GMO Series #6: GMOs & the FDA

An FDA-Created Health Crisis Circles the Globe
How corporations engineered the non-regulation of dangerous genetically modified foods
People are often confused as to how countries like France, Germany, and Peru have banned GMOs, and yet the United States has not banned GMOs or even required labeling products so that consumers have the choice about what they may want to purchase and consume. How is this possible? What is happening behind the scenes?

Government officials around the globe have been coerced, infiltrated, and paid off by the agricultural biotech giants. In Indonesia, Monsanto gave bribes and questionable payments to at least 140 officials, attempting to get their genetically modified (GM) cotton approved.[1] In India, one official tampered with the report on Bt cotton to increase the yield figures to favor Monsanto.[2] While most industry manipulation and political collusion is subtle, none was more significant than that found at the US Food and Drug Administration (FDA).

The FDA's "non-regulation" of GM foods

Genetically modified crops are the result of a technology developed in the 1970s that allow genes from one species to be forced into the DNA of unrelated species. The inserted genes produce proteins that confer traits in the new plant, such as herbicide tolerance or pesticide production. In the US, new types of food substances are normally classified as food additives, which must undergo extensive testing, including long-term animal feeding studies.[4] If approved, the label of food products containing the additive must list it as an ingredient.There is an exception, however, for substances that are deemed “generally recognized as safe” (GRAS). GRAS status allows a product to be commercialized without any additional testing. According to US law, to be considered GRAS, the substance must be the subject of a substantial amount of peer-reviewed published studies (or equivalent) and there must be overwhelming consensus among the scientific community that the product is safe. GM foods had neither. Nonetheless, in a precedent-setting move that some experts contend was illegal, in 1992 the FDA declared that GM crops are GRAS as long as their producers say they are. Thus, the FDA does not require any safety evaluations or labels whatsoever. A company can even introduce a GM food to the market without telling the agency.
Such a lenient approach to GM crops was largely the result of Monsanto’s legendary influence over the US government. According to the New York Times, “What Monsanto wished for from Washington, Monsanto and, by extension, the biotechnology industry got. . . . When the company abruptly decided that it needed to throw off the regulations and speed its foods to market, the White House quickly ushered through an unusually generous policy of self-policing.” According to Dr. Henry Miller, who had a leading role in biotechnology issues at the FDA from 1979 to 1994, “In this area, the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do.”
Following Monsanto’s lead, in 1992 the Council on Competitiveness chaired by Vice President Dan Quayle identified GM crops as an industry that could increase US exports. On May 26, Quayle announced “reforms” to “speed up and simplify the process of bringing” GM products to market without “being hampered by unnecessary regulation.”[5] Three days later, the FDA policy on non-regulation was unveiled.

Fake safety assessments

Biotech companies do participate in a voluntary consultation process with the FDA, but it is derided by critics as a meaningless exercise. Companies can submit whatever information they choose, and the FDA does not conduct or commission any studies of their own. Former EPA scientist Doug Gurian-Sherman, who analyzed FDA review records obtained through the Freedom of Information Act, states flatly, “It is clear that FDA’s current voluntary notification process (even if made mandatory) is not up to the task of ensuring the safety of future GE [genetically engineered] crops.” He says, “The FDA consultation process does not allow the agency to require submission of data, misses obvious errors in company-submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat.”[12] Similarly, a Friends of the Earth review of company and FDA documents concluded:
“If industry chooses to submit faulty, unpublishable studies, it does so without consequence. If it should respond to an agency request with deficient data, it does so without reprimand or follow-up. . . . If a company finds it disadvantageous to characterize its product, then its properties remain uncertain or unknown. If a corporation chooses to ignore scientifically sound testing standards . . . then faulty tests are conducted instead, and the results are considered legitimate. In the area of genetically engineered food regulation, the ‘competent’ agencies rarely if ever (know how to) conduct independent research to verify or supplement industry findings.”[13]
At the end of the consultation, the FDA doesn’t actually approve the crops. Rather, they issue a letter including a statement such as the following:
“Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . . As you are aware, it is Monsanto’s responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements.”[14]
The National Academy of Sciences and even the pro-GM Royal Society of London[15]describe the US system as inadequate and flawed. The editor of the prestigious journalLancet said, “It is astounding that the US Food and Drug Administration has not changed their stance on genetically modified food adopted in 1992. . . . The policy is that genetically modified crops will receive the same consideration for potential health risks as any other new crop plant. This stance is taken despite good reasons to believe that specific risks may exist. . . . Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health.”[16]

