ProSupps USA and its president/CEO, Robert Reynolds, have been formally warned by the US Food and Drug Administration, or FDA, after the company’s Mr. Hyde Blue Razz supplement was implicated in 2 customer complaints.
The first known complaint was reported to the company in March of 2015. The customer complained that the supplement, which is clearly labeled as containing caffeine, caused shortness of breath and insomnia. ProSupps should have, said the agency, investigated the report immediately as required by federal law but did not. Instead, it conducted a review of a certificate of analysis and only concluded that review more than 2 months later.
ProSupps allegedly did not file a Serious Adverse Event Report, or SAER, as required by law.
Hospitalization Blamed On Mr. Hyde Blue Razz
The second known complaint actually involved a hospital stay for the consumer. Neither the FDA nor ProSupps have released much information about the incident but the agency alleges that ProSupps neither reviewed or investigated the complaint.
The company did eventually file a SAER, but waited more than 6 months to do so.
Inspection of ProSupps
The company was the target of a formal multi-day FDA inspection between early February and mid-March of 2016. During that time the agency’s investigation turned up what the warning letter to ProSupps describes as “significant violations”.
Most of the alleged violations involve shoddy quality control. The company has an obligation, the agency says, to make sure that its products are safe and meet quality standards regardless of whether ProSupps manufactures them or simply puts its name on a pre-packaged container. The agency says that the company has no process in place to do that. Inspectors cite as an example a case in which ProSupp employees simply accepted from the manufacturer bottles of Dr. Jekyll Watermelon V2 supplements that were mislabeled.
The letter to Robert Reynolds and ProSupps USA gives the company the standard 15 working days to respond.