FREQUENTLY ASKED QUESTIONS

ESTABLISHMENT LICENSING and PRODUCT REGISTRATION

1.      What types of establishments are required to apply for a License to Operate with BFAD?

      Establishments involved in the manufacture, packaging, re-packaging, importation, exportation, distribution, and retailing
      of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance
      products must secure a License to Operate from BFAD. 

 

2.      What types of products are registered with BFAD?

      BFAD handles the registration of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and
      household hazardous substance products.

 

3.      How do we register our products?

      A local company in the Philippines must secure a License to Operate (LTO) from BFAD before applying for product
      registration.  All issuances and guidelines, checklists of requirements, and forms pertaining to licensing of establishments
     and product registration may be downloaded from the BFAD Website: www.bfad.gov.ph.

4.      How do we know which type of checklist to use for establishment licensing and product registration?  How do we know whether our product will be classified by BFAD as food, drug, or cosmetic?

      Clients may apply for product classification at BFAD.  Application documents with sample and complete product information and proof of payment may be submitted at the Policy, Planning, and Advocacy Division - Public Assistance and Compliance Division (PPAD-PAICS), Room 101. 

5.      Where can we get a copy of the guidelines for licensing of establishment and product registration?

      Guidelines may be downloaded from the BFAD Website thru the Laws and Regulations link: http://www.bfad.gov.ph/left_laws_regulations.htm.  New guidelines may also be downloaded thru the New Issuances link: http://www.bfad.gov.ph/new_issuances.htm

6.      How much is the processing fee for licensing or product registration?

      Fees are listed in Administrative Order No. 50 s. 2001: Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs. This is available thru http://www.bfad.gov.ph/AO/ao 50 2001.pdf.   

7.      We need to conduct a specific test analysis for our products.  How can we have our products tested?

      Clients may access the BFAD Website for the list of recognized laboratories (http://www.bfad.gov.ph/laboratories_modified.htm).  The list contains the addresses, contact numbers, and types of analysis offered by the laboratories.   
 

PUBLIC / CONSUMER INFORMATION

1.      How do we know if a certain product is registered with BFAD?

      For product registration verification, consumers may contact the Policy, Planning, and Advocacy Division at telephone number 8425606.  Consumers are advised to provide details such as the complete product name, registration number, and name of manufacturer or distributor.  

[Note: BFAD assigns unique registration numbers for processed food (FR-#), drug (DR-#, BR-#, VR-#, HMR-#, HDL-#), medical device (DVR-#), diagnostic reagent (RR-#), cosmetic (CR-#, CL-#), and household hazardous products (HHR-#).  This registration number must be indicated on the label or packaging of products except for some food products.]   

2.      How can we avoid purchase of unregistered products?

      Consumers are advised to verify the existence of the License to Operate (LTO) of the establishment/outlet which should be conspicuously displayed and the existence of the applicable BFAD Product Registration Number on the label of the products intended to be bought.  The absence of such information is indicative of possible illegal source/product.

      Furthermore, consumers must ask for receipts of payment of purchased products reflecting the business name and address, Tax Identification Number (TIN), and name of printer (BIR Permit No.) with inclusive serial number of booklets and date of issuance of receipts and the description of the goods bought.

3.      How does BFAD process consumer complaints?

      Consumers are advised to coordinate with the nearest Department of Health Center for Health Development (CHD) for product complaints.  If the Acting Consumer Arbitration Officers deem it fit that the complained product needs laboratory analysis, the product will be forwarded to the BFAD Laboratory Services Division.

      Contact details of the CHDs may be downloaded from the BFAD Website thru: http://www.bfad.gov.ph/DIRECTORY GUIDE.htm.

 
Q: How to spot false claims?

A: Typical fraudulent health claims will use the following promotional techniques to fool their customers:

  • The product is advertised as a quick and effective cure-all for a wide range of illness.

  • Certain key words like "scientific breakthrough, miracle cure, all natural without side-effects or ancient remedy" are used.

  • The promote claims that medical professionals and scientists have conspired to suppress the product.

  • Adverts contain undocumented, anecdotal cases, but with amazing results. No science involved.

  • These products sell falls hope for extreme physical attractiveness and shortcuts to weight loss. They will never emphasize the value of healthy lifestyles, like avoiding smoking, excess drinking of alcohol, eating appropriately, adequate rest and sleep, and regular exercise.

  • Remember that legitimate health supplement products will never carry claims for quick cures; claims such as cancer prevention, good for arthritis, good for diabetes or good for hypertension, should be high suspect.

  • The product is advertised as available from only one source.

  • There is a money-back guarantee promise.
Q: What are some precautions in taking dietary supplements?

A: Some dietary supplements have documented benefits; the advantages of others are unproven and claims about those products may be false or misleading.

  • For example, claims that you can eat all you want to lose weight effortlessly just by taking their products are not true.

  • One other example are those body building products that can tone you up effortlessly or build muscle mass without exercise.

  • Other questionable claims involve those products advertised as effective in curing insomnia, reversing hair loss, relieving stress, curing impotency, improving memory or eye sight, and slowing the aging process.

  • In addition to lacking documented effectiveness, some dietary supplements may be harmful under some conditions of use.

  • A label of "Natural" is no guarantee of a product's safety or effectiveness.

  • Consumers must read product labels and consult health professionals before taking dietary supplements (especially for children, adolescents, the elderly or chronically ill persons, and pregnant or breast-feeding women)

Oftentimes, these products are imported without the necessary papers and there are claims that they are US FDA approved or Japan FDA approved. The US FDA does not regulate health supplements like these. Endorsements frequently come from foreign-authoritatively looking individuals.

 
Q: What are the requirements to avail the 20% discount in the purchase of medicines for personal use of the Senior Citizen?

A: Requirements to avail of the 20% discount in the purchase of medicines for personal use are:

  • Present the national identification (ID) card and your purchase slip booklet duly approved by the OSCA chairman.

  • Doctor's prescription pad should have the following information:

          1. Patient name, age, address, and date

          2. Generic name of the medicine prescribed

          3. Name and address of the doctor; his PTR number and S2 license (if prohibited and regulated drug)

  • Those who cannot afford the consultation fee of a private doctor can consult at their nearest health center or government hospital and get a prescription free of charge.

  • Any single dispensing should not be more than one week's supply. However, when drugs are for chronic conditions requiring continuous use for more than a month, such as hypertension, diabetes, Parkinson's disease, arthritis, TB, cancer, psychosis, a maximum of one month's supply may be dispensed at a time.

  • The following should be recorded in a special record Book for Senior Citizens Discount provided under RA 7432:

          1. Name

          2. Address

          3. National ID number of Senior Citizen

          4. Generic Name of the drug/medicine

          5. Number of units dispensed