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FDA’s Regulatory Review of Food Ingredients

The Food Safety News recently published an enlightening article regarding the regulatory processes associated with FDA’s review of food ingredients (accessible at http://www.foodsafetynews.com/2012/12/ingredients-many-routes-to-the-nutrition-label/#.UNNcRW8qZMm).

Generally speaking, food ingredients in the U.S. fall in one of three categories: GRAS (generally recognized as safe), food additives, and color additives. “GRAS substances” are those substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of their intended uses. The general recognition of safety can be made through a widespread history of consumption for food use by a significant number of consumers.

Alternately, it can be made through scientific procedures, requiring the same quantity and quality of scientific evidence as would be required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.

GRAS substances may be self-affirmed by the manufacturer or affirmed by FDA and written into regulation. A company may also submit a GRAS notice to FDA to inform the agency of their determination that a substance is GRAS.

Food additives are those substances that are not generally recognized as safe and must be approved by FDA through a petition process. Color additives are neither food additives nor GRAS, but instead are approved through the color additive petition process. Color additives MUST be approved by FDA for their intended use, even natural ones such as fruit and vegetable juices.

FDA routinely detains food products for non-permitted ingredients. FDA has a multitude of import alerts related to certain food ingredients and color additives. FDA will refuse entry to products deemed to contain unapproved food additives.

If you are concerned about the regulatory status of the ingredients found in your products, Registrar Corp can assist. Our Label & Ingredient Review service will inform you of the regulatory status of your ingredients so that you may determine whether it will be permitted by FDA. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.