Consumer Health – USA/Europe/Asia/ROW Regulatory News – June 2024

USA

FDA Proposes Exemption for Certain Cottage Cheese Products from Traceability Requirements

The FDA has proposed exempting Grade “A” cottage cheese regulated under the Pasteurized Milk Ordinance (PMO) from the Food Traceability Rule requirements. The PMO reflects the latest scientific standards for safe production of milk products, and most cottage cheese in the U.S. falls under this framework through the National Conference on Interstate Milk Shipments (NCIMS). The proposed exemption would apply to all Grade “A” cottage cheese listed under the Interstate Milk Shippers Program.

FDA Continues Actions Following Lead and Chromium Contamination in Apple Cinnamon Puree

After investigating elevated lead and chromium levels in apple cinnamon puree pouches last fall—triggered by reports of high blood lead levels in children—the FDA has completed initial response activities. The Agency continues preventive, surveillance, and compliance efforts to avoid future contamination events.

FDA Issues Warning Letter to Bimbo Bakeries for Allergen Labeling Violations

The FDA issued a warning letter to Bimbo Bakeries USA, Inc. after late‑2023 inspections revealed undeclared major food allergens in several bakery products. The mislabeled products contained ingredients that were not included in the product formulations, rendering them misbranded under the Federal Food, Drug, and Cosmetic Act.

EUROPE

EFSA Highlights Importance of Preparedness on World Food Safety Day 2024

On 7 June, EFSA marked World Food Safety Day by emphasizing preparedness for unexpected food safety incidents. Despite the EU’s strong food and feed safety standards, unforeseen events still occur. EFSA released new materials outlining its role in managing food‑borne outbreaks, aligned with the joint Safe2Eat campaign with EU Member States.

EFSA Updates Its Independence Policy

The European Food Safety Authority has strengthened its Independence Policy following a comprehensive review of the 2017 version. The updated policy enhances mechanisms for managing expert interests and mitigating undue influence.

ASIA

SINGAPORE

Consumer Safety Notice: Safe Use of Allopurinol

Allopurinol, commonly used to treat gout and conditions linked to elevated uric acid, should only be taken under medical supervision. It lowers uric acid production and is also prescribed for uric acid stones and some kidney conditions.

HSA Alerts Public to Illegal Products Containing Banned or Potent Ingredients

The Health Sciences Authority warns against using “88 Total White Underarm Cream,” “Susanoo Cellulite Pills,” and “Pelan sing Double Strong.” Three consumers—two requiring hospitalization—experienced adverse effects after using these products. Testing revealed banned or harmful substances, including sibutramine and high mercury levels.

KOREA

APFRAS 2024: Advancing Food Safety Innovation

The APFRAS 2024 forum convened to discuss evolving global food regulatory landscapes and explore collaborative strategies for addressing emerging food safety challenges under the theme “New Pathways for Food Safety Innovation in the Asia‑Pacific Region.”

REST OF WORLD

AUSTRALIA

Update on GLP‑1 Receptor Agonist Compounding Changes

The Therapeutic Goods Administration (TGA) continues addressing pharmacy compounding issues related to GLP‑1 receptor agonists such as Ozempic, Mounjaro, and Trulicity. The TGA highlights the importance of sustaining reliable community access to these medicines.

Updated Manufacturing Principles for Therapeutic Goods

The Minister for Health and Aged Care has issued updated Manufacturing Principles for therapeutic goods, including active pharmaceutical ingredients (APIs) and sunscreens. These principles must be followed by Australian manufacturing sites in compliance with the PIC/S Guide to Good Manufacturing Practice (GMP).