FDA’s latest tainted dietary supplement alert seems to signal a shift in the agency’s approach to this problem. FDA alerts on these products have not typically referenced OCI investigations in this fashion. Perhaps the agency is beginning to grasp the need to attack this threat more strategically and collaboratively with OCI. I continue to support the need for FDA to spearhead a national law enforcement operation with DOJ’s Consumer Protection Branch (formerly the Office of Consumer Litigation) that targets convenience stores, gas stations, and other brick-and-mortar retailers with misdemeanor prosecutions under the FD&C Act. Such an approach (a woefully under-utilized but highly effective FD&C Act hammer) has the potential to change corporate behavior and make these dangerous products less accessible to vulnerable consumers in storefront retail establishments. See my most recent post on this topic here.
- FDA TO DEVELOP NEW ENFORCEMENT STRATEGIES TARGETING UNSAFE AND ILLEGAL DIETARY SUPPLEMENTS February 15, 2019
- FDA’S FIRST DSCSA WARNING LETTER TARGETS VERIFICATION LAPSES BY MCKESSON February 13, 2019
- LAUNCHING DSCSA PILOT PROJECTS IS GREAT BUT FDA MUST DO MORE TO PROTECT OUR SUPPLY CHAIN February 10, 2019
- FDA LEADERSHIP IS THE ANTIDOTE TO SHORTAGE DRUG DIVERSION SCHEMES January 24, 2019
- THE UNSETTLING SHORTAGE DRUG DILEMMA FACING HOSPITALS AND MEDICAL CLINICS December 1, 2018
- A POTENTIAL SHIFT IN FDA’S APPROACH TO TAINTED DIETARY SUPPLEMENTS November 29, 2018