natural Tobacco Company Inc.: Natural American Spirit cigarettes with the MRTP claims “natural” and “additive-free”
  • Sherman’s 1400 Broadway N.Y.C. Ltd.: Nat Sherman cigarettes with the MRTP claim “natural”

The FDA determined that the labeling of these products as “natural” and “additive-free” need an FDA modified risk tobacco products order before they can be legally introduced into interstate commerce. The manufacturers have 15 business days to respond to the FDA and explain how they will remedy the violation or to provide reasoning and supportive information to the FDA if they believe they are not in violation.

The Family Smoking Prevention and Tobacco Control Act of 2009

Issuing the warning letters to ITG Brands LLC, Santa Fe Natural Tobacco Company, Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. Is the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 to pursue regulatory action. Specifically, the FDA found that the companies were in violation of section 911 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Under this section of the FD&C Act, a “modified risk tobacco product” is defined as “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.” As described by the FDA, “this includes products, the label, labeling, or advertising of which represents implicitly or explicitly that the product or its smoke does not contain or is free of 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.” If the companies fail to obey federal tobacco law, they may be liable for civil money penalties, criminal prosecution seizure, and/or injunction.