As most of our readers likely know, the FTC and FDA share jurisdiction over claims for foods, cosmetics and OTC drugs. The two agencies have in place a written protocol which sets forth where each should defer to the other, for example, FDA has primary jurisdiction over food labeling while it defers to the FTC on food advertising. For the most part the two agencies co-exist in relative harmony and it’s tempting to think if you’ve checked off one agency box you can check off the other agency box as well, but it’s not always that simple.
A recent warning letter sent by FDA to several tobacco manufacturers is a great example of how advertisers can sometimes get whipsawed between the two agencies. In 1999 the FTC entered into a consent order with R.J. Reynolds regarding its advertising for its Winston “no additives” cigarettes. (A similar order was subsequently signed by what was then the Santa Fe Natural Tobacco Company). While RJR made no express claims that its “no additives” cigarettes were safer the FTC alleged in its complaint that such a message was implied. The consent order required that RJR include in its advertising for its product a prominent disclaimer that “No additives in our tobacco does NOT mean a safer cigarette.” The FTC Bureau Director at the time was quoted in the Agency’s press release as stating “Reynolds’ disclosure should clear up any misconception that cigarettes without additives are safer to smoke than other cigarettes . . . .”
And that should have been that, which brings us to the FDA. After the consent order was entered, the FDA acquired primary jurisdiction over tobacco products by virtue of the FSPTCA or the Family Smoking Prevention and Tobacco Control Act, if you hate government acronyms. One provision of the FSPTCA mandates that modified risk tobacco products may not be sold without an FDA order that permits the sale of such products. You might be forgiven for thinking that there’s no problem here because the FTC already is on record as stating that its required disclosure “clear[s] up any misconception that cigarettes without additives are safer.” But you’d be wrong. FDA recently sent a warning letter to several manufacturers of “no additives” cigarettes, including the new owner of Winston and Sante Fe Natural Tobacco Company stating that their products are being marketed as reduced risk products in violation of the FSPTCA. FDA did at least manage to acknowledge the existence of the FTC consent order but it is a series of sentences that might make George Orwell proud the letter acknowledges that the FTC order permits marketing of the products with the “not safer” disclaimer but says the companies can’t sell the products because they are marketed as “safer.” Try to figure that one out. As of today the claims can still be found on at least some of the products. If the matter goes to court it will be interesting to see whether the Court sides with the FTC or the FDA. And if you’re worried that your “no additives” claim is going to trigger regulatory action based upon an implied safer message, context is king, but that seems unlikely unless you are marketing a product that the public health community considers to be unsafe.