Evaluations miss most health problems

Although the body of safety studies on GM foods is quite small, it has verified the concerns expressed by FDA scientists and others.
  • The gene inserted into plant DNA produces a protein never before seen in the food supply that is inherently unhealthy.
  • The inserted gene has been found to transfer into human gut bacteria and may even end up in human cellular DNA, where it might produce its protein over the long-term.
  • Toxic substances in GM animal feed might bioaccumulate into milk and meat products.
  • Farmer and medical reports link GM feed to thousands of sick, sterile, and dead animals.
But there is not a single government safety assessment program in the world that is competent to even identify most of these potential health problems, let alone protect its citizens from the effects.[21]
A review of approved GM crops in Canada by professor E. Ann Clark, for example, reveals that 70% (28 of 40) “of the currently available GM crops . . . have not been subjected to any actual lab or animal toxicity testing, either as refined oils for direct human consumption or indirectly as feedstuffs for livestock. The same finding pertains to all three GM tomato Decisions, the only GM flax, and to five GM corn crops.” In the remaining 30% (12) of the other crops tested, animals were not fed the whole GM feed. They were given just the isolated GM protein that the plant was engineered to produce. But even this protein was not extracted from the actual GM plant. Rather, it was manufactured in genetically engineered bacteria. This method of testing would never identify problems associated with collateral damage to GM plant DNA, unpredicted changes in the GM protein, transfer of genes to bacteria or human cells, excessive herbicide residues, or accumulation of toxins in the food chain, among others. Clark asks, “Where are the trials showing lack of harm to fed livestock, or that meat and milk from livestock fed on GM feedstuffs are safe?”[22]

Because genetically modified organisms are relatively new to our food supply, pro-GM arguments often claim that “[it is] generally agreed that long-term monitoring of the human health risks of GM food through epidemiological studies is not necessary because there is no scientific evidence suggesting any long-term harm from these foods.”[31] However, there is a flaw in the biotech logic: because no long-term epidemiological studies are in place, we have no evidence showing long-term harm. Without the studies, the harm cannot be unveiled.
Here is a quote from Dan Glickman, the pro-GM US Secretary of Agriculture under President Clinton:
What I saw generically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn’t good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you’re against it, you’re Luddites, you’re stupid. That, frankly, was the side our government was on. Without thinking, we had basically taken this issue as a trade issue and they, whoever ‘they’ were, wanted to keep our product out of their market. And they were foolish, or stupid, and didn’t have an effective regulatory system. There was rhetoric like that even here in this department. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issues being raised. So I pretty much spouted the rhetoric that everybody else around here spouted; it was written into my speeches.”[32]
Fortunately, not everyone feels that questioning GM foods is disloyal. On the contrary, millions of people around the world are unwilling to participate in this uncontrolled experiment. They refuse to eat GM foods. Manufacturers in Europe and Japan have committed to avoid using GM ingredients. And the US natural foods industry, not waiting for the government to test or label GMOs, is now engaged in removing all remaining GM ingredients from their sector using a third party verification system. The Campaign for Healthier Eating and The Non-GMO Project in America are circulating non-GMO shopping guides in stores nationwide so that consumers have clear, healthy non-GMO choices. With no governmental regulation of biotech corporations, it is left to consumers to protect themselves.

[4] See Federal Food, Drug and Cosmetic Act (FFDCA)
[5] Dan Quayle, “Speech in the Indian Treaty Room of the Old Executive Office Building,” May 26, 1992.
[13] Bill Freese, “The StarLink Affair, Submission by Friends of the Earth to the FIFRA Scientific Advisory Panel considering Assessment of Additional Scientific Information Concerning StarLink Corn,” July 17–19, 2001.
[14] FDA Letter, Letter from Alan M. Rulis, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, FDA to Dr. Kent Croon, Regulatory Affairs Manager, Monsanto Company, Sept 25, 1996. See Letter for BNF No. 34 at
[15] See for example, “Good Enough To Eat?” New Scientist (February 9, 2002), 7.
[16] “Health risks of genetically modified foods,” editorial, Lancet, 29 May 1999.
[21] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[22] E. Ann Clark, “Food Safety of GM Crops in Canada: toxicity and allergenicity,” GE Alert, 2000.
[31] Mike Zelina, et al., The Health Effects of Genetically Engineered Crops on San Luis Obispo County,” A Citizen Response to the SLO Health Commission GMO Task Force Report, 2006.
[32] Bill Lambrecht, Dinner at the New Gene Café, St. Martin's Press, September 2001, pg 139

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