The FDA says descriptors such as ‘natural’ or ‘additive-free’ are no longer acceptable for tobacco products, including the top-selling super-premium cigarette brand in the U.S.
By Timothy S. Donahue
It seems no words are safe. After more than 30 years of selling “natural” and “additive-free” products, Santa Fe Natural Tobacco Co. (SFNT) has been instructed to stop making such claims on its packaging and in advertising. The warning is an unwelcome development for the North Carolina, USA-based cigarette manufacturer, which has built a successful business selling natural and additive-free tobacco products. In recent years, sales of its American Spirit brand skyrocketed even as the overall U.S. cigarette market plummeted.
In a regulatory filing posted on its website, Reynolds American Inc. (RAI), SFNT’s parent company, states that American Spirit is the leading super-premium cigarette brand and a top 10 best-selling cigarette brand. “It is priced higher than most other competitive brands and is differentiated from key competitors through its use of all-natural, additive-free tobacco, including styles made with organic tobacco,” the company writes.
The U.S. Food and Drug Administration (FDA), however, takes a dim view of such claims. Promoting tobacco brands with terms such as “natural” or “additive-free,” it believes, misleadingly suggests that they are less harmful to health than are other tobacco products—even though SFNT has been careful to add a disclaimer to its products and advertisements stating that natural tobaccos are not safer than others.
In late August, the agency duly served SFNT with a warning letter about its use of the descriptors. SFNT was not the only target. ITG Brands, the U.S. arm of U.K.-based Imperial Tobacco, and Nat Sherman also received warning letters stating that their cigarette brands carry alleged modified-risk tobacco product (MRTP) descriptors on their labeling without an FDA MRTP order that permits a tobacco product to be introduced as such into interstate commerce.
“The FDA found that this labeling represents that the products or their smoke does not contain or is free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco,” explains Patricia Kovacevic, general counsel and chief compliance officer for Nicopure Labs and former in-house counsel for several large tobacco companies. “These findings amount to violations of Section 911 of the Tobacco Control Act.” Section 911 defines MRTP 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.”
The recent warning letters are the latest development in a long-running crackdown on purportedly misleading product descriptors. Over the years, authorities around the world have outlawed labels such as “mild” and “light,”forcing cigarette manufacturers to come up with alternative tags to communicate to consumers the tastes of these brands. The EU ban on product descriptors may have even contributed to Japan Tobacco’s decision to change the name of its Mild Seven brand to Mevius.
In the U.S., Judge Gladys Kessler, of the D.C. District Court, banned the use of certain descriptions for traditional cigarettes that include “low tar,” “light” and “ultra-light,” saying cigarettes marketed in that way have been found to be no safer than others. The ban was part of Kessler’s landmark 2006 ruling that found tobacco manufacturers had deceived the public about the dangers of smoking and whether certain products were marketed in a way that implied they were lower-risk. The FDA banned the use of the terms in June 2010.
Bryan Haynes, partner with Troutman Sanders law firm and an experienced tobacco attorney, says the regulatory agency first dealt with “light” and “mild” because those descriptors were specifically called out in the statute. “Why did they wait so long for ‘natural’ and ‘additive-free’?” Haynes asks. “Congress could have called out those descriptors but they didn’t.” According to Haynes, the real reason for action now may have been a recent SFNT advertising campaign coupled with a joint complaint letter from several anti-smoking organizations. “They complained the disclaimer is now less prominent than it was in the past, and the advertising campaign put these claims in the public limelight,” says Haynes. “It’s hard to ignore the coincidence of the timing of the letter compared to the receipt of the complaints.”
“[The] FDA did not prioritize examining possible violations of Section 911 of the [Tobacco Control Act] with respect to the ‘natural’/’additive-free’ claims until such time [that] at least one anti-tobacco organization became very vocal about this issue earlier this year,” echoes Kovacevic. The Winston-Salem Journal noted that the FDA warning came about a month after SFNT began a national advertising campaign with full-page ads in magazines, but what the Journal failed to report was that the company has had such ads for at least a decade.
The FDA letters requested responses to the warnings within 15 days to explain what actions the companies would plan to take to “remedy the violation” or, if they do not believe that they are in violation, provide reasoning and supporting information. The companies’ responses were not publicly available at press time.
FDA Center for Tobacco Products director Mitch Zeller says the FDA has the responsibility to ensure that 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.” This marks the first time the U.S. government has attempted to regulate the use of the word “natural” in relation to a consumer product other than poultry and other meats.
Haynes says the companies are likely considering lawsuits to protect their right to commercial free speech. “They are probably looking at whether the FDA has sufficient evidence that these words constitute a modified-risk claim,” says Haynes. “Another thing is whether this is the type of action that requires further rule-making. This has been all good for so many years, why now? Is this a fundamental change that requires new rule-making? These are questions the industry will expect the FDA to answer.”
Kovacevic points out that the FDA has lost several First Amendment challenges, notably in Thompson v. Western States Medical Center, where a U.S. Supreme Court ruling concluded that government restrictions on the advertising of compounded drugs were too broad, as well as other cases involving labeling of dietary supplements and off-label drug uses (which did not directly address the First Amendment issue but is nevertheless relevant).
The recent FDA letters have already led to some serious legal issues for the companies. A Florida law firm has filed a class-action lawsuit against SFNT and RAI, claiming the cigarette maker’s packaging and advertising are intended to mislead smokers into thinking American Spirit cigarettes are healthier than other tobacco products. A representative of SFNT said that company policy prevented him from commenting on the lawsuit.
The complaint seeks damages for smokers who “smoke American Spirits because they have been deceived by claims, labels and advertising into regarding them as safer than other cigarettes.” Descriptions such as “additive-free,” “natural” and “organic,” the lawsuit says, “are patently deceptive, especially in today’s market, where these terms have a potent meaning for the health- and environmentally-conscious consumer.”
In a Tobacco Reporter straw poll of 33 American Spirit smokers, 27 said they preferred American Spirits because they were not owned by Big Tobacco (In reality, SFNT has been part of Reynolds American for years). The fact they were additive-free was overwhelmingly the second reason.
The legal filing in Florida states that SFNT exploits its marketing message by, among other items, selling its cigarettes in health food stores. The filing also states that SFNT “accompanies its cigarettes with literature from ‘America’s leading natural foods teacher,’ who claims that the cigarettes are medicinal and that Native Americans smoke such additive-free cigarettes without developing cancer.”
Haynes believes the FDA action adds no validity to this class-action claim. “It’s just another example of plaintiffs’ lawyers looking for another way to make money,” he says, adding that SFNT is already subject to a Federal Trade Commission consent order, issued in 2000, that requires the company’s advertising to include a disclosure that “no additives in our tobacco does NOT mean a safer cigarette.”