Regulatory Support for Dietary Supplements

  • Overview
  • Benefits of Regulatory Support
  • Why Work With NSF?
  • Stability Guidelines

Our dietary supplements experts can help your company with a variety of regulatory support services which speed the process of introducing new products to the market.

Benefits of Regulatory Support

Our  trained regulatory support staff can support your company in the following services:

  • Regulatory label services – Our trained consultants worldwide can provide a regulatory review of product labels to national and international requirements. Domestic label reviews ensure compliance to Food and Drug Administration (FDA), Federal Trade Commission (FTC) and Dietary Supplement Health and Education Act (DSHEA) 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-affirmation, 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.
  • Botanical risk assessments – Our experienced toxicologists and pharmacologists conduct botanical 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 scientists and regulatory specialists possess extensive knowledge and expertise in the dietary supplement industry and can assist you in solving your most challenging regulatory issues. Our professionals help you determine the appropriate steps to secure regulatory approval, and assist with the submission of the necessary paperwork to the FDA and other regulatory agencies worldwide.

Stability Guidelines

Although federal regulations do not require the use of dietary supplement product expiration dates, most, if not all products include some kind of expiration or use-by date. In addition, the preamble to the current Dietary Supplement GMPs 21 CFR 111 requires that companies manufacturing and selling dietary supplements with product expiration dates should justify these with " that qualifies the stability of the products and container closure systems."

In the fall of 2009, a stability working group was established to develop a voluntary guideline for industry to assist with the development of stability programs consisting of shelf-life studies. These stability studies can provide justification for the establishment of expiration dating on dietary supplement finished products. The working group was comprised of representatives from various industry stakeholders including major trade associations, dietary supplement manufacturers and analytical laboratories, with FDA serving as an observer to the process.

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