Consumer Health-USA and Asia Regulatory News-Sept 2023

USA

FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products

FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the respondent organize their registration and listing submission to include the information needed for FDA and will give the respondent access to their previous Cosmetic Direct registrations and listing submissions.

Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing

The Office of Cosmetics and Colors (OCAC) and the Office of the Chief Scientist (OCS) in the Food and Drug Administration (FDA, Agency, or we) are soliciting applications from members of the cosmetic product industry interested in participating in a voluntary pilot program to conduct user acceptance testing to help OCAC and OCS evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing. This electronic submission portal is being implemented pursuant to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). OCAC and OCS plan to accept up to nine participants for the pilot program. The pilot program is intended to provide OCAC and OCS input to inform evaluation of this new electronic submission portal.

CHPA Petitions FTC to Withdraw Notice of Penalty Offenses Sent to Hundreds of Companies

The Consumer Healthcare Products Association submitted a Citizen Petition to the U.S. Federal Trade Commission urging it to withdraw a notice it sent to nearly 700 companies which sell over-the-counter medicines, dietary supplements, functional foods, and homeopathic products in April this year. The Citizen Petition was supported by the American Herbal Products Association (AHPA), the Food Industry Association (FMI), Natural Products Association (NPA), Personal Care Products Council (PCPC), and the United Natural Products Alliance (UNPA).

Update on FDA dietary supplements program under proposed reorganization

The Commissioner of Food and Drugs published an update on certain aspects of FDA’s Human Foods Program (HFP) that the Agency aims to improve as part of the program’s proposed redesign. Under the new proposed HFP structure, the Office of Dietary Supplement Programs will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). However, instead of reporting to the CFSAN Center Director, the OFCSDSI Director is set to report to a Deputy Commissioner. In continuing to prioritize the dietary supplements program, FDA intends to modernize the assessment of food chemicals, facilitating safe and innovative ingredients for use in foods and dietary supplements with the new OFCSDSI.

ASIA

China

Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients

On September 4, 2023, NIFDC released the finalized Guidelines with immediate effect. Consisting of 11 parts, the Guidelines systematically outlines vital points and technical principles for filling in and submitting ingredient safety information, covering aspects of ingredient basic information, brief descriptions of ingredient production technique, necessary quality control requirements, limit requirements for risk substances, etc.

Guidelines for Submitting Information on the Cosmetic Ingredient Safety Information Submission Platform

On September 4, 2023, China National Institutes for Food and Drug Control (NIFDC) approved the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform (the Guidelines). The objective of developing the Guidelines is to provide guidance to ingredient manufacturers on the correct use of the Ingredient Safety Information Submission Platform (the Platform) and standardize the submission of ingredient safety information. The Guidelines consists of 13 Articles, including the basis, purpose, application scope, submitting entity, submission content, the generation and use of ingredient submission codes, etc.

Technical Guidelines for Filling in and Submitting Cosmetic Formula

The Guidelines provides instructions for enterprises seeking to register or notify special/general cosmetics, outlining the requirements for completing the cosmetic formula table, which includes ingredient names, concentration, main use purpose, remarks and safety information, etc. During the review of registration and notification information, NIFDC has found problems in the filling-in of product formulas, such as non-standard and unreasonable ingredient names, use purposes, etc., which contributes to the introduction of the Guidelines. To address these problems, NIFDC has sorted out the specific issues involved in the filling-in and provided corresponding guidance to enterprises.

Safety and Technical Standards for Cleaning Products

China notified WTO of a draft national standard titled Safety and Technical Standards for Cleaning Products. This mandatory standard is currently open for comments until October 27, 2023.1 Upon its approval, the existing standard GB/T 26396—2011 Technical Specification for Safety of Soaps and Detergents will be replaced. Stakeholders will be given a 12-month transitional period to ensure compliance with the new standard.

Indonesia

Regulation concerning Permitted Ingredients Changes in Cosmetics

On August 24, 2023, Indonesia introduced draft of Regulation concerning Permitted Ingredients Changes in Cosmetics, amending the Appendices in the Technical Requirements for Cosmetic Ingredients. The main amendments are: 1) Appendix I: List of Restricted Ingredients – 1 added and 6 revised, 2) Appendix II: List of Permitted Colorants – 1 revised, 3) Appendix III: List of Permitted Preservatives – 2 revised, 4) Appendix IV: List of Permitted Sunscreens – 2 revised.

Philippines

Philippines Adopts New Dietary Standards for Prepackaged Processed Foods

On September 7, 2023, the Philippines FDA issued FDA Circular No.2023-009, announcing to adopt the 2015 Philippine Dietary Reference Intakes (PDRI) Percent Recommended Energy Intakes/Recommended Nutrient Intakes (%REI/RNI) as the new dietary standard for all prepackaged processed foods. This move repeals Bureau Circular No. 16 s. 2005, which previously adopted the 2002 Recommended Energy and Nutrient Intakes (RENI) as the dietary standard.

Singapore

Singapore Amends Food Regulations 2023, Targeting Non‑RTE Food

On September 4, 2023, Singapore Food Agency (SFA) issued Food (Amendment No. 3) Regulations 2023, primarily focusing on microbiological standards for non-ready-to-eat (non-RTE) foods. The amendment will come into effect on March 4, 2024. In the new amendment, SFA introduces microbiological standards for multiple non-RTE product categories, including non-intact beef products, blood-cockles and oysters, meat and meat products, pasteurized poultry shell eggs and other pasteurized egg products, as well as raw poultry shell eggs and other raw egg products.