Generally Recognized as Safe (GRAS)

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Generally Recognized As Safe (GRAS) is a regulatory term used by the United States Food and Drug Administration (FDA) to describe certain compounds that are allowable as ingredients in consumer foods products. Mostly, this is a list of natural compounds such as Zinc, Magnesium, and Glutamic Acid.

GRAS status is granted to some novel forms of compounds, such as nicotinamide riboside chloride (Niagen), as an acceptable food additive version of Vitamin B3. When you eat foods, such as breakfast cereals, that have been “fortified” with certain minerals—those compounds are GRAS. The FDA defines a compound qualifying for GRAS status as follows:

any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive

GRAS status may be granted to a compound based on the following two criteria (R):

  1. Scientific procedure demonstrating its safety, or;
  2. For a substance used in food before 1958, through experience based on common use in food

The FDA’s GRAS is outlined in the Code of Federal Regulations Title 21, part 182 and covers many substances that are allowable as food additives. This listing isn’t meant to be comprehensive, as there are far too many “natural” compounds to list. The FDA commissioner notes this consideration as such:

It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use

Critics of the GRAS program claim companies are able to introduce new compounds into consumer foods without effective federal oversight. In 2016, the FDA updated the type of scientific evidence required for a compound to earn GRAS status. It was hoped this update to the definitions and requirements of scientific evidence required for GRAS status would amend such concerns.

Consumer watchdog groups, such as the Consumers Union, didn’t feel much was done. Laura MacCleery, VP of Policy and Mobilization for Consumer reports had this to say:

FDA missed a major opportunity to clean up the food system. This final rule on the safety of food ingredients fails consumers. Companies will still be able to introduce novel substances into food in secret, without having to show they are safe.  The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing.”