Garlive Recovery
Mediterranean Diet special issue

CONSULTANT AND CERTIFICATIONS

The purpose of this section is to provide information regarding the compliance of the activities carried out by the Italian company MAGI’S LAB SRL in the U.S. in relation to compliance on current U.S. legal and tax regulations.

Our Italian company is in charge of selling dietary supplements and promoting the Mediterranean diet and healthy eating.

1_ LEGAL REGULATION OF THE COMPANY STRUCTURE

Our company has several obligations regarding the following aspects:
taxation: our Italian company is subject to other requirements such as sales taxes in the various US states and State TAX ID (EIN – Employer Identification Number);
advertising and communication: we engage the services of lawyers and food consultants who are experts in regulating the claims made on the packaging of our dietary supplements and the advertising language used on our websites or brochures;
the registration and regulation of our own trademark: the use of a trademark must comply with all U.S. regulations and be regulated through its registration with the U.S. Trademark Office;
– compliance with all regulations regarding the ‘export/import of products to the US: our company is present in the US market through AMAZON FBA. Under this type of contract, MAGI’S LAB is responsible for sending products to the US, while Amazon FBA is responsible for storage and distribution logistics.
To bring our products to Amazon US warehouses, we had to provide precise documentation, such as:
CBP Form 5106, as our company is the Importer of Record (IOR) for shipments from Italy to the US;
payment of Entry Bond;
Customs Duties;
Prior Notice to FDA;
FDA Product Registration.

2_ PRODUCT SAFETY

Product safety is ensured through compliance with FDA regulations and product traceability.

  • FDA REGULATIONS
    Our company is committed to ensuring every legal, safety and quality aspect of our dietary supplements.
    To accomplish this, we have engaged the services of a consultant on dietary supplement regulations and advertising, Export USA New York Corp.
    This figure is useful in case of an emergency related to a dietary supplement, as the FDA, in such cases, contacts the U.S. agent and not other personnel. By law, the U.S. agent must have a U.S. residence and be physically present in the United States.

    FDA – Certificate of Registration

  • PRODUCT TRACEABILITY
    Our company works with experts in the FDA regulatory field, such as attorneys and consultants. These provide us with stamped and signed opinions on the compliance of our dietary supplements with FDA regulations.
    These opinions are written for each individual product and are:
    Claim legal report;
    Label Composition legal report;
    Communication advertising language legal report;
    Legal label compliance report;
    Certificated of Analysis (CoA).

3_ QUALITY COMPANY CERTIFICATIONS

In order to comply with U.S. regulations and have excellent business quality standards, it is necessary to obtain certifications to prove their validity. These certifications are mainly:
ISO9001: 2015 Quality Management System (QMS)
Good current manufacturing practices (cGMP).
In addition, our company collaborates with industry experts to conduct audits and gap analysis to understand how to improve internal processes and to identify any issues.

4_ OUR AFFILIATION

To ensure quality product and service offerings, MAGI’S LAB continuously invests in scientific research.
For this reason, our company has joined the Council for Responsible Nutrition (CRN), fully embracing its CRN’s Code of Ethics and registering our dietary supplements in CRN’s registry.

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