Category: Cosmetic Announcements

ANNOUNCEMENT || ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

In the interest of service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct an “Online Public Consultation on the Draft Guidelines for the Regulation of Vapor Products and Heated Tobacco Products in Relation to the Provisions under RA 11346, RA 11467, and EO 106” on the following dates:

29 September 2020
Vapor Product Draft Regulatory Guidelines
AM Session (Batch 1)
8:00-8:15 Opening Remarks
8:16-9: 15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for Vapor Products
10:31-10:45 Break + Q&A
10:46-11 :45 Policy Salient Points and Product Labelling Guidelines
11:46-12 :00 Q&A and Closing
PM Session (Batch 2)
1:00-1:15 Opening Remarks
1:16-2:15 Policy Overview and Licensing Guidelines
2:16-2:30 Break + Q&A
2:31-3:30 Product Marketing Authorization Guidelines for Vapor Products
3:31-3:45 Break + Q&A
3:46-4:45 Policy Salient Points and Product Labelling Guidelines
4:46-5:00 Q&A and Closing
01 October 2020
Heated Tobacco Product Draft Regulatory Guidelines
8:00-8:15 Opening Remarks
8:16-9:15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for HTPs
10:31-10:45 Break + Q&A
10:4d-11:45 Policy Salient Points and Product Labelling Guidelines
11:46-12:00 Q&A and Closing

All stakeholders are invited to participate by registering through the links provided below:

Vapor Product Stakeholders: https://forms.ele/evNeVDiYXtNJtHac9

Heated Tobacco Product Stakeholders: https://forms.ele/fWdxwzaWG6LERnPS6

The FDA shall accommodate a maximum of one hundred (100) participants per session and shall be on a first-come, first-serve basis. To ensure that all stakeholders are given equal opportunities to attend the public consultation, only one (1) representative per company/industry association shall be allowed to register.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected]

For your information and guidance.

Attachment:-> CCRR_PubCon with revision

/ In Cosmetic Announcements / By FDA Admin3 / Comments Off on ANNOUNCEMENT || ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

Revised Draft Guidelines on the Regulation of Heated Tobacco Products (HTPs)

Pursuant to Republic Act No. (RA) 11346 and RA 11467, the Food and Drug Administration (FDA) publishes the following revised draft guidelines on the regulation of Heated Tobacco Products (HTPs) for the second public consultation of the proposed policy:

1)     General Guidelines for the Regulation of Heated Tobacco Products

1.1   Annex A – Heated Tobacco Product Refill/Cartridge and Device Standards

1.2   Annex B – Labeling Requirements for Heated Tobacco Product Refills and Cartridges

1.3   Annex C – Labeling Requirements for Heated Tobacco Product Electronic Delivery Devices

1.4   Annex D – Glossary

2)     Licensing Guidelines

2.1   Annex A – Online User’s Registration Form

2.2   Annex B – Template for the Authorization Letter

2.3   Annex C – Documentary Requirements for LTO Application

2.4   Annex D – Fees and Charges for LTO Application

3)     Product Marketing Authorization Guidelines for Heated Tobacco Products

3.1   Annex A – Guidelines for the Preparation of PIF for Heated Tobacco Products

3.2   Annex B – Schedule of Fees

4)     Guidelines for the Issuance of Pre-Application Documentary Evaluation for Heated Tobacco Products

5)     Batch Declaration of Heated Tobacco Products

Following the initial online posting of the draft guidelines dated 08 April 2020, the FDA had consolidated, discussed, and reviewed all received comments from 08 April to 30 June 2020, and had taken all submissions into consideration during the revision of the draft guidelines.

Kindly send your comments through email at [email protected] on or before 30 July 2020.

For your information and guidance.

