Regulatory Similarities Between GMO Foods and Pharmaceuticals

Mixing biotechnology and agriculture is controversial to many, which has led several states to consider passing laws requiring the labeling of several or all types of foods containing ingredients produced from genetically modified organisms, or GMOs. It has also led to a widely unfavorable view of biotech seed companies such as Monsanto (NYSE: MON  ) and Dow Chemical (NYSE: DOW  ) , while friction is brewing between the public and food companies such as Kellogg (NYSE: K  ) , General Mills, and Coca-Cola that oppose state-by-state GMO labeling.

At the heart of the issue is a widespread fear that GMO foods are or could somehow pose a risk to human health. Controversy persists despite overwhelming scientific evidence that demonstrates GMO foods are just as safe as traditionally produced foods. In fact, all engineered products must go through comprehensive testing to prove substantial equivalence compared with products produced through traditional means. There are certainly differences, but there are actually many regulatory similarities between GMO foods and pharmaceutical compounds, which tend to generate much less of an uproar before getting tossed into our bodies. How do the two types of products compare from a regulatory standpoint?

The value of time and population
In the United States, each pharmaceutical compound is tested for effectiveness and safety in clinical trials conducted under the watchful eye of the Food and Drug Administration. Similarly, each GMO food must undergo a range of tests mandated by specific regulatory agencies. The United States Department of Agriculture and the Environmental Protection Agency oversee livestock and environmental safety, while the FDA is tasked with ensuring substantial equivalence for new food products for human and animal consumption. Foods and pharmaceuticals go through different regulatory channels before gaining marketing approval, but each progresses through a robust, multi-year process.

That hasn't stopped many people from pointing to the fact that GMO foods have "only" been available for two decades. Ironically, when a pharmaceutical compound is approved after one decade of testing people tend to associate the time it took to get to market with words such as "finally" and phrases similar to "wow, that took a mighty long time." It's useful to consider how widespread biotech crops have become in "only" 20 years:

Not all countries growing biotech crops have approved them for human consumption. Source: GMOanswers.com.

That map illustrates that many people worldwide alive today have safely consumed GMO foods. Indirectly, the map shows the robustness of the international regulatory environment (link opens a PDF) that has approved biotech products multiple times for multiple uses through independent analysis. How specifically do pharmaceuticals and biotech crops compare?

The pharmaceutical regulatory process

Source: Wikimedia Commons / Janet Stephens.

Pharmaceutical compounds must run through a staggering amount of preclinical and clinical work to demonstrate that they are effective, safe, and that the benefits gained from treatment outweigh the risks or improve upon the accepted standard of care. The number of people enrolled and the allowable range of toxicity depend on the disease being treated and the size of the company conducting the trials but generally fit to the following guidelines.

Preclinical work consists of cell culture and animal testing that demonstrate feasibility and collect general safety data. Companies or organizations can then move to human testing, also known as clinical trials. Phase 1 trials enroll up to 100 people to determine safety, establish a dosing range, and determine possible side effects. If a compound is well tolerated and side effects aren't too cumbersome, it moves into a phase 2 trial, which enrolls up to 500 people. In mid-stage trials, the safety and effectiveness of a compound is tested against a placebo. Data are also collected that help determine how to design the final stage of clinical testing to best demonstrate that a compound is worthy of FDA approval.

A compound that successfully enters into a phase 3 trial will be tested against the standard of care or a competing therapy in several thousand people. Disease-specific endpoints are established with the FDA before a late-stage trial is initiated, but unforeseen safety complications can still lead to failure, no matter how effective.

It could take up to a decade or longer to collect sufficient data to gain marketing approval. Even after initial approval, the FDA may require further long-term safety studies before approving a compound for broader use. It's an expensive and rigorous process -- and it isn't perfect -- but it does a great job of ensuring consumer safety nonetheless.

The biotech crop regulatory process  

Source: Wikimedia Commons.

Companies or organizations developing biotech products must go through thorough regulatory processes, too. They must complete testing before gaining marketing approval for specific use as energy crops, animal feed, human food, imports, and commercial cultivation in general. Not all regulatory approvals are mandatory, but it is within the best interest of developers to complete all voluntary submissions given the legal ramifications if problems arise. All GMO foods on the market today have undergone full review.

Tests evaluating the environmental and human health impacts of the traits of pesticide (herbicides, insecticides, fungicides, and the like) introduced into biotech crops are submitted to the EPA. Crops containing Bt toxins (Cry proteins) to ward off insect pests fall under this jurisdiction, although not all crops contain pesticide traits.

