Effective Date: March 6 2025

FDA & EU compliance statement

Regulatory Compliance Overview
SÄGE MUSH is committed to maintaining the highest standards of safety, transparency, and compliance with the regulatory frameworks of the United States (FDA) and the European Union (EFSA) for dietary supplements and functional foods.

FDA Compliance (United States)

SÄGE MUSH products are classified as dietary supplements and functional foods under U.S. law.
Our products comply with the Dietary Supplement Health and Education Act (DSHEA) of 1994 and applicable FDA (Food and Drug Administration) guidelines.
Not FDA Evaluated: Our products and statements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.
Manufacturing Standards: Our products are manufactured in FDA-registered and GMP (Good Manufacturing Practices)-certified facilities to ensure quality and safety.
Labeling & Claims: We adhere to FDA regulations by providing accurate ingredient lists, nutritional information, and legally compliant health claims.

EFSA Compliance (European Union)

SÄGE MUSH follows the European Food Safety Authority (EFSA) regulations for dietary supplements and food products.
Health Claims Regulation: We comply with Regulation (EC) No 1924/2006, ensuring that all health claims are based on approved scientific evidence and are not misleading.
Novel Food Approval: If required, our ingredients comply with EU Novel Food Regulations to ensure their legal status.
Ingredient Transparency: All ingredients used in our products meet EU safety and purity standards.
No Medical Claims: As per EFSA regulations, our products do not make medical or therapeutic claims.

Import, Labeling & Consumer Safety

Country-Specific Regulations: Compliance with import and labeling laws in the U.S., EU, and other markets where our products are sold.
Allergen & Safety Information: Our packaging clearly identifies potential allergens and proper usage instructions.
Customs & Duties: International customers are responsible for ensuring our products comply with their local regulations before purchasing.

Commitment to Transparency & Safety
SÄGE MUSH is dedicated to maintaining compliance with all relevant food and supplement regulations. If updates to regulatory requirements occur, we will adjust our products and policies accordingly.

Contact for Compliance Inquiries

For questions about our regulatory compliance, please contact: info@sagemush.com