Close the Loophole That Lets Frankenfoods Escape Safety Testing

Every year about 75 new ingredients get into our food through a Food & Drug Administration loophole known as “Generally Recognized as Safe” (GRAS). These ingredients, made with petrochemicals, genetic engineering, nanotechnology, synthetic biology, lab-grown cells, or modified microbes, are never safety tested as required by Congress's 1958 Food Additives Amendment.

The FDA has proposed a rule that would require food companies to give them notice when they intend to avoid safety testing a new ingredient via the GRAS loophole.

That in itself is a huge disappointment. The hope was that the FDA would close the loophole, not just make it more transparent. Really closing the loophole would mean requiring companies to submit food additive petitions for new ingredients. For consumers, the benefit of a food additive petition versus a GRAS submission is that the FDA has to publish a final regulation that authorizes a specific use of the additive, based on a legally reviewable determination of "reasonable certainty of no harm." That regulation, which must withstand legal challenge, puts the FDA's credibility on the line. By contrast, while GRAS has a legal standard, too (a scientific consensus among qualified experts that a substance is generally recognized as safe), the courts have held that the FDA can let manufactures say for themselves what's GRAS.

The new GRAS rule wouldn't change that, but its lack of ambition isn't its only problem. Even in its attempts to improve transparency, the proposed rule would do more harm than good.

The proposed rule ostensibly aims to reassert control over food additives that companies secretly self-affirmed as GRAS. But, what it actually does is offer amnesty! For one year, it would accept streamlined GRAS notices without any supporting data or information. This would be an even worse violation of Congress’s 1958 Food Additives Amendment than the current voluntary self-affirmed GRAS process.

If the rule is finalized, expect a huge dump of new ingredients into the food supply with zero information about what the health effects might be.

Additionally, the proposed rule would widen the “Threshold of Regulation” (TOR) loophole that allows toxic (but non-carcinogenic) substances in our food in small amounts by expanding TOR from food contact substances to ingredients.

TAKE ACTION BEFORE DECEMBER 9: Tell the FDA to Close the Loophole That Lets Frankenfoods Escape Safety Testing!

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PETITION TO THE FDA:

The Food & Drug Administration should close the “Generally Recognized as Safe” (GRAS) loophole and start enforcing the 1958 Food Additives Amendment as Congress intended.
Consumers have every reason to be concerned about the more than 1,000 novel ingredients that have been slipped into our food through GRAS. None have gone through the premarket testing and review that food additives are supposed to have.

Every year, about 75 more ingredients go through the GRAS loophole. They can be made with petrochemicals, genetic engineering, nanotechnology, synthetic biology, lab-grown cells, or modified microbes. It’s all GRAS to the FDA!

No matter how novel, the FDA never requires ingredients to be considered food additives under the law. Companies get to choose for themselves which path to take, so it's no surprise that since 2000, 863 GRAS notices have been filed but only 10 food additive petitions.

In this proposed rule, the FDA claims to promise greater transparency, but it is actually offering companies amnesty. For one year, new GRAS petitions could be submitted without any supporting data or information. Supposedly, this is to bring secretly self-affirmed GRAS substances out of the shadows, but it could easily be used to declare any substance GRAS without basis. What's to stop companies from using the amnesty year to slip broad categories of ingredients we've never eaten before into our food?

Another problem with the proposed rule is the expansion of the Threshold of Regulation (TOR) loophole from food contact substances to food ingredients. The TOR loophole is why there's perchlorate in children's breakfast cereals. Very low levels of perchlorate exposure are linked to lower IQ scores for children.

Ultimately, it's the FDA's refusal to fully enforce Congress's 1958 Food Additives Amendment that’s really the problem. Please start regulating all new food ingredients as food additives under the law. Currently, the only way to avoid untested ingredients is to eat organic, but everyone who eats deserves the same assurance of food safety.

Thank you.

Appetite for a Change