A yellow, naturally occurring plant alkaloid found in herbs such as goldenseal and barberry, berberine has been commercially sold as a supplement for decades.
Before being dubbed as “nature’s Ozempic” in the 2020s, berberine was primarily marketed for blood sugar control, cholesterol management and gastrointestinal health, following a long history of use in traditional Ayurvedic and Chinese medicine.
However, its rise to TikTok fame in recent years pushed the alkaloid under the regulatory microscope, with EFSA linking berberine supplementation to genotoxicity, hepatoxicity and carcinogenicity. It was also found to interact with certain prescription medications, although significant data gaps remain.
In response, EFSA launched a public consultation, inviting stakeholders to submit data and comments on the safety of plant preparations containing berberine.
The Alliance for Natural Health (ANH) Europe has now warned that EFSA’s broad conclusion that no safe intake can currently be established risks being misused by the European Commission, Member States or other risk managers as justification for sweeping restrictions or a de facto ban.
“The totality of available evidence—including years of clinical experience and human studies involving berberine preparations used to support metabolic health and blood sugar regulation—points to the need for proportionate, targeted risk management, not blanket prohibition,” said Dr. Rob Verkerk, scientific director of ANH Europe. “Europe urgently needs rational frameworks that protect consumers from genuine risks while preserving responsible access to natural products that many people and practitioners use to address today’s metabolic health crisis.”
The berberine market
Berberine entered the mainstream in 2023 after going viral on TikTok. It received its #naturesozempic hashtag after influencers promoted it as a natural alternative to GLP-1 weight loss drugs.
At the time, US-based supplement retailer NOW Foods reported that berberine sales were up by 623%, causing the retailer to run out of stock. In 2026, Dan Richard, NOW’s vice president of global sales and marketing, said the ingredient continues to be “very hot”.
“Last year, we saw more than 20% growth, and this year we estimate that number will be even higher,” he said. “Sales have expanded to multiple types of berberine, including berberine phytosome. NOW has four berberine SKUs today, and all are selling very well.”
Data from U.S. market insights firm SPINS paints a similar picture, with sales totaling $96 million in the past 12 months—up 39% year over year, when sales totaled $69 million.
Berberine is also popular outside the United States, with UK-based retailer Holland & Barrett reporting that sales are up 167% since this time last year.
“The category has delivered triple-digit growth for the past two years, demonstrating sustained consumer interest,” said Jessica Pasco, category director for vitamins, minerals, and herbal supplements (VMHS) at H&B.
This strong market growth could be considered surprising given the ongoing safety debate and its regulatory uncertainty. However, George Kokkinis, CEO of Pharmako Biotechnologies, which produces BioBerb, a bioavailable berberine ingredient, said the category shows no signs of waning.
“Commercially, berberine is one of the most recognized ingredients in the metabolic health category and interest remains strong, particularly for high quality scientifically substantiated products,” he said. “Some companies may take a more cautious approach to new product development during periods of regulatory concern, but we have not seen that change long-term interest in the ingredient.”
Safety of berberine: What does the science say?
EFSA’s safety assessment of berberine was triggered after the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) raised concerns regarding a potential risk to consumers.
The ANSES opinion stressed that the consumption of food supplements made with plants or plant preparations containing berberine can pose risks including gastrointestinal disorders, hypoglycemia and hypotension. Children and adolescents, pregnant and breastfeeding women, diabetic individuals and individuals with liver or heart disorders were deemed to be at higher risk of adverse events and advised to refrain from taking berberine supplements.
Responding to these concerns, EFSA analyzed the current scientific literature and released a draft scientific opinion. It included references to an in vitro study which found that berberine is capable of inducing gene mutations and a two-year mouse study linking berberine from Goldenseal (Hydrastis canadensis) to carcinogenic activity in the liver.
Consumption of berberine from the aerial parts of Greater Celandine (Chelidonium majus) was also found to be associated with liver disease, according to several systematic reviews and case reports which identified 45 independent cases of liver injury following berberine consumption. EFSA noted that these reactions are idiosyncratic, meaning they are unpredictable and may occur only in susceptible individuals regardless of dose.
Beyond these specific plant preparations, EFSA concluded that the toxicity profiles of the other plant species remain largely unknown. Dr. Umar Jan, president of European operations at ingredient supplier Sabinsa, which produces standardized berberine extract Rebersa, said that the public should therefore not interpret EFSA’s conclusion as evidence that berberine is unsafe.
