Reiteration of the issuance of FDA Advisory No. 2017-323 regarding the false, deceptive and misleading health claims of pantyliners/sanitary napkins.
The Food and Drug Administration (FDA) reissues this advisory to inform the general public the proliferation of pantyliners/sanitary napkins with health claims e.g. relieves tension, reduces irritation, prevents/cures diseases/infection such as UTI, Myoma, vaginal odor, hormonal imbalance etc., and releases negative ions.
While as general rule, pantyliners/sanitary napkins are not required to seek proper authorization from the FDA, pantyliners/sanitary napkins with health claims, require such authorization. The sale/marketing of such unregistered product constitutes violation of Section 10 of Republic Act No. 9711 otherwise known as the “Food and Drug Administration Act of 2009”.
On the other hand, the false, deceptive and misleading advertisement of these pantyliners/ sanitary napkins, constitutes violation of Title III, Chapter I of Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines of 1992”.
The public is thus advised to be vigilant and observe precautionary measures in purchasing unregistered pantyliners/sanitary napkins with health claims, false, deceptive and misleading health claims.
All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.
All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through email at [email protected] or call (02) 857-1900 local 8301.
Attachment-> : FDA Advisory No. 2019-246