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.
- PERSPECTIVES ON FDA’S MOST RECENT DSCSA GUIDANCE September 24, 2019
- FBI DRUG DIVERSION CASE HIGHLIGHTS FATAL DSCSA FLAW September 23, 2019
- FDA’S OCTOBER 2018 DRAFT GUIDANCE ON DSCSA VERIFICATION SYSTEMS IS MIA June 17, 2019
- THE TIME HAS COME FOR NOVEL APPROACHES TO SECURING OUR NATION’S DRUG SUPPLY April 11, 2019
- FDA AND CBP TO INCREASE JOINT INTERNATIONAL MAIL FACILITY EFFORTS April 5, 2019
- FDA’S LONG OVERDUE NATIONAL WHOLESALE DISTRIBUTOR LICENSING STANDARDS March 14, 2019