FDA Advisory No. 2020-512 || Public Health Warning on the Presence of Tadalafil in BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men

The public is hereby informed that the Food and Drug Administration (FDA) has conducted sampling of specific batches of BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men as part of the strengthened post-marketing surveillance of this Office.

The analyses of the FDA Laboratory showed that the abovementioned product under the specific lot number ABV38E20T and expiry date 20 June 2021 have tested positive for TadalafilTadalafil is a prescription drug used to treat male sexual function problems such as impotence or erectile dysfunction (ED).

Tadalafil is prohibited in food/dietary supplements, since it poses potential health risks to the unwary consuming public especially those who have had a stroke, severe vision loss, persons experiencing stomach ulcers, heart problems, kidney problems, liver problems, bleeding problem, blood cell problems, and low or high blood pressure. Possible side effects which can occur are as follows:

  • indigestion                                            •    back pain
  • muscle aches                                         •    stuffy or runny nose
  • flushing                                                 •    headaches

The presence of drug ingredient Tadalafil deems the food/dietary supplement as ADULTERATED, which is in violation of R.A. 9711 (FDA Act of 2009) and R.A. 10611, otherwise known as the Food Safety Act of 2013.

Consumers are advised to:

  1. Stop taking BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men with lot number ABV38E20T.
  1. Consult a healthcare professional in case you experience any of the side effects upon consumption of the product.
  1. Exercise caution when purchasing food supplements for men that can be potentially adulterated with drug ingredients which can seriously harm the consumers.

The FDA shall ensure that the market authorization holder (MAH) will conduct a voluntary recall for the implicated products.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that the said products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above adulterated food supplement, email us at [email protected], or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8105.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-512

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