Latest Advisory

  • FDA Advisory No. 2018-049 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

    FDA Advisory No. 2018-049 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

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  • FDA Advisory No. 2018-048 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2018-048 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2018-047 || ASEAN Advisory Statement on Talc

    FDA Advisory No. 2018-047 || ASEAN Advisory Statement on Talc

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  • FDA Advisory No. 2018-046 || Public Health Warning Against the Use of Unregistered Medical Device (Mersilk Black Braided Silk Suture N536)

    FDA Advisory No. 2018-046 || Public Health Warning Against the Use of Unregistered Medical Device (Mersilk Black Braided Silk Suture N536)

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  • FDA Advisory No. 2018-045 || Voluntary Product Recall of Guider Softip Guiding Catheter

    FDA Advisory No. 2018-045 || Voluntary Product Recall of Guider Softip Guiding Catheter

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  • FDA Advisory No. 2018-044 || VOLUNTARY RECALL OF THE MALECOT NEPHROSTOMY CATHETERS WITH PRODUCT REGISTRATION MDR NO. 02508

    FDA Advisory No. 2018-044 || VOLUNTARY RECALL OF THE MALECOT NEPHROSTOMY CATHETERS WITH PRODUCT REGISTRATION MDR NO. 02508

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  • FDA Advisory No. 2018-043 || VOLUNTARY RECALL OF INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM

    FDA Advisory No. 2018-043 || VOLUNTARY RECALL OF INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM

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  • FDA Advisory No. 2018-042 || Lifting the Advisory of LIPA YOUNG COCONUT WATER WITH COCONUT BITS under FDA Advisory No. 2016-071, Subject: “Public Health Warning Against the Use of the Following Unregistered Food Product: Lipa Fresh Buko Juice Young Coconu

    FDA Advisory No. 2018-042 || Lifting the Advisory of LIPA YOUNG COCONUT WATER WITH COCONUT BITS under FDA Advisory No. 2016-071, Subject: “Public Health Warning Against the Use of the Following Unregistered Food Product: Lipa Fresh Buko Juice Young Coconu

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  • FDA Advisory No. 2018-041 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)

    FDA Advisory No. 2018-041 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)

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  • FDA Advisory No. 2018-040 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 3)

    FDA Advisory No. 2018-040 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 3)

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  • FDA Advisory No. 2018-039 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 3)

    FDA Advisory No. 2018-039 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 3)

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  • FDA Advisory No. 2018-038 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 2)

    FDA Advisory No. 2018-038 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 2)

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  • FDA Advisory No. 2018-037 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 1)

    FDA Advisory No. 2018-037 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 1)

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  • FDA Advisory No. 2018-036-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Hair Organics Ocara Hair Grower Hair Vitamins Gugo + Aloe Vera + Minoxidil Shampoo 150 mL.

    FDA Advisory No. 2018-036-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Hair Organics Ocara Hair Grower Hair Vitamins Gugo + Aloe Vera + Minoxidil Shampoo 150 mL.

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  • FDA Advisory No. 2018-036 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Hair Organics Ocara Hair Grower Hair Vitamins Gugo + Aloe Vera + Minoxidil Shampoo 150 mL.

    FDA Advisory No. 2018-036 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Hair Organics Ocara Hair Grower Hair Vitamins Gugo + Aloe Vera + Minoxidil Shampoo 150 mL.

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  • FDA Advisory No. 2018-035-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot:

    FDA Advisory No. 2018-035-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot:

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  • FDA Advisory No. 2018-035 || Public Health Warning Against the Purchase and Use of the Following Unregistered  Drug Products:

    FDA Advisory No. 2018-035 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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  • FDA Advisory No. 2018-034 || Reiteration of Grace Periods Given to the Cosmetic Industry for Ingredients Banned or Restricted During the Recent ASEAN Cosmetic Committee (ACC) Meetings and Its Related Events

    FDA Advisory No. 2018-034 || Reiteration of Grace Periods Given to the Cosmetic Industry for Ingredients Banned or Restricted During the Recent ASEAN Cosmetic Committee (ACC) Meetings and Its Related Events

