12/16/2015 11:40 am ET Updated Dec 06, 2016

FDA Deceptions Enabled the Marketing of GMOs

A trove of official documents reveals that the FDA knew genetically-engineered foods (GE foods or GMOs) pose unique risks to humans as far back as 1991. In its lawsuit against the FDA, the Alliance for Bio-Integrity obtained 44,000 pages of reports, messages, and memoranda from the agency. Twenty-four of the most illuminating documents are posted on the organization's website, and the executive director, public interest attorney Steven Druker, explains their importance in his new book, Altered Genes, Twisted Truth.

The FDA records are highly relevant to the biggest current issue on Capitol Hill: the crucial government spending bill that must be passed by December 11. Here's why. In July, the House passed HR 1599, called "The Safe and Accurate Food Labeling Act of 2015" which bans the ability of states to require GMO labeling. Opponents of the bill call it the DARK (Denying Americans the Right to Know) Act. This legislation includes a change to the Food, Drug, and Cosmetic Act that would specifically exempt genetically-engineered products from the requirement for safety testing -- a statutorily-imposed mandate that the FDA has been illegitimately waiving since 1992. Although the Senate has not even formally considered HR 1599 yet, Monsanto and the biotech industry are trying to inject some of its provisions as a rider to the must-pass spending bill, thereby avoiding open and reasoned debate on them.

But if our legislators were made aware of the key facts in the FDA files (and other official records), it's doubtful Monsanto and its allies could succeed. For instance, these documents reveal:

  1. The FDA has acknowledged that it follows a policy "to foster" biotechnology.(1)
  2. In releasing its 1992 policy statement on GE foods, the FDA claimed that it was "not aware of any information" showing that these products differ "in any meaningful way" from other food (2), even though its own scientists had submitted several memos explaining that they entail a unique set of risks to consumers.
  3. The extent of the concerns is evidenced by an FDA compliance officer, who wrote that the agency "was trying to fit a square peg into a round hole ... [by] trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices." She then stated, "The processes of genetic engineering and traditional breeding are different, and according to technical experts in the agency, they lead to different risks." (3)
  4. In light of the risks, the FDA's scientists asserted that Genetically Engineered (GE) foods should undergo special testing, including toxicological tests.
  5. Not only did the FDA's biotech task force warn that GE foods posed greater risks than their conventionally-bred counterparts, the agency's biotech coordinator explicitly conceded that there was not a general consensus in the scientific community that GE foods are safe. (4)
  6. Nonetheless, the FDA's 1992 policy statement claimed that GE foods are "Generally Recognized as Safe" (GRAS) among scientists, which is supposed to entail that there is an overwhelming consensus about their safety.
  7. Even if such consensus actually exists, the law stipulates that a product still cannot qualify as Generally Recognized as Safe (GRAS) unless there is evidence from technical studies demonstrating its safety. (5) But the FDA's files contain admissions that the agency did not possess any such evidence for GE foods. (6)

Regrettably, the FDA persists in falsely claiming that GE foods qualify as Generally Recognized as Safe, and to this day, it continues to exempt them from the requirement of safety testing.

Moreover, the FDA has misled Congress and the public by instilling the illusion that the purely voluntary "consultation process" it promotes is a genuine scientific review, even though the FDA's own Biotechnology Strategic Manager has admitted that the process is not a scientific review and that the agency doesn't receive or request original data. (7)

The FDA recently continued its misleading assertions about GMO safety during an Oct. 21, 2015 Senate Agricultural Committee hearing, when an official repeated its false claim that the agency is "not aware" of any information showing that GE foods differ in any meaningful way from other foods. (8) This, despite the fact that besides the warnings it had received from its own scientists, the agency had received additional information about the dangers of GMOs -- including a report by an expert panel of the Royal Society of Canada stating that "the default presumption" for each GE food should be that genetic alteration has induced one or more unintended side effects that could be detrimental to the health of the consumer. (9)

Further, that same FDA official assured the senators that the voluntary consultation process is so rigorous that it resolves "all safety issues." (10) But, as Steven Druker points out, this statement is not only misleading but "ridiculous" because the process "is far too superficial to achieve such certitude."

Thus, FDA's current policy with regard to GMOs was adopted:

  • in opposition to the advice of its own scientists
  • without requiring these products be subjected to a genuinely scientific review
  • to give the biotech industry unfettered self-regulation
  • to permit the free flow of GMOs into the food supply
  • in violation of the requirements of the law

As Druker asserts: "If the American people learned how the FDA has been deceiving them, they would be outraged; and the entire DARK Act would almost surely be doomed." (11)


1. "Genetically Engineered Foods," FDA Consumer, Jan.-Feb. 1993, p.14.

2. Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991

3. Document 1 at

4. Document 8 at

5. 21 CFR Sec. 170.30 (a-b). For a fuller explanation of what the law requires for GRAS status, and how the FDA has been violating the requirements, see Chapter 5 of Altered Genes, Twisted Truth or Steven Druker's article, "Why the FDA's Policy on Genetically Engineered Foods is Unscientific, Irresponsible, and Illegal."

6. E.g. Document 1 at

7. Maryanski, J., "Safety Assurance of Foods Derived by Modern Biotechnology in the United States," July 1996.

8. Statement of Susan Mayne, PhD, Director, FDA Center for Food Safety and Applied Nutrition, before the Committee on Agriculture, Nutrition, and Forestry, U.S. Senate, October 21, 2015.

9. "Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and Environment Canada" The Royal Society of Canada, January 2001

10. Ibid.

11. "Interview with Steven Druker." Telephone interview. 3 December. 2015.