Latest Advisory

  • 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 Advisory No. 2018-031 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2018-031 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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  • FDA Advisory No. 2018-030 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2018-030 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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  • FDA Advisory No. 2018-029 || Public Warning Against Circulating “Unverified, Misleading and False Information” in Social Media and Text Messages Concerning Canned Food Products from Thailand

    FDA Advisory No. 2018-029 || Public Warning Against Circulating “Unverified, Misleading and False Information” in Social Media and Text Messages Concerning Canned Food Products from Thailand

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FDA calls for sobriety On contraceptives row

The Food and Drugs Administration (FDA) today asked the various groups involved in the issue on the reevaluation and recertification of contraceptives to “exercise sobriety” and “keep the productive dialogue going”.

FDA Director-General Nela Charade Puno issued the call in the wake of what the FDA said is “an escalating attack on the integrity of the agency and its processes” as it comes closer to concluding its review of the contraceptives products.

The ongoing FDA review followed a recent Supreme Court (SC) statement that it may lift the Temporary Restraining Order (TRO) on the country’s Reproductive Health Law as soon as the FDA completes the required public hearing and technical review process on contraceptives which do not induce nor cause abortion.

The TRO was issued at the instance of the Alliance for the Family Philippines, Inc. (AFLI), an anti-RH group.

FDA Circular No. 2017-012

Training Courses/Seminars and Schedule of Fees for Regional Licensing Seminar for Drugstores and Outlets (LSD-O) Offered by the Food and Drug Administration (FDA) Academy – Policy and Planning Service (PPS) for Calendar Year 2017

I. BACKGROUND

As part of its continuous service, the Food and Drug Administration established the FDA Academy to provide access to relevant and effective training. The conduct of such trainings ensures proper dissemination of policies, procedures and guidelines implemented by FDA in the exercise of its regulatory powers. FDA Academy trainings are designed to ensure that the industry representatives or Qualified Persons in Industry Regulatory Affairs (QPIRA) nominated by regulated establishments demonstrate competence and professionalism in preparing and submitting correct and complete applications.

SANOFI, WATSONS FINED

FDA Warns Cancellation of  Firms' License to Operate

The Food and Drug Administration (FDA) recently penalized French Pharmaceutical giant Sanofi Pasteur Inc.  and drug and beauty chain Watsons Personal Care Philippines for  illegally promoting and advertising the dengue vaccine, Dengvaxia.

The FDA said this is a violation of RA 9711 or the Food and Drug Act of 2009 and Administrative Order No. 65.

Section 2.3 of AO 65 provides that  "No pharmaceutical product classified by BFAD as prescription or ethical drug shall be advertised or promoted in any form of mass media except through medical journal, publications and/or literature solely intended for medical and allied professions."

Dengvaxia manufactured by Sanofi is classified as a prescription product.

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