Food Additive Safety

Food Additive Safety

Many people presume that some federal agency is overseeing the safety of the ingredients in our food supply. That’s reasonable, because that is actually what the federal Food and Drug Administration (FDA) is supposed to be doing, and what Congress told it to do in a 1958 law.But since 1997, FDA has punted on that core responsibility, allowing companies to make their own secret determinations of a substance’s safety for use in our food.

The legal standard is supposed to be that an ingredient is “generally recognized as safe,” or GRAS. That originally applied to things like oil and vinegar-foodstuffs that are widely accepted as safe to consume. Now the loophole is swallowing the law: companies are deciding in secret that almost anything they want to put in food is GRAS, and FDA is letting them.

If companies decide a new ingredient is GRAS, they don’t have to tell FDA what their investigations show about safety or even tell the government what or how much of anything they have decided to add to food. In short, the food industry—not FDA—is in charge of what you eat.

What can you do about this shocking failure by the government to ensure our food is safe?

First, check out and share our great new infographic exposing the spaghetti-tangle of FDA‘s failure to ensure the safety of food additives. Click to Tweet it!

Then, join our campaign to strengthen FDA’s role on food safety.


New Food Additive: “GRAS”?

Who decides if a new food additive is “safe”? Often times, the company profiting off of it.

What does it mean when a food ingredient is labeled “safe”? The question seems straightforward, but the answer proves to be disorienting. Recently, the biotechnology company Senomyx, Inc. was in the news following confusion over a safety determination for one of its products.

The San Diego-based company develops, manufactures, and sells a variety of flavor ingredients for use in food and drinks. Their latest product – a flavor modifier called Sweetmyx – is a “sweetener enhancer,” which allows food and beverage manufacturers to reduce sweetener use while maintaining taste intensity. Under a 2010 agreement, Pepsi holds exclusive rights to use Sweetmyx in non-alcoholic beverages.

On March 11, Senomyx issued a statement announcing, “Sweetmyx flavor ingredient, previously referred to as S617, has been determined to be Generally Recognized As Safe (GRAS) under the provisions of the Federal Food, Drug and Cosmetic Act, administered by the United States Food and Drug Administration (FDA).

Shortly after the announcement, news outlets reported that Sweetmyx had been determined safe by the FDA. A Reuters headline read, “FDA says Senomyx sweetener enhancer safe” while a subhead by the financial news outlet Barron’s declared, “The biotech received a nod from the FDA for the sweetener Sweetmyx.” Subsequently, the value of Senomyx stock shares jumped as high as 26 percent on the day before closing up 17 percent.

So what’s the problem?
The FDA Does Not Determine “Generally Recognized As Safe” Status

The FDA issued a statement the day after Senomyx’s announcement, underlining the fact that the agency had not made the GRAS determination and even going so far as to chide Senomyx. “When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients,” the agency said.

Whether or not the wording of Senomyx’s announcement was purposefully misleading, the situation did highlight serious confusion over how GRAS determinations are made and what it means for food ingredients to be labeled “safe.”

The GRAS Process

For new ingredients (or by legal terms, “substances”) to be added to food, companies must comply with the Federal Food, Drug, and Cosmetic Act of 1938. Food Safety News points out that under the law, “Substances are added to food either as food additives or as GRAS. The difference between the two paths is significant: FDA must sign off on food additives, but companies can use GRAS substances without FDA approval. Notably, companies make their own GRAS determinations, which they may or may not voluntarily submit to FDA for review.” (Emphasis added)

In other words, industry is allowed to police itself when it comes to the safety of a significant number of ingredients added to the foods and beverages our families eat and drink every day.

In a recent article, Marion Nestle, a nutrition professor at New York University, weighed in on Sweetmyx, the GRAS process, and what she calls a “shocking gap in FDA regulatory authority over GRAS determinations.” She asked the involved parties:

Pepsi: Don’t you want FDA approval before putting this stuff in your drinks?
    Chemists: What is Sweetmyx, anyway?
    FDA: Don’t you think you ought to take a look at this thing?
    Congress: How about insisting that the FDA establish a better system for dealing with food additives?

