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The Food and Drug Administration (FDA) informs the public that the Toys and Childcare Articles (TCCA) Babyflo Silicone Nipple Medium Hole with Notification No. 5000004691067, has been notified by the Market Authorization Holder (MAH), Philusa Corporation, in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in the FDA Advisory No. 2020-337 is hereby lifted.

The public is advised to always check if a Toys and Childcare Articles (TCCA) is notified with the FDA. The FDA website ( has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

To report any sale or distribution of unnotified Toys and Childcare Articles (TCCA), email us at [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-337-A