On Thursday, August 27, the Food and Drug Administration issued warnings to three cigarette manufacturers for violating labeling provisions of the Food Drug and Cosmetic Act. Specifically, the FDA issued warnings to the makers of Natural American Spirit, Winston, and Nat Sherman cigarettes deeming the usage of terms “natural” and “additive free” on their packaging represented unauthorized modified risk claims. These warnings mark the first time the agency has expanded the modified risk labeling provisions beyond explicit claims that a product poses fewer risks than other tobacco products, such as the claims “light”, “low tar”, or “mild”.
Passed in 2009, the Family Smoking Prevention and Tobacco Control Act vests the FDA with regulatory authority over tobacco products including the responsibility to oversee the manufacturing, marketing, distribution, and sale of tobacco products. As part of the Act, the FDA was granted authority to restrict the product content, labeling, and advertising of regulated tobacco products. Manufacturers seeking to market a tobacco product as providing a modified or reduced risk, such as claims of “low tar” or “light” cigarettes, are required to first receive authorization from the FDA. Authorization will only be granted if the scientific evidence supports the claim. This stringent requirement was in large part based on the findings of U.S. v. Philip Morris USA, a 2006 Federal RICO suit against the tobacco industry. The decision helped uncover the industry’s multi-decade history of deliberately misleading the public regarding the health effects of cigarettes. In particular, the case brought to light past industry efforts to promote various harm reduction advancements such as low-tar or lighter cigarettes, despite failing to substantiate such claims, and, in some cases, intentionally misrepresenting their risks. To date no product has received authorization to make a modified risk claim, however a smokeless tobacco product manufactured by Swedish Match is currently under review with an agency determination expected later this year.
When the Tobacco Control Act was originally passed, the industry challenged the regulatory constraints on modified risk labeling as a violation of their commercial speech rights under the First Amendment. However, the modified risk restriction provision was upheld by the sixth circuit in Discount Tobacco City and Lottery Inc. v. United States (formerly Commonwealth Brands v. United States) specifically citing the findings in Philip Morris as evidence that given the extensive history of deception by the industry, such a stringent standard was the least restrictive means available to ensure the protection of public health.
When issuing modified risk warnings in the past the FDA has focused on more explicit violations, such as online retailers continuing to market cigarettes as “light” or “low tar”, rather than the use of implicit risk modifying terms in product labeling. However, research has long demonstrated that the use of certain terms like “natural” or “additive/particular-free” and even certain colors for product labels are linked to a lower harm perception for a product. These recent warnings suggest the agency will be taking a harder look at product labeling where lower harm is more implicitly evoked. Such an expansion could have major implications for the impending regulation of e-cigarettes, a class of products frequently promoted as low risk.
Kyle Gregory (J.D./M.S.H.A ’14) is a post-doctoral fellow with the Tobacco Center of Regulatory Science at Georgia State University School of Public Health. He conducts research in a variety of areas in health and public health law, with a particular focus on translating tobacco research to better inform FDA regulation under the Family Smoking Prevent and Tobacco Control Act.