FDA Warns Public Not to Purchase the Following Products

In separate advisories, the Food and Drug Administration (FDA) – Philippines warned the public not to purchase and use the following products:

FDA Advisory No.2206, Series of 2020

According to the FDA, the public is warned from purchasing and using the unauthorized cosmetic product:
  • Collagen by Watsons Moisturising & Brightening Facial Mask

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Photo Source: FDA

In the advisory, FDA has verified through postmarketing surveillance and it showed that the said product has no valid Certificate of Product Notification (CPN) as of December 15, 2020.

As stated in the advisory, under the FDA Act of 2009, the following is prohibited without the proper authorization from the FDA:

  • manufacture
  • importation
  • exportation
  • sale,
  • offering for sale
  • distribution
  • transfer
  • non-consumer use
  • promotion
  • advertising
  • sponsorship of any health

FDA Advisory No. 2193, Series of 2020

Under the FDA advisory, the public is warned from purchasing and using the non-compliant cosmetic product:
  •  IWHITE Korea Matcha Ice Cream Wash Off Mask

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Photo Source: FDA

The cosmetic product’s non-compliance is that the ingredients listed on the label are inconsistent with the information declared in the acknowledged product notification according to the FDA advisory.

Furthermore, FDA has verified the product as Non-compliant through post-marketing surveillance.

FDA stated on the advisory that “based on the CPN issued to the company, any subsequent changes to the information previously submitted to FDA will render the notification invalid.”

Also, the FDA added that “all concerned establishments are warned not to distribute violative product until they have fully complied with the rules and regulations of the FDA.”

FDA Advisory No. 2184, Series of 2020

The public  and all health professionals are warned by FDA not to purchase and use the unnotified medical device products:
  • Hisamitsu® Bye-bye Fever (For Adults)
  • Hisamitsu® Bye-bye Fever (For Babies)

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Source: FDA

Through post-marketing surveillance, FDA verified that the said products are not “not notified and no corresponding Product Notification Certificates have been issued.”

In addition, the quality and safety of the abovementioned medical products cannot be assured since it has not gone through the evaluation process of FDA.

FDA Advisory No.2188 and FDA Advisory No.2187

Under the FDA Advisories, the public is warned not to purchase and use the following unauthorized cosmetic products:


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Photo Source: FDA

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Photo Source: FDA

According to the advisory,  the said products were “verified by FDA through postmarketing surveillance and shows that no valid CPN as of December 17, 2020.

As stated in the advisory, since the unauthorized products “has not gone through the notification of process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.”

Report Sale/Distribution

To report any sale or distribution of unnotified medical device products, non-compliant cosmetic products, and unauthorized cosmetic products, report through the online reporting facility eReport.

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Source: FDA Advisory No.2206, FDA Advisory No. 2193FDA Advisory No. 2184, FDA Advisory No.2188, FDA Advisory No.2187

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