EFSA publishes ‘major blow’ as monacolins deemed unsafe at any dose
The European Food Safety Authority (EFSA) determined that monacolins from red yeast rice (RYR) are unsafe at any dose even in small amounts, and could pose significant health risks.
As food safety expert Lucca Bucchini told NutraIngredients, this decision affects supplement companies, consumers using monacolins for cholesterol management, and healthcare providers.
EFSA’s report warned that even a 3 mg dose of monacolin K could cause serious health issues like rhabdomyolysis and liver damage. The authority found insufficient evidence to establish a safe daily intake level, citing the similarity between monacolin K and the prescription statin drug lovastatin.
If the EU adopts this stance, it could lead to a ban on RYR supplements, with companies facing legal repercussions if they continue selling these products. While EFSA’s opinion doesn’t have an immediate legal impact, the European Commission is expected to draft a regulation in 2025, likely resulting in a full ban by mid-2026.
Expert Insights: Must know nutrition regulatory changes for 2025
At the beginning of the year, regulation experts shared their key takeaways from 2024 and what they thought was necessary to know as the supplement industry set up to face more regulatory shifts in 2025.
They discussed rising legal pushback, as companies are looking to hold regulators like the EFSA and the European Commission accountable, pushing for fair assessments of ingredients. They also noted increasingly loud calls for clearer probiotic regulations.
They also discussed increased botanical scrutiny, with ingredients like ashwagandha coming under fire for safety concerns, with new restrictions looking likely in 2025. Furthermore, they noted that businesses are having to grapple with last-minute regulatory delays, especially on sustainability laws, which are eroding trust and creating uncertainty.
In more positive news, the industry saw several new ingredients, such as water lentil protein and ashitaba stem juice, gained approval in 2024. And courts ruled in favor of industry in cases like “raw” honey labeling and the classification of luo han guo, which the experts noted signalled a growing resistance to inconsistent regulation.
Bayer expands nutraceutical offering with new menopause range
Bayer’s Canesten brand entered the menopause category with its new CanesMeno range, aiming to educate, destigmatize, and empower women to take control of their health.
The product line includes a day and nighttime supplement, a vaginal gel, and an educational hub featuring downloadable resources and a menopause tracker for personalized insights.
CanesMeno Multi Support aims to target hormonal regulation, cognitive function, as well as bone and skin health with a blend of 19 vitamins and minerals, including red clover extract.
For nighttime relief, Bayer introduced CanesMeno Night, which combines hops and ashwagandha extracts to ease stress and improve sleep.
The range also features a vaginal gel with Ectoin to relieve vaginal atrophy symptoms like dryness, itching, and burning.
The UK market for menopause supplements is projected to hit £100m by 2028, up from £42m in 2020. Heather Jackson, CEO of GenM, highlighted the growing interest, noting that women aged 45-55 now represent the fastest-growing health and beauty shopper segment, yet their needs remain underserved.
Louis Dreyfus Company to acquire BASF’s health ingredients business
The Louis Dreyfus Company (LDC) announced that it would acquire BASF’s Food and Health Performance Ingredients business, including a production site and R&D center in Germany.
The deal gives LDC access to a diverse portfolio, such as plant sterol esters, conjugated linoleic acid (CLA), omega-3 oils, aeration agents, emulsifiers, and fat powder grades.
LDC CEO Michael Gelchie said the acquisition was a chance to expand in the fast-growing plant-based ingredients market, marking LDC’s first investment in large-scale production facilities for food and health performance ingredients.
BASF, which previously made major nutrition acquisitions, now sees limited synergy in the food and nutritional ingredients sector.
The deal, whose financial terms remain undisclosed, includes three BASF application labs outside Germany and involves the transfer of about 300 employees to LDC. Completion is subject to regulatory approvals.
Unlocking longevity: How the microbiome shapes healthspan
Personalized microbiome modulation may hold the key to reversing age-related decline, according to Bruno Balen, co-founder of Ani Biome, who emphasized the need for rigorous molecular analysis to drive meaningful impact in gut-focused interventions.
Balen noted that many biohacking approaches lack scientific rigor, limiting their impact and that the microbiome’s rapid responsiveness to environmental and internal changes makes it a powerful tool for detecting and addressing systemic shifts in biology.
Ani Biome’s platform employs 39 machine learning algorithms and over 50 intelligent agents to provide personalized insights. It integrates microbiome data with neurobiology, immunology, and systemic biology to map and modulate the mind, reprogram cellular memory, and combat aging-related entropy.
He explained that as people age, their microbiome diversity declines, beneficial species decrease, and opportunistic species rise, contributing to inflammation and weakened immunity. Ani Biome’s research shows personalized interventions can restore microbiome diversity and reduce inflammatory markers, mimicking the biology of younger organisms and enhancing resilience.