Dietary Supplement Regulations

  • Overview
  • Services
  • Why Work With NSF?

NSF International’s dietary supplement consulting program pairs our history of improving global human health with the expertise of the industry’s brightest minds. Focused on supporting client needs, NSF employs a flexible and adaptable team of consultants with decades of industry experience to deliver customized and exceptional results. This seasoned team of professionals can conduct this work on-site or virtually and also features capabilities for companies seeking English, Spanish and Mandarin communications.

Services

Our experts can provide a variety of consulting services. Our team has the capabilities to conduct this work on-site or virtually through remote sessions.

  • GMP consultative gap audit: Benefit from a consultative audit by a seasoned expert in the dietary supplement industry. Because the audit takes place in a lower stress context, the auditor can give valuable advice and assist with prioritization of efforts. This audit package is based on FDA 21 CFR Part 111 GMP requirements and elements of 21 CFR Part 117 regulations, and provides pre-audit document review, gap assessment and consulting to assist companies with compliance to the regulations.
  • GMP facility design consultation: Our team of experts reviews plant diagrams based on FDA 21 CFR Part 111 GMP requirements and elements of 21 CFR Part 117 (FSMA) regulations. We also review existing documents for new construction, plans to retro-fit an existing space and suggested plant diagrams based on customized needs.
  • Process improvement services: Our highly trained consultants are able to assist with root cause analysis, corrective action implementation, SOP writing and general process improvement efforts.
  • Regulatory label services: Our team of consultants can provide a regulatory review of product labels to national and international requirements. Domestic label reviews ensure compliance to Food and Drug Administration, Federal Trade Commission and Dietary Supplement Health and Education Act of 1994 requirements. Reviews against international regulations ensure product label compliance prior to entering new global markets.
  • GRAS (generally recognized as safe) dossiers: We can prepare regulatory submissions or self-affirmations, as appropriate. Our experts can help compile the necessary documentation based on generally available safety data and information about the substance’s use and manufacture. We can also coordinate an expert panel to determine consensus among qualified experts that the data and information establish the substance as safe under the conditions of its intended use.
  • New dietary ingredient (NDI) notifications: The FDA requires companies introducing products that contain an ingredient not marketed in the U.S. prior to October 1994 to submit an NDI notification verifying that the ingredient is safe for human use. Our expert scientists and consultants can help compile the necessary scientific substantiation for an NDI notification including a review of the product use history and safety studies, development of toxicology data as appropriate and preparation and submission of the NDI notification.
  • Ingredient risk assessments: Our experienced toxicologists and pharmacologists conduct ingredient risk assessments by reviewing and evaluating comprehensive scientific literature, identifying and resolving data gaps and applying toxicology and exposure modeling tools to support risk management decisions.

Why Work With NSF?

Our experts have over 50 years of industry of combined experience and we have a seasoned team of dietary supplement experts on staff. We can provide 21 CFR Part 111 guidance and help you work through potential challenges. Simply put, our knowledge, flexibility and experience performing consulting on-site or virtually will work to your advantage.

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