Arnica Montana - FDA approval - yes or no? Does that make it safe (or unsafe) to use?
Is Arnica Montana FDA Approved?
Doctor Answers 4
Arnica montana and FDA approval
Arnica montana is a natural substance and the active compound is found in the US Pharmacoepia. It is a natural occuring medication. The FDA does not approve herbal supplements, so you will not find an FDA number.
No FDA Approval
Botanicals are not examined or approved by the FDA. The public is pretty much on their own in this regard. This may be brought into question, since these OTC p[roducts ahve some definite and at times serious side effects (see Tryptophan).
As far as Arnica Montana. This has been around since the Middle Ages under the name of Wolf's Bane and Leopard's Bane. It has been used for colds, coughs, muscle aches, and bruising. It almost sounds like one of those ads at the turn of the 19th century since its been trumpeted as a cure for baldness and arthritis.
Most recently it seems to have found favor due to its fairly well documented effects on wound healing and bruising. However, for something that is recommended so often, there is not a whole lot of true scientific data to back it up.
First, you definitely want to stay away from the tablet form unless you have a VERY reliable source. Some of the plant, may contain choline, which can have adverse effects of blood vessels. There are reports of necrotizing gastroenteritis associated with Arnica. It can cause profound muscular weakness and even death.
As for the creams and gels: Dermatologist Leslie Baumann, concerned about the paucity of data on the subject, performed a well controlled, split faced study with post-laser treatment. She found that, though there was no statistically difference, the arnica treated side showed quicker healing from bruising.
Dr. Baumann thus recommends topical Arnica ( never oral due to the potential for severe side effects). She utilizes Boericke and Tafel Homeopathic's Arniflora Arnica gel
This is generally considered a dietary supplement and as such does not require approval by the FDA. It is a homeopathic medication that is available in ingestible tablet form or as a topical treatment.