The United States requires no premarket safety or efficacy review for the overwhelming majority of supplements. Most of the developed world requires something. This guide answers the most common questions about those working alternatives, synthesized from Prove It and the appendix, "What Should Change."
No — and that matters, because it rules out the most common objection to reform. No peer country runs its entire supplement market through a full drug-approval pathway. What they do instead is require something before a product reaches a shelf, scaled to actual risk, which is the one requirement the U.S. has never included at all since 1994.
Health Canada requires every natural health product to obtain a Natural Product Number before sale — genuine premarket review, scaled to the product. A well-established ingredient with a modest, pre-vetted claim can move through review quickly against an existing monograph; a novel ingredient or a more assertive claim requires the company to submit its own supporting evidence first. Nothing reaches a Canadian shelf without someone outside the manufacturer reviewing the evidence.
The Therapeutic Goods Administration runs a three-tier, risk-based model. Low-risk products with well-established ingredients can self-certify as "Listed" (AUST L) — fast, lightly reviewed. Products making a more specific health claim move into an "Assessed Listed" tier, requiring the company to submit evidence for that claim before it can appear on a label. The highest-risk products require full "Registered" status, comparable to a fuller safety and efficacy review.
| Country | Core requirement |
|---|---|
| United States | No premarket safety or efficacy review required |
| Canada | Product license (NPN) required before sale, evidence scaled to claim |
| Australia | Three-tier risk classification: Listed / Assessed Listed / Registered |
| European Union / UK | Positive list — only pre-approved ingredients may be used at all |
The EU takes the strictest approach on paper: under Directive 2002/46/EC, only the specific vitamins, minerals, and forms listed in the directive's own annexes may be used in a food supplement — trading in an unlisted vitamin or mineral source has been prohibited across the EU since August 2005. A genuinely novel ingredient requires formal safety evaluation by the European Food Safety Authority before it can be added to the list. The United Kingdom preserved essentially the same positive-list structure after leaving the EU.
The evidence points the other way. DSHEA exists because a stricter FDA posture toward supplements in the early 1990s provoked a consumer and industry backlash large enough to produce a law removing premarket authority almost entirely — a specific political outcome in a specific political moment that most other developed democracies simply never replicated.
"The American approach isn't a reflection of a value no other democracy shares. It's the surviving result of one legislative fight, thirty years old, that the rest of the developed world resolved differently."Prove It
A specific recommendation, not just a diagnosis. The appendix "What Should Change" proposes a tiered evidence framework for the U.S., modeled directly on the pieces of Canada's and Australia's systems that are narrowest and best-evidenced — paired with the mandatory product listing requirement already closest to passing in Congress.
Every figure on this page is drawn from the sourced reporting in Prove It. See the book and appendix for full citations.