“EFSA’s conclusion doesn’t say berberine is dangerous; it says the dataset isn’t complete enough to draw a firm safe-intake number,” he said. “That’s a fair scientific position to take when the underlying studies are older, use non-standard strains or lack full reporting. Where I’d push back is on treating all 13 plant species in the mandate as a single risk profile.”
Although berberine as a singular compound is facing a potential ban or restriction, EFSA’s own safety opinion acknowledges that there are a wide variety of berberine-containing plants which appear to have differing safety profiles. And while hundreds of plant species contain berberine, EFSA only evaluated 13 for which safety data were available, including Berberis aristata (tree turmeric), Berberis vulgaris (barberry), Berberis aquifolium (Oregon grape) and Hydrastis canadensis (goldenseal).
Berberine is typically extracted from these plants by using water, ethanol or dilute acids to dissolve the alkaloid, followed by a chemical conversion process that isolates and purifies the berberine into a crystalline salt. The result is typically an extract ranging from 85% to 98% purity.
However, as with all plant extracts, there is always some level of co-occurring compounds in the final product, such as other alkaloids, toxins and chemicals unique to the plant source. Dr. Jan said it is therefore important for EFSA to consider the unique safety profiles of each plant preparation when it comes to determining a regulatory status, rather than considering berberine as a singular compound.
“Berberis aristata, for instance, has essentially no dedicated repeated-dose toxicity literature of its own, which is a data gap, not a demonstrated hazard,” he said. “It’s a different situation from Hydrastis canadensis, where EFSA cites actual carcinogenicity findings in rodents. Folding those together risks a regulatory outcome shaped more by the thinnest part of the evidence base than by the compound’s actual clinical history.”
Pharmako’s Kokkinis agreed, noting that any regulatory decision should be based on the totality of the scientific evidence, including human data, exposure considerations and ingredient specific information.
“We also believe it is important to distinguish between the different berberine containing ingredients/formulations,” he said. “Ingredients derived from Berberis aristata root should be assessed based on their own safety and composition data, rather than being grouped together with all berberine sources.
“Ultimately the focus should be on managing risks appropriately while preserving consumer access to well characterized responsibly used ingredients.”
The path forward: What is the most likely outcome of the safety consultation?
Despite calls from industry bodies such as the ANH, regulatory experts have previously warned that the future of berberine looks bleak. Luca Bucchini, managing director of Hylobates Consulting, said that when EFSA determines that no safe intake level can be established, this typically leads to prohibition.
Katia Merten-Lentz, a regulatory expert and partner at Food Law Science & Partners, agreed, adding that strict regulatory restriction is very likely.
“While measures such as maximum intake levels remain possible, EFSA’s conclusion that no safe intake level can currently be established means that stronger restrictions, such as a full ban on berberine-containing plant preparations in food supplements, cannot be ruled out,” she said.
However, she added that this is not cause for immediate concern as EFSA’s final opinion is not expected until early next year, after which the European Commission will decide on any regulatory action.
“In practice, when restrictions such as maximum daily intake levels or mandatory warning labels are adopted, a transition period is usually provided to allow manufacturers to reformulate products, and food business operators to update labels and ensure compliance before the new rules become fully applicable,” she said.
ANH Europe is now urging regulators to ensure that precaution does not become prohibition by default and is calling for EFSA to revise its conclusions to distinguish between preparations with specific evidence of concern, preparations requiring further targeted data and well-characterized products that may be managed through specifications, dose limits, duration guidance, contraindications, medication warnings and post-market vigilance.
Berberine suppliers such as Saanroo and Sabinsa have made similar calls, agreeing that while a science-based, risk proportionate approach is needed, warning statements or conditions of use may represent a more appropriate solution than a blanket prohibition.
“A more workable outcome would tier the response to the actual evidence: pursue the additional in vivo genotoxicity studies EFSA has specified for berberine itself, while allowing continued market access at established, clinically studied dose ranges,” Dr. Jan said.
“A tiered outcome, standardized preparations with defined berberine content, upper intake limits and warning labels for pregnant/breastfeeding women, children and those on interacting medications, would address the specific concerns ANSES and EFSA have raised without removing a widely used ingredient from the market while additional studies are generated.”