Revised Draft Guidelines on the Regulation of Vapor Products

Pursuant to Republic Act No. (RA) 11346 and RA 11467, the Food and Drug Administration (FDA) publishes the following revised draft guidelines on the regulation of Vapor Products for the second public consultation of the proposed policy:

1)    General Guidelines for the Regulation of Vapor Products

1.1   Annex A – Vapor Product Refill and Cartridge Standards

1.2   Annex B – Packaging and Labeling Requirements for Vapor Product Refills and Cartridges

1.3   Annex C – Labeling Requirements for Vapor Product Electronic Delivery Devices

1.4   Annex D – Glossary

2)     Licensing Guidelines

2.1   Annex A – Online User’s Registration Form

2.2   Annex B – Template for the Authorization Letter

2.3   Annex C – Documentary Requirements for LTO Application

2.4   Annex D – Fees and Charges for LTO Application

3)    Product Marketing Authorization Guidelines for Vapor Products

       3.1. Annex A – Guidelines for the Preparation of Product Information File (PIF) for Vapor Products

       3.2 Annex B – Schedule of Fees

4)    Guidelines for the Issuance of Pre-Application Documentary Evaluation for Vapor Products

5)     Batch Declaration of Vapor Products

Following the initial online posting of the draft guidelines dated 08 April 2020, the FDA had consolidated, discussed, and reviewed all received comments from 08 April to 30 June 2020, and had taken all submissions into consideration during the revision of the draft guidelines.

Kindly send your comments through email at [email protected] on or before 30 July 2020.

For your information and guidance.

FDA Advisory No. 2020-644 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic PNF PEINFEN® PLAY COLOR LIPSTICK (10 MEI SHANG)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. PNF PEINFEN® PLAY COLOR LIPSTICK (10 MEI SHANG)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no record of valid Certificate of Product Notification (CPN) as a form of authorization. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-644

EXTENSION OF DEADLINE FOR THE SUBMISSION OF COMMENTS FOR THE DRAFT GUIDELINES ON VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS 

This is to inform all concerned stakeholders that the FDA shall be extending the deadline for the submission of comments for the draft guidelines on vapor products and heated tobacco products to 24 April 2020.

Please send your comments, inquiries, and clarifications through email at [email protected] on or before the provided deadline.

For your information and guidance.

Attachment:->EXTENSION FOR THE SUBMISSION OF COMMENTS

Draft Implementing Guidelines for Administrative Order No. 2019-0019 ”Repeal of Administrative Order No. 2015-0038 dated 08 September 2015 Entitled Removing the Requirements of Licensing as Importers, Exporters, Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”for Public Comments

This is to notify all concerned stakeholders and the general public that the Draft Implementing Guidelines of Administrative Order No. 2019-0019, “Repeal of Administrative Order No. 2015-0038 dated 08 September 2015 Entitled Removing the Requirements of Licensing as Importers, Exporters, Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products” is now posted in the FDA Website for public comments.

Kindly send your comments through email at [email protected] or [email protected] on or before 28 February 2020.

For your information and guidance.

Attachment:-> FDA MEMORANDUM NO.2020-002

/ In Cosmetic Announcements / By Administrator / Comments Off on Draft Implementing Guidelines for Administrative Order No. 2019-0019 ”Repeal of Administrative Order No. 2015-0038 dated 08 September 2015 Entitled Removing the Requirements of Licensing as Importers, Exporters, Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”for Public Comments

Public Consultation on Draft IRR of AO 2019-0019 HUHS

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct a “Public Consultation on the Draft Implementing Guidelines of Administrative Order No. 2019—0019 ”Reinstatement of the Licensing of Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers or Re-packers of those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products on 2 March 2020:

 

2 March 2020

PM Session
12:30 – 1:00 Registration
1:00 – 2:30 Presentation of Draft Implementing Guidelines of AO 2019-0019
2:30 – 4:00 Open Forum

All stakeholders are invited to attend. Registration through this LINK is on a first-come, first-serve basis as only the first one-hundred (100) pre-registrants shall be accommodated. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

For any concerns or inquiries, kindly contact CCRR at (02) 8857-1900 local 8107 or 8113, or through email at [email protected] .

For your information and guidance.

