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 RECEIVES FUNDING TO BATTLE LONGSTANDING BULGES IN OUR NATION’S PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN April 1, 2020
- OUTSOURCING FACILITIES GREEN-LIGHTED BY FDA TO COMPOUND HYDROXYCHLOROQUINE March 26, 2020
- THE CORONAVIRUS PANDEMIC AND THE COUNTERFEIT CHLOROQUINE SPECTER March 20, 2020
- ROGUE MEDICAL SPAS CONTINUE TO THREATEN VULNERABLE PATIENTS January 27, 2020
- UNRAVELING AND LEGITIMIZING MURKY SHORTAGE DRUG TRANSACTIONS WITH SECONDARY WHOLESALE DISTRIBUTOR SOURCES-A DUE DILIGENCE ROAD MAP FOR HOSPITALS January 14, 2020
- A DSCSA ENFORCEMENT STRATEGY PEP TALK FOR FDA December 19, 2019