    FDA Advisory No. 2018-034

    Reiteration of Grace Periods Given to the Cosmetic Industry for Ingredients Banned or Restricted During the Recent ASEAN Cosmetic Committee (ACC) Meetings and Its Related Events 

    In the interest of public service and in line with the Food and Drug Administration’s (FDA’s) thrust to strengthen its enforcement of existing rules, regulations and standards, the Center for Cosmetics Regulation and Research (CCRR) hereby reiterates the impending end of the grace periods given to the cosmetic industry through FDA Circulars No.  2017-006 and 2017-007 for newly banned ingredients or ingredients with new restrictions adopted during the 25th and 26th ASEAN Cosmetic Committee (ACC) meetings and its related events.

    • FDA Circular No. 2017-006 “Updates and Amendments of the ASEAN Cosmetic Directive as Adopted During the 25th ASEAN Cosmetic Committee Meeting and Its Related Events

    ACD Annex and Reference No.

    Chemical / Substance

    Maximum Authorized Concentration and/or Other Limitations and Requirements

    Grace Period

    Annex III Ref. No. 15d

    Potassium Hydroxide

    1.5% as callosity softener / remover

    Conditions of use and warning which must be printed on the label:

    ·         Contains alkali.

    ·         Avoid contact with eyes

    ·         Keep out of reach of children

    ·         Read directions for use carefully

    31 August 2018

    Annex IV Color Index (CI) 77266

    Carbon Black

    Additional Restriction/Conditions of Use:

    Purity >97 %, with the following impurity profile: Ash content ≤ 0.15%, total sulphur ≤ 0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤ 5ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, total Hg ≤ 1ppm.

    31 August 2018

    Annex IV CI 77266 (nano)

    Carbon Black (Nano)

    10%

    Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.

    Only nanomaterials having the following characteristics are allowed:

    — Purity >97%, with the following impurity profile: Ash content ≤0.15%, total sulphur ≤0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤5 ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, and total Hg ≤1 ppm;

    — Primary particle size ≥20 nm.

    31 August 2018

    Annex VI Ref. No. 57

    2-Methyl-2H-isothiazol- 3-one

     

    Methylisothiazolinone

    0.01%

    Allowed to be used only in rinse-off products.

    Prohibited in leave-on products.

    31 August 2018

    Annex VII Ref. No. A29

    Zinc Oxide

     

    Additional Restriction/Conditions of Use:

    “Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.”

    31 August 2018

    Annex VII Ref. No. A29a

    Zinc Oxide (nano)

    25%1

    Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.

    Only nanomaterials having the following characteristics are allowed:

    -          purity ≥96% with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water whilst other impurities are less than 1% in total.

    -          Median diameter of the particle number size distribution D50 (50% of the number below this diameter) >30 nm and D1 (1% below this size) >20nm.

    -          Water solubility <50 mg/l.

    -          Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects2

    31 August 2018

    Annex VII Ref. No. 27a

    Titanium Dioxide (nano)

    25%3

    Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.

    Only nanomaterials having the following characteristics are allowed:

    - Purity ≥99%

    - Rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,

    - Median particle size based on number size distribution ≥30 nm,

    - Aspect ratio from 1 to 4.5 and volume specific surface area ≤460 m2/cm3,

    - Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects4

    - Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference,

    - Nanoparticles are photostable in the final formulation.

    31 August 2018

     

    1 In case of combined use of Zinc Oxide and Zinc Oxide (nano), the sum shall not exceed the maximum authorized concentration which is 25%.

    2The amendment to the original restriction on the coating material for Zinc Oxide (nano) is adopted during the 26th ACC Meeting and its related events and disseminated through FDA Circular No. 2017-007.

    3 In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the maximum authorized concentration which is 25%.

    4The amendment to the original restriction on the coating material for Titanium Dioxide (nano) is adopted during the 26th ACC Meeting and its related events and disseminated through FDA Circular No. 2017-007.

