A dietary supplement manufacturer is on notice from the FDA because the firm’s products were prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
Staff from the Food and Drug Administration inspected the San Francisco, CA, location of Reishi D. International Inc. from Aug. 2-7, 2017, and discovered “serious violations” of the Current Good Manfacturing Practice (cGMP) regulation for foods, according to a Feb. 7 warning letter made public by the FDA in recent days.
Additionally, review of the firm’s product labels resulted in misbranding violations, “during the inspection of your facility, our investigator collected labels and brochures for your Reishi D. dietary supplement which contain violations of the Act and applicable regulations.” according to the letter sent to Zheng Xiong Li, CEO of Reishi D. International Inc.
Specifically, FDA’s Division 5, West Director Darla Bracy, noted the following observations logged during the inspection:
- During the inspection you did not provide documentation of the approval for release of your dietary supplements by your quality control personnel.
- You distributed Reishi D., Lot #CC4020-6160 and failed to collect and hold a reserve sample. The firm also informed the FDA investigator that they were not aware of the requirement to collect and hold reserve samples of finished dietary supplements they received from their contract manufacturer.
- You told our investigator that you did not have any written procedures for handling any returned dietary supplements.”
- The firm’s Reishi D. product is misbranded because the label fails to identify the part of the plant, e.g., root, leaves, from which each botanical dietary ingredient in the product is derived.
- The firm’s serving size declared on the labels are incorrect. The suggested use states “Take 1 capsule twice daily,” but the serving size lists “2” capsules. The serving size listed should be one capsule. An incorrect serving size could lead a consumer to overconsume the product.
- The firm makes the false claim in their 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 percent or more of the RDI or DRV of the nutrients that are the subject of the claim. The Supplement Facts label for the firm’s Reishi D. product does not list any minerals or vitamin C, E, A or B vitamins. Furthermore, an RDI has not been established for “provitamin A.”
The FDA noted a response letter from firm on Oct. 15, but evaluated all of their corrective actions as inadequate. Once again, the FDA requested that the the firms next response “include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions.”
Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.
(To sign up for a free subscription to Food Safety News, click here.)© Food Safety News