Attachment:-> Announcement re. Public Consultation on Draft IRR of AO 2019-0019 HUHS

Cascading and Retooling,Writing Workshop, and IT System Development for Administrative Order No. 2019-0007 and Administrative Order No. 2019-0019

The Center for Cosmetics Regulation and Research will conduct the “Cascading and Retooling,Writing Workshop, and IT System Development for Administrative Order No. 2019-0007 and Administrative Order No. 2019-0019” on 18-22 November 2019 at a venue within Tagaytay City.

In this regard, no transactions will be made on these dates.

All operations will resume on Monday, 25 November 2019. For information and guidance of all concerned stakeholders.

TEMPORARY SUSPENSION ON THE IMPLEMENTATION OF ADMINISTRATIVE ORDER 2019-0007 “REVISED RULES AND REGULATIONS ON ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEM (ENDS/ENNDS)” DATE : 07 November 2019

This is to inform all concerned stakeholders that the FDA shall be temporarily suspending the implementation of Administrative Order 2019-0007, “Revised Rules and Regulations on Electronic Nicotine And Non-Nicotine Delivery System (ENDS/ENNDS)” until further notice. The suspension is upon the recommendations of the FDA Legal Services and Support Center (LSSC) and the Office of the Solicitor General (OSG) in compliance with the issued Writ of Preliminary Injunction enjoining the Department of Health (DOH) and the Food and Drug Administration (FDA) from implementing A.O. 2019-0007.

The FDA shall place all received applications for a license to operate (LTO) and product registration (FERN) on hold until the Court issues a resolution.

For any concerns or inquiries, you can send an e-mail to the Center for Cosmetics Regulation and Research (CCRR) at fdaccrr.tr[email protected]
For your information and guidance.

Attachment:-> TEMPORARY SUSPENSION ON THE IMPLEMENTATION OF ADMINISTRATIVE ORDER 2019-0007 REVISED RULES AND REGULATIONS ON ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEM (ENDSENNDS) DATE 07 November 2019

/ In Cosmetic Announcements / By Administrator / Comments Off on TEMPORARY SUSPENSION ON THE IMPLEMENTATION OF ADMINISTRATIVE ORDER 2019-0007 “REVISED RULES AND REGULATIONS ON ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEM (ENDS/ENNDS)” DATE : 07 November 2019

31st ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings

The Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme was signed by the ASEAN Economic Ministers on 02 September 2003 to enhance cooperation among ASEAN Member States in ensuring the safety, quality and claimed benefits of all cosmetic products marketed in ASEAN and to eliminate restrictions to trade of cosmetic products through harmonization of technical requirements, Mutual Recognition of Product Registration Approvals and adoption of the ASEAN Cosmetic Directive (ACD). To date, all ASEAN member states have signed this Agreement and bi-annual meetings are convened to provide updates to this directive.

Upon the signing of the Agreement, the ASEAN Cosmetic Committee (ACC) was established, in accordance with Article 6 “Institutional Arrangements” of the Agreement to oversee and monitor the implementation of the Agreement.

The Philippines will host the 31st ACC meeting and its related meetings on 12-15 November 2019 at the Acacia Hotel, Alabang, Muntinlupa City, Philippines. The ASEAN Cosmetic Scientific Body (ACSB) and ASEAN Cosmetic Testing Laboratory (ACTLC) will convene its meetings on 12-13 November 2019 while the ACC meeting will be scheduled on 14-15 November 2019.

The meetings will be attended by the regulators from the 10 ASEAN Member States, representatives from the ASEAN Cosmetic Association (ACA), representatives from South Korea’s Ministry of Food and Drug Safety (MFDS), endorsed members by the cosmetic industry associations, and The ASEAN Secretariat.

Cancellation of Regional Cascading in Pampanga on 29-30 October 2019

This is to inform all concerned stakeholders that the “Regional Cascading of Administrative Orders on the Regulation of Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations (IRR) of RA 10620” Pampanga will not push through on 29-30 October 2019 due to low number of registered participants.

