US: FDA draft guidance on homeopathic products

The US Food and Drug Administration (FDA) has issued draft guidance to its staff and industry on how it intends to prioritise enforcement and regulatory actions on products labelled as homeopathic and marketed in the US without the required FDA approval. It proposes a stricter enforcement policy that will target products posing the greatest safety risks, including those with reported safety concerns, products containing potentially harmful ingredients, products with routes of administration other than oral or topical (e.g. injections), those being marketed for the prevention or treatment of serious or life-threatening diseases and conditions and those aimed at infants, children, elderly people or pregnant women.

The guidelines will not be binding on the FDA or the public, but they do signal increased scrutiny for these products. In Germany, both the Bundesverband der Pharmazeutischen Industrie (BPI – German Pharmaceutical Association) and  the Bundesverband der Arzneimittel-Hersteller (Association of German medicines manufacturers – BAH) have issued statements confirming that high standards are already in place in Germany and the rest of Europe ensuring the high quality and safety of these products.