Regulation

EU Ombudsman Decision A ‘Missed Opportunity’ To Bring Clarity To Probiotics Market

 
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IPA Europe responds critically to recent EU Ombudsman's decision that the EC’s position in relation to probiotics is “reasonable". “While we respect the Ombudsman’s role, its conclusions fail to address the main critical concerns raised by stakeholders,” the association insists.

FTC Proposed Rule Change Targeting Direct Sellers Gets Direct Challenge From Incoming GOP Majority

 

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

EU Probiotics Deadlock: Ombudsman Finds ‘No Maladministration’ By The Commission

 
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In response to an IPA Europe complaint, European Ombudsman Emily O’Reilly finds that the Commission’s interpretation of EU food legislation in relation to probiotics is “reasonable and in line with the main goal of this legislation, which is to ensure a high level of consumer protection.”

US ‘Healthy’ Labeling Rule Applies To Supplements While Acknowledging Structure/Function Claim Use

Vitamin, mineral and supplement products “may bear nutrient content claims, including ‘healthy,’’ if they meet structure/function claim criteria “without being subject to the requirements of the ‘healthy nutrient content claim” stated in the final rule FDA published recently.


UK Finds Turmeric Supplements Pose Risk To Health

 
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UK food toxicity committee says substantial exceedances of the Acceptable Daily Intake of turmeric - such as through excessive supplement use - represents a potential health risk to humans.

Texas Opens Door On 2025 State Legislation To Age-Restrict Sales Of Supplements, OTCs

 

Texas bill filed in advance of the state’s next legislative session starting in January while bills proposing prohibiting sales of supplements and OTC drugs for weight loss or bodybuilding to minors remain active in three states where current sessions continue, Massachusetts, Michigan and New Jersey.

US ‘Best If Used By’ Labeling Initiative Targets 50% Food Waste Reduction In Five Years

 

FDA and USDA ask for comments on questions on date labeling for food, supplements in response to Biden administration’s June 2024 final National Strategy for Reducing Food Loss and Waste and Recycling Organics.

US Infant Formula Supply Regulation Overhaul Extends To Guidance On Reporting Disruptions

 

Formula manufacturers must notify FDA of permanent discontinuance or interruption in production “likely to lead to a meaningful disruption in the supply … and the reasons for such discontinuance or interruption” no later than five business days after a problem is identified.


Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit

 

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.

EU Commission Confirms Olivér Várhelyi In Health Role

 

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Supplement Firms Could Lighten FDA Inspection Load, Need Lighter Drug Preclusion Touch – CRN

 

CRN suggestion that FDA prioritize facility inspections on firms which haven’t been cleared in third-party audits apparently has support at agency. But FDA hasn’t been receptive to adjusting its policy on precluding from use as dietary ingredients any substance studied or approved as a drug.

Defining Lawful Hemp In US Soon On Regulatory And Legislative Menu For Different Cooks

 

Whether Democrat Harris or Republican Trump is in White House or which party has majority in either chamber of Congress, the FDA’s conundrum will continue around a regulatory pathway for allowing use of ingredients derived from hemp in supplements.


Magnesium Brain Health Supplement Sold Across US Authorized As Novel Food In EU

 
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Dietary supplement ingredient promising enhanced memory and mental clarity marketed widely across the US has been authorized for sale in Europe.

CRN Urges Tighter NDI Enforcement, Offers Its OWL As Model For FDA’s Potential Mandatory List

 

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

Age-Restricting Sales Of Supplements, OTCs Remains Action Item For New Jersey Lawmakers

 

New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.

CRN Appeals To US Supplement Industry For ‘Promoting A More Responsible Industry’

 

In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”


Help Or Hindrance To Food Supplement Innovation? Experts Assess New EU Novel Food Guidance

 
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EFSA has published new guidance to assist companies navigating the EU’s novel food authorisation process. HBW Insight speaks to experts Dr Mari Eskola of Medfiles and Dr Jérôme Le Bloch of FoodChain ID who offer differing views on the benefits and drawbacks of the guidance for industry.

Senate Hemp Regulation Bill’s Broad Prohibition On Synthetics In Supplements Has Industry Attention

 

Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

Death Linked To Caffeine Powder Prompts UK Supplements Guidance

 
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Food Standards Agency tells companies marketing caffeine supplements, “It is your responsibility to ensure food supplements you sell are safe for human consumption.”