Policy & Legislation
Live FDA Enforcement & Federal Legislation Tracker
Protecting Market Integrity
We track federal bills and FDA database updates that touch honey. This page follows legislation on honey purity and trade protections for domestic producers, along with FDA enforcement actions and recalls involving honey and wound dressings.
Active Federal Legislation
The following bills are currently moving through Congress and have direct implications for honey standards, trade enforcement, and the medical-grade supply chain. We update this section as bills progress through committee hearings, floor votes, and regulatory implementation.
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FDA Regulatory Intelligence
This tracker queries two FDA enforcement databases simultaneously: the food enforcement system for honey adulteration, undeclared ingredient violations, and import safety actions, and the device enforcement system for recalls affecting 510(k)-cleared wound dressings. Class I designates the highest risk. Class II covers products with potential for temporary adverse health outcomes. Results are pulled live on each page load and cached for six hours.
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Regulatory Framework Overview
Medical-grade Manuka honey operates under a complex regulatory framework spanning multiple agencies. Understanding this structure helps clinicians and procurement officers verify product compliance and identify legitimate suppliers.
FDA (United States)
In the United States, honey-based wound dressings are sold as medical devices and have been cleared through the FDA 510(k) pathway. A 510(k) clearance means the maker showed that its product is substantially equivalent to a device already on the market. Honey sold as food is regulated as a food and carries no such clearance.
FDA 510(k) ProgramCE Marking (European Union)
Medical devices sold in the European Union carry a CE mark under the Medical Device Regulation (EU) 2017/745. Depending on the risk class, a notified body reviews the product before it can be sold. Products must meet the regulation's general safety and performance requirements.
MDR 2017/745 Full TextUMF Honey Association (New Zealand)
Industry body that licenses the UMF trademark. Licensed brands have their honey tested for the grading markers and must meet the association's requirements. Check the association's website for its current licensing rules.
UMF Honey AssociationManuka Honey Picks
Three manuka honey jars from our price guide. These are affiliate links: if you buy, we earn a commission at no extra cost to you. New to the numbers? Read the MGO and UMF guide. Jars sold as food are not sterile and are not wound dressings.
Manuka Health MGO 400+
Labeled MGO 400+. Daily spoonful use if you want a brand-name jar at the MGO 400 level.
Manuka Health MGO 400+: $60.00Manuka Health MGO 600+
Labeled MGO 600+. Gifts. It is the MGO 600+ Extra jar packed with a gold spoon and a drawstring bag.
Manuka Health MGO 600+: $75.00Manuka Health MGO 1000+
Labeled MGO 1000+. Buyers who want a high-potency jar from Manuka Health at a lower price than the Pinnacle.
Manuka Health MGO 1000+: $200.00Products sourced from Manuka Health New Zealand, a UMF Honey Association-licensed producer. These are food-grade consumer products. For clinical wound care, consult your facility's procurement officer for 510(k)-cleared medical device dressings. Affiliate disclosure.
Why Regulation Matters for Wound Care
Regulated wound dressings are reviewed for sterility and labeling before they are sold, which honey sold as food is not. For wound care, ask a clinician or your facility's procurement team which cleared products they use.