FDA warns vs unlisted cosmetic products

MANILA – The Food and Drug Administration (FDA) yesterday cautioned the public against purchasing and using unregistered cosmetic products that could potentially contain harmful ingredients.

“The use of substandard and possibly adulterated cosmetic products may lead to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure,” the FDA said in its advisory.

The FDA has identified several cosmetic products, including Pond’s Complete Solution (Acne Clear White), Miss D Gluta Almond Milk soap, Green Therapy Oatmeal soap, PDI Anti Melasma cream, PDI Artisan Niacinamide soap, Aladan Instant Whitening soap, Happy Brows serum, BYS Concealer Duo 03, Ellana Eyes Up Lifting and Brightening Eye serum, Hair Care Collection conditioner, Mayfair Cocoberry Whitening soap, Yoko Whitening cream, and Tokyo White glutathione lotion, which lack a valid Certificate of Product Notification (CPN) as of February 27, 2024.

As these cosmetic products have not undergone the FDA’s notification process, the agency cannot guarantee their quality and safety.

According to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act 9711, also referred to as the “Food and Drug Administration Act of 2009,” it is prohibited to manufacture, import, export, sell, offer for sale, distribute, transfer, use for non-consumer purposes, promote, advertise, or sponsor any health product without proper authorization from the FDA.

Therefore, all concerned establishments have been cautioned against distributing such cosmetic products until they have fully complied with the FDA’s rules and regulations.

The FDA Regional Field Offices and Regulatory Enforcement Units, in collaboration with law enforcement agencies and local government units, have been requested to ensure that unauthorized products are not sold.

The public is advised to always verify if a product has been notified by the FDA by utilizing the FDA Verification Portal feature, which is accessible at https://verification.fda.gov.ph. This can be done by entering the name of the product before making a purchase and/or using the cosmetic products.

Additionally, to report any sale, distribution, complaints, or adverse events related to the use of banned cosmetic products, individuals can use the online reporting facility, eReport, accessible at ereport@fda.gov.ph or call the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research’s (CCHUHSRR) hotline at (02) 8857-1900 loc. 8113 or 8107.

Chemo injectable recall

On Monday, the FDA advised all hospitals, health facilities, health care professionals and the public to stop the use of Methotrexate 100 mg or mL Solution for Injection (I.M/I.V) [Trexasaph] manufactured by Bruck Pharma Pte. Ltd., India, and imported by Nelpa Life Sciences Inc., Parañaque City, regardless of the batch.

In response, the Private Hospitals Association of the Philippines (PHAPi) and the Pharmaceutical and Healthcare Association of the Philippines (PHAP) said they comply with the directive to recall a chemotherapy injectable found with bacteria.

“We follow the FDA directive. It is a chemotherapeutic agent and not used very frequently, only for specific indications. I am sure the oncologists were advised already,” Dr. Rene De Grano, PHAPi president, told The Manila Times.

“Manufacturers, distributors, and retailers who are members of PHAP have established their respective Risk Management Plans (RMP) that aim to mitigate any potential risks related to the quality, safety, and efficacy of medicines, vaccines and diagnostics,” PHAP Executive Director Teodoro Padilla said.

As part of the required RMP, PHAP members routinely check with the FDA for advisories or alerts on product recalls, counterfeits and other relevant public health information for immediate action.