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Regulatory Compliance Statement
Satoriia Regulatory Compliance Statement
Last Updated: June 23, 2025
At Satoriia, we weave beauty, care, and wellness together with a heartfelt commitment to your safety and our planet. This Regulatory Compliance Statement reflects our dedication to ensuring the quality, safety, and transparency of our wellness-driven cosmetic products, in harmony with U.S. federal and state laws, including the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and FDA regulations. Let’s nurture your trust with every strand of care.
1. FDA Registration and MoCRA Compliance
We craft our products with love, ensuring compliance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Our manufacturing facilities, registered with the U.S. Food and Drug Administration (FDA), produce each wellness-driven cosmetic with care.
Every marketed product is listed with the FDA, accompanied by a complete ingredient list, and we maintain up-to-date registrations and listings as required by law.
2. Responsible Person and Contact Information
In alignment with MoCRA and FDA guidelines, the responsible person for all Satoriia cosmetic products in the United States is:
SATORIIA LLC
Questions or concerns?
Call: 1-800-795-0114
Visit: www.satoriia.com
Email: care@satoriia.com
Manufactured by: LGLUGUS S.A., Guayaquil, Ecuador
Imported by: LUGUS USA CORP., Miami, Florida
Distributed by: SATORIIA LLC
If you have questions, concerns, or wish to report an adverse event, please reach us using the information above. We are dedicated to reporting serious adverse events to the FDA as mandated by law.
3. Adverse Event Reporting and FDA Notification
Satoriia nurtures your safety by maintaining a thoughtful system to monitor and respond to adverse events related to our cosmetic products, as required by MoCRA.
If you experience a serious adverse event—such as infection, significant allergic reaction, or hospitalization—please notify us immediately by emailing care@satoriia.com with the subject line “Adverse Event Report.” Include your full name, product used, batch number (if available), description of symptoms, and any medical attention received.
We are committed to:
• Reporting any serious adverse events to the U.S. Food and Drug Administration (FDA) within 15 business days of receiving your information.
• Submitting any new, material medical information related to the adverse event within one year of the initial report, as required by law.
• Documenting and retaining all safety-related reports for at least 6 years, cooperating fully with FDA inspections and audits.
4. Ingredient Disclosure
Transparency is at the heart of our wellness journey. Every Satoriia product page offers a complete list of ingredients, in accordance with FDA and state requirements, including the California Safe Cosmetics Act.
We embrace ingredient openness and comply with all relevant federal, state, and international cosmetic disclosure laws for exported products.
5. Safety and Quality Assurance
We ensure the safety of our wellness-driven products with planet-loving care, manufacturing them in accordance with Good Manufacturing Practices (GMP).
Our scientifically robust methods substantiate product safety, and we exclude all ingredients prohibited by federal or state law, including PFAS, formaldehyde, phthalates, and other restricted substances.
Records supporting safety are meticulously maintained for FDA review.
6. Connecting with Us
For questions, concerns, or to report an adverse event, reach care@satoriia.com, call 1-800-795-0114, or visit www.satoriia.com.
This Regulatory Compliance Statement is part of our shared commitment to nurturing beauty and wellness.