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

Robert Underwood
Flavonoid Sciences
965 Cherry Ridge Dr
PO Box 5017
Traverse City, MI 49696

Ref. No. DT-06-07

Dear Mr Underwood:

The Food and Drug Administration (FDA) has reviewed the labeling, including your websites at www.flavonoidsciences.com, for your CherryFlex and Wild BlueBerry IQ products. This 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 are drugs [Section 201(g)(1)(B) of the Act, 21 USC 321 (g)(1)(13)]. The labeling for your products bears the following claims:

Your website also includes claims in the form of testimonials. Some examples include:

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, because they establish that these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 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 or 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 farther 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 the above address.

Sincerely,
/s/
Joann M. Givens
District Director

This page was posted on March 28, 2006.

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