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

Public Health Service
Food and Drug Administration
Pacific Region
Seattle District

 

22201 23rd Dr SE
Bothell, WA 98021-4421
Telephone: 425-488-8788
FAX: 425-483-4998

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

Ivan Taylor, Owner
TPG Enterprises, Inc.
2148 W Hwy 26
Othello, WA 99344-9562

Ref. No. SEA-06-01

Dear Mr Taylor:

The Food and Drug Administration (FDA) has reviewed the labeling of your Tart Cherry Concentrate and Fresh Apple Slices, including your website at www.tpg-usa.com. 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 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:

Tart Cherry Concentrate

Fresh Apple Slices

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

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.

This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all 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.

In addition, FDA conducted an inspection of your facility, located at 2148 W Hwy 26, Othello, WA, on January 4, 2005. During that inspection labeling for your Tart Cherry Concentrate was collected. The labels for your Tart Cherry Concentrate include the following claims:

If your labels continue to include these claims, these claims may also cause your Tart Cherry Concentrate product to be a drug.

In addition to the claims cited above, we noted other deviations from the labeling regulations on the labels of your Tart Cherry Concentrate product collected during the January 2005 inspection:

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 sent to the Food and Drug Administration, Attn: Lisa Althar, Compliance Officer, 22201 23rd Dr SE, Bothell, WA 98021-4421.

Sincerely,
/s/
Charles M. Breen
District Director

This page was posted on March 28, 2006.

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