    • FDA Circular No. 2017-007 “Updates and Amendments of the ASEAN Cosmetic Directive as Adopted During the 26th ASEAN Cosmetic Committee Meeting (ACC) and Its Related Events

    ACD Annex and Reference No.

    Chemical / Substance

    Maximum Authorized Concentration and/or Other Limitations and Requirements

    Grace Period

    Annex III Ref. No. 312

    Diethylene Glycol Monoethyl Ether (DEGEE)

     

    Ethoxydiglycol

    a.       Oxidative hair dye products – 7%

    b.       Non-oxidative hair dye products – 5%

    c.        Rinse-off products other than hair dye products – 10%

    d.       Other non-spray cosmetic products – 2.6%

    e.        The following spray products: fine fragrances, hair sprays, anti-perspirants and deodorants – 2.6%

     

    (a) to (e) The level of ethylene glycol impurity in Ethoxydiglycol must be ≤0.1 %

    Not to be used in eye products and oral products.

    01 December 2018

    Annex III Ref. No. 313

    Polidocanol

     

    Laureth-9

     

    a.       Leave-on products – 3.0%

    b.       Rinse-off products – 4.0%

    01 December 2018

    Annex III

    Hair Dye Entries

    Additional conditions of use and warning which must be printed on the label:

    Do not use to dye eyelashes or eyebrows

    01 June 2018

    Annex VII Ref. No. 4

    Oxybenzone (INN)

    6%

     

    Conditions of use and warning which must be printed on the label:

    Contains oxybenzone

     

    01 December 2018

    Cosmetic establishments are strongly advised to recall their products containing the abovementioned ingredients whose use is outside the new restrictions and conditions laid down in the ASEAN Cosmetic Ingredient Annexes by the end of the grace period. Violation of the new restrictions and conditions after the grace period has ended shall subject the violator to appropriate regulatory actions.

    For more information, cosmetic establishments may check the FDA website (www.fda.gov.ph) for updates and amendments to the ASEAN Cosmetic Directive (ACD), its annexes and appendices.

    Dissemination of the information to all concerned is requested.

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  • FDA Advisory No. 2018-033 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2018-033 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2018-032 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2018-032 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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FDA Circular No. 2017-015

Adoptation of the ASEAN Cosmetic Directive (ACD) Annexes II and VI as Standards for Household/Urban Pesticides

 

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FDA Circular No. 2017-014

New Procedure in the Application of the Variation of Certificate of Product Registration for Medical Devices

I. Background

Republic ACt (RA) No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA No. 9711 (Food and Drug Administration Act of 2009) were all enacted to establish an effective regulatory system for the authorization, registration and monitoring of health products.

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FDA Circular No. 2017-013

Guidelines on the Issuance of Clearance for Customs Release of Radiation Devices by the Food and Drug Administration - Center for Device Regulation, Radiation Health and Research

I RATIONALE / BACKGROUND

Pursuant to Section 1(a) of Presidential Decree (PD) No. 480 entitled "Creating Radiation Health Office in the Department" dated 06 June 1974 as amended by PD No. 1372 and under Republic Act No. 9711 also known as "The Food and Drug Administration Act of 2009", the Center for Device Regulation , Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA) is empowered to regulate the import and export of radiation devices that can be ionizing such x-ray devices and non-ionizing such as laser, ultrasound, scanners and infrared radiation devices and others.

By virtue of FDA Personnel Order No. 2017-876, please be advised that the Center for Device Regulation Radiation Health and Research (CDRRHR) - Product Research and Standard Development Division (PRSDD) will be having a Consultative Workshop on Labeling of Medical Devices from December 20 - 22, 2017, On such dates, PRSDD will not be able to entertain clients nor accept document for processing.

Regular transactions resume on 27 December 2017.

Attachments:
Download this file (NOTICE.pdf)NOTICE.pdf

ANNOUNCEMENT 

Postponement of the Conduct of The Licensing Seminar on A.O.34 For Drugstores and Outlets

Please be informed that the conduct of the Licensing Seminar on A.O. 34 for Drugstores and Outlets on 13 December 2017 and 19 December 2017, is POSTPONED and moved to FIRST QUARTER OF 2018

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