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

Public Health Service
Food and Drug Administration
Detroit District

 

300 River Pl #5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

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

George Wright
H & W Farms
13375 Belding Rd
Belding, MI 48809

Ref. No. DT-06-09

Dear Mr Wright:

The Food and Drug Administration (FDA) has reviewed the labeling of your Tart Cherry Juice Concentrate on your website at www.hwfarms.com as it appeared on August 10, 2005. 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 USC 321(g)(1)(B)j. The labeling for your product on your website bears the.following claims:

Your website also includes claims in the form of testimonials. One example is as follows:

"I use cherries to counteract the pain of gout…."

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 USC 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 USC 321(p)]. Under section 505 of the Act (21 USC 505), 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, 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 Judith A. Putz, Compliance Officer, at above address.

Sincerely,
/s/
Joann M. Givens
District Director

This page was posted on March 28, 2006.

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