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

July 24, 1997
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Samuel C. Johnson, Chairman of the Board
SC Johnson & Son, Inc.
1525 Howe St
Racine, WI 53403-2236

Ref. No. MIN-97-55

Dear Mr Johnson:

During a recent inspection of your facility in Sturtevant, WI, samples were collected of "Aveeno Bath Treatment" (natural and oilated) and "Aveeno Cleansing Bar." "Aveeno Bath Treatment" contains colloidal oatmeal. "Aveeno Cleansing Bar" contains, among other ingredients, colloidal oatmeal and salicylic acid.

"Aveeno Bath Treatment" is offered for, among other things, the relief of eczema and psoriasis. "Aveeno Cleansing Bar" is offered for, among other things, the relief of "oily or Acne-Prone Skin." These claims make the products drugs as defined under Section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act).

"Aveeno Bath Treatment" is subject to the Final Rule for Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Over-the-Counter (OTC) Human Use under Title 21, Code of Federal Regulations (CFR) Section 358.750 which became effective on December 4, 1992, and was amended January 28, 1994, as listed under 21 CFR Section 358.701. "Aveeno Cleansing Bar" is subject to the Final Rule for Topical Acne Drug Products for OTC Human Use under 21 CFR 333.350 which became effective on August 16, 1992, as listed under 21 CFR 333.301. The formula and labeling for these products do not conform to the Final Rules. These products are, therefore, new drugs as described under Section 201(p) of the Act and may not be legally marketed in the United States without an approved New Drug Application (NDA) under Section 505(b) of the Act. These products are also misbranded as defined in Section 502(f)(1) of the Act because the directions for use, warnings, etc., do not meet the regulations.

The above list of violations is not intended to be an all-inclusive list of defiaencies for these products marketed by your firm. It is your responsibility to ensure that the drug products you manufacture or distribute meet all requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include, but are not limited to, seizure and/or injunction.

Please notify this office in writing within 15 working days of the receipt of this letter of the specific actions you will take to correct the violations. Your response should also include an explanation of each step being taken to prevent recurrence of similar violations. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time within which corrections will be completed.

Your response should be addressed to Acting Compliance Officer Rhonda L. Mecl at the address indicated on the letterhead.

Sincerely,
/s/
Edwin S. Dee
Acting District Director

This page was posted on August 20, 2006.

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