For FDA reviews of “generally recognized as safe” ingredients, time is not an issue­­ #GRAS #FoodSafety

By Tom Neltner

In our work with retailers and food manufacturers, EDF strongly recommends submitting all ingredients for U.S. Food and Drug Administration (FDA) safety review, especially those additives deemed ‘generally recognized as safe’ (GRAS). This includes things such as flavors, sweeteners, preservatives and the like. If an unreviewed ingredient is identified in a recipe, we also recommend that the grocer or manufacturer require the supplier to send the ingredient through an FDA GRAS review.

One question we often get is, “Doesn’t that take a long time?” Quite simply, the answer is no. But some players in the food industry try to perpetuate that myth so they can continue to self-certify safety and bypass FDA’s scrutiny.

In the 2014 report, “Generally Recognized as Secret: Chemicals Added to Food in the United States,” more than fifty companies were shown to be deliberately avoiding FDA reviews of 275 chemical additives marketed for food uses. On their own, the companies determined that the substances’ uses were GRAS, without making the safety assessment of the chemical publicly available or submitting it for review by FDA. It’s tough to imagine how it could be “generally recognized” if the safety studies are kept secret.

One reason these companies gave for avoiding the agency’s review: FDA is too slow, resulting in delays in product marketing and sales.

So, are FDA reviews so long as to justify bypassing the agency?

In short, no. FDA explicitly allows the use and marketing of a self-certified GRAS substance while a review is under way. No delay there.

Even if a company were to wait, FDA’s target is to complete a review in 270 days, and they have been quite consistent in meeting that target. Since 2010, FDA has published a performance report; the chart below summarizes median time frames by quarter.

For roughly four out of five cases, FDA finds the GRAS safety conclusion adequate and issues a “no question letter” for the additive. On occasion, the agency has taken up to several years to review a GRAS notification, but those cases usually involve complex scientific issues that need to be resolved by the company. For example, it took FDA four years (2002-2006) to conclude its safety review and issue a no-question letter for the use of arachidonic acid-rich fungal oil and docosahexaenoic acid (DHA)-rich tuna oil in preterm and term infant formula. The company submitted 10 amendments to address issues raised by the agency.

When companies are unable or unwilling to answer FDA’s questions, they can ask FDA to ”cease to evaluate” the submission. Catechins from green tea extract, lupin flour and soy isoflavone extract are examples of ingredients where safety reviews were stopped, but which are currently in our food supply.

Reviews Necessary for Keeping Food Safe

FDA is responsible for ensuring that companies comply with the law, that food is safe, and that GRAS safety determinations are made properly. If FDA doesn’t know what chemicals are in our food or what types of food they are in, it can’t do its job. The GRAS exemption, as it is currently being implemented by FDA, means that the agency is unable to protect our food and our health. And FDA agrees.

To recap: review is voluntary, and a company can request that FDA stop its review when agency scientists ask too many questions. Businesses can market their products while under review, or without notifying the agency of its decision.

But when FDA is given the opportunity to review safety data, it does it in a timely manner, most of the time. Blaming FDA for a “slow review turnaround” to justify a deliberate decision to keep the agency and the public in the dark doesn’t pass muster.

So take our advice: require suppliers to confirm that all of their ingredients have been reviewed by FDA. If they tell you it will take too long, call their bluff. It’s the cost of doing business with you, because your customers and their safety come first.

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