Information about how and where biotech crops are grown during field tests is submitted to the USDA. The agency is responsible for ensuring that tests are conducted under controlled conditions and evaluating the environmental consequences of planting biotech crops. In addition, the USDA keeps track of where engineered crops are commercially grown and harvested.

Recently, the largest concern for consumers has been the perceived health risks posed by GMO foods. Luckily, a detailed analysis is conducted for each product. Data from health and safety assessments are submitted to the FDA for regulatory approval, which largely focuses on proving substantial equivalence, or that a new food or ingredient is similar to existing foods and ingredients. That requires analysis that shows comparable fat, protein, amino acid, vitamin, mineral, and starch content compared with similar foods.

GMO foods or ingredients that are substantially equivalent to existing foods but have other unique characteristics are subject to further testing, as are foods not deemed substantially equivalent. Similarly, the toxicity and allergenicity of foods are studied in animal testing, which must meet regulatory guidelines for approval.

The FDA requires a label if a food contains an unusual amount of a nutrient that a consumer would otherwise not expect, or if elevated levels of allergens are detected. Otherwise, no label is necessary, because the process in which a product is created conveys no meaningful information to the consumer. Not every GMO food will be required to pass through all three regulatory agencies, but each body has the legal power to seek immediate removal from the market should concerns under their jurisdiction arise.

Foolish bottom line
While no regulatory process is foolproof and recalls for pharmaceutical compounds and GMO foods have occurred, I get the feeling most people aren't aware of just how difficult it is to get a product to the market. Scientists at Monsanto and its peers aren't bursting out of labs, throwing seeds into the ground, and grabbing the nearest hose to irrigate their new creation. I hope that illustrating the regulatory process GMO products must go through helps quell any fears you may have about the safety of such products.

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Read/Post Comments (8) | Recommend This Article (3)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On November 24, 2013, at 10:55 AM, keneade wrote:

    This is not accurate with respect to genetically engineered foods. They are not put through a rigorous testing process at all. The industry submits its own reports to the FDA (there are no specific requirements) and if the industry reports the food as safe, there is not even any FDA consultation. This is official government policy. The upper levels of the USDA, FDA and EPA are headed by ex employees of Monsanto. They have drafted and implemented these policies over the past 15 years.

  • Report this Comment On November 24, 2013, at 6:00 PM, Gary603 wrote:

    Time and again the Fool displays their allegiance to the money trail with absolutely no regard for the consequence. It has been said that if a lie is told enough times then it becomes truth. Every time I see an article about Bio-engineered products that are "generally deemed safe for human consumption" I become more and more nauseous. The truth is at your fingertips. The internet has all of the answers as well as the all of the facts. Need a starting point? My references include, but are not limited to (1) responsible technology"dot"org, (2) Wikipedia systemic pesticides (3) www.epa"dot"gov/pesticides (4) Wikipedia herbicides (5) www.epa"dot"gov/herbicides (6) Wikipedia ESPS synthase. Some of the terminology may be hard to understand, but bringing this threat to your attention is vitally important.

  • Report this Comment On February 03, 2014, at 10:45 AM, alexrey wrote:

    http://​www.ncbi.nlm.nih.gov/​pubmed/17356802

    Arch Environ Contam Toxicol. 2007 May;52(4):596-602. Epub 2007 Mar 13.

    New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity.

    Séralini GE, Cellier D, de Vendomois JS.

    Source

    Committee for Independent Information and Research on Genetic Engineering CRIIGEN, Paris, France. criigen@unicaen.fr

    Abstract

    Health risk assessment of genetically modified organisms (GMOs) cultivated for food or feed is under debate throughout the world, and very little data have been published on mid- or long-term toxicological studies with mammals. One of these studies performed under the responsibility of Monsanto Company with a transgenic corn MON863 has been subjected to questions from regulatory reviewers in Europe, where it was finally approved in 2005. This necessitated a new assessment of kidney pathological findings, and the results remained controversial. An Appeal Court action in Germany (Münster) allowed public access in June 2005 to all the crude data from this 90-day rat-feeding study. We independently re-analyzed these data. Appropriate statistics were added, such as a multivariate analysis of the growth curves, and for biochemical parameters comparisons between GMO-treated rats and the controls fed with an equivalent normal diet, and separately with six reference diets with different compositions. We observed that after the consumption of MON863, rats showed slight but dose-related significant variations in growth for both sexes, resulting in 3.3% decrease in weight for males and 3.7% increase for females. Chemistry measurements reveal signs of hepatorenal toxicity, marked also by differential sensitivities in males and females. Triglycerides increased by 24-40% in females (either at week 14, dose 11% or at week 5, dose 33%, respectively); urine phosphorus and sodium excretions diminished in males by 31-35% (week 14, dose 33%) for the most important results significantly linked to the treatment in comparison to seven diets tested. Longer experiments are essential in order to indicate the real nature and extent of the possible pathology; with the present data it cannot be concluded that GM corn MON863 is a safe product.

