KSM-66 Ashwagandha

Origin of Ingredient

Withania somnifera roots; commercial extraction

History of Ingredient

KSM-66 Ashwagandha is a modern branded nutraceutical ingredient. Its relevant history is the development of the proprietary extraction/formulation process and supplier-sponsored analytical and clinical programme rather than long-standing traditional use.

Scientific Makeup of Ingredient

withanolide-standardised extract

UK Legal Claim

No specific authorised GB/EU health claim identified in this review for the ingredient as named. Do not convert scientific evidence into a consumer health claim unless the exact substance/claim is authorised or a valid transitional/on-hold botanical position applies. Conditions: Verify exact substance, dose, target population, food category and wording in the current register before use.

EU Legal Claim

No specific authorised GB/EU health claim identified in this review for the ingredient as named. Do not convert scientific evidence into a consumer health claim unless the exact substance/claim is authorised or a valid transitional/on-hold botanical position applies. Conditions: Verify exact substance, dose, target population, food category and wording in the current register before use.

US Legal Claim

FDA does not pre-approve ordinary dietary-supplement structure/function claims. Example for regulatory review only (NOT FDA-approved wording): “Supports a healthy inflammatory response.” The marketer must hold substantiation, avoid disease claims, use the DSHEA disclaimer and notify FDA within 30 days after first marketing.

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August 24, 2024

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