Our Scans · Food Regulators · Weekly Summary

• [New] Regulatory Compliance and Recall Risk: The US FDA and AAFCO impose stringent nutritional standards and ingredient labeling requirements. IMARC Group
• [New] Since cultivated meat is jointly regulated by USDA-FSIS and FDA, every cultivated meat producer will need to register its facilities with FDA (regardless of the type of product they make). / USA The Good Food Institute
• [New] Pharmaceutical supply chain disruptions trigger FDA reporting obligations, healthcare provider notification requirements, and potential patient safety implications. CYBERSOL B.V.
• [New] Moving melatonin into the drug category would require formal FDA drug approval pathways, which could limit consumer access, reduce product variety, and significantly increase costs for both manufacturers and consumers. Live Science
• [New] Sensitivities concentrate around FDA pigment oversight decisions and ECHA microplastic regulation enforcement dates that could accelerate inventory write-downs. MarkWide Research
• [New] Stakeholders must monitor pending FDA colour additive petitions and EU ECHA microplastic restrictions to anticipate reformulation timelines and inventory transition costs. MarkWide Research
• [New] Ensitrelvir has already been approved as a prophylactic in Japan, with an FDA decision in the U.S. expected soon. Gizmodo
• Food & beverages are expected to dominate, with nearly a 35% share in 2026, due to FDA and EU approvals that permit direct food-contact applications. Persistence Market Research
• AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Stock Titan
• In March, the FDA released its first-ever guidance to industry on flavours, stating that menthol, coffee, mint and spice flavours could have a role in appealing to adult smokers. San Diego Union-Tribune
• Schedule III brings cannabis into the fold of federal regulation, which means the FDA will likely take a more active role in product safety and labeling. Goldleaf
• AEMS will consolidate multiple FDA adverse event legacy systems, with some systems, such as the FDA Adverse Event Reporting System, being replaced immediately, and others being replaced in May, such as the Manufacturer and User Facility Device Experience. Jones Day
• The US Food and Drug Administration has not approved kratom for any medical use, and federal agencies have warned about potential risks, including addiction and serious side effects. Futurity
• Regulatory responses are uneven: while the U.S. Food and Drug Administration has authorized their marketing, other jurisdictions have enacted prohibitions that risk perpetuating cigarette consumption. PubMed
• Only e-cigarettes that are under scientific review will qualify to launch without FDA authorization. Fortune
• Rather than targeting flavours, the FDA said its new enforcement approach will focus on vapes with specific youth-appealing features, such as designs that resemble children's toys. Fortune
• FDA should prohibit any Bluetooth or other two-way communication between an e-cigarette and external devices or parties that might externally control device characteristics and affect nicotine delivery. Stanton Glantz blog

Last updated: 19 June 2026