Such exaggerated claims about the health benefits of goji berry and derived products triggered strong reactions, including from government regulatory agencies. In 2006, the U. S. Food and Drug Administration (FDA) placed two goji juice distributors on notice with warning letters about unproven therapeutic benefits. These statements were in violation of the United States Food, Drug and Cosmetic Act [21 USC/321 (g)(1)] because they "establish[ed] the product as a drug intended for use in the cure, mitigation, treatment, or prevention of disease" when wolfberries or juice have had no such scientific evaluation. Additionally stated by the FDA, the goji juice 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. [dubious – discuss] New drugs may not be legally marketed in the United States without prior approval of the FDA.