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    Today, the United States spends $218 billion a year growing, processing, transporting, and disposing of food that is never eaten. Fortunately, there are a number of ways to reduce food waste.Click here to read IFT Achievement Awardee Edward Hirschberg’s solution for how we can address food loss due to poor transportation and storage. Link available in bio or copy/paste this link: http://bit.ly/IFTFoodWaste Today, we are celebrating women in science for International Women's Day! The International Women's Day is a global day celebrating the social, economic, cultural and political achievements of women. These particular five women have been at the forefront of some of today’s most complex and controversial scientific issues including genetic engineering and lab-grown meat. In addition to highlighting their work, these interviews explore the influence of gender in food and science. Click link in bio #IWD2017 #internationalwomensday #womeninstem #foodscience http://hubs.ly/H06wKB60 Roughly one third of the food produced in the world for human consumption every year — approximately 1.3 billion tons — gets lost or wasted. Fruits and vegetables have the highest wastage rates of any food. What can we do with spilled, wilted, blemished produce? Click here to read IFT Achievement Awardee Edward Hirschberg’s solution for bringing life back to the "ugly" lettuce. Link available in bio or copy and paste the following to view solution: http://bit.ly/IFTFoodWaste #Repost @hanna_instruments ・・・
The Hanna Texas team had a great time at @iftfoodscience's Lunch & Learn at @nasajohnson on 2/23. Hanna USA proudly sponsored this event featuring a talk by @nasa scientist Dr. Shannon Walker, a tour of the food lab facility, and behind-the-scenes tour of Mission Control! Thank you again to IFT and NASA for an incredible event.

Should the FDA more closely regulate GRAS?

The U.S. Food and Drug Administration appears ready to take another look at how it regulates GRAS.

The federal Government Accountability Office’s February report on FDA’s oversight of food ingredients and food contact materials that are considered “Generally Recognized As Safe” (GRAS) revisits some important bedrock concepts about how food is regulated in the United States, and soon may lead to some changes in FDA’s approach.

Conceptually, GRAS status has a certain degree of elegance. It is a state of nature, a status that needs no government confirmation, and the legal basis for the use of many food ingredients and food contact substances. That makes regulatory oversight harder, perhaps, but it doesn’t necessarily lead to safety concerns.

GRAS status is a state of nature in that a particular use of a food ingredient is either GRAS or isn’t GRAS, and it doesn’t matter if anyone has said so, especially the FDA. GRAS status of a use of a food ingredient or food contact material depends on whether relevant experts agree that the use is safe and generally recognized as such among themselves and other similar experts, based on generally accepted and available information (or that it has been safely used in food since before 1958). A company has no obligation to ask FDA’s concurrence or even give FDA notice of its conclusion.

It’s a fascinating concept to build into a legal framework for assuring the safety of the food supply, and perhaps uniquely American in its flavor, because its conceptual core is freedom rather than government regulation.

And it’s probably safe to say that FDA just doesn’t like that. Why? Because FDA is generally uncomfortable with incomplete information, given that Congress expects the agency to be responsible overall for the safety of the food supply.

Remember, though, that the realm of GRAS substances is one of relatively low safety risks. It’s a solid assumption that companies’ GRAS analyses are conducted in good faith, considering the risks of customer and international standards, public relations damage, and even potential civil liability.

So now comes the GAO report, in which it reviewed how FDA keeps tabs on GRAS substances in and on food. GAO made six recommendations to FDA, including figuring out a way to require companies to give FDA notice of their independent GRAS determinations  and post them publicly (FDA says that idea might not work, since the public might mistake a listing for an FDA blessing).  GAO also recommended that FDA undertake a more systematic approach to post-marketing safety re-evaluations, and FDA agrees that would be a good idea. (GAO gave FDA a look at the report in draft form, then published FDA’s reactions together with the report.)

GAO also wants FDA to take an especially close look at engineered nanomaterials that a manufacturer determines to be GRAS, and FDA agrees, saying it will issue guidance soon  to help manufacturers evaluate GRAS status for uses of such materials.

Perhaps the biggest news coming out of FDA’s responses to the report is that FDA says it will finally start making a final rule version of the 1997 proposed rule that explains to companies how to submit GRAS Notices for FDA review. Though since 1997 the rule has been in “proposed” form, ever since its publication, industry and government have been operating under it as if it were final. When it finalizes the rule, FDA says it will address GAO’s recommendation that it offer some parameters for choosing experts to review GRAS status to avoid conflicts of interest.

Eric F. Greenberg
Eric F. Greenberg PC

2 Responses

  1. I am opposed to the considered effort for the USFDA to increase its scrutiny of GRAS, for the following reasons:
    1. Under USFDA regulations manuracturers can go to market without prior apporval.
    2. Under USDA regullations prior approval is always required before a product can be sold in any US market.
    3. By seeking to regulate GRAS the USFDA could conceivable put itself in a regulatory position of requiring prior approval before allowing a product to go to market, just as USDA does currently. Please note that GRAS is the core reason why our lawmakers choose to not require prior approval of USFDA regulatory perview.
    4. This is consistent with the current administration’s proven tract record of expanding its presence in all aspects of our lives.
    5. Lastly, the public would not be any safer. Proof? Compare the health and safety incidents over the past several years of the two different regulatory jurisdictions.

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