Consumer Health – USA, S America, Asia and ROW Regulatory News – Mar 2025

USA

HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families

Under the leadership of HHS Secretary Robert F. Kennedy Jr., the FDA is intensifying efforts to ensure the safety, quality, and resilience of the U.S. infant formula supply. This includes launching a comprehensive review of infant formula nutrients for the first time since 1998, increasing testing for heavy metals and contaminants, and extending the personal importation policy for formula. The FDA is also encouraging greater transparency and clearer labeling from manufacturers, while collaborating with scientific organizations to address research gaps on the long-term health impacts of formula feeding. These initiatives aim to strengthen the formula supply, ensuring it remains safe, nutritious, and reliable for families, especially those relying on formula as the sole source of nutrition for their infants.

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

Under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr., the FDA introduced the Chemical Contaminants Transparency Tool (CCT Tool), an online database that consolidates and provides searchable information on contaminant levels used to assess health risks in human foods. The tool includes data on tolerances, action levels, and guidance levels for various chemical contaminants, which help the FDA determine when food may be unsafe. These contaminants can occur during food production, storage, or processing, despite efforts to eliminate them, and the tool aims to help consumers and industry stakeholders better understand the safety of the food supply. Acting FDA Commissioner Dr. Sara Brenner emphasized that while zero contaminants are the ideal, consuming a variety of nutrient-dense foods across food groups can mitigate risks. The CCT Tool is part of a broader initiative to modernize food chemical safety and improve transparency, empowering Americans with knowledge about what’s in their food. By continuing to test food and enhance transparency, the FDA under Secretary Kennedy’s leadership is committed to ensuring the safety of the food supply and promoting public health.

FDA Roundup: March 18, 2025

The U.S. Food and Drug Administration provided an update regarding a legal action against Totally Cool, Inc., a Maryland-based ice cream and frozen dessert manufacturer. On March 18, 2025, the United States District Court for the District of Maryland issued a consent decree of permanent injunction against the company and its CEO, Michael J. Uhlfelder. This follows an FDA inspection on July 8, 2024, that revealed the presence of Listeria monocytogenes (L. mono) in the facility, along with multiple violations of food safety practices, including sanitation failures. The consent decree prohibits Totally Cool and Mr. Uhlfelder from handling, processing, or distributing any food until they meet specified safety and sanitation requirements.

ARGENTINA

Additions to the Argentine Food Code – INAL, March 2025

The National Administration of Drugs, Foods and Medical Devices (ANMAT) has announced updates to the Argentine Food Code (CAA) through newly published joint resolutions. These updates include the incorporation of Article 579 in Chapter VIII, officially defining, classifying, and characterizing dairy desserts; the amendment of Article 12 in Chapter II to update the definitions and classifications of retail food premises such as retail outlets and food stores; and the addition of Articles 1334 tris and 1334 quater in Chapter XVI, which define and characterize balsamic vinegar and traditional balsamic vinegar, respectively. These changes aim to enhance clarity and standardization in food classification and regulation across Argentina.

ANMAT in numbers: Advertising Monitoring and Inspection Program

The Program for Monitoring and Oversight of Advertising and Promotion of Products Subject to Health Surveillance is responsible for analyzing the advertisements disseminated through digital and traditional media on those products regulated by ANMAT: medicines, food, medical products, household products, cosmetics and personal hygiene products. This report provides statistical details of the advertisements audited during the first two months of 2025, comparing the results with the same period the previous year.

Additions to the Argentine Food Code – INAL

ANMAT has announced several important updates to the Argentine Food Code (CAA), published in the Official Gazette. These include the incorporation of new enzymes into the positive list in Article 1263 of Chapter XVI to reflect technological advances (RESFC-2025-7); the addition of caper, chili pepper, and habanero pepper to the list of recognized vegetables in Chapter XI, aiming to boost regional economies (RESFC-2025-8); updates to Article 1285 on mustard paste, along with the inclusion of Article 1285 bis defining mustard-based dressings and setting a maximum sodium limit in line with Law No. 26,905 on sodium reduction (RESFC-2025-9); and the official recognition of cinnamon pepper as a spice in Chapter XVI, supporting its cultivation and economic relevance in the Patagonian region (RESFC-2025-10). These changes aim to modernize regulations and support regional and public health initiatives.

