Cherry companies warned by FDA against making health claims
November 1, 2005
WASHINGTON -- Twenty-nine cherry companies received warning letters from the Food & Drug Administration in October telling them to stop making unsupported claims about the powers of cherries to prevent and cure diseases on product labels and on their web sites.
The 29 companies that received the warnings were marketing dried fruit, fruit juice and juice concentrate as a means for treating or preventing of a variety of diseases, including cancer, heart disease and arthritis.
An FDA spokesman said that the agency sends these letters when it sees a "concentration within an industry" of unsupported health claims. "We don't want it to become widespread," he said.
The warning letters told the 29 companies that a food claiming to treat, cure or prevent a disease is making a drug claim, which triggers drug-safety rules. In some cases, food companies can make certain health claims if FDA reviews and approves industry petitions.
The companies offered many claims on their product labels and on their web sites, according to the FDA warning letters. For example, Friske Orchards was cited for labeling cherries with the statement, "Tart cherries contain anthocyanins and bioflavanoids, which may be 10 times stronger than aspirin in relieving pain." On its web site, the company also listed articles from the Cherry Marketing Institute that said tart cherries may reduce the risk of colon cancer, and may alleviate the pain for people suffering from fibromyalgia.
But the Cherry Marketing Institute said that it does not advise growers what to say on their labels and on their web sites. "We are telling everyone to take the letters seriously, and to let FDA know what they will do next," said the group's Joe Lothamer.
The FDA letters require the companies to notify the agency in 15 days of steps they will take to correct the violations, or they could face enforcement action.
These are small businesses, often growers, who didn't know the extent of the FDA health claim regulations and the fact that web sites are viewed by FDA as an extension of product labels. "They are just trying their hardest to sell a great-tasting product," Mr. Lothamer added.
In the meantime, the institute is holding a meeting to respond to the latest incident, including the issue of whether growers should include links to the Cherry Marketing Institute's web site, which lists the latest studies on health-related research. The institute also plans to take a look at how other marketing groups handle this issue. Although cherries appeared to be the target of FDA's concerns this time, Mr. Lothamer questioned whether other commodities could face the same scrutiny.
On its web site, the Cherry Marketing Institute calls tart cherries the "healing fruit" since ongoing research shows that cherries can relieve the pain of arthritis and gout, and lower the risk of cancer, heart disease and other chronic diseases.
"Health-related marketing is a powerful tool," said Christine Filardo, director of public relations for the Produce for Better Health Foundation. "It is important that information the industry provides regarding the health benefits of fruits and vegetables and their nutrient content follow federal regulations. The regulations protect consumers from misleading information."
The foundation said that one of its missions is to make sure rules are constantly updated to reflect the changes in scientific evidence, the food supply and the changing needs of the population.
Most of the companies that received the FDA warning letters are located in Michigan: Amon Orchards in Acme, Brownwood Acres in Eastport, Cherry Republic in Glen Arbor, Coloma Frozen Foods in Coloma, Eden Foods Inc. in Clinton, Flavonoid Sciences in Traverse City, Friske Orchards in Ellsworth, Heritage Products International in Livonia, H&W Farms in Belding, King Orchards in Central Lake, Leelanau Fruit Co. in Suttons Bay, Leland Cherry Co. in Leland, Obstbaum Orchards in Salem, Orchard's Harvest in Traverse City, Skyview Orchards in Ludington, Sunrise Dried Fruit Co. in Northport, The Country Mill LLC in Charlotte and Traverse Bay Farms in Bellaire.
Wisconsin-based businesses that received the warning are Cherry Lands Best in Appleton, Cherry Rx in Genoa City, Country Ovens Ltd. in Forestville and Seaquist Orchards in Sister Bay.
FDA also sent warning letters to Washington-based Chukar Cherry Co. in Prosser, Overlake Foods Corp. in Olympia, Rowley & Hawkins Fruit Farms in Basin City, Royal Ridge Fruit & Cold Storage in Royal City and TPG Enterprises Inc. in Othello.
