Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Southwest Region
Denver District

 

Bldg 20, Denver Federal Ctr
6th Ave & Kipling St
PO Box 25087
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

October 17, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Philip B. Rowley, President & Co-Owner
Tod M. Rowley, Co-Owner
Rowley's South Ridge Farms, Inc.
300 W 900 S
Santaquin, UT 84655

Ref. No. DEN-06-02

Dear Messrs Rowley:

The Food and Drug Administration (FDA) has reviewed the labeling for your Red Tart Cherry Concentrate and other cherry products, including your website at www.southridgefarms.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products. 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 USC 321(g)(1)(B)]. The labeling for your cherry products on your website bears the following claims:

Your website also includes a link to www.cherrymkt.org, which includes numerous other claims regarding the purported effect on cherries on various diseases.

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 products to be drugs, as defined in section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act [21 USC 321(p)]. Under section 505 of the Act (21 USC 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 based on 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.

During an inspection of your facility in September 2004, our investigator collected copies of your product brochure entitled "ROWLEY'S South Ridge FARMS Farm fresh gifts", and the label for your cherry juice concentrate.

The following claims were found on your product brochure:

"Cherries relieve the symptoms of arthritis and gout? Not only that, but recent research claims that cherries are full of anti-cancer agents as well. … [T]he anthocyanins in red tart cherries give 10 times the anti-inflammatory relief of aspirin, without irritating the stomach. These anthocyanins are (also) being called 'Mother Nature's all-natural chemotherapy agents.'" (quoting article from Newsweek)

The following claims were found on your product label for "South Ridge FARMS Montmorency Tart Cherry Juice Concentrate 12.5 fl. oz. … Ingredients: Montmorency Tart Cherry Juice Concentrate":

"According to research, Montmorency tart cherries contain natural anti-inflammatory compounds that may relieve the pain of arthritis and gout. They also have melatonin and other powerful antioxidants that aid in the prevention of degenerative diseases. … Relieves Arthritis and Gout"

The statements are further evidence that your Montmorency Tart Cherry Juice Concentrate is intended to be used as a drug. If these materials are currently distributed with your products, they constitute labeling and further cause your products to be unapproved new drugs.

Please advise this office in writing, within 15 working days of receipt of this letter, as to 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 Shelly L. Maifarth at the address in the letterhead. Ms Maifarth may be reached at (303) 236-3046.

Sincerely,
/s/
Howard E. Manresa, for
B. Belinda Collins
District Director

This page was posted on March 28, 2006.

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