AUSTRALIA

Plain English Allergen Labelling: One year of clearer, safer food labels

One year after the Plain English Allergen Labelling (PEAL) requirements became mandatory in Australia and New Zealand, food labels are now clearer and easier to understand, helping millions of consumers with food allergies make safer choices. Introduced under Proposal P1044 and approved by FSANZ in 2021, the PEAL changes standardised allergen declarations using simple, consistent terms like “milk” instead of “casein” and specifying individual tree nuts. Since the transition period ended on 25 February 2024, thousands of products have adopted the new format. FSANZ CEO Dr Sandra Cuthbert highlighted the success of the initiative, noting early feedback shows it’s meeting its goal of supporting informed consumer decisions and enhancing trust in the food supply.

Strengthening food safety after a recall

In response to conducting a food recall, most businesses in Australia and New Zealand take proactive steps to prevent future food safety issues, with 90% implementing multiple corrective actions. These include staff training, updating product labels, modifying handling procedures, changing ingredients, improving manufacturing processes, and upgrading equipment. As part of food recall reporting, businesses must identify the corrective actions taken. Food Standards Australia New Zealand (FSANZ) coordinates food recalls in Australia alongside state and territory enforcement agencies, while the Ministry for Primary Industries manages recalls in New Zealand. FSANZ also provides resources like the Food Industry Recall Protocol to help businesses manage recalls effectively. A strong recall system plays a vital role in protecting consumers and supporting long-term food safety and compliance. If you suspect unsafe food, it’s advised to first contact the food business, and if unresolved, report it to the relevant enforcement agency.

FSANZ Board Meeting Summary – March 2025

The FSANZ Board met from 11–12 March 2025 to address key standards, governance, performance, and strategic matters. As the agency’s accountable authority, the Board approved application A1302, allowing food derived from genetically modified insect-protected corn line MZIR260, which will be notified to the Food Ministers’ Meeting (FMM) within 10 business days. The Board also held in-depth discussions on three high-interest standards matters—cultured quail as a novel food (A1269), carbohydrate and sugar claims on alcoholic beverages (P1049), and energy labelling on alcoholic beverages (P1059)—ahead of an extraordinary FMM later in March. Strategic updates included progress on egg food safety (P1060), definitions for gene technology (P1055), and consumer understanding of plant-based product labelling (W1164). The Board also reviewed FSANZ’s international activities and future plans, and addressed governance and performance issues through reports from the Finance, Audit and Risk Management, and People and Culture Committees.

CHILE

ISP issues alert for unregistered cosmetics sold on websites and social media.

The Public Health Institute (ISP) of Chile has issued a public alert warning against the purchase of unlicensed cosmetic products being promoted and sold via social media and the website. An investigation confirmed the site sells products lacking proper sanitary registration. The ISP warns that buying cosmetics from the informal market poses health risks, as the composition and manufacturing conditions of such products are unknown and unregulated. These unauthorized products may cause adverse effects like irritation or burns. The ISP urges consumers to only use products with verified health authorization—available through their official registry—and to avoid purchasing from questionable sources. Any suspicious or illegal cosmetic sales can be reported through the ISP complaints portal.

INDIA

FSSAI Directs States to Step Up Food Safety Checks on Dairy Analogues          

On March 11, 2025, the Food Safety and Standards Authority of India (FSSAI) instructed all States and Union Territories to enhance surveillance of Dairy Analogues throughout March, due to the increased demand during the festive season. This initiative is part of FSSAI’s ongoing efforts to prevent food adulteration and mislabeling. Dairy Analogues are products that substitute milk constituents with non-milk ingredients, resembling milk in appearance, texture, and functionality, but are not considered true milk products. FSSAI emphasized the need for strict testing and label checks to ensure these products are not misrepresented as dairy products. The agency’s actions aim to protect consumers and uphold food safety standards.

