Skip to content

The Center for Public Integrity, a nonpartisan, nonprofit investigative news organization has just published a number of articles about how companies have added thousands of ingredients to foods with little or no government oversight. This loophole is a decades old law that allows an additive to be "generally recognized as safe" or GRAS without the FDA getting involved. This is why there are some additives in American foods that are NOT allowed in Europe or other countries. And that is why I always read the ingredient lists of foods. I even hate to buy foods that have the nice sounding "natural ingredients" in the ingredient list. What are these so-called natural ingredients that have been concocted in some lab and added to our foods? Does anyone know?  Some earlier posts on this issue: August 19, 2014 and June 16, 2014 . The following are excerpts from the April 14, 2015 story from NPR:

Why The FDA Has Never Looked At Some Of The Additives In Our Food

Companies have added thousands of ingredients to foods with little to no government oversight. That's thanks to a loophole in a decades-old law that allows them to deem an additive to be "generally recognized as safe" — or GRAS — without the U.S. Food and Drug Administration's blessing, or even its knowledge.

The loophole was originally intended to allow manufacturers of common ingredients like vinegar and table salt — when added to processed foods — to bypass the FDA's lengthy safety-review process. But over time, companies have found that it's far more efficient to take advantage of the exemption to get their products on shelves quickly. Some of these products contain additives that the FDA has found to pose dangers. And even ingredients the agency has agreed are GRAS are now drawing scrutiny from scientists and consumer groups that dispute their safety.

Critics of the system say the biggest concern, however, is that companies regularly introduce new additives without ever informing the FDA. That means people are consuming foods with added flavors, preservatives and other ingredients that are not reviewed at all by regulators for immediate dangers or long-term health effects. The vast majority of food additives are safe. Some, however, have proved to cause severe allergic reactions or other long-term health effects. Scientists and advocates worry about the growing number of ingredients that the FDA doesn't know about and is not tracking.

Rather than going through the painstaking FDA-led review process to ensure that their new ingredients are safe, food companies can determine on their own that substances are "generally recognized as safe." They can then ask the FDA to review their evaluation — if they wish. Or they can take their ingredients straight to market, without ever informing the agency."FDA doesn't know what it doesn't know," said Steve Morris of the Government Accountability Office, which published a report in 2010 that found that "FDA's oversight process does not help ensure the safety of all new GRAS determinations."

For a company to determine that an ingredient is "generally recognized as safe," it must establish that the additive's safety is commonly understood by qualified scientific experts. But some ingredients defy consensus, as consumers, scientific groups and sometimes even the FDA have pointed out. Even GRAS additives that have been used in food for decades are now coming under fire as their uses expand and scientific research emerges that casts doubt on their safety. This is true of one of the most known — and vilified — GRAS additives: partially hydrogenated oil, a form of trans fat. Widely used in food products including fried foods and cake mixes, trans fats have been named by public health experts as a contributor to heart disease, stroke and Type 2 diabetes. Despite strong pushback from industry, the FDA in November 2013 made a tentative determination that artificial trans fats should not have GRAS status, and the agency is likely to make that determination final this summer.

But it's the ingredients the public doesn't know about that have critics of the GRAS system most worried. Researchers for the Pew Charitable Trusts and the Natural Resources Defense Council say that allowing companies to make safety determinations without telling the FDA makes it nearly impossible to identify whether there are health effects caused by long-term exposure to certain ingredients.

Their concerns are heightened because safety decisions often rest in the hands of a small group of scientific experts selected by companies or consulting firms with a financial incentive to get new ingredients on the market. Several of these scientists, a Center for Public Integrity investigation found, previously served as scientific consultants for tobacco companies during the 1980s and 1990s, when the tobacco industry fought vigorously to defend its products.

The GRAS loophole was born in 1958. Americans were growing concerned about the increased use of preservatives and other additives in food, so Congress passed — and President Dwight Eisenhower signed — the first law regulating ingredients added to food.

To restore confidence, the law set up a system requiring companies to submit new ingredients to an extensive FDA safety review before going to market..."There are plenty of ingredients that are receiving GRAS status the safety of which are in dispute.In the past five decades, the number of food additives has skyrocketed — from about 800 to more than 10,000. They are added to everything from baked goods and breakfast cereals to energy bars and carbonated drinks.

