Product Safety

South Korea MFDS Consults On Draft Amendment To Food Labelling And Advertising Enforcement Decree

South Korea’s Ministry of Food and Drug Safety has opened a consultation until 14 July 2026 on draft amendments to the enforcement decree under the Food Labelling and Advertising Act to tighten rules on food branding that resembles medicines. If adopted, the changes will force food and beverage companies to review product names and advertising that reference popular pharmaceuticals to avoid misclassification risks and potential enforcement action.

19 May 2026, 15:28mfds.go.krSouth Korea

China NMPA Incorporates Three Revised Standards Into Cosmetics Safety Technical Specification (Announcement No.48 of 2026)

China’s NMPA has issued Announcement No.48 (15 May 2026) incorporating revised standards for o-phenylphenol and its salts, Acid Violet 43 (CI 60730) and mercury compounds into the national Cosmetics Safety Technical Specification, with implementation dates in July 2026 and June 2028. Cosmetics registrants and manufacturers should review formulations and testing for these substances and plan to implement the new standards ahead of the respective 2026 and 2028 effective dates to avoid non-compliance.

19 May 2026, 15:28nmpa.gov.cnChina

China SAMR Consults on Draft Advertising Review Measures for Drugs, Medical Devices and Health Foods

China’s market regulator has launched a public consultation on sweeping new advertising review measures for drugs, medical devices, health foods and special medical-purpose formula foods, published on 15 May 2026. If adopted, the rules would tighten content and livestream restrictions while simplifying some review procedures, raising compliance stakes for pharma, device and health-food advertising and demanding closer coordination between regulatory and marketing teams.

19 May 2026, 15:27samr.gov.cnChina

Gansu Market Regulator Launches Six-Month Crackdown on Online Food and Health Food False Advertising

From April 2026, the Gansu provincial market regulator is running a six-month enforcement campaign targeting false online advertising of food and health foods across e-commerce and livestreaming platforms. Online food brands and platforms operating in Gansu face heightened scrutiny, licence revocation and blacklisting risks, signalling a tougher enforcement climate for digital food and health-product marketing in China.

19 May 2026, 15:27samr.gov.cnChina

India BIS Mandates Rated Capacity Verification For Portable Lithium Batteries

India’s Bureau of Indian Standards has issued implementation guidelines requiring manufacturers of portable lithium cells and batteries to verify declared rated capacity using a defined test method, with phased compliance deadlines running to 2027. This introduces a new mandatory performance-testing step in the BIS compulsory registration process, forcing battery and device makers to plan re-testing, third-party reports, and documentation updates for products sold into the Indian market.

19 May 2026, 09:14crsbis.inIndia

Hong Kong L.N. 28 of 2026 Sets Staggered Effective Dates for Mercury-Added Product Restrictions

Hong Kong has issued Legal Notice No. 28 of 2026 to set staggered commencement dates from March 2026 through December 2027 for expanded mercury-added product restrictions under the Mercury Control Ordinance. Manufacturers, importers and distributors of mercury-containing batteries and fluorescent lighting face phased bans and a final supply cut-off in January 2029, requiring early portfolio review and substitution planning.

19 May 2026, 08:25info.gov.hkHong Kong SAR China

New York Senate Bill S10514 Introduces "Synthetic Kratom Kills Act" to Ban Synthetic Kratom and Regulate Natural Products

New York has introduced Senate Bill S10514, the Synthetic Kratom Kills Act, to ban synthetic and adulterated kratom products, cap the potent alkaloid 7-hydroxymitragynine at 2% of total alkaloids, and impose strict testing, labelling, packaging and age-21 controls on natural kratom. If enacted, kratom manufacturers and retailers would face robust third-party testing and disclosure obligations, escalating civil penalties and a defined 90-day plus 180-day implementation window, signalling significantly tighter state scrutiny of kratom and related controlled-substance risks.

18 May 2026, 17:53nysenate.govUnited States

Missouri HB 3104 on Products Liability Claims Referred to House Emerging Issues Committee

Missouri lawmakers are considering HB 3104, a bill to amend the state’s products liability statutes, which has now progressed to the House Emerging Issues Committee after its introduction earlier in 2026. If enacted, the measure could change litigation risk and defence strategies for manufacturers, distributors, and retailers selling products into Missouri, warranting close monitoring by legal and product-safety teams.

18 May 2026, 17:52house.mo.govUnited States

China SAMR Details 2026 Enforcement Priorities for Key Industrial Product Quality and Online Sales

In May 2026 China’s market regulator detailed new licensing rules, online-sales controls and inspection campaigns to tighten quality and safety supervision of key industrial products. These moves signal tougher oversight of low-priced and children’s goods, especially those sold via major e-commerce platforms, increasing enforcement and compliance risk for manufacturers, importers and retailers supplying the Chinese market.

18 May 2026, 17:51samr.gov.cnChina

Vermont House Passes S.198 on Regulation of Tobacco Products and Tobacco Substitutes

The Vermont House has passed S.198, a comprehensive bill to tighten licensing, taxation, enforcement and youth-protection rules for tobacco products and nicotine substitutes, following earlier Senate approval in April 2026. If enacted in its current form, the measure would significantly raise compliance expectations and costs for tobacco and vaping supply chains in Vermont, especially around retail and wholesale licensing, high-nicotine products, online sales and youth-oriented marketing.

