Regulatory notes · 3 markets
The rules change at the border.
A specification that works for one market may not satisfy another. These buyer-oriented notes explain the framework, the documents we can supply, and the questions your regulatory team still owns.
Direct answer
In the US, supplements are regulated as food under DSHEA, with cGMP and NDI rules. In the EU, botanical supplements sit between the Food Supplements Directive, national rules, novel food, contaminants, MRLs, and health claims. In the UK, GB and Northern Ireland can follow different paths. None of this is legal advice.
United States
Dietary supplements are regulated as a category of food. FDA does not approve supplements or botanical ingredients; the brand is responsible for safety, labeling, and claims.
Read the market notes →European Union
Food supplements are regulated at EU level for certain categories and at member-state level for botanicals. Novel food, contaminants, pesticide MRLs, and health claims all apply.
Read the market notes →United Kingdom
Great Britain applies retained EU law with UK regulators and registers; Northern Ireland continues to follow EU rules under the Windsor Framework. The two paths can differ.
Read the market notes →Scope
What these notes are — and what they are not
These pages summarize publicly available frameworks for business-to-business orientation. They are not legal advice, and they do not determine whether a specific extract, dose, or finished product is compliant in a specific market. That determination belongs to the brand and its regulatory advisor.
What we can do is provide the ingredient documentation — specification, COA, methods, contaminant results, allergen and GMO statements, origin record, and certificates where covered — so your review starts from a complete file.
Next step
Tell us the destination before the quote.
Market-specific limits and documents are part of the specification. Share the country, product category, and intended dose and we will list what applies.