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

USA

Updated FDA Ingredient Directory for Dietary Supplements

The FDA has revised its Ingredient Directory—now titled “Information on Select Dietary Supplement Ingredients and Other Substances.” Updates include new classification categories indicating the type of FDA action or communication for each ingredient, date stamps showing when ingredients were added, and simplified introductory text to improve usability.

Qualified Health Claim on Yogurt and Type 2 Diabetes Risk

The FDA issued a letter of enforcement discretion stating it will not object to certain qualified health claims linking yogurt consumption with a reduced risk of type 2 diabetes, provided claims are presented in a non‑misleading manner and all applicable requirements are met.

EUROPE

Restrictions on Bisphenol A (BPA) and Other Bisphenols in Food-Contact Materials

The European Commission is moving to ban BPA in food-contact materials, including plastic and coated packaging, following EFSA’s assessment indicating health concerns. The initiative also targets other bisphenols to prevent substitution with equally harmful alternatives and outlines transitional measures and possible derogations for affected businesses.

INDIA

Finalized Guidelines for Sampling of Drugs, Cosmetics & Medical Devices

CDSCO has issued finalized Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices. The guideline consists of 10 sections and 5 annexes covering sampling plans, sample selection, sampling locations, sample quantities, timelines, monitoring systems, and laboratory testing procedures.

JAPAN

Approval of New Designated Food Additive: Polyvinyl Alcohol

Japan’s MHLW has announced that “Polyvinyl Alcohol” is now regulated as a designated food additive. Japan’s food additive specifications encompass general rules, testing methods, reagent standards, ingredient and storage requirements, manufacturing standards, and usage standards.

Amendment to the Food Labeling Standard

Japan’s Consumer Affairs Agency (CAA) has issued Amendment No. 752 to the Food Labeling Standard. The update revises labeling names for certain additives and allergens to align with changes to Japan’s Specifications and Standards for Food Additives.

PHILIPPINES

Proposed New Requirements for License to Operate (LTO)

The Philippines FDA has opened consultation on revised rules and procedures for applying for an LTO for health product establishments. The proposal updates and replaces Administrative Order No. 2020‑0017.

“No Added-Sugar on Baby Foods Act” Introduced

The Philippine Senate has introduced Senate Bill No. 2518, which would prohibit the manufacture, sale, import, or distribution of baby foods containing added sugar. Labels and product quality would need to meet FDA requirements, and a national awareness campaign would be initiated. Baby food is defined as food made for infants and young children aged 6–36 months, excluding breastmilk.

TAIWAN

Revised Regulations on Nutrition Claims for Prepackaged Foods

TFDA has announced updated nutrition claim regulations for prepackaged foods. Key changes include:

• Nutrition claims for special dietary foods must comply unless otherwise specified. 
• Products holding special dietary food permits must comply starting January 1, 2026. 
• Simplified requirements for “contain,” “source,” and similar claims. 
• New nutrients and criteria added for claims such as “high,” “rich in,” and related expressions.

THAILAND

Draft Regulations on Drinking Water, Beverages, and Ice

The Thai FDA is seeking public comments on proposed regulations governing packaged drinking water, beverages, and ice. Feedback is requested by March 30, 2024.