For the full investigation, head to the Center for Public Integrity's site. 

I've always recommended that people eat as many unprocessed foods as possible, and that one should always read the ingredient list when buying processed and prepared foods. The Center for Science in the Public Interest strongly urges that people avoid the following food ingredients: aspartame, food dyes, mycoprotein (Quorn), and partially hydrogenated oils (trans fat). The following article may be an eye opener for those who think that the FDA (Food and Drug Administration) carefully regulates what goes into our food. Link to the full article to read all the health concerns with mycoprotein (Quorn), Epigllocatechin-3-gallate (EGCG), and carageenan. From The Washington Post:

Food additives on the rise as FDA scrutiny wanes

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

And in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show. “We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.

The FDA has received thousands of consumer complaints about additives in recent years, saying certain substances seem to trigger asthmatic attacks, serious bouts of vomiting, intestinal-tract disorders and other health problems.

At a pace far faster than in previous years, companies are adding secret ingredients to everything from energy drinks to granola bars. But the more widespread concern among food-safety advocates and some federal regulators is the quickening trend of companies opting for an expedited certification process to a degree never intended when it was established 17 years ago to, in part, help businesses.

A voluntary certification system has nearly replaced one that relied on a more formal, time-consuming review — where the FDA, rather than companies, made the final determination on what is safe. The result is that consumers have little way of being certain that the food products they buy won’t harm them“We aren’t saying we have a public health crisis,” Taylor said. “But we do have questions about whether we can do what people expect of us.”

In the five decades since Congress gave the FDA responsibility for ensuring the safety of additives in the food supply, the number has spiked from 800 to more than 9,000, ranging from common substances such as salt to new green-tea extracts. This increase has been driven largely by demand from busy Americans, who get more than half their daily meals from processed foods, according to government and industry records. 

Within the past six months, top officials at the FDA and in the food industry have acknowledged that new steps must be taken to better account for the additives proliferating in the food supply. 

For new, novel ingredients — or when approved additives are used in new ways — the law says companies should seek formal FDA approval, which must be based on rigorous research proving the additive is safe. The agency uses the phrase “food additive,” in a narrow legal sense, to apply to substances that get this approval.

But many other additives are common food ingredients — vinegar is considered a classic example. The law allows manufacturers to certify, based on research, that such ingredients are already Generally Recognized as Safe, or GRASFor both types of additives, FDA scientists initially conducted detailed reviews of the company’s research. The agency also published its own evaluation of that research in the Federal Register.

This oversight system shifted dramatically in 1997. In response to a shortage of staff members and complaints from industry that the process was too cumbersome and did not improve food safety, the FDA proposed new rules. The agency told companies that were going the GRAS route — which turned a years-long process into one of months — that they no longer would have to submit their research and raw data. The companies can share just a summary of their findings with the agency.

The changes didn’t work out as planned. For starters, most additives continued to debut without the FDA being notified. Moreover, companies that did choose to go through the FDA oversight process largely abandoned the formal approval route, opting instead for the new, cursory GRAS process, even for additives that could be considered new and novel, according to agency documents and an analysis of those records by the Natural Resources Defense Council.

An average of only two additive petitions seeking formal approval are filed annually by food and chemical companies, while the agency receives dozens of GRAS notifications, according to an NRDC analysis of FDA data. Hundreds of other food chemicals and ingredients have been introduced without notifying the FDA at all, according to agency officials, trade journals and food safety groups.

Companies often bypass the FDA altogether. Under the rules, companies may make their own GRAS determination. Sharing it with the agency and getting it to sign off is voluntary. This is the opposite of what the overisght law intended, the FDA’s Taylor said. 

Even when the FDA approves a new additive or signs off on a company’s GRAS determination, a safe ingredient can turn dangerous if its use becomes more widespread than the agency envisioned. And under the rules, the agency has little way of monitoring this threat after the initial introduction of the additive, called “post-market.”

During the initial review, the FDA sets limits for how much of a chemical or ingredient can be used in a particular product. But the cumulative consumption can soar as the additive is used in more and more types of food and beverages.