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FDA Shakes up GRAS Approval Process

9/13/16 8:48 AM

On August 17, the FDA released its final rule on the presence of substances generally recognized as safe (GRAS) in food. The rule represents a major shift in the approval process, as the FDA will step away from testing and review completely, granting food producers the right to use any substance that "qualified experts" consider safe. This transition, first proposed back in 1997, is designed to streamline GRAS approval, but skeptics are concerned the FDA is ceding valuable regulatory power.

Substances that are generally recognized as safe can be added to a food product by its manufacturer at any time without the product needing to be reviewed by the FDA. The list includes everything from vitamins like B-12 to preservatives like sodium benzoate to homeopathic remedies like ox bile extract.

GRAS status has existed in the U.S. since the 1958 Food Additives Amendment, which sought to support public health and food safety by removing strong pesticides and carcinogens from food. The program grew its true teeth as a regulatory body in the mid-to-late 70s, following President Richard Nixon's creation of the Select Committee on GRAS Substances. Between 1972 and 1982, the committee reviewed over 400 substances, creating the foundation of today's GRAS list of 214 approved additive categories.

Skeptics worry that the final rule gives food producers excessive self-regulatory power and makes it too easy for corporations to greenlight a food additive without adequately rigorous testing. Senator Ed Markey of Massachusetts used an education metaphor to illustrate the potential weaknesses of FDA's final rule, calling it "a self-graded take home exam that the industry does not even have to hand in."

The overall goal of the shift, however, is to create a program that keeps consumers safe while avoiding red tape and saving taxpayer dollars. While skeptics fear deregulation will ultimately harm consumers, research from the Pew Charitable Trust declared that the existing FDA system was "plagued with systemic problems, which prevent[ed] the agency from ensuring that [substances'] use is safe," asserting that the nearly sixty-year-old program simply wasn't protecting people the way it was designed to anymore.

MadgeTech, a recognized industry vanguard in the field of data logger technology, manufactures a variety of food data loggers that support food safety. While they can't detect ox bile extract, these loggers validate cooking temperatures, verify pasteurization processes and monitor the incubation of eggs. Just like the FDA, MadgeTech's goal is to help producers create food that is safe, enjoyable, and profitable.

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