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Roadmap for Claims: A guide to establish a claim for food, food ingredients or dietary supplements

Establishing a claim for foods, food ingredients or dietary supplements is not as straight-forward as it sounds, but is a complex undertaking and some early decisions may preclude future options. In fact, the wording for a claim is actually the second step that companies should take and follows the initial step of navigating a maze of regulatory touch stones, as well as deciding which regulatory agencies might share jurisdiction. Also, if the substance incorporates nanotechnology, or if it is a genetically modified organism (or a product of a GMO), additional steps may be mandated.

Regardless of the regulatory agencies involved, eventual claim or whether nanotechnology has been employed, safety must be established, whether through a GRAS determination, or by FDA via a food additive petition or a New Dietary Ingredient Notification. Once safety is established, the type of claim must be decided upon and that choice determines the length of the timeline to market. For example, a Health Claim or Qualified Health Claim requires at least 270 days for an FDA response, but a structure-function claim does not require FDA pre-market approval and the product may be marketed immediately.