FDA Advisory No. 2019-141 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. 8-9/2019/K

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public on the report from ASEAN Post-Marketing Alert System (PMAS) on the following Cosmetic Products which are found to contain DIPHENHYDRAMINE:

BRAND / PRODUCT NAME

1. Bao Fu Ling Snow Lotus Cream 15g
2. Bao Fu Ling Skincare Cream

*Attached is a copy of the Malaysia PMAS Report with Reference No. 8-9/2019/K

The aforementioned products have been tested by the National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

The aforementioned products were found to contain Diphenhydramine, an antihistamine that is not allowed to be part of a cosmetic product based on the ACD. Adverse effects associated with topical application of Diphenhydramine include mild stinging, allergic reactions such as rash, hives, itching, swelling of the mouth, face, lips, tongue, or throat, and skin irritation. Side effects common to all antihistamines include nausea, dizziness, anxiety, dry mouth, blurred vision, difficulty urinating, and constipation.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA, through any of the following channels, any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, Report, at www2.fda.gov.ph/ereport.

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 2 8070751 Website: www.fda.gov.ph Email: [email protected]

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www2.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-141

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