    PMID:

    17356802

    [PubMed - indexed for MEDLINE]

  • Report this Comment On February 03, 2014, at 10:46 AM, alexrey wrote:

    http://​www.ncbi.nlm.nih.gov/pmc/​articles/PMC2952409/

    Abstract

    We summarize the major points of international debate on health risk studies for the main commercialized edible GMOs. These GMOs are soy, maize and oilseed rape designed to contain new pesticide residues since they have been modified to be herbicide-tolerant (mostly to Roundup) or to produce mutated Bt toxins. The debated alimentary chronic risks may come from unpredictable insertional mutagenesis effects, metabolic effects, or from the new pesticide residues. The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed. The tests are not compulsory, and are not independently conducted. The test data and the corresponding results are kept in secret by the companies. Our previous analyses of regulatory raw data at these levels, taking the representative examples of three GM maize NK 603, MON 810, and MON 863 led us to conclude that hepatorenal toxicities were possible, and that longer testing was necessary. Our study was criticized by the company developing the GMOs in question and the regulatory bodies, mainly on the divergent biological interpretations of statistically significant biochemical and physiological effects. We present the scientific reasons for the crucially different biological interpretations and also highlight the shortcomings in the experimental protocols designed by the company. The debate implies an enormous responsibility towards public health and is essential due to nonexistent traceability or epidemiological studies in the GMO-producing countries.

    Keywords: GMOs, Health risks, Pesticides, Regulatory toxicology, Animal testsDebate on GMOs Health Risks after Statistical Findings in Regulatory Tests

    www.ncbi.nlm.nih.gov

    We summarize the major points of international debate on health risk studies for...See More

  • Report this Comment On February 03, 2014, at 10:46 AM, alexrey wrote:

    GMOs should be safety tested - AMA

    Thursday, 21 June 2012 12:07

    NOTE: U.S. regulators rely almost exclusively on information provided by GM crop developers like Monsanto on an entirely voluntary basis, and those data are not normally published in journals or subjected to peer review. This is why many critics regard U.S. regulation of GM foods as a rubber-stamp approval process that does nothing to ensure the safety of GM foods.

    The American Medical Association's stance echoes what the British medical journal The Lancet said in an editorial more than a decade ago, "Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health."

    http://bangmfood.org/quotes/24-quotes/29-regulatory-breakdow...

    ---

    ---

    GMOs should be safety tested before they hit the market says AMA

    Monica Eng

    Chicago Tribune, 20 June 2012

    http://www.chicagotribune.com/features/food/stew/chi-gmos-sh...

    The American Medical Association called for mandatory pre-market safety testing of genetically engineered foods as part of a revised policy voted on at the AMA's meeting in Chicago Tuesday.

    Currently biotech companies are simply encouraged to engage in a voluntary safety consultation with the Food and Drug Administration before releasing a product onto the market.

    Some activists concerned about foods made with genetically modified organisms, or GMOs, had hoped the association would have gone so far as to support mandatory labeling of genetically engineered foods. But some still view the policy change as a major breakthrough.

    "We applaud the AMA for taking the lead to help ensure a safe and adequate food supply," said Anne Dietrich of the Truth In Labeling Campaign, which advocates labeling of genetically engineered foods. When Monsanto Co., the world's largest biotech seed company, testified Sunday at the AMA committee hearing on the policy, its representative did not raise any objections to the mandatory safety assessment provision.

    On Tuesday, however, Monsanto spokesman Tom Helscher would not say whether or not the company supports mandatory pre-market testing, only that the current voluntary consultation process "is working," he wrote to the Tribune. "All of Monsanto's biotech products, and to our knowledge all those of other companies, go through the FDA consultation process, which provides a stringent safety assessment of biotech crops before they are placed on the market."

    The AMA's Dr. Patrice Harris said the testing provision was aimed at addressing public interests and ensuring public health.