The new schedule and confirmed venue will be announced accordingly.

For your information and guidance.

Thank you.

Attachment:-> Cancellation of Regional Cascading in Pampanga on 29-30 October 2019

Cancellation of Regional Cascading in Iloilo City on 28-29 October 2019

This is to inform all concerned stakeholders that the “Regional Cascading of Administrative Orders on the Regulation of Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations (IRR) of RA 10620” in Iloilo City will not push through on 28-29 October 2019 due to low number of registered participants.

The new schedule and confirmed venue will be announced accordingly.

For your information and guidance.

Thank you.

Attachment:-> Cancellation of Regional Cascading in Iloilo City on 28-29 October 2019

APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS

This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph.

  1. LTO Application for E–Cigarette Establishment Documentary Requirements and Other Reminders
  2. Guidelines for Manufacturers and Traders
  3. Guidelines for Distributors
  4. Guidelines for Retailers

For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Attachment-> : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS

ISSUANCE OF USER ACCOUNTS FOR LTO AND FERN APPLICATIONS FOR ENDS/ENNDS.

This is to inform all concerned stakeholders that the FDA will be accepting User Account registrations for License to Operate (LTO) and FDA Electronic Registration Number (FERN) applications for ENDS/ENNDS starting today, 05 September 2019.

The User Account Registration Form can be assessed thru: bit.ly/ePortal2.

Furthermore, an Authorization Letter must be attached to the registration form if the applicant is not the owner of the establishment. Kindly refer to the attachment below for the Authorization Letter template.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Attachment-> : Authorization Letter Template
Attachment-> : ISSUANCE OF USER ACCOUNTS FOR LTO AND FERN APPLICATIONS FOR ENDS-ENNDS

LICENSING SEMINAR FOR ENDS/ENNDS MANUFACTURERS, TRADERS, DISTRIBUTORS, AND RETAILERS

This is to inform all concerned stakeholders that the FDA shall be conducting a licensing seminar for ENDS/ENNDS manufacturers, traders, distributors, and retailers on 4 and 11 September 2019, at the DOH Convention Hall, DOH, Sta. Cruz, Manila.

Please take note of the following schedule:

4 September 2019

11 September 2019

AM Session Licensing Seminar and Workshop for ENDS/ENNDS Manufacturers and Traders Licensing Seminar and Workshop for ENDS/ENNDS Retailers and Online Sellers
8:30-12:00 NN
PM Session Licensing Seminar and Workshop for ENDS/ENNDS Distributors (Importers, Exporters, and Wholesalers)
1:00-4:00 PM

Only the first one-hundred fifty (150) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Furthermore, due to limited slots, only one (1) representative per company will be allowed to attend the seminar.

You can register on the link provided with this announcement. For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Attachment-> : Licensing seminar for Manufacturers, Distributors, and Retailers

Notice of Cascading-Workshop of Center for Cosmetics Regulation and Research (CCRR) on 15 to 16 of August 2019

By virtue of FDA Personnel Order No. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients.

Regular transactions will resume on Monday, 19 August 2019

Attachment-> : Notice (Cascading CCRR)

CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct a “Cascading of the Administrative Orders on the Regulation of Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS), Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations of RA 10620” on the following dates:

  7 August 2019 9 August 2019

AM Session

8:30-9:00 Registration
9:00-10:00 Presentation of AO on ENDS/ENNDS Presentation of AOs on HUPs and PCOs
10:00-12:00 NN Open Forum

PM Session

1:30-2:00 Registration
2:00-2:30 Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013 Presentation of AO on HUHS
2:30-4:00 Open Forum

All stakeholders are invited to attend. Registration through this link is on a first-come, first-serve basis as only the first one-hundred (100) pre-registrants (per session) shall be accommodated. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns).For your information and guidance.

Attachment-> : FDA Announcement re. Cascading of New Policies

/ In Cosmetic Announcements / By Administrator / Comments Off on CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620
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