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Many of the things you eat and drink have never been formally tested, because, as the Washington Post just highlighted in a major front-page story, the U.S. Food and Drug Administration gave them a pass under the legal concept known as “Generally Recognized as Safe.” Critics charge that new, unfamiliar, and unstudied ingredients are slipping into our pantries and fridges through the GRAS process. If you’re concerned about the safety of what you consume, it’s time to commune with GRAS.
Generally Recognized as Safe (GRAS) (adj.): a legal status conferred on food ingredients that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of their intended use.
The FDA’s “GRAS” system is meant to exempt traditional and widely consumed food ingredients (think salt or poppy seeds) from pre-market safety testing. The Washington Post, however, says that the makers of processed foods and nutritional supplements have turned the exemption into a massive loophole. (The Post’s report relies heavily on research from NRDC, which publishes OnEarth.)
Novel food additives, which can include flavorings, preservatives, and thickening agents, are coming onto the market through the GRAS process with inadequate safety data. Food manufacturers might even be suppressing negative trial results in which test subjects suffer hives, diarrhea, or vomiting so intense that it breaks blood vessels in the consumers’ eyes. All of this explains why FDA critics want to see the GRAS process reformed.
The history of food regulation is a history of outrages:
- The 1906 publication of Upton Sinclair’s meat industry exposé The Jungle caused a public uproar. In response, Congress passed the Pure Food and Drug and the Meat Inspection acts, which banned the misrepresentation and adulteration of foods.
- In 1937, Elixir Sulfanilamide—a novel liquid formulation of an existing drug that had been proven safe in pill and powder form—killed more than 100 people. Soon after, Congress passed the Food, Drug, and Cosmetic Act, the first law to require safety testing for pharmaceuticals before they went on the market (food products weren’t covered).
- In the 1950s, a Congressional committee found that approximately one-half of food additives lacked adequate safety data.
The obvious next move was to extend the pre-market approval process for pharmaceuticals to food additives, but this presented a problem: how to deal with thousands of existing ingredients that everyone believed were largely risk-free. For example, would Americans have to live without salt, rosemary, and cinnamon until the FDA completed laboratory and clinical studies on their safety?
To avoid that unnecessary and burdensome process, the Food Additives Amendment of 1958 introduced the concept of generally recognized as safe, which was later turned into the acronym GRAS.
A GRAS ingredient was, in the language of the law:
Generally recognized among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
The FDA granted GRAS status to a list of traditional food ingredients—things like basil, cumin, vanilla, coffee, and cola nut—soon after the law passed. After that period, if manufacturers wanted GRAS status for a food additive, they needed to convene a panel of experts who would compile either laboratory data or evidence of a long history of the ingredient’s safe use. The panel would then submit its findings to the FDA, which would approve the research.
The process changed in 1997. The FDA had a major backlog, and some manufacturers were simply ignoring the process altogether. To manage the situation, the FDA asked manufacturers to voluntarily submit a summary of their findings rather than the data itself.
Since then, the Post reports, hundreds of additives have appeared on the market without thorough review by (or even to the knowledge of) the agency charged with keeping the food supply safe. It seems pretty clear this wasn’t what Congress intended when it created the GRAS process.
The current GRAS controversy concerns whether administrative expedience has undermined consumer safety. For its part, the FDA claims GRAS products are just as safe as those that go through the more burdensome process of study and agency review. The FDA says:
[A] GRAS substance is neither more safe nor less safe than an approved food additive. Rather, the distinction between a GRAS substance and an approved food additive is that, for a GRAS substance, there is common knowledge of safety within the expert community (Federal Register 62:18937–18964, 1997).
Not everyone’s buying it. Tom Neltner, a NRDC senior attorney, calls the current GRAS regime a “side door” for manufacturers to slip products on the market quickly and quietly. The GRAS process is so much faster and easier than a full-blown safety review that some manufacturers are passing off largely new and untested ingredients as time-tested. Many don’t even inform the FDA of their findings before speeding the product to market—a move that isn’t technically illegal. Critics say the current system requires the public to prove a product is harmful, rather than requiring the manufacturer to prove the product is safe.
Putting the burden of proof on the public makes it tough to definitively show that the GRAS loophole has harmed anyone. The Post article makes the case that a GRAS ingredient in the vegan meat substitute Quorn has triggered allergic reactions in some consumers, but lots of foods that cause allergic reactions are generally recognized as safe—like peanuts (cough).
Still, a consensus is growing that the FDA’s system needs some tweaking, but so far the agency has taken a pass on GRAS reforms (sorry). Will we see changes before a 21st century food safety outrage arrives?
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