INDONESIA

BPOM Affirms Commitment to Strict Supervision and Accurate Information on Cosmetic Products Circulating in the Community

The Indonesian Food and Drug Authority (BPOM) has reaffirmed its commitment to strictly supervising all cosmetic products circulating in the market, emphasizing that each product undergoes a rigorous evaluation process before a distribution permit is granted. This statement comes in response to misinformation spreading on social media, falsely alleging that certain cosmetic factories—despite having official permits—have been taken to court by BPOM multiple times and are involved in mercury distribution. BPOM clarified that these claims are entirely baseless. The factory in question was only subject to a temporary suspension due to administrative requirements, not due to the discovery of hazardous materials, and has since resumed operations after complying with BPOM’s recommendations. BPOM expressed concern over the negative impacts of such misinformation, which can damage the reputation of compliant producers, disrupt business relationships, and threaten job security in the cosmetics industry. The public is urged to verify information through official sources such as the Cek BPOM mobile app or the BPOM website (www.pom.go.id/public-warning), and to always check the BPOM distribution permit number on product packaging. BPOM also encourages the public to report suspicious products or adverse reactions through the Consumer Complaints Service (ULPK) at 1500533 or ulpk@pom.go.id. BPOM remains committed to ensuring the safety, efficacy, and quality of cosmetic products while supporting a fair and healthy business environment, and calls on the public to be smart consumers by verifying information from trusted sources.

Eradicate the Circulation of Illegal TABITA Cosmetics in Online Media

BPOM has confirmed the continued circulation and online promotion of illegal cosmetic products under the TABITA and TABITA GLOW brands, which have no BPOM distribution permits and do not meet safety, efficacy, or quality standards. These products were found to contain hazardous substances such as mercury and hydroquinone, which can cause serious health risks including skin discoloration, irritation, kidney damage, and other adverse effects. BPOM Head Taruna Ikrar has ordered the immediate eradication of these products from all online platforms and has coordinated with the Indonesian E-Commerce Association (idEA) and the Ministry of Communication and Digital to remove their listings. BPOM has also launched cyber investigations to trace the sources and will impose strict sanctions under Law No. 17 of 2023, with penalties up to 12 years in prison or a fine of 5 billion rupiah for violators. The public is urged to be vigilant, avoid misleading promotions, and always Check KLIK (Packaging, Label, Distribution Permit, Expiration). Consumers can verify product legality through the Cek BPOM app or website (www.cekbpom.pom.go.id) and report suspicious products to BPOM via 1500533 or local BPOM offices.

MEXICO

COFEPRIS begins Lent 2025 operation

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has launched the 2025 Lent operation, running from March 5 to April 27, with the goal of ensuring the safe consumption of fish and seafood during the Lenten season. In coordination with the Health Risk Protection Areas in all 32 federal entities, COFEPRIS will monitor the processing and sale of fish, seafood, prepared foods, water, and ice. The initiative includes inspections of markets and food establishments, as well as educational efforts such as hygiene talks and the distribution of informational materials to vendors. Additionally, microbiological analyses will be carried out by the National Network of State Public Health Laboratories (RNLESP) to detect harmful microorganisms that could lead to gastrointestinal illnesses. With these actions, COFEPRIS aims to promote good hygiene practices and protect public health during a period of increased seafood consumption.

SINGAPORE

Additional recall of two Supremely Gourmet Dark Chocolate products due to undeclared milk allergen

The Singapore Food Agency (SFA) has expanded its recall to include Supremely Gourmet Mint Dark Chocolate and Orange Dark Chocolate, in addition to the previously recalled Premium Dark Chocolate (96g). These products were found to contain undeclared milk, a known allergen.

Importer: Redmart Pte Ltd 

Reason: Milk allergen not declared on packaging 

Risk: May cause allergic reactions in individuals’ sensitive to milk 

Action: Affected consumers should avoid consumption and seek medical advice if unwell. For enquiries, contact your point of purchase.

Status: Recall is ongoing.