Developing Nutritional Labeling Claims (Regulatory & Scientific Roadmap for Claims)

Before establishing a labeling claim for a food or dietary supplement product, companies must first negotiate a maze of regulatory requirements, even determining which agency has jurisdiction over the product. At the baseline of this procedure is the question of safety, whether affirming an ingredient as GRAS (generally recognized as safe), filing a food additive petition, or making a New Dietary Ingredient (NDI) notification.

Once safety is established, a company can move on to ascertain which type of claim is most fitting, including a health claim, qualified health claim, nutrient claim or structure/function claim. Pre-market approval is not required for structure/function claims.

The Burdock Group, an ingredient safety and regulatory consulting firm in Orlando, Fla., developed a flow-chart roadmap illustrating how companies can determine type of claim for different types of products. This executive summary provides a brief look at the steps involved in making these determinations; for the complete graphic presentation, log on to NaturalProductsINSIDER.com/eBooks and register to receive the free .pdf version of the roadmap.

As mentioned earlier, the first step for a company with a substance for which a claim is being developed is to ascertain safety. If a substance is the product of a previous GRAS determination or food additive petition, it is a fairly easy process to ensure there have been no new developments in the safety of the substance and that the new use proposed will not impact safety.

One of the new areas that may well impact the determination of safety is whether the ingredient being marketed is a product of nanotechnology, as nano-sized particles have a high probability of not behaving like “macro” particles. Another consideration is whether a substance is a genetically modified organism (GMO) or the product of genetic modification; this may require further GRAS or food additive safety review steps.

If the substance is to be used as a dietary supplement, the critical question is whether NDI notification is required, which is based on whether there is persuasive evidence that the substance was marketed as a dietary supplement prior to implementation of the Dietary Supplement Health & Education Act (DSHEA) of 1994. It is important to note that if a substance has not been approved for food, it may only be used as a dietary supplement ingredient.

The use of scientifically-validated claims for foods and dietary supplements can incrementally increase sales of a product, as consumers look for guidance on the use of such products for health promotion. However, companies have an obligation to ensure safety of their products, whatever road to market they might take.

George A. Burdock, Ph.D., Diplomate, American Board of Toxicology (DABT), and Fellow, American College of Nutrition (FACN), is president of the ingredient toxicology consulting firm Burdock Group (BurdockGroup.com). Amy Mozingo serves as the company’s senior project manager and John Rochowicz assists the toxicology team as a project manager.