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Regulatory Compliance Statement
Satoriia Regulatory Compliance Statement
Last Updated: June 28, 2026
At Satoriia, your safety and trust are the foundations of every product we make. This Regulatory Compliance Statement describes how Satoriia LLC meets its obligations under U.S. federal and state laws governing cosmetic products, including the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and all applicable FDA regulations.
1. FDA Registration and MoCRA Compliance
Satoriia’s products are cosmetics as defined under the Federal Food, Drug, and Cosmetic Act. We comply fully with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Our manufacturing facility is registered with the U.S. Food and Drug Administration (FDA), and all Satoriia products are listed with the FDA with complete ingredient disclosures, in accordance with MoCRA requirements. We maintain and renew our registrations and product listings as required by law.
Satoriia products are cosmetics — not drugs. No Satoriia product is intended to diagnose, treat, cure, or prevent any disease or medical condition. Satoriia products are cruelty-free and are not tested on animals.
2. Responsible Person and Contact Information
As required by MoCRA, the responsible person for all Satoriia cosmetic products marketed in the United States is:
SATORIIA LLC
Phone: 1-800-795-0114
Website: 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
The responsible person ensures that all labeling and product safety obligations are met and is the primary contact for FDA reporting purposes.
3. Adverse Event Reporting
Satoriia maintains a system to monitor, document, and report adverse events related to our products, as required by MoCRA.
A serious adverse event includes: disfigurement, infection, significant allergic reaction, neurological impairment, or any event requiring medical intervention such as hospitalization or emergency treatment.
If you experience a serious adverse event that you believe is related to a Satoriia product, please notify us immediately by emailing care@satoriia.com with the subject line “Adverse Event Report.” Please include:
• Your full name and contact information
• The product used (name and batch/lot number if available)
• Description of the event and any symptoms
• Date of onset and any medical attention received
We are committed to:
• Reporting serious adverse events to the FDA within 15 business days of receiving your information
• Reporting any new, material medical information related to the event within one year of the initial report, as required by law
• Retaining all safety-related records for a minimum of 6 years
• Cooperating fully with FDA inspections and audits
4. Ingredient Disclosure and Transparency
Satoriia is committed to full ingredient transparency. Every product page on our Site discloses a complete ingredient list in accordance with FDA labeling requirements and, where applicable, the California Safe Cosmetics Act.
We comply with all relevant federal and state ingredient disclosure laws for products sold in the United States, and with applicable international cosmetic regulations for products exported outside the U.S.
5. Safety and Quality Assurance
All Satoriia products are manufactured in accordance with Good Manufacturing Practices (GMP) as required under MoCRA and FDA guidelines.
Product safety is substantiated using scientifically robust methods prior to market introduction. We exclude all ingredients prohibited under federal or state law. Our formulas do not contain PFAS compounds, formaldehyde, phthalates, or other regulated restricted substances.
Safety substantiation records are maintained and available for FDA review as required by law.
6. Patch Test Recommendation
Before first use of any Satoriia product, we recommend performing a patch test: apply a small amount to a discreet area of skin (such as the inner wrist or behind the ear) and wait 24–48 hours. If you experience redness, itching, swelling, or discomfort, discontinue use and consult a healthcare professional. If a serious reaction occurs, follow the adverse event reporting process above.
7. Contact Us
For questions, concerns, or to report an adverse event, contact us at care@satoriia.com, call 1-800-795-0114, or visit www.satoriia.com.
This Regulatory Compliance Statement reflects our commitment to your safety, ingredient transparency, and honest haircare.
External Use Only. For external use only. Avoid contact with eyes; rinse thoroughly if contact occurs. Discontinue use if irritation occurs. Keep out of reach of children. Perform a patch test 24–48 hours before first use.
Cosmetic Use Statement. Satoriia products are cosmetics intended to cleanse, condition, smooth, and beautify hair. They are not drugs and are not intended to diagnose, treat, cure, or prevent any disease.