Apr 7, 2007FDA: Companies Must Stop Promoting Health Benefits of Cherries on Labels
On Oct. 17, the U.S. Food and Drug Administration (FDA) sent warning letters to 29 companies that manufacture, market or distribute products made from cherries and some other fruits. The letters instructed the companies to stop making unproven health claims on their Web sites and product labels.
The warnings came as a surprise to some of their recipients.
“We didn’t understand that we were breaking any laws,” said Loren Queen, product manager for TPG Enterprises. “That wasn’t our intention.”
If the companies cited fail to take prompt corrective measures, they might face FDA enforcement action – including seizure, injunctions or criminal sanctions – without further notice, according to the FDA.
The products in question include dried fruit, fruit juice and juice concentrate. Companies have claimed these products can treat or prevent a variety of diseases, including cancer, heart disease and arthritis, according to the FDA.
The warning letter sent to TPG Enterprises, Othello, Wash., was similar to the other letters. It said the product labeling for two of TPG’s products, Tart Cherry Concentrate and Fresh Apple Slices, violated the Federal Food, Drug and Cosmetic Act. The letter included TPG’s Web site as part of the labeling.
“Under the act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs,” the letter said.
The letter highlighted many of the claims made on TPG’s Web site, including: “Try our cherry concentrate, an all natural alternative to Vioxx!”
The letter also highlighted claims in the form of customer testimonials, including: “I have arthritis and gout. I’ve been taking two separate prescriptions for these afflictions. I have been using tart cherry juice for about four weeks and I stopped taking the medicine.”
The letter also highlighted claims made on Tart Cherry Concentrate labels, including: “All Natural Pain Reliever and Anti-Inflammatory.”
Because of those health claims, the products are considered drugs. Drugs can’t be legally marketed in the United States without FDA approval. In order to get approval, drug sponsors must go through the proper application process, according to the FDA.
Queen said TPG was complying with the letter by changing its Web site and redesigning the controversial label. TPG’s products should not be considered replacements for pharmaceuticals, he said.
“As a company, we don’t want to advise any consumer to change their health regimen based on anything we told them,” Queen said.
TPG based many of its health claims on information from the Cherry Marketing Institute (CMI), he said.
CMI, a research and promotion organization representing U.S. tart cherry growers, is attempting to clarify the FDA’s instructions for the companies at fault. Businesses need to be careful about the way they make health claims, said Joe Lothamer, CMI’s director of promotions.
“In their exuberance, they were probably making some statements they shouldn’t have been making,” he said. “Nobody intentionally wanted to break the law.”
Many of the health claims made by the companies were gleaned from information on CMI’s Web site – information based on scientific research, Lothamer said.
It appears the FDA wants some sort of separation between the products and information about their health benefits. So, instead of making claims on their own Web sites, some of the companies now provide links to CMI’s site, he said.
Overlake Foods Corporation, Olympia, Wash., removed research findings from its Web site after receiving a warning letter from the FDA, and replaced them with a general statement about health benefits. It also provided customers with links to the sources of the research, including CMI and the U.S. Highbush Blueberry Council, said CEO Rod Cook.
“We try not to promote any of the products we sell as being curative, but we do want to express to the consumer the information that is being released by researchers,” he said.
Cook said he understands what the FDA is trying to do and for the most part he agrees, but to suggest that a Web site listing the health benefits of cherries is equivalent to a product label is a bit of a stretch.
Queen, TPG’s product manager, said his company is grateful the FDA sent out the warning letters. It’s made consumers more aware of the issue.
“We’re taking a very positive tack on this,” he said. “It’s a good opportunity for us to make corrections, and for consumers to find out there may be health benefits to tart cherries.”
Warning letters also were sent to Amon Orchards, Acme, Mich.; Brownwood Acres, Eastport, Mich.; Cherry Lands Best, Appleton, Wis.; Cherry Republic, Glen Arbor, Mich.; Cherry Rx, Genoa City, Wis.; Chukar Cherry Company, Prosser, Wash.; Coloma Frozen Foods, Coloma, Mich.; Country Ovens, Forestville, Wis.; Eden Foods, Clinton, Mich.; Flavonoid Sciences, Traverse City, Mich.; Friske Orchards, Ellsworth, Mich.; Heritage Products International, Livonia, Mich.; H & W Farms, Belding, Mich.; King Orchards, Central Lake, Mich.; Leelanau Fruit Company, Suttons Bay, Mich.; Leland Cherry Company, Leland, Mich.; Obstbaum Orchards, Salem, Mich.; Orchard’s Harvest, Traverse City, Mich.; Payson Fruit Growers, Payson, Utah; Rowley and Hawkins Fruit Farms, Basin City, Wash.; Rowley’s South Ridge Farms, Santaquin, Utah; Royal Ridge Fruit & Cold Storage, Royal City, Wash.; Seaquist Orchards, Sister Bay, Wis.; Skyview Orchards, Ludington, Mich.; Sunrise Dried Fruit Co., Northport, Mich.; The Country Mill, Charlotte, Mich.; and Traverse Bay Farms, Bellaire, Mich.