The Food and Drug Administration (FDA) continues to work towards strengthening its capability and processes consistent with its relentless quest to achieve toxic-free products. Recognizing the vital role of non-government organizations, the FDA acknowledges every effort including activities that can aid the agency in establishing data to justify regulatory actions.
Disposition of Flood-Affected Health Products
The heavy rains brought about by the Typhoons Ondoy and Pepeng caused extreme flooding including long and massive electrical disruptions in Manila and its surrounding areas and triggered landslides and floods in Northern Luzon. As a result of such flooding, countless factories, warehouses, or establishments in which health products are
manufactured, processed, packed, or held for introduction to domestic commerce including drugstores and retail stores have been submerged in flood waters including their respective products thereby adversely affecting or compromising the quality, safety, efficacy, or purity of such health products. For purposes of this advisory, health products refer to food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, or household/urban hazardous substances and/or a combination of and/or a derivative thereof.
In the interest of public health, safety and welfare, the Department of Health - Food and Drug Administration (FDA) hereby warns establishments as well as the public of health products that were submerged and/ or otherwise affected by the floods that are offered for sale or resale. Thus, this Office hereby enjoins those concerned of their strict compliance to the following:
Warning on Unregistered Imported Processed Food, Drugs, Devices and Cosmetics
The Departmenl of Health-Bureau of Food and Drugs (DOH-BFAD) hereby reilerates its advice to the public to be wary of unregistered processed food, cosmetic medical device products,as well as, drugs including herbal and Chinese medicines that have been illegally imported and are offered for wholesale or retail. These products were obtained from unknown sources posing doubts on their safety, efficacy, quality and purity. Illegally imported products also rob the government of valuable lax incume.
The manufacture, importation. exportation, sale, offering for sale, distribution, or transfer of any drug or device which is not registered with the BFAD is strictly prohibited pursuant to Republic Act 3720 as amended by Executive Order No. 175. otherwise known as the Food, Drugs and Devices. and Cosmetics Act, as well as Republic Act 7394 or
the Consumer Act of the Philippines. Likewise. existing rules and regulations of the DOH-BFAD mandatorily require that imported processed food and cosmetics must be registered with the above Office prior to the products' distribution in the local market.
Immediate Recall of Penrex Herbal Supplement for Men
In the interest of public health, safety and welfare, the Department of Health-Bureau of Food and Drugs announces to the public that it has directed the Importer/Distributor of Penrex Herbal Supplement for Men to immediately recall the said product from the Philippine market. The said product is marketed as food supplement, as such, should not contain any active ingredient for drug products. However, examination conducted by the BFAD on the samples of the drug product collected directly from the importer/distributor revealed the presence of Sildenafil Citrate, a known active ingredient of prescription drugs fro erectile dysfunction.
It must be emphasized that consumers, especially with diabetes, high blood pressure, or heart diseases, may be put at considerable risk when using the above product in question since the use of products containing the active ingredient Sildenafil Citrate may interact' with the active ingredients found in other prescription drugs. Thus, products containing the active ingredient Sildenafil Citrate can only be bought upon a doctor's advice and sold and dispensed only through a prescription issued by a licensed physician.
Consumers who have used or are using the above product are therefore advised to discontinue their use and consult their health care providers and directly report to BFAD if they have experienced any adverse events that are related to the use of the product.
Application for License to Operate (Opening) of Drug Outlets, and Importers/Distributors of Processed Foods, Drugs, Cosmetics, Medical Devices and Household Hazardous Substances.
This is to inform you that in order for us to improve our efficiency and services starting 01 March 2007, we will only accept applications for issuance of License to Operate (LTO) from Mondays to Thursdays from 7 AM to 5 PM, Fridays will be allotted to our additional tasks.
We will inform you later when we will resume acceptance of applications until Fridays.
For your information and guidance.