Regulatory and FDA Disclaimer
The private nature of Access FDA, its lack of affiliation with the FDA and the difference between registration and approval.
Draft pending legal review. This text is not yet the final, binding version.
Private consulting
Access FDA is a private consulting firm operated by Grupo Nativot S.C. It is not affiliated with, endorsed by, or part of the U.S. Food and Drug Administration (FDA), nor any other U.S. or Mexican authority.
The use of “FDA” in our brand and on this site describes the regulatory field in which we work; it does not indicate an official relationship, sponsorship or authorization by the FDA.
Registration is not approval
- Registering a facility with the FDA does not mean the FDA approves the facility or its products.
- The FDA does not approve food facilities, or most foods, cosmetics or dietary supplements, through registration.
- Some products and substances do require specific premarket authorization (for example, certain color additives or food additives); when it applies, we point it out in the assessment.
- A registration number must not be presented as an FDA certification, approval or endorsement.
Private certificates and documents
The certifications, attestations or recognitions issued by Access FDA, including those of the GMP Assessment and Certification Program, are private documents. They do not constitute a certification issued, approved or sponsored by the FDA, unless expressly stated and supported by official documentation.
No assurance of results
Regulatory decisions belong to the authorities. Access FDA does not promise product approval, acceptance of filings, release of detained shipments or border crossing. Our work is to assess, prepare and support compliance within the contracted scope.
General information, not legal advice
The content of this site, including the Resources guides, is general information about regulatory requirements. It is not legal advice and does not replace the specific assessment of each product, facility or situation. Regulations change: always check the current version or ask us.
Third-party references
Names of authorities, regulations and third-party brands are mentioned for descriptive purposes only and do not imply any relationship or endorsement.