Regulatory Label Reviews

NSF-DBA consultants can provide a regulatory review of product labels to domestic and international requirements. Domestic label reviews ensure compliance to FDA, Federal Trade Commission and Dietary Supplement Health and Education Act of 1994 requirements. Reviews against international regulations can also be conducted to ensure products' labels compliance prior to going to market.

Safety Assessments

• 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. Co-ordination 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.
• Botanical Risk Assessments
  Review of available toxicological information and history of use for a botanical substance to determine its safety.