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

USA

Constituent Updates: 

FDA Proposes to Exempt Certain Cottage Cheese from Traceability Requirements

The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods the agency has designated for inclusion on the Food Traceability List. In the final rule, the FDA announced its intention to consider exempting cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) from the rule’s requirements. The PMO represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese. Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS), which relies on the PMO. The FDA and NCIMS have together developed a cooperative, federal-state program (the Interstate Milk Shippers Program) to ensure the sanitary quality of milk and milk products shipped interstate. The proposed exemption would apply to all Grade “A” cottage cheese that appears on the Interstate Milk Shippers List.

FDA Takes Additional Steps Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products

The U.S. Food and Drug Administration is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the Agency is continuing to explore prevention, compliance, and surveillance activities going forward.

FDA Issues Warning Letter to Bimbo Bakeries Over Food Allergen Labeling Concerns

U.S. Food and Drug Administration (FDA) issued a warning letter to Bimbo Bakeries USA, Inc. because, during two inspections in late 2023, FDA found that some of the company’s bakery products included ingredients that are or contain major food allergens on their labels, but those ingredients were not included in the product formulations. Food products must bear truthful and non-misleading labeling; otherwise, they are misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

EUROPE

Prepare for the unexpected – EFSA marks World Food Safety Day 2024

Food safety is a shared responsibility involving many actors, all working together to ensure the food we consume is safe. The EU has among the most rigorous food and feed safety standards in the world, but unexpected incidents still occur, sometimes posing serious health risks to consumers. In such situations, rapid response is needed, so being prepared is essential.

This year’s World Food Safety Day on 7 June focuses on food incidents and on the crucial need for preparedness for unexpected events. EFSA is marking the day by releasing new material aimed at explaining its role in responding to food-borne outbreaks, also in the framework of the joint EFSA-Member States Safe2Eat campaign

EFSA updates Independence Policy

The European Food Safety Authority (EFSA) has updated its Independence Policy, further strengthening the measures it has in place to manage the interests of the scientific experts and professionals with whom it works and to guard against undue influence. The new policy includes targeted revisions based on a thorough review of the 2017 policy.

ASIA

Singapore

Consumer Safety alert

Safe use of allopurinol (gout medicine)

Allopurinol is a medication commonly used to treat gout, a condition where high levels of uric acid in the body result in crystals forming in the joints and skin. It is also used to treat uric acid stones and kidney disease caused by high levels of uric acid. Allopurinol reduces the production of uric acid (a natural waste product from purines found in foods like sardines, dried beans, beer and certain meats) and lowers the uric acid level in the body.

As a prescription-only medicine, allopurinol should only be used under medical supervision.

HSA Alert: Three Products Found with Banned or Potent Ingredients; Three Consumers Suffered Adverse Effects

The Health Sciences Authority (HSA) is alerting members of the public not to purchase or use “88 Total White Underarm Cream”, “Sausando Cellulite Pills” and “Pelangsing Double Strong”. Three consumers experienced adverse effects, of whom two were hospitalised, after using “88 Total White Underarm Cream” and “Sausando Cellulite Pills”. HSA’s tests revealed that these illegal products contained banned or potent ingredients, including sibutramine and a high level of mercury.

Korea

APFRAS 2024 New Pathways for Food Safety Innovation

APFRAS 2024 is convened to analyze rapidly changing global food regulatory environment and discuss about strategic collaboration for addressing new food safety issues under the theme of ‘New Pathways for Food Safety Innovation in Asia-Pacific Region.’

ROW

Australia

Update on the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) pharmacy compounding changes

The TGA acknowledges the importance of medicines like Ozempic (semaglutide), Mounjaro (tirzepatide) and Trulicity (dutaglutide) for the health and wellbeing of the people who require them, and the need to have a reliable supply in the community.

PIC/s Guide to Good Manufacturing Practice (GMP): manufacturing principles for medicines, APIs and sunscreens

The Minister for Health and Aged Care to determine Manufacturing Principles – Therapeutic Goods (Manufacturing Principles) Determination- external site – that must be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients (API) and sunscreens, at Australian manufacturing sites.