Regulatory Review, Regulatory Submissions, and Safety Assessments
At NSF-DBA Dietary Supplements, our scientists and regulatory specialists have the expertise to provide guidance on the regulatory framework for various manufacturers, from the dietary supplement, food ingredient, and food contact material industries. Our extensive professional staff can help clients to determine the appropriate steps towards regulatory approval, while assisting with the submission of the necessary paperwork to the FDA. A few of the various service offerings include:
- 21 CFR Material Formulation Review
Perform a formulation review of a material to determine whether the ingredients in the formulation are FDA compliant to 21 CFR regulations for the intended end use of the material and to identify any associated testing or chemical purity specifications that may be required for such compliance.
- Threshold of Regulation Exemption Request
Submission of a threshold of regulation exemption request to the FDA for substances used in food packaging or food processing equipment. Applications are prepared in accordance with 21 CFR §170.39 and are based on toxicological evaluation of the substance and an estimated dietary concentration of the substance not to exceed 0.5 ppb (1.5 micrograms/person/day) from the intended end use of the material.
- 21 CFR Migration and Exposure Testing
Conduct the appropriate laboratory analyses for food contact materials to determine potential leaching at varying conditions of exposure.
- Food Contact Notifications (FCN)
Compilation and submission of a Food Contact Notification as a requirement of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations (CFR) for indirect food additive and secondary additive substances that are not GRAS (Generally Recognized as Safe) or previously authorized by the FDA for the intended end use.
- Food Additive Petitions (FAP)
Compilation and submission of a Food Additive Petition as a requirement of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations (CFR) for direct food additive substances that are not GRAS (Generally Recognized as Safe) or previously authorized by the FDA for the intended end use.
- New Dietary Ingredient (NDI) Notifications:
If a company is planning to use an ingredient that was not marketed in the United States in a product prior to October 1994, the FDA requires that the company submit a safety assessment (NDI Notification) verifying that the ingredient is safe for human use. This includes a review of the product use history and safety studies, development of toxicology data as appropriate, and preparation and submission of the NDI Notification.
- GRAS (Generally Recognized as Safe) Dossiers
Preparation of regulatory submissions or self-affirmation, as appropriate. Compilation of the necessary documentation based on generally available safety data and information about the use and manufacture of the substance. Coordination of an Expert Panel to determine whether there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.
- Safety Assessments
Our experienced toxicologists can conduct safety and risk assessments on various substances through the review and evaluation of comprehensive scientific literature, identification and resolution of data gaps, and application of various toxicology and exposure modeling tools to support risk management decisions.