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Report Identifies Chemicals ‘Quietly Added’ to Food Under GRAS

The “generally recognized as safe,” or GRAS, determination for food additives has been getting a lot of attention lately for being a regulatory loophole.

The main issue is that GRAS allows companies to decide whether a substance meets the definition of GRAS without mandating a review by the U.S. Food and Drug Administration before being added to food.

The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives used today are being used based on undisclosed GRAS safety determinations. NRDC’s latest report attempted to find out more about the chemicals reported as GRAS based solely on a company determination and to examine safety decisions of companies which voluntarily submit additives for FDA review.

The organization was able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations and found that, of the requests for FDA review, about one in five notices is rejected or withdrawn from review.

NRDC stated that communications between FDA and companies seeking agency review – information obtained under the Freedom of Information Act – revealed that FDA carefully reviews notifications and “asks tough questions. The agency’s reviews often raise serious safety concerns or reveal that the company’s scientific analysis is flawed or inconsistent with the law.”

If the agency rejects a GRAS notice, it sends an explanation of the safety concerns in a letter to the company and publishes the letter online.

“But when a company withdraws a notice and asks FDA to stop further review,” the report notes, “the agency issues a letter confirming the withdrawal without publicly explaining any of the concerns that could have prompted the withdrawal.”

Furthermore, such a withdrawal doesn’t prevent the company from marketing the product for use in food. The report details four chemicals with withdrawn GRAS notices – epigallocatechin-3-gallate (EGCG), gamma-amino butyric acid (GABA), theobromine, and sweet lupin protein, fiber, and flour – noting that, despite safety concerns, they have been listed as an ingredient in some food products.

“There are gaping holes in the safety net for chemicals that are added to our food supply,” said Erik Olson, NRDC senior strategic director for health and food.

Ultimately, the report concluded, “A chemical additive cannot be ‘generally recognized as safe’ if its identity, chemical composition, and safety determination are not publicly disclosed.”

NRDC recommends that FDA publish safety concerns even when companies withdraw notices, require that FDA be informed of GRAS determinations, and limit conflicts of interest.

© Food Safety News
  • Safety First

    I know there are many companies with high moral integrity that take Food Safety very seriously in both their business endeavors and personal life. But it seems we are constantly at the mercy of “people” who care only about the bottom line. They put aside human concerns, and make extremely poor decisions. The obvious, look at all the safety alerts. Most created by negligence and extremely poor leadership. We need more passionate people in this industry, and must educate our younger generations to pursue what is “right” in the food industry. I have started my “second” career in the food industry, and with all the concerns my utmost priority is supplying a safe/quality product that people can “trust” (my life depends on it). So lets develop a higher moral code, and stay way above that line.

  • Mark Anderson

    GRAS gives free reign to poison. If it isn’t obvious then have a happy convulsion.

  • flameforjustice

    It’s very shameful that ‘Nobody’ cares about what the consumers of foods eat and drinks even the government agencies who’re paid by our tax dollar to do just that.

  • Kitsy Hahn

    All the more reason for us to avoid any “food” with additives. We won’t be left with too many choices, as the grocery shelves are riddled with boxes of chemicalized garbage, but we’ll be a lot healthier if we stick to just whole foods. Most of us know what they are.

  • jae1

    Let’s see now… EGCG is a primary compound found in tea (more in green and white tea than in black tea), and is touted by natural and organic foods manufacturers as having cancer-preventing qualities; GABA is used safely in medications–no need to reinvent that wheel by testing it again; theobromine is one of the primary compounds found in tea and chocolate, and chocolate high in theobromine is touted for its healthful properties by natural and organic food manufacturers; sweet lupin (a form of pea, people) protein, fiber, and flour is used to increase the protein and fiber content of natural and organic gluten-free foods (as well as some non-gf ones). So, what’s this about “chemicals” being added to our food supply being so terrible? If all the people saying “eat natural” or “eat organic” to avoid chemical additives are right, then why is the natural and organic market pushing these same additives as healthful. They’re not hidden, they’re advertised!

    Folks, _everything_ is ultimately a chemical. Table salt is a chemical. Baking soda is a chemical. Apples are ultimately a whole bunch of chemicals. There’s nothing to see here.

  • The report mentions 275 suspect chemicals, but only shows 4. How can we learn what the rest were?