Producers grapple with marketing claims after FDA warning
According to the FDA, products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs and are regulated as such.
Fruit companies in states from Washington to Michigan are scrambling to determine how to promote the health benefits of their products without having them classified as drugs by the government.
The U.S. Food and Drug Administration in October sent letters to 29 cherry growers and packers warning them to remove certain claims from their Web sites and product labels regarding the products' health benefits. It's the first time the agency has taken such a step against one particular food product.
Jane Depriest,marketing director for the Cherry Marketing Institute, a trade group representing cherry growers and marketers, said that the Cherry Marketing Institute took the warning seriously and the companies it works with are taking it very seriously also.
"We have always encouraged companies to follow the law," she added. "They are responding."
Producers of cherries, apples, blueberries, pomegranates, and other produce are touting a torrent of research indicating consumption of such products provides considerable health benefits. The FDA warned the companies in question for claiming on their Web sites that fruit products, including juice concentrates, are effective in treating, or preventing, ailments ranging from breast cancer to arthritis to Alzheimer's disease.
Depriest said the individual companies that CMI works with are responsible for knowing and following regulations governing their industry. CMI didn't receive a warning, she said. "We don't sell cherries; we only help companies market them."
Health claims not disputed
Depriest emphasized that the FDA didn't discount the health benefits of cherries; it's just that the companies didn't follow protocol.
"This is nothing new," she said. "Almost every other health product is promoting similar health benefits. I interpreted the [FDA] letters as saying, 'You can't have the sales page of your Web site and the health messages on the same page.' "
TPG Enterprises, Washington State's largest producer of cherries and cherry products, received one of the letters.
TPG marketing director Loren Queen said, "We've let the FDA know we're responding to all their requests. We're revising our Web site and our product labels in line with what they want."
Among several statements the FDA objected to on TPG's Web site were:
-"Try our tart cherry concentrate, an all-natural alternative to Vioxx!"
-"There are at least 17 compounds in tart cherries with antioxidant properties.... Antioxidants have been shown to...possibly decrease risk of infection...."
The FDA also objected to label content on TPG's Tart Cherry Concentrate boasting, "All Natural Pain Reliever and Anti-Inflammatory."
The letters state that such claims put the fruit products in the classification of drugs, and thus render them subject to regulations pertaining to the promotion of drugs unless the content is revised.
The FDA letters state: "These claims cause your products to be drugs."
Queen said his products are made from fruit, and he doesn't want them to be classified as a drug.
"We need to obey that law," he said. "We want to be a law-abiding company."
Queen echoed Depriest in noting that the FDA letters were written in regards to marketing efforts and said nothing about quality or safety claims.
"They're not saying our products won't do [what we've said they'd do]," Queen said. "There's plenty of evidence to support everything we've said.
TPG cites data from the Cherry Marketing Institute's Web site concerning research at the University of Texasand Michigan State University, among others, to back many of its health claims concerning tart cherries' high content of melatonin and antioxidants.
TPG and other companies were warned as well about testimonials from customers posted on their sites.For example, one such testimonial on TPG's site stated: "I have had fibromyalgia for about 12 years. Since May 2002, I have been using tart cherry juice concentrate. It has turned my life around. While I am still on medication for the fibromyalgia, drinking the cherry juice every day has helped tremendously with the pain."
Depriest said, "Part of what's driving the promotion of health benefits of tart cherries is the enthusiasm of the customers. Perhaps some companies got carried away. Perhaps they overstated the benefits. The story now is that the companies are responding."
According to the FDA, new drugs are approved on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The FDA letter states that enforcement action could include seizures of violative products, and injunction against the manufacturers and distributors of violative products.
However, Stephanie Magill, a spokesperson with the FDA's Seattle office, said such sanctions are the exception, as targets of such warnings usually revise the promotions to meet the agency's expectations.
Case by case
"Any sanctions would depend on what kind of claim they're making," Magill said.
"Violations would be looked at case by case."
Since almost all of the citations in the warning letters cite deviations on the Web site, FDA will check the Web sites for corrections.
"FDA will also review the firms' written responses addressing their promised corrections and, hopefully, steps to prevent future violations," she stated.
Bill Reinert is a freelance writer in Toppenish, Washington.