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

Public Health Service
Food and Drug Administration
Minneapolis District

 

240 Hennepin Ave
Minneapolis, MN 55401-1999
Telephone: 612-334-4100

January 28, 1997
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Donald L HilIestad, President
Hillestad International, Inc.
178 Hwy 51 N
Woodruff, WI 54568

Ref. No. MN-97-30

Dear Mr Hillestad:

This letter is written in reference to the marketing of the products Z-23 Prostate Formula, Opti-Cran Freeze-dried Cranberry with Aloe, Citri-C Wafers, Ginseng Plus "C" Chewing Gum and Dialyvite Multi-vitamins for Chronic Renal Failure by your firm.

Product labeling, namely immediate container labcls, product brochures, the newsletter "Quality Living," and the catalog "Quality Family Products," suggests that the products Z-23 Prostate Formula, Opti-Cran Freeze-dried Cranberry with Aloe, and Dialyvite Multi-vitamins for Chronic Renal Failure arc useful for treating or preventing various disease conditions. Product labeling for the products Citri-C Wafers and Ginseng Plus "C" Chewing Gum suggest that these products arc useful as smoking deterrants. Details of these statements are further discussed below. The claims made for these five products cause each to be drugs [Section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act)].

  1. Z-23 Prostate Formula.

    The product brochure claims that this product may be useful in the treatrncnt or prevention of prostate cancer and benign prostatic hypertrophy. The front page of the November 1995 edition of the newslcttcr "Quality Living" claims that this product maybe useful in treating or preventing "Prostate problems."

  2. Dialyvite Multi-vitamins for Chronic Renal Failure.

    The immediate container label for this product claims that this product is useful in the treatment or prevention of chronic renal failure.

  3. Opti-Cran Freeze-dried Cranberry with Aloe.

    The product brochure claims that this product is useful in the treatment or prevention of bladder and urinary tract infections and that components of thec product act as infection fighters and have anti-inflammatory and antibacterial properties.

  4. Citri-C Wafers and Ginseng Plus "C" Chewing Gum.

    The immediate containcr labels for these two products bear the statements, "Replace smoking urges with a Citri-C chewable wafer" and "Replace smoking urges with Ginseng Plus C Chewing Gum," respectively. Further, the "Quality Family Products" catalog, in the section concerning Citri-C Wafers, states that this product may be used "as an aid in quitting smoking."

    Under Title 21 of the Code of Federal Regulations Part 310.544 (copy enclosed), smoking-deterrent drug products may not be marketed except under an approved new drug application (NDA).

We are unaware of any evidence that the aforementioned five drug products are generally recognized as safe and effective for their intended uses. Therefore, these drugs are new drugs [Section 201(p)] which may not be marketed in this country since no New Drug Applications (Section 505) have been approved for these drugs. These drugs are misbranded in that their labeling is false and misleading because it suggests that the drugs are generally regarded as safe and effective for their intended uses when, in fact, this is not the case. The drugs are further misbranded bccausc their labeling fails to bear adequate directions for use (Section 502).

This letter does not rcprcscnt a comprehensive review of all the products distributed by your firm, nor does it represent a complete review of all product labeling including immediate container labels, product brochures, product catalogs and newsletters. As the president of your firm, it is your rcsponsibfity to ensure that all products distributed by your firm meet the requirements of the Act and the regulations promulgated thereundcr.

We request that you notify this office in writing within 15 working days of receipt of this letter stating the action you will take to discontinue the marketing of these drugs or otherwise bring them into compliance. Failure to promptly correct these violations may result in enforcement action being initiated without further notice. The Act provides for seizure of illegal products (Section 303) and for injunction (Section 302) against the manufacturer and/or distributor of illegal products.

Your reply should be directed to Compliance Officer Howard E. Manresa at the address indicated on the letterhead. Mr Manresa maybe reached at 612-334-4100, extension 156.

Sincerely yours,
/s/
John Feldman,
District Director

Enclosure:
21 CFR 310.544

This page was posted on August 20, 2006.

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