FDA Regulatory

FDA Regulatory Status:

Maca is an herb and thus is a permissible dietary ingredient for a dietary supplement, as listed in the Definition of Certain Foods as Dietary Supplements, in Section 3 of DSHEA (1994). Maca is not a new ingredient (having been imported into the U.S. since 1994) so no DSHEA Section 8 filing on reasonable safety is required. We have seen reports that weight lifters and body builders have turned to Maca as a natural alternative to anabolic steroids, which are banned by the FDA.

Safety Statement:

Based on historical use and common use as food, Maca appears to be safe. Due to the fact that this herb has not been reviewed by the APHA Botanical Safety Handbook, Maca would be considered to be a class 4 herb: "Herbs for which insufficient data are available for classification."

Structure/Function Statements Permitted under Section 6 of DSHEA

May Increase energy, stamina, and mental clarity
May Support the thyroid
May Support normal sexual function

May Promotes hormone balance

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