It has been just about eight months since the Food and Drug Administration (FDA) sent certified letters to 29 cherry farmers and distributors, most of them in Michigan, warning them they were overdoing their online claims about the health benefits of tart cherries.
Using data provided by their industry trade association to help position tart cherries as less of a pie filling and more of a health food, the farmers and distributors had posted on their Web sites studies and customer testimonials that the fruit in concentrated form helps counter gout, arthritis, and diabetes, and may help prevent cancer.
Now, bear in mind, a warning letter from the FDA isn't the same as a warning from a police officer that you were speeding and if you get caught again, you'll receive a citation. It's actually more akin to a scarlet letter. It shows up whenever someone does a Web search on your company.
LIVING WITH FEAR.
The highly respected Casewatch.org, which monitors "health fraud and quackery-related legal matters," cautions in its listings of companies that have received warning letters (including the cherry farmers and distributors) that "it is wise for consumers to assume that the product is problematic and should be avoided." In addition, such a letter officially opens the door to a raid by federal agents in which they may seize products, computers, and other such items and shut businesses down—and possibly even file criminal charges against the owners.
All of that helps explain why Michael Berst, sales manager of King Orchards, a 300-acre cherry farm not far from Traverse City, Mich., that was one of the recipients of the FDA letter, "lived all winter in terror they would come after us." Just because the FDA hasn't come doesn't mean it won't. The warning letter is open-ended, meaning the marshals could show up tomorrow, or could show up 10 years from now.
The agency's letter to King Orchards quoted several examples of statements from King Orchards' Web site that it said had the effect of placing tart cherries into the category of a drug. One example: "Perhaps George Washington wouldn't have chopped down his father's cherry tree if he knew what chemists now know. They have identified a group of naturally occurring chemicals abundant in cherries that could help lower blood sugar levels in people with diabetes."
FLOOD OF LETTERS.
The FDA's letter added, ominously, "The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. Failure to promptly correct these violations may result in enforcement action without further notice."
An FDA spokesperson says the agency doesn't have cumulative data on how many enforcement actions it initiates each year, but a review of its Web site suggests about 5 to 10 each month are initiated against producers of foods, nutritional supplements, drugs, and medical devices. A similar review of warning letters suggests 30 to 60 are sent out to companies each month.
John King, one of the orchard's owners, says he removed from the company Web site all the statements specified by the FDA as examples and spoke with Judith Putz, the FDA compliance officer in Detroit mentioned in the letter, to determine what he might do to correct future problems. "Once they started talking about registering as a drug, we stopped talking," he says. Registering as a drug, of course, means investing many millions of dollars and years of effort to conduct human trials demonstrating a drug's efficacy and safety.
He decided that taking up the FDA's offer to review his promotional materials on a case-by-case basis wasn't something he wanted to do, either. "We didn't see the benefit of involving them in our marketing campaigns."
He also decided to hire a Washington lawyer who specializes in FDA-related cases, Jonathan Emord, who says that trying to get the FDA to provide guidance in remedying the alleged violations, not to mention exoneration, is tricky. "The FDA is often mercurial," Emord says. "It hides the ball…to leave open the possibility of prosecution."
So far, the best some of the farmers seem to have gotten from the FDA is an acknowledgment they're on the right track toward remediation. "Your response is both timely and positive," says one from Ms. Putz, the FDA compliance officer, to a producer who offered to remove offending statements. "I will make it a permanent part of the Establishment File" for the orchard. (The producer who provided this letter prefers not to have his name used for fear of raising his profile with the FDA.)
Yet the FDA doesn't seem ready to officially let the farmers and distributors off the hook. Ms. Putz declined to answer my questions, referring me to an agency public information officer who says only that "a majority" of the 29 businesses receiving letters responded within the mandated 15 days, and that the agency has taken no further actions against any of the businesses.
But, he adds, "The investigations are open and we cannot comment on ongoing activities." And while the original warning letters remain posted on the FDA's site, none of the "timely and positive" type responses from the FDA to some of the farmers and distributors are posted.
What does it take for an accused cherry producer to satisfy the FDA that it is no longer peddling food as a drug? Here confusion reigns, in part because the FDA offers no courses or other organized guidance to recipients of warning letters. So most have simply attempted to acquiesce, in one way or another.
Payson Fruit Growers, a Payson (Utah) grower who received a warning letter, decided to remove all references to the potential health benefits of cherries, says General Manager Chad Rowley. All that is left is a chart with nutritional data on each of its products. Friske Orchards of Ellsworth, Mich, states on its site that cherries "promote many health benefits including improved joint health,* heart health,* natural pain relief,* and enhanced restorative sleep.*"
The asterisks lead to the boilerplate: "These statements have not been evaluated by the U.S. Food and Drug Administration. The information here is not intended to be used to diagnose, treat, cure, or prevent any disease." Says Richard Friske, president, "We don't have the means to fight the FDA."
The Cherry Marketing Institute, a trade organization, says it hired a lawyer to advise the accused cherry growers and distributors on how to avoid further trouble with the FDA. Jane DePriest, its marketing director, says the lawyer advised sellers to abide by the "two-click rule"—in other words, have health-related statements two clicks into the site. The lawyer also recommended certain phrasing; for example, that cherries are "a natural source of antioxidants" rather than "high in antioxidants."
What made the FDA decide to go after the cherry farmers and distributors, when it seems that all kinds of food companies, large and small, promote the health benefits of their products? For example, Kellogg's claims that its HeartSmart cereal is "the best way to treat heart disease," and Welch's has an entire Web page linking to studies suggesting grape juice can inhibit breast cancer tumor formation, be an "anti-aging" food, and "may have a positive effect on blood pressure."
The FDA official says the agency first noticed inappropriate health claims by the cherry producers during "an inspection at one of the firms" and, further investigation into the claims made by that firm revealed "other firms making similar claims for their fruit-based products." As for the health claims made by Kellogg's and Welch's, the official declines to comment.
The case of the cherry producers raises other questions as well. Where does freedom of speech end and worry about public health begin? On what basis does the FDA extend its regulation of food labels to regulation of Web sites? (In a 2001 letter, the FDA argued that court precedent suggests that Internet sites comprise labels, and said that "for the time being" it would "use a case-by-case approach" to make its decisions.
It would be easy to dismiss the problems of the cherry producers as one of overstepping bureaucrats picking on unsuspecting small businesses, yet it really is more troubling than that. The FDA possesses powers on a par with the Internal Revenue Service with respect to being able to shut businesses down. It operates on important levels without oversight.
Even though many of the FDA's targets are no doubt guilty of scams or pose a public health menace, some, like the cherry producers, do not. Yet the FDA retains the authority to turn on its head the U.S. legal system's guarantee of "innocent until proven guilty." The cherry producers appear to be guilty until proven innocent, with no clear path to even proving their innocence.