Inspections, Compliance, Enforcement, and Criminal Investigations
Cherry Rx 17-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Minneapolis District Office |
212 Third Avenue South
Minneapolis, MN 55401
Telephone : (612) 758-7114
FAX: (612) 334-4142
October 17 , 2005
RETURN RECEIPT REQUESTED
Refer to MIN 06 - 05
W186 Tombeau Boulevard
Genoa City, Wisconsin 53128
Dear Mr. Kwain:
The Food and Drug Administration (FDA) has reviewed the labeling of your Cherry Rx product on your web site at r.vww.cherrycure.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of this product. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Under the Act, articles intended for use in the diagnosis; cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g) (1) (B) of the Act; 21 United States Code (U.S.C.) 321(g)(1)(B)] . The labeling for your Cherry Rx product on your web site bears the following claims:
"About three years ago, my wife, Michelle, picked up a quart of cherry juice at a farm stand near our house. They told her some anecdotes about how cherry juice had been found to help gout, migraines, and arthritis . . . . The arthritis in my wrists and ankles was excruciating . . . . With skepticism, I gave the juice a try. . . . To my surprise, within two weeks after beginning to drink 8_ ounces of cherry juice a day, I was completely out of pain. . . ."
"Researchers at Michigan State University were among the first to identify the presence of three powerful anthocyanins in tart cherries with the potential to inhibit the growth of colon cancer tumors ."
"Tart cherries contain anthocyanins and bioflavonoids which . . . prevent inflammation in the body. Further investigations revealed that daily consumption of tart cherries has the potential to reduce the pain associated with inflammation, arthritis, and gout."
"The antioxidant activities of the anthocyanins may account for the beneficial effects derived from the consumption of fruits and vegetables high in anthocyanins, such as cherries, against cardiovascular and other diseases."
Your website also includes claims in the form of testimonials. Some examples are as follows:
"I'm thrilled to find something natural for my arthritis."
"I purchased a quart of concentrated cherry juice. I used it four times a day for four days and my gout was gone."
"I heartily recommend cherries for anyone who suffers from arthritis."
This list of claims is not intended to be all-inclusive, but represents the types of claims found in your product labeling.
These claims cause your product to be a drug, as defined in Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505 of the Act (21 U.S.C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
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. Enforcement action may include seizure of violative products, injunction against the manufacturers and distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
Please advise this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur.
Your reply should be directed to Compliance Officer 'lyra S. Wisecup at the address in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
W. Charles Becoat