The Food and Drug Administration has launched a preliminary review of a new advertising campaign by the Kellogg Co. that links its All-Bran cereal to cancer prevention.
The Kellogg ad campaign is the first by a major food manufacturer to specifically link its product to cancer prevention, a claim the FDA fears may violate federal rules. Under FDA regulations, it is illegal to make health claims about specific foods without prior FDA approval.
"Is this promotion, in its language, offering a drug because of the product's linkage to the disease called cancer?" said FDA spokesman Bruce Brown. If so, then Kellogg has failed to win FDA approval of All-Bran as a way to prevent cancer, Brown added.
The FDA's review of Kellogg's month-old advertising campaign comes at a time when more and more food manufacturers are using health claims to promote their products. With an increasingly health-conscious consumer, many products are now being advertised for their low salt, low fat or high fiber content.
However, Kellogg's All-Bran advertisement represents the first time a major manufacturer has gone a step further and cited the quality of a specific food -- in this case high fiber -- as a way to prevent a specific disease.
As a result, federal regulators say they are faced with a serious problem. On the one hand, Brown noted, they applaud Kellogg for bringing vital health information to the public. For the ad clearly points out that the "National Cancer Instittue believes a high fiber, low fat diet may reduce your risk of some kinds of cancer."
Nonetheless, Brown said, the claims may ultimately be considered misleading by federal regulators because it not include enough information. Although the promotion encourages consumers to eat All-Bran, it may give the impression that all consumers need to do to prevent cancer is to eat All-Bran.
That is has apparently angered California's Cancer Advisory Council, which, under the auspices of the state's Department of Health Services, is currently drafting a letter to the FDA.
State officials declined to talk about the letter, saying it was premature to discuss it since it had not been approved and mailed yet. Advertising Age, however, noted that the cancer advisory council was disturbed because there is no scientific proof that All-Bran prevents cancer.
Kellogg officials, however, said that all they were trying to do was work with the National Cancer Institute to publicize the cancer awareness prevention project. "We want to communicate the NCI report that says that a high fiber, low fat diet may reduce your risk of some kinds of cancer," said Celeste Clark, director of corporate publicity. "This is the first time Kellogg has mentioned cancer in its advertisements . . . We worked very closely with NCI in developing the advertising message."
Over several months, Kellogg consulted NCI, according to Paul Van Nevel, NCI's associate director for cancer communications. NCI scientists reviewed their claims to make sure Kellogg was not misrepresenting the institute's findings, while its lawyers made sure the message didn't represent an NCI endorsement of All-Bran, Van Nevel said. NCI officials made some minor suggestions for changes, he said. But overall, he added, the institute was very pleased with the ads, saying "it is an effective way to get out our message."
Food industry officials also say that the company consulted the Federal Trade Commission, which regulates advertising claims (the FDA regulates claims on product labels, such as the cancer-prevention comments on All-Bran's boxes).
Although NCI was consulted, "we weren't," said FDA's Brown.
Among the possible objections FDA could have, Brown said, was that there are many different types of cancer. Kellogg implies high-fiber is a good way to prevent all types of cancer.
Additionally, Brown said, the claims don't say how to use All-Bran if it really is to prevent cancer.
Beyond the specific concern, FDA has a more fundamental concern, as William Grigg, FDA's director of press relations noted. If FDA lets the Kellogg ad continue, "You open the door to all types of medical claims being made for food products . . . You then get the people who will sell bees' knees and other crazy foods, with wild advertisement claims."