WHAT WE ASSESS
Regulatory status is not a property of an ingredient. It is a function of the ingredient, the dose, the dosage form, the route, the claim and the market. We assess all of them together, because an ingredient permitted at one level is frequently not permitted at the level a formula actually needs.
BY JURISDICTION
01
Canada
Monograph status, permitted source material, dose ranges, permitted claims and whether the product sits under the NHP framework, the supplemented foods framework, or neither.
02
United States
Whether the ingredient was marketed before 15 October 1994, whether a new dietary ingredient notification is required, and the exceptions that may apply. Notification is generally due at least 75 days before interstate marketing.
03
European Union and United Kingdom
Novel food status, authorisation history, and the divergence between EU and GB registers since they separated.
04
Australia
Whether the ingredient appears on the permitted list for complementary medicines, at what level, and what it implies for the manufacturing site.
WHAT YOU RECEIVE
A decision, not a literature review.
Regulatory status by market for each ingredient assessed.
Dose, form and route feasibility at your intended levels.
Claim availability tied to each status.
Supplier documentation requirements to support the position.
Flags on restricted substances, novel status and pre-market notification obligations.
A go, revise or no-go recommendation per ingredient, with reasoning.
WHEN TO USE IT
The assessment is cheapest and most useful at concept stage, when substitution is still free. It is also worth running when an existing formula is moving into a new market, when a supplier changes source material, or when a novel active is under consideration and the commercial case depends on being able to sell it.
Bring us the ingredients, the intended doses and the markets you want to sell in. We will come back with a status per ingredient and a recommendation on each.