Regulation
CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
In its first health claim assessment of 2025, the European Commission has rejected an application by Sweden's Greenleaf for its Appethyl supplement.
Jim Jones resigna due to widespread layoffs at the agency the Trump administration’s Department of Government Efficiency imposed.
At a recent European Parliament event, IPA Europe called on EU institutions to “prioritize proportional and coherent rules on the European probiotic food and food market, to ensure EU policies are fit for competitiveness.”
HBW Insight speaks to food supplement market experts about what manufacturers should be looking out for over the coming year.
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 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.
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.”
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 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 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.
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.
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.
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.
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
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.
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.
Dietary supplement ingredient promising enhanced memory and mental clarity marketed widely across the US has been authorized for sale in Europe.