A spate of FDA warning letters detailing labeling violations and an open letter from Commissioner Margaret Hamburg largely quash any hopes the food industry might have had for regulatory latitude to make aggressive health claims.

The latest actions from an increasingly vigilant agency will add another element firms must consider when looking to push the claims envelope in search of a marketing edge.

While the majority of the 17 warning letters - mostly issued Feb. 22 and posted March 3 - identify unauthorized nutrient content claims, a few highlight disease claims that may make the products unapproved drugs.

The letters all originate from the Center for Food Safety and Applied Nutrition and were posted in conjunction with an open letter to industry from Hamburg, who clarifies that public safety is not the only factor driving issuance of warnings.

While saying that she senses "a strong desire within the industry for a level playing field and a commitment to producing safe, healthy products," Hamburg adds that "we continue to see products marketed with labeling that violates established labeling standards."

Additionally, Hamburg notes the agency continues preparing a draft guidance to standardize front-of-pack food labeling requirements - an effort that gathered steam following the failure of an industry-sponsored labeling initiative in 2009 (¹ 'The Tan Sheet' Nov. 2, 2009, In Brief).

Coordinated Message To Industry

The warning letters taken as a whole comprise a more concentrated and coordinated message to industry than the May 2009 warning to General Mills regarding heart health claims linked to Cheerios , which originated from an FDA district office (² Also see "FDA Cheerios Warning Signals Tougher Stance On Health Claims Enforcement" - Pink Sheet, 18 May, 2009.).

"The Cheerios letter sort of came out of the blue, it was sort of anomalous," said food and drug attorney Georgia Ravitz with Arent Fox in Washington.

Among the companies warned for making drug claims were POM Wonderful, for citing the beneficial effects of its pomegranate juice and POMx supplement products on atherosclerosis, prostate cancer and erectile function on its Web site.

Redco Foods Inc. and Fleminger Inc. were cited separately for online claims about the benefits of green tea, while Diamond Food Inc. was warned for Web site language touting the supposed anti-cancer effects of omega-3s in walnuts.

FDA consistently has considered a product Web site to be labeling. So, whether online or on a label, food firms should refrain from making bold claims that mention any beneficial action on a disease state, experts advise.

"It's not really a question of how good the science is, it's a question of whether or not you're making claims that you can make for a food product," said attorney Christopher Hagenbush, a partner in the Washington office of Patton Boggs.

"Clearly if you're promising that your product can cure or treat a disease, it's not a food product anymore," Hagenbush said.

He also noted there is no reason a company with proper internal controls and oversight should have to learn through an FDA warning that its labeling is in violation of the law.

The warning letters "should give impetus and incentive to companies to make sure they have those kinds of facilities in place," Hagenbush said.

Getting Literal On Nutrient Claims

Ravitz noted that nutrient content claims, the subject of the bulk of FDA's Feb. 22 letters, historically have received a pass from the agency.

"I think the message here is that, when making a nutrient content claim, you'd better dot your i's and cross your t's because FDA is really being very literal and picayune about the rules," she said.

Food firms should retreat from the one-upmanship that has come to define marketing and stick to scientifically sound claims language, according to Elisa Zied, a registered dietician and spokeswoman for the American Dietetic Association.

"Just providing the basic information, and then providing general information on your Web site about healthy eating and how this product can fit into a healthy lifestyle. I don't think the FDA has a problem with that," she said.

Among the warned firms, Ken's Foods Inc. did not meet the nutrient requirements to make the claim "healthy" on its Ken's Healthy Options salad dressings and Spectrum Organic Products did not qualify for "cholesterol free" claims for its Organic All Vegetable Shortening, the agency said.

Space For Science?

Whether so-called emerging science will have a place in food labeling and marketing looks increasingly doubtful in the wake of FDA's actions.

The Center for Science in the Public Interest, long an advocate for more aggressive FDA enforcement against food claims, called the cluster of warning letters "a signal event in FDA history" and the first indication in years of the agency's seriousness on the subject.

CSPI Legal Affairs Director Bruce Silverglade said during a March 3 media call that he sees little room for emerging science in food marketing.

"I'm not sure it's valid for government to help food companies convey tenuous scientific information to consumers," he said.

"While companies will continue to pressure the FDA, the courts and Congress to have the right to make those kinds of claims, I'm not at all sure it's in the public interest that that kind of information appear on food labels," Silverglade added.

The Grocery Manufacturers Association says it supports "truthful and non-misleading food labels" and adds that the subjects of FDA's warnings are not reflective of the industry as a whole.

"GMA and its member companies support, and are working with, the FDA to enhance our ability to convey nutrition information clearly and consistently to consumers," a spokesman said in an e-mail.

- Dan Schiff ( ³ d.schiff@elsevier.com )

FDA's Flurry Of Food Claim Warnings Sends Bold Enforcement Message

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