The American distributor of the dietary supplement Reishi D has been formally warned by the U.S. Food and Drug Administration, or FDA, for multiple “serious violations” involving the way the product is marketed.
From FDA’s letter to Zheng Xiong Li, we learn that the agency paid a multi-day visit to Reishi D. International, Inc., back in August. There, agents collected product labels and brochures used to promote the supplement.
Li’s company does not actually make Reishi D; the supplement is contracted out. But as an official distributor, says FDA, Li has a legal responsibility to make sure the product conforms to FDA regulations. Li, alleges the agency, needs to step up his quality control. For example, Li was apparently not collecting and reserving samples of each shipment he received, as required.
Reishi D is also “misbranded”, says FDA, because its label omits critical information like which part of the plant (leaves, roots, flowers, etc.) is used to make it. There is also a possibility for confusion about the correct dosage.
Reishi D is further in trouble for making health claims dietary supplements are not allowed to make. Phrases like “Chinese medicine” and words like “infections” and “diseases” suggest the supplement is actually marketed as a drug, says the agency.
Reishi D. International was given the normal 15 working days to respond.
Categories: FDA Warning Letters