Assurance regime; jurisdiction US
Dietary supplements (US)
A regime that moved backward: pre-market review removed by statute, private verification never made mandatory, no oversight of the verifiers. Shows that a trigger does not guarantee reform.
Path signature
R rollback V voluntary T trigger A access/publication S standards
Similarity of its opening to frontier AI: 0.33 (matched opening RVTAS)
Stages reached
| Voluntary | 2001 |
| Trigger | 2003 |
| Mandate | not reached |
| Standards | 2007 |
| Oversight | not reached |
| Independence | not reached |
| Access | 2006 |
Mechanisms
| Before reform | Now | |
|---|---|---|
| pays | A | A |
| selects | A | A |
| access | shallow | shallow |
| publishes | summary | summary |
| oversees | none | none |
Voluntary marks; no oversight of verifiers.
Payer, access, publication
Who pays. Manufacturer pays private verifiers; verification is voluntary.
Access. Voluntary submission of samples and facility audits.
Publication. Verification marks public; adverse event reports to FDA.
Milestones
| Year | Kind | Event | Strength | Harm | |
|---|---|---|---|---|---|
| 1994 | rollback | DSHEA removes pre-market approval for supplements. | source | ||
| 2001 | voluntary assurance | USP launches a voluntary supplement verification program. | source | ||
| 2003 | trigger | Ephedra-linked deaths, including a professional athlete. | deaths: Deaths linked to ephedra including a professional athlete | source | |
| 2006 | publication rule | Dietary Supplement and Nonprescription Drug Consumer Protection Act requires serious adverse event reporting. | 1 | source | |
| 2007 | standards | FDA current good manufacturing practice rule for supplements. | 2 | source |
seed; secondary sources, years spot-checked; verify against a primary source before citing in the paper Data: data/industries/dietary-supplements.json