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.
The flow-chart graphic below illustrates the decision-tree nature of the claims determination process and aims to make initial planning easier for those with less than a thorough knowledge of the complexities of the regulatory environment. Burdock Group originally introduced this graphic in June 2008 as part of an accepted scientific poster at the IFT Annual Meeting in New Orleans. In its entirety, the poster outlines a 13-step process that includes a series of significant questions for innovators and marketers to discuss along the way.