FDA EIR - KRK Supplements

This FDA Consumer Complaint/Injury Report, dated September 21, 2021, documents an adverse event concerning Beta Sitosterol, Plant Sterol Complex. The product is manufactured by Aviva Natural Supplements, LLC and distributed by KRK Supplements. On June 25, 2021, the FDA received a complaint from a consumer who reported severe stomach pain and a subsequent diagnosis of a small bowel obstruction after taking two pills of the supplement on May 26-27, 2021. The consumer required an emergency room visit and an NG tube, with treating physicians later confirming the obstruction and suggesting the supplement as a possible cause. KRK Supplements responded by asserting that their products comply with Current Good Manufacturing Practices (21 CFR Part 111) and use only lawful and safe ingredients under Section 402(f) of the FD&C Act. They also stated that each lot is independently tested, denying any product fault or responsibility for the consumer's medical costs. The FDA processed the complaint, conducting an initial evaluation, and referred the case to the appropriate district office for follow-up. While follow-up activities were noted as completed, the report does not detail specific regulatory violations found or enforcement actions taken against the companies.