Safety Assessment of Probiotics for Human Use

Are Probiotics Safe?

  1. Please refer to the article written by Sanders et al. in the esteemed journal Gut Microbes.* As will be evident from reviewing this recent article, all probiotic strains manufactured by well-established firms with stringent c-GMP conditions either for food or dietary supplement use are assured of its safety.  US FDA, recognizes these probiotic strains as “Generally Recognized As Safe – (GRAS)” status. There exists no commercial scale manufacturing facility to produce any probiotic strains with a Drug Master File (DMF).  Hence, there are currently no probiotic products classified as a drugs.Safety Assessment of Probiotics
  1. Our raw materials are sourced from one of the top three probiotic manufacturers in the world, based out of the United States of America. They are US FDA inspected and adhere to controlled Good Manufacturing Production (c-GMP) facility guidelines – with in-house and external verification, certification, and documentations.
  1. Likewise our finished product formulations are manufactured by a US FDA inspected facility in the United States – with in-house and external verification, certification, and documentations.
  1. The final manufactured products are each tested for its quality, viable counts, purity and other needed tests for every lot produced by our manufacturer at Kibow’s R&D labs. We also perform stability studies periodically at 4 degrees Celsius, monthly for three consecutive months and then quarterly for a period of two years (expiration period) for each lot.
  1. Kibow also has two outside contract labs in the United States for fatty acid analysis and for strain verification in our products, and for contamination analysis for any pathogenic or harmful microbial strains.
  1. As of now, there are no complaints reported either directly to us or notified to US FDA on any safety issues by the use of RENADYL™ from any of our customers since April 1, 2010 when we started selling the product – RENADYL™ with our structure function claim “Helps maintain a healthy kidney function”.

Natarajan Ranganathan, Ph.D., – Managing Director (R&D)

*Sanders, Mary Ellen, Lois M.a. Akkermans, Dirk Haller, Cathy Hammerman, James T. Heimbach, Gabriele Hörmannsperger, and Geert Huys. “Safety Assessment of Probiotics for Human Use.” Gut Microbes 1.3 (2010): 164-85.