Regulatory Status

The German Commission E lists saw palmetto as an approved herb. The berry is the only part of the plant approved for use. The approved uses include urination problems associated with BPH stages I and II and urination problems associated with prostate adenoma. This evaluation is based on reasonable proof of safety and efficacy (35).

Saw palmetto is considered a dietary supplement by the Food and Drug Administration (3). Saw palmetto was previously included in the National Formulary (NF) and the United States Pharmacopeia, but was deleted in 1950 and 1916, respectively. Saw palmetto was deleted because no active ingredient could be found to account for its use (2). Saw palmetto was again included in the NF as an official monograph in 1998 (4).

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