18 May 2026, 17:49legislature.vermont.govUnited States

US FDA Warns Consumers Not To Use Expired Amazon Basic Care Levonorgestrel 1.5 mg

In May 2026, the US Food and Drug Administration warned consumers not to use expired Amazon Basic Care levonorgestrel 1.5 mg emergency contraceptive tablets after finding that several lots had been delivered past their labelled expiry dates. This alert highlights the importance of robust expiry-date controls in pharmaceutical supply chains and should prompt retailers and manufacturers to review their own oversight of over-the-counter medicines and other time-sensitive health products.

18 May 2026, 17:46fda.govUnited States

US FDA Approves GAMUNEX-C FlexBag Labeling Supplement

US FDA has approved a post-approval labeling supplement for GAMUNEX-C FlexBag, revising the prescribing information and packaging artwork to align with the previously approved alternate closure system. Regulatory and labeling teams must update prescribing information, SPL files, packaging, and promotional materials in line with the approved content and associated FDA submission requirements.

18 May 2026, 17:43fda.govUnited States

Alaska SB 111 Moves to House Rules After Committee Substitute on Digital Product Repair

Alaska’s Senate-passed Digital Product Repair bill (SB 111) has advanced in the House, with the Labor and Commerce Committee reporting a committee substitute and sending it to the House Rules Committee in mid-May 2026. If enacted, the law would expand consumer and independent repair access for digital electronic products by adding new unlawful acts under Alaska’s Unfair Trade Practices and Consumer Protection Act, increasing compliance expectations for manufacturers and retailers.

18 May 2026, 17:36akleg.govUnited States

Illinois SB3919: Committee/Third Reading Deadline Set For Hemp Product Regulation Bill

Illinois lawmakers have set a 22 May 2026 committee and third-reading deadline for SB3919, a bill that would tighten regulation of hemp products for human consumption and synthetic hemp products. If enacted, hemp growers, processors and retailers in Illinois would face stricter testing, labelling, packaging and age-restriction requirements and an outright synthetic hemp ban, making early compliance planning important.

18 May 2026, 17:35ilga.govUnited States

US FDA Updates Final Guidance on Cybersecurity in Medical Devices Premarket Submissions

In February 2026, the US FDA issued updated final guidance on cybersecurity in medical devices, aligning expectations with its new Quality Management System Regulation and clarifying how premarket submissions should demonstrate compliance with section 524B of the FD&C Act. Device manufacturers now need to embed cybersecurity into their quality systems and development lifecycles, and be ready to provide robust risk management documentation, software bills of materials, security testing evidence, and lifecycle vulnerability management plans for US submissions involving devices with cybersecurity risk.

18 May 2026, 17:31fda.govUnited States

US FDA Issues Final Guidance on Voluntary Patient Preference Information Over the Total Product Life Cycle

In March 2026, the US FDA’s device and biologics centres issued final guidance on how sponsors can incorporate voluntary patient preference information into regulatory decision-making across the total life cycle of FDA-regulated medical devices. This non-binding guidance will influence evidence-generation and submission strategies by encouraging earlier and more systematic use of patient preference data in benefit–risk assessments, design decisions, and post-market evaluations.

18 May 2026, 17:31fda.govUnited States

US FDA CBER Virtual Town Hall On BLA Submissions For Cell And Gene Therapy Products

On 4 June 2026, FDA’s Center for Biologics Evaluation and Research will host a one-hour virtual town hall on best practices for preparing Biologics License Applications for cell and gene therapy products. Sponsors planning or refining BLA submissions can use this session to clarify expectations, strengthen data and CMC packages, and align internal planning with current FDA thinking on review readiness.

18 May 2026, 17:30fda.govUnited States

US FDA Lists Ongoing Accelerated Approvals for Infectious Disease Vaccines

In May 2026 the US FDA refreshed its public listing of vaccines that hold accelerated approval for infectious-disease indications, detailing the associated confirmatory postmarketing trials and projected completion dates for each product. These timelines indicate when key efficacy evidence could trigger conversion to full approval or regulatory action, helping manufacturers and healthcare stakeholders assess portfolio risk and plan for potential labelling or market-access changes.

18 May 2026, 17:30fda.govUnited States

New York Senate Bill S10449 Proposes Tighter Storage and Distribution Controls for Flavored Vapor Products

In May 2026 New York introduced Senate Bill S10449 to tighten its flavored vapor product ban by prohibiting storage and distribution of flavored vapor products in or near retail premises and expanding enforcement powers over vapor product dealers and sellers. If enacted, this would significantly increase compliance risk for vapor product manufacturers, wholesalers and retailers in New York by closing inventory and wholesale loopholes, raising fines, and imposing stricter record-keeping and inspection obligations that require proactive auditing of supply chains and store operations.

18 May 2026, 17:28nysenate.govUnited States

US FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria for Rheumatoid Arthritis and Ulcerative Colitis

In May 2026, the US FDA approved Immgolis (golimumab-sldi) and Immgolis Intri as the first interchangeable biosimilars to Simponi and Simponi Aria for adults with rheumatoid arthritis and, for Immgolis, ulcerative colitis in the United States. This expands lower-cost treatment options for autoimmune disease patients and signals growing US momentum behind biosimilar competition, with implications for biologic pricing, market share, and portfolio strategy for originator products.

18 May 2026, 17:25fda.govUnited States