Companies attributing health claims from using dietary supplements of velvet antler have received warning letters from the US Food and Drug Administration (FDA) concerning the sale of encapsulated powders connected to their marketing claims.[12] The claims were in violation of the United States Food, Drug and Cosmetic Act [21 USC/321 (g)(1)][36] because they "establish the product as a drug intended for use in the cure, mitigation, treatment, or prevention of disease" when velvet antler has no such scientific evaluation. Additionally stated by the FDA, velvet antler was "not generally recognized as safe and effective for the referenced conditions" and therefore must be treated as a "new drug" under Section 21(p) of the Act. New drugs may not be legally marketed in the United States without prior approval of the FDA.[12][14][15][16][17] As of 2018, it is legal to sell velvet antler powder, extract or spray in the U.S. as a dietary supplement as long as no disease treatment claims are made and the label bears the FDA disclaimer: "This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure or prevent any disease."
A systemic review on human interventions[25] makes note of a study conducted on patients of osteoarthritis (Edelman et al. 2000; cannot be located online) which found improvements in joint pain symptoms relative to baseline in the Velvet Antler group and not placebo, although a lack of information on blinding and randomization precludes results that can be drawn from this study.
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