GRAS status of botanical ingredients

by Donna Berry
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Just because an extract is naturally derived from a plant does not mean it can be marketed as a food ingredient. The Food and Drug Administration (FDA) stated as much in its January 2001 “Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods.” The federal agency emphasized that ingredients that go into foods and beverages must be either approved as a food additive or generally recognized as safe (GRAS), and with the latter, self-affirmation is an option.

FDA identifies GRAS plant extracts in 21 CFR 182.20. Some possess flavor and color while most have recognized benefits and qualify as a botanical. For example, ginger extract has long been known to soothe stomach discomfort.

Another GRAS list of plant extracts located in 21 CFR 172.510 lists extracts specifically identified as natural flavoring substances, with some qualifying as botanicals because of recognized benefits. For example, aloe extract is associated with reducing discomfort associated with heartburn and ulcers.

FDA lists plant extracts recognized as color additives “exempt from certification” in 21 CFR 73. For the most part, the color component of these plants is often rich in bioactives; thus, the extract is a concentrated source of beneficial compounds. The color additive turmeric comes from Curcuma longa L. It can impart a rich, custard-like yellow color to all types of bakery products including yellow cake, frosting and biscuits. Turmeric is also known for its antioxidant and anti-inflammatory benefits, with recent studies indicating that it may promote learning and memory abilities.

Plant extracts not on these lists can still be used as food ingredients once they are reviewed by an expert panel for safety and the marketer files a GRAS self-affirmation with FDA. This is increasingly being done with ingredients extracted from the fruits of plants.

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