A lack of European coordination on berberine
Recently, berberine has seen growing success in Europe. This alkaloid, extracted from roots and barks, is used in traditional medicine against gastrointestinal infections, and especially for its regulatory effects on blood sugar and cholesterol.
However, the regulatory framework for this dietary supplement remains incomplete, with legislation that varies from one country to another. While berberine is frequently used in traditional Asian medicines, this alkaloid is only beginning to enter the European market. This situation results in a relative lack of knowledge about this food product and significant regulatory uncertainty.
Banned in some countries (Sweden, Greece…), berberine is sold in a limited way in others (Poland, Belgium…), or even freely marketed. This is the case in France, where berberine is found in plants used as dietary supplements – in particular barberry, with no dose limit. This raises questions, since, as Anses points out, no toxicological study has yet been conducted on berberine.
Inadequate safety of berberine use
Due to a lack of in-depth research on berberine, there is to date no established safety of use. Anses can base its analyses only on the available clinical data, which, however, already point to some important observations to be taken into account.
In a seemingly paradoxical way, while berberine is supposed to treat gastrointestinal disorders, it can also cause them at high doses. The absence of dose limits in France is precisely one of the sticking points highlighted by Anses, which indicates that from 400 mg/day, berberine ceases to be a mere dietary supplement and becomes a full-fledged medicine. At this dose, berberine affects heart rate and blood pressure, and may have multiple uncontrolled effects, including anti-inflammatory, hypoglycemic, immunosuppressive, or anticonvulsant effects.
Even at limited doses, as in Belgium with 10 mg/day, berberine could have pharmacological effects.
A worrying lack of information on berberine
Given the lack of existing scientific data on berberine, Anses issues several warnings about its use. This dietary supplement is thus particularly not recommended for pregnant or breastfeeding women, even though in theory the labeling of berberine-containing products is already supposed to indicate this.
Anses also extends its warnings to children and adolescents, who would be at higher risk than the adult population, and also to anyone predisposed to liver, diabetes-related, or heart disorders.
Furthermore, berberine is likely to interact with an ongoing medication regimen. Anses therefore recommends exercising the greatest caution with this plant extract, while calling for in-depth toxicological studies to be carried out as soon as possible.