Nestle isn’t alone. The Pew Charitable Trusts and the Natural Resources Defense Council (NRDC) have also been vocal in criticizing the process and expressing hope for reform. Additionally, a 2010 U.S. Government Accountability Office (GAO) report called for the FDA to update the GRAS process, citing conflict of interest issues. A 2013 study published by the American Medical Association backed up those concerns, concluding, “Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS.”

Robert McQuate, CEO of GRAS Associates, LLC, doesn’t see the GRAS process leaving the public overly vulnerable. In February, McQuate told Kelly Damewood of Food Safety News, “If FDA sees that there is an issue that adversely affects public health, even if [the substance] has previously enjoyed GRAS status, FDA does have the authority and capability to make changes.” He went on to cite the FDA’s proposal to “de-GRAS” partially hydrogenated oils, the primary source of industrially produced trans fatty acids, which can cause heart disease.

True, the FDA proposal to remove Generally Recognized As Safe status from partially hydrogenated oils was a step in the right direction, one that the Center for Effective Government strongly supported. But the fact that it would take the agency a decade to take action suggests serious flaws in the process, leaving Americans at risk from under-scrutinized food additives that may harm their health.


Monsanto Developing GMO Soybeans For Fake Fish Oil
Originally published August 12 2011
Monsanto preys on popularity of omega-3s by developing GMO soybean that produces fake fish oil
by Ethan A. Huff, staff writer

(NaturalNews) Leave it to Monsanto to take a good thing and corrupt it for financial gain. According to a recent report in Forbes, the multinational biotechnology-slash-agriculture-manipulating monolith has developed a new genetically-modified (GM) soybean that artificially produces stearidonic acid, a type of omega-3 fatty acid — and the US Food and Drug Administration (FDA) is expected to approve the “frankenbean” sometime this year.

Monsanto appears to be introducing the omega-3 enhanced GM soybean oil, called Soymega or “stearidonic acid soybean oil” (SDA oil), at a craftily strategic time when much of the world is still reeling from the Fukushima Daiichi mega-disaster, which left ocean waters ridden with radioactive isotopes. And since omega-3s just happen to be most readily found in fatty ocean fish, the perpetual fear over radioactive and other poisons that may be lurking in such fish could drive many to embrace Monsanto’s fake fish oil instead.

According to an FDA letter responding to Monsanto’s request to have SDA oil approved for use as a food additive and acknowledged as being “generally recognized as safe” (GRAS), the FDA noted that Monsanto intends to use its omega-3-enhanced oil in a variety of food applications. These include baked goods, breakfast cereals, fish products, frozen dairy desserts, cheeses, grains and pastas, gravies, nuts, poultry, fruit juices, processed vegetable products, and soups — yes, basically every processed food product in existence.

Monsanto created its GM soybean oil by injecting two specific enzymes into soybean genes. One came from Primula juliae, a type of flower, and the other from Neurospora crass, a type of red mold that grows on bread. As a result, the beans produce SDA oil and gamma-linolenic acid, two compounds not normally found in soybeans.

In its original request letter, Monsanto claims that its company-funded trials prove that SDA oil is safe for animal and human consumption, and that “no toxicologically significant effects were observed.” However, the data does not specifically highlight the long-term effects of the oil in animals or in humans — it merely alleges that nothing bad was observed during the 16-week trial period, which is hardly enough reassurance that the product is undeniably safe for consumption.

Nevertheless, the FDA has already granted Soymega GRAS status, which means that the agency acknowledges Monsanto’s safety claims, and essentially has no problems with or objections to them. And if the FDA grants full approval for Soymega, you can expect to see it turning up in all sorts of consumer food products.

Have all the ocean disasters in recent years been a catalyst for forcing people over to artificial, patented varieties of omega-3s?

Between BP’s “Deepwater Horizon” oil disaster in the Gulf of Mexico in April 2010, and the earthquake and tsunami that ravaged the Fukushima Daiichi nuclear facility in March 2011, many of the world’s oceans, and corresponding fish stocks, have been severely tainted. Add in perpetual mercury poisoning and other pollution that has been afflicting ocean life for many decades, and seafood appears less and less enticing as a safe and healthy source of omega-3s.

Enter Monsanto. By positing its omega-3 GM soybean variety as a safer, healthier alternative to natural seafood and sea-based fish oils, the company stands to gain an incredible amount of profit while ultimately steering public preference away from natural sources of omega-3s, and towards its own patented varieties of omega-3s. (Read more)