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

Public Health Service
Food and Drug Administration
Chicago District Office

 

300 S Riverside Plaza #550 South
Chicago, IL 60606
Telephone: 312-353-5863

July 14, 1997
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Harris Schnall, President
JB Harris, Inc.
4324 Regency Dr
Glenview, IL 60025

Ref. No. CHI–35–97

Dear Mr Schnall:

This letter is written in reference to the marketing of "Kolorex Capsules" and "Kolorex Cream" by your firm. Labeling for these products, namely the pamphlet entitled, "Naturally Control Candida, Thrush and other fungal problems with Kolorex Capsules and Kolorex Cream." states that these products are useful in treating or preventing Candida infections, thrush and other fungal problems. These claims cause the products to be drugs as described in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

We are unaware of any evidence which establishes that these drugs are generally recognized as safe and effective for their intended use. Further, "Kolorex Cream" does not meet the requirements of the final rule covering over-the-counter antifungal drug products under Title 21, Code of Federal Regulations, Sections 333.201 through 333.280. Therefore, "Kolorex Capsules" and "Kolorex Cream" are new drugs as described in Section 201(p) of the Act, which may not be marketed in this country since no new drug application required by Section 505 of the Act has been approved for these drugs.

These drugs are misbranded under Section 502(a) of the Act as their labeling is false and misleading because they falsely suggest that there is evidence that these drugs are safe and effective for their intended use. The drugs are further misbranded as stated in Section 502(f)(1) of the Act, since their labeling fails to bear adequate directions for use.

This letter is not intended to be an all inclusive review of all labeling and products your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act.

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 products or otherwise bring them into compliance. Failure to promptly correct these violations may result in enforcement action being initiated without further notice. Such actions include, but are not limited to seizure. The Act provides for seizure of illegal products under Section 303 of the Act and injunction as stated in Section 302 of the Act.

Your reply should be directed to Paul A. Boehmer, Compliance Officer; Food and Drug Administration, 300 S Riverside Plaza #550 South, Chicago, IL 60606.

Sincerely,
/s/
Raymond V. Mlecko
District Director

This page was posted on August 20, 2006.

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