Warning On TCM Claim, CRN Counsel, UNPA Asia: Health And Wellness News

Reishi D. International Inc.'s references in labeling and other text to "traditional Chinese medicine" and other claims for its namesake dietary supplements renders the products unapproved new drugs, FDA's Office of Regulatory Affairs San Francisco District said in a Feb. 7 warning letter. The warning, which followed an April 2017 inspection at the firm's facility in South San Francisco and a review of its labels and packages for its products, also detailed good manufacturing practice regulation violations as well as misbranding problems. In addition to references to TCM, violative claims for Reish D. brand supplements included bees "use propolis to protect themselves from bacteria and diseases" and propolis "contains more than 30 different flavonoids and antioxidants to help control free radicals," according to the letter.

The firm's GMP problems stem from its reliance as an own-labeler on its contract manufacturers' assurance of compliance rather than conducting its own, particularly in failing to approve or reject any packaged and labeled supplement, including a repackaged or relabeled products; collect and hold reserve samples of each lot of packaged and labeled supplements its distributes; and establish and follow written procedures for fulfilling the requirements for returned products, ORA stated. Misbranding for Reishi D. products included failing to identify the part of the plant from which each botanical dietary ingredient in a product is derived and stating incorrect serving sizes