The FDA has sent a warning letter to the Reishi D. International dietary supplement facility in South San Francisco, California. Inspectors found serious violations of the current Good Manufacturing Practice, which means the product is considered adulterated. Inspectors also collected labels and brochures for the supplement that contain violations of the Act and regulations.
The supplement is considered a drug because it is “ntended for use in the cure, mitigation, treatment, or prevention of disease.” Claims on the product, such as “has been used in Traditional Chinese Medicine for thousands of years..” and “Propolis … contains more than 30 different flavonoids and antioxidants to help control free radicals. Free radicals are caused by waste from our body cells that increase with … infections … and toxins. The antioxidants help to neutralize the free radicals and prevent cell damage” are on the product labels. The Reishi D. product is not generally recognized as safe and effective for these uses, and is thus considered a “new drug.”
In addition, the product is considered adulterated because it is held under conditions that do not meet FDA regulations. The company did not collect and hold a reserve sample. There was no documentation of the approval of release by quality control. They did not have written procedures for handling returned supplements. The product is misbranded because the label doesn’t identify the part of the plant form which each ingredient is derived.
In addition, the serving size on the labels is wrong. That could lead a consumer to over consume the product. And there is a false claim in the brochure, which states that “Propolis is a rich source of minerals …” To be labeled “rich in” a product must contain 20% or more of the recommended daily intake of nutrients.
The FDA also said that corrective actions submitted by the company were inadequate. The company has 15 working days to respond to the warning letter.
