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

Andy LaPointe
Traverse Bay Farms
7053 S M88 Hwy
PO Box 1229
Bellaire, MI 49615

Ref. No. DT-06-18

Dear Mr LaPointe:

The Food and Drug Administration (FDA) has reviewed the labeling of your Cherry Juice Concentrate, Wild Blueberry Juice Concentrate, and Fruit Advantage Dried Cherries, and Fruit Advantage Tart Cherry Capsules on your website at www.traversebayfarms.com. Our review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of these 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 products on your website bears the following claims:

Cherry Juice Concentrate

"Ongoing research shows that tart cherries are a rich source of antioxidants, including melatonin, which may help to relieve the pain of arthritis, gout and possibly fibromyalgia."

Cherry Juice Concentrate, Fruit Advantage Dried Cherries and Fruit Advantage Tart Cherry Capsules

Wild Blueberry Juice Concentrate

"Though small, in size the Wild Ones [wild blueberries] are packed with antioxidants that may help your body fight … cancer.""Recently published USDA research (2004) confirms that a serving of Wild Blueberries delivers more antioxidant power than 20 different fruits and berries — including cultivated blueberries. … Antioxidants are important because of their.potential to protect against oxidative cell damage that can lead to conditions like Alzheimer's disease."

Your website also includes claims in the form of testimonials. Some examples are as follows:

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 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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