Reishi D. International, Inc. FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

“[B]ees use propolis to protect themselves from bacteria and diseases. Propolis has been around for over 40 million years and has been used by man for thousands of years ….”

“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.”

You make the following claim in your product brochure: “Propolis is a rich source of minerals, vitamins C, E, provitamin A, and B-Complex ….” To bear “rich in” claims, a product must contain 20% or more of the RDI or DRV of the nutrients that are the subject of the claim, in accordance with 21 CFR 101.54(c). The Supplement Facts label for your Reishi D. product (60 capsules) and (30 capsules) does not list any minerals or vitamin C, E, A or B vitamins. Furthermore, an RDI has not been established for “provitamin A.” We note that under 21 CFR 101.54(a) and 21 CFR 101.13(n), you must comply with the labeling provisions in 21 CFR 101.36 to make this nutrient content claim.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Reishi D. International, Inc..

Regulatory Context

Your quality control unit must approve for release, or reject any packaged and labeled dietary supplement, including a repackaged or relabeled dietary supplement, for distribution, as required by 21 CFR 111.127(h). You must also provide written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, as required by 21 CFR 111.140(b)(2). Specifically, during the inspection you did not provide documentation of the approval for release of your dietary supplements by your quality control personnel.

Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you distributed Reishi D., Lot #CC4020-6160 and failed to collect and hold a reserve sample. You also informed our investigator that you were not aware of the requirement to collect and hold reserve samples of finished dietary supplements you received from your contract manufacturer.

You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515. Specifically, you told our investigator that you did not have any written procedures for handling any returned dietary supplements.