FDA warns several tobacco manufacturers for marketing their products with health-related claims

Campaign for Tobacco-Free KidsAug 28 2015

The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:

The Food and Drug Administration today has taken a critically important action to protect the American public from tobacco industry deception by warning several manufacturers – most prominently Reynolds American's subsidiary, Santa Fe Natural Tobacco Company, and its Natural American Spirit cigarette brand – that they are violating the law by marketing their products with health-related claims, including "additive-free" and "natural." If these products continue to make these claims, the FDA can and should order them removed from the market.

This is not the first time the government has had to act to prevent the tobacco industry from using its marketing of the term "additive-free" in ways that mislead the public and it is a reflection of the length to which the tobacco industry has gone to undermine the effectiveness of the prior efforts. The FDA's warning sends a strong message to the tobacco industry that its long history of deception about the dangers of tobacco use will no longer be tolerated. It is one of the strongest enforcement actions the FDA has taken under the landmark 2009 law that gave the agency authority over tobacco products, including the power to strictly regulate any health claims.

There is no question that terms such as "additive-free" and "natural" imply a safer cigarette, as confirmed by consumer research and the industry's own documents. Consumers buying goods marketed with such terms expect to get a healthier product. Studies have found that smokers associate these terms with reduced risk, and a 2007 review of tobacco industry documents showed that tobacco companies have understood, for decades, that "natural" implies unwarranted health claims. Reynolds has provided no evidence that Natural American Spirit cigarettes expose smokers to any fewer toxins or carry any lower risk of disease.

The marketing for Natural American Spirit is the most deceptive of any major U.S. cigarette brand currently on the market. It has helped the brand increase sales by 86 percent from 2009 to 2014, even as overall cigarette sales in the United States fell by 17 percent during the same period. The FDA today also warned ITG Brands LLC – which now owns Winston - and Sherman's 1400 Broadway N.Y.C. Ltd. – which owns Nat Sherman cigarettes.

While marketing for Natural American Spirit has long featured terms such as "100% additive-free" and "natural" – and also "organic," which is also commonly used in Natural American Spirit marketing – their use has become larger and bolder over time. These claims are featured more prominently than ever in a new magazine advertising campaign launched in July (view current and past advertising for Natural American Spirit).

As a result, these claims overwhelm two legally mandated disclaimers at the bottom of Natural American Spirit ads that state "No additives in our tobacco does NOT mean a safer cigarette" and "Organic tobacco does NOT mean a safer cigarette." These disclaimers were added to resolve deceptive advertising complaints made by the Federal Trade Commission in 2000 and state attorneys general in 2010. Reynolds' ever-bolder use of these claims, even after facing legal action, shows that the company has not changed despite its frequent claims to be "transforming tobacco" for the better.

The FDA took action under a key provision of the 2009 law that prohibits tobacco companies from making health claims without premarket FDA review and an FDA order allowing the claim. This provision prohibits implicit or explicit claims that a tobacco product is less harmful than other tobacco products (called "modified risk" claims) unless the manufacturer provides the FDA with scientific evidence to support such a claim and demonstrates that allowing the claim will benefit public health. This provision is intended to end the tobacco industry's long record of deception about the health risks of its products, most prominently in the marketing of "light" and "low-tar" cigarettes as safer when in fact they were no less hazardous than other cigarettes.

In response to the new advertising campaign for Natural American Spirit, the Campaign for Tobacco-Free Kids and 27 other public health organizations earlier this week wrote to the FDA urging action to stop the brand's claims implying a safer cigarette. Given the timing of the FDA's action, it is clear that the FDA both initiated its investigation and made the decision to take action even before receipt of this letter.