Two Utah-based businesses were cited by FDA: Payson Fruit Growers Inc. in Payson and Rowley's South Ridge Farms Inc. in Santaquin.
The 29 companies that received the warnings were marketing dried fruit, fruit juice and juice concentrate as a means for treating or preventing of a variety of diseases, including cancer, heart disease and arthritis.
An FDA spokesman said that the agency sends these letters when it sees a "concentration within an industry" of unsupported health claims. "We don't want it to become widespread," he said.
The warning letters told the 29 companies that a food claiming to treat, cure or prevent a disease is making a drug claim, which triggers drug-safety rules. In some cases, food companies can make certain health claims if FDA reviews and approves industry petitions.
The companies offered many claims on their product labels and on their web sites, according to the FDA warning letters. For example, Friske Orchards was cited for labeling cherries with the statement, "Tart cherries contain anthocyanins and bioflavanoids, which may be 10 times stronger than aspirin in relieving pain." On its web site, the company also listed articles from the Cherry Marketing Institute that said tart cherries may reduce the risk of colon cancer, and may alleviate the pain for people suffering from fibromyalgia.
But the Cherry Marketing Institute said that it does not advise growers what to say on their labels and on their web sites. "We are telling everyone to take the letters seriously, and to let FDA know what they will do next," said the group's Joe Lothamer.
The FDA letters require the companies to notify the agency in 15 days of steps they will take to correct the violations, or they could face enforcement action.
These are small businesses, often growers, who didn't know the extent of the FDA health claim regulations and the fact that web sites are viewed by FDA as an extension of product labels. "They are just trying their hardest to sell a great-tasting product," Mr. Lothamer added.
In the meantime, the institute is holding a meeting to respond to the latest incident, including the issue of whether growers should include links to the Cherry Marketing Institute's web site, which lists the latest studies on health-related research. The institute also plans to take a look at how other marketing groups handle this issue. Although cherries appeared to be the target of FDA's concerns this time, Mr. Lothamer questioned whether other commodities could face the same scrutiny.
On its web site, the Cherry Marketing Institute calls tart cherries the "healing fruit" since ongoing research shows that cherries can relieve the pain of arthritis and gout, and lower the risk of cancer, heart disease and other chronic diseases.
"Health-related marketing is a powerful tool," said Christine Filardo, director of public relations for the Produce for Better Health Foundation. "It is important that information the industry provides regarding the health benefits of fruits and vegetables and their nutrient content follow federal regulations. The regulations protect consumers from misleading information."
The foundation said that one of its missions is to make sure rules are constantly updated to reflect the changes in scientific evidence, the food supply and the changing needs of the population.
Most of the companies that received the FDA warning letters are located in Michigan: Amon Orchards in Acme, Brownwood Acres in Eastport, Cherry Republic in Glen Arbor, Coloma Frozen Foods in Coloma, Eden Foods Inc. in Clinton, Flavonoid Sciences in Traverse City, Friske Orchards in Ellsworth, Heritage Products International in Livonia, H&W Farms in Belding, King Orchards in Central Lake, Leelanau Fruit Co. in Suttons Bay, Leland Cherry Co. in Leland, Obstbaum Orchards in Salem, Orchard's Harvest in Traverse City, Skyview Orchards in Ludington, Sunrise Dried Fruit Co. in Northport, The Country Mill LLC in Charlotte and Traverse Bay Farms in Bellaire.
Wisconsin-based businesses that received the warning are Cherry Lands Best in Appleton, Cherry Rx in Genoa City, Country Ovens Ltd. in Forestville and Seaquist Orchards in Sister Bay.
FDA also sent warning letters to Washington-based Chukar Cherry Co. in Prosser, Overlake Foods Corp. in Olympia, Rowley & Hawkins Fruit Farms in Basin City, Royal Ridge Fruit & Cold Storage in Royal City and TPG Enterprises Inc. in Othello.
Two Utah-based businesses were cited by FDA: Payson Fruit Growers Inc. in Payson and Rowley's South Ridge Farms Inc. in Santaquin.
