A lack of European consultation on berberine
Recently, berberine has been gaining increasing popularity in Europe. This alkaloid, extracted from roots and barks, is used in traditional medicine for gastrointestinal infections, and especially because of its regulatory effects on blood sugar and cholesterol.
The regulatory framework for this dietary supplement remains incomplete, with legislation varying from one country to another. While berberine is frequently used in traditional Asian medicines, this alkaloid is just beginning to enter the European market. This results in a relative unfamiliarity with this food product and a considerable regulatory uncertainty.
Banned in some countries (Sweden, Greece…), berberine is sold in a limited manner in others (Poland, Belgium…), or even freely available. This is the case in France, where berberine is found in plants used as dietary supplements—particularly barberry, without a dosage limit. This raises questions, as highlighted by Anses, since no toxicological study has yet been conducted on berberine.
Deficient safety of berberine use
Due to the lack of extensive research on berberine, to date there is no safety of use. Anses can only base its analyses on available clinical data, which already highlight some important observations that need to be considered.
In an apparently paradoxical manner, though 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 stops being just a dietary supplement to become a full-fledged drug. At this dose, berberine affects heart rate and blood pressure, and may have multiple uncontrolled effects such as anti-inflammatory, hypoglycemic, immunosuppressive, or even anticonvulsant activities.
Even at limited doses, such as in Belgium with 10 mg/day, berberine is likely to have pharmacological effects.
A worrying lack of information on berberine
Given the deficit of existing scientific data on berberine, Anses provides several warnings about its use. This dietary supplement is particularly discouraged for pregnant or breastfeeding women, even if theoretically, the labeling of berberine-based products is already supposed to indicate this.
Moreover, Anses extends its warnings to children and adolescents, who would present higher risks than the adult population, as well as to anyone predisposed to liver, diabetic, or cardiac disorders.
Moreover, berberine is likely to interact with ongoing medication treatments. Anses, therefore, recommends exercising the utmost caution with this plant extract, while calling for in-depth toxicological studies to be conducted as soon as possible.