    Just now!

    The AMA's Dr. Patrice Harris said the testing provision was aimed at addressing public interests and ensuring public health.

    "Recognizing the public's interest in the safety of bioengineered foods, the new policy also supports mandatory FDA pre-market systemic safety assessments of these foods as a preventive measure to ensure the health of the public," Harris said in a statement. "We also urge the FDA to remain alert to new data on the health consequences of bioengineered foods."

    Tuesday afternoon FDA officials would not say whether the department supported mandatory testing. "New foods have an obligation under the Federal Food, Drug & Cosmetic Act to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements," the agency said. "In meeting their legal obligation, firms do conduct premarket safety testing."

    The agency was referring to testing manufacturers commission for their own use. Critics, however, argue that independent testing overseen by regulatory authorities often produces different results than testing paid for by the manufacturer.

    After the policy was announced Tuesday, Consumers Union senior scientist Michael Hansen released a statement saying: "We wholeheartedly commend AMA for coming out in support of mandatory pre-market safety assessment of (genetically engineered) foods, but are disappointed that AMA did not also support mandatory labeling. ... Studies in the scientific literature have suggested that genetic engineering could introduce new food allergens, increase the levels of known allergens, raise or lower nutrient levels and have adverse effects on the animals that eat such foods."

    Just Label It, the national campaign for the labeling of genetically engineered foods (www.justlabelit.org), issued a statement saying "just the fact that the AMA even considered this measure is a significant win for the vast majority (91%) of Americans (see the Mellman Poll findings) who believe they have the right to know about the foods they eat and feed their families -- a fundamental right already enjoyed by citizens in more than 50 countries worldwide, including all of Europe, Japan, Russia and China."

  • Report this Comment On February 03, 2014, at 10:48 AM, alexrey wrote:

    This fool site is aptly named- its all about big money- the writer of this article has no idea about agent orange, the dumping of pcb in ground water or anything else. But not to worry, anyone on here who writes articles like this will soon see all their "work" disappear, and Monsanto is about to face something they never expected very shortly ;) and they wont recover, you can count on it. There is a big difference between real science and science corrupted by big money- as the tobacco and pharmaceutical industry are now learning :)

    and here's the ironic thing- the pharmaceutical industry is just as bad- thats why we have class action lawsuits going AGAINST vioxx, celebrex, avandia and topamax, as well as antidepressants, because research studies were doctored and the fda got money on the backend from the pharma industry

  • Report this Comment On February 03, 2014, at 10:53 AM, alexrey wrote:

    and here's the ironic thing- the pharmaceutical industry is just as bad- thats why we have class action lawsuits going AGAINST vioxx, celebrex, avandia and topamax, as well as antidepressants, because research studies were doctored and the fda got money on the backend from the pharma industry- to the point of where doctors themselves are revolting against the drug industry for all their false advertizing on tv and creation of fake ailments to make a larger market for their products, this has NOTHING to do with science and everything to do with business- just like the tobacco industry.

  • Report this Comment On February 03, 2014, at 11:21 AM, aroeelkema wrote:

    The article talks about "substantial equivalence" as a basis for regulatory approval; the US is one of the few countries where legislators and regulatory agencies accept this ridiculous argument. Biotech companies somehow convinced us that their seeds were novel enough to require patent protection, but not different enough to require being identified as such...what?! That doesn't even pass the laugh test.

    Yes, GMO crops are mostly the same, in regards to macronutrient profile and vitamin content; they look, grow and even taste pretty much the same; the key difference lies in the very small fraction of novel proteins, such as the Bt toxin, not found in non-GMO crops. The effect of these novel toxins are absolutely not well studied, in the environment or in the food supply, due to the extremely lax regulatory process by which the industry basically self-certifies. Further, the way the system is set up allows these companies to terminate and bury forever studies that aren't going the way they'd like them to, reporting to the FDA only those results that match their desired outcome; evidence suggests that this happened multiple times in animal feeding studies in Europe; of course, it's probably happened more often than that, but how would we ever know?

    Additionally, previous use of the Bt toxin shows that it may be allergenic in some people even if it causes not other problems. With the strict labeling and processing requirements for other allergens in the food supply, this fact alone should be enough to require labeling for the good of public health.

    Consumers ought to have the right to know if the food they buy is made with/from GMO crops; it really is that simple. Advocating asymmetrical information only enhances the perception that GMO producers really do have something to hide, and will only increase the inevitable consumer backlash.

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