Consumer Health – USA/Europe/Asia Regulatory News –  Feb. 2024

USA

New Directory of Ingredients Used in Products Marketed as Dietary Supplements

The U.S. Food and Drug Administration (FDA) has updated the agency’s Ingredient Directory, including renaming the web page to be Information on Select Dietary Supplement Ingredients and Other Substances. In addition to the new title, the directory updates include adding categories to classify the type of FDA action or communication for each listed ingredient; recording the date each listed ingredient was added to the directory; and streamlining the introductory text on the page.

Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met.

EUROPE

Restrictions on bisphenol A (BPA) and other bisphenols in food contact materials

This initiative will impose a ban on the use of BPA in food contact materials (FCMs), including plastic and coated packaging. This follows the publication of the European Food Safety Authority’s opinion, which indicates a concern for human health. The measure will also: address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances, set out derogations and transitional periods that may apply to businesses.

INDIA

Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices

India Central Drugs Standard Control Organization (CDSCO) published the finalized version of the Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices. The Guidelines consists of 10 parts and 5 annexes: Introduction, Sampling Plan, Selection of Sample, Selection of Sampling Location, Number of Samples, Quantity of Samples, Timelines, Database/ Monitoring, NSQ / Spurious Alerts, Testing Laboratories.

JAPAN

Approval of a new designated food additive

Japan MHLW announced that “Polyvinyl Alcohol” would be regulated as “Designated Additive”. The specifications for food additives in Japan consist of various aspects, including general rules, testing methods, reagents & testing solutions, ingredient & storage standards, manufacturing standards, and usage standards.

Amendment of Food labelling standard

Japan Consumer Affairs Agency (CAA) unveiled Amendment No. 752 for the Food Labeling Standard with immediate effect. According to the amendment, due to the revision of Japan’s Specifications and Standards for Food Additives, the labeling names of additives and allergens have been updated accordingly.

Philippines

FDA Proposes New Requirements for LTO Application

Philippines Food and Drug Administration (FDA) initiated a consultation on a new draft of Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017. Any comments can be sent to pfpid@fda.gov.ph

No Added-Sugar on Baby Foods Act

The Philippines Senate introduced and revealed Senate Bill No. 2518 titled No Added-Sugar on Baby Foods Act. As per the proposed bill, no person or entity shall manufacture, sell, import, or distribute in commerce any baby food containing added sugar. The quality and label of no-added sugar baby foods shall fulfill the FDA’s requirements. In addition, the government shall organize nationwide campaign to adequately promoted the benefits and rationale of no-added sugar baby foods. It should be noted that baby food refers to all consumed food other than breastmilk that is made specifically for older infants and young children aged beyond 6 months to 36 months old.

Taiwan

Regulations on Nutrition Claim for Prepackaged Food Products

The Taiwan Food and Drug Administration (TFDA) aanounced the revised Regulations on Nutrition Claim for Prepackaged Food Products. Revisions in the new Regulations are as follows: Nutrition claims of special dietary food shall be in line with the Regulations unless otherwise specified. For products that have obtained a special dietary food permit before promulgation, those manufactured from January 1, 2026, must adhere to the provisions.  Requirements for claims like “contain”, “source” and equivalent expressions are simplified. New nutrients and content requirements are added for claims such as “high”, “rich in” and other synonymous expressions.

Thailand

Regulatory Requirements for Packaged Drinking Water, Beverage and Ice

Thai Food and Drug Administration announced to seek for public feedback on the draft regulations for prepackaged drinking water, beverage and ice. Comments shall be submitted by March 30, 2024.