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Labeling Milk from Cows Not Treated with rBST: Legal in all 50 States as of September 29th, 2010

Under the Food, Drug and Cosmetic Act and accompanying regulations, the Food and Drug Administration (FDA) is charged with promulgating regulations pertaining to food, including the labeling of food. Specifically, FDA must ensure that labels are not false or misleading to consumers. Until earlier this fall, the FDA’s determination that milk from cows treated with artificial growth hormones was the same as milk from untreated cows had never been challenged by a court. In International Dairy Foods Association v Boggs, the 6th circuit found that the two milks are in fact different, disregarding the FDA’s prior determination, and struck down an Ohio regulation prohibiting milk producers from labeling milk as coming from non-treated cows.

FDA approval for rBST and labeling policy
In 1987, Monsanto submitted to the FDA a new animal drug application for Posilac, a synthetic growth hormone that increases milk production in dairy cows (also known as an rBST or rBG). It took Monsanto over 6 years to bring rBST to market, and Monsanto supplemented the application with studies and reports documenting the safety and effectiveness of the drug. After reviewing those materials, the FDA approved Monsanto’s application for the use of Posilac in 1993. In January 1994, a Congressional task force concluded that the FDA’s position was adequately supported.

In addition to approving rBST for public use, the FDA had to determine whether milk from rBST treated cows should be labeled differently than regular milk. Besides enforcing requirements necessary to ensure that the labeling is not false of misleading, the FDA is prohibited from placing some additional requirements on labeling—the agency cannot require labeling based solely on differences in the production processes of identical foods. After an extensive agency investigation outlined above, the FDA found that there was no material difference between milk from rBST-treated cows and milk from non-rBST-treated cows, and accordingly it could not impose additional labeling requirements.

The standard for determining if two foods are the same is a materiality standard. Materiality relates to nutritional, organoleptic, or functional characteristics of the food. In general, the FDA has not found that foods from genetically modified organisms are different than their conventional counterparts. Therefore, the FDA could not require any additional labeling of rBST milk. This decision was specifically upheld in Stauber v. Shalala, when the Wisconsin district court determined that absent evidence of a material difference between milk from rBST-treated cows and non-rBST-treated cows, the FDA could not create any additional labeling requirements. Later, the FDA advised that milk from untreated cows could be labeled as such, but recommended the inclusion as a disclaimer that accompanying the statement “from cows not treated with rbST” with the statement that “No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”

6th circuit finds rBST milk “materially different”
In International Dairy Foods Association v. Boggs, the 6th Circuit determined that Ohio’s 2008 law prohibiting the labeling of milk from non-rBST treated cows was unconstitutional under the 1st amendment. The court based this decision in part on its finding that the two milks were different, thus overruling the FDA’s prior determination. The court cites three reasons milk produced by rbST-treated cows is different: increased levels of the hormone IGF-1, a period of milk with lower nutritional quality during each lactation, and increased somatic cell counts in the milk. The court further noted that higher somatic cell counts indicate milk is poor quality and will turn sour more quickly.

The 6th circuit’s willingness to overturn the FDA’s determination could have important implications for other genetically modified foods on the market and those looking to enter the market, including genetically modified salmon. Companies spend enormous amounts of resources convincing the agency and the public that their products are safe to eat, have no environmental harms, and are overall the “same” as conventional foods. In fact, producers of genetically modified foods encourage labeling restrictions so that consumers cannot tell from the label which foods are genetically modified and which are not. The argument goes that since the FDA says the two types of food are materially the same, consumers should not be told that they are different in any way. Telling a consumer that a product is made from “cows not treated with rBST” creates an impression that milk from treated cows is worse, and thereby creates confusion.

As demonstrated by the Ohio case, specific regulations in each state can be the target of suits by consumers or producers of conventional foods. Companies will now need to continuously manage public and scientific opinion of their food products. In fact, genetically modified food producers will need to decide if they even want to pursue labeling requirements, when doing so could force them to defend the FDA’s materiality determination in 50 separate suits.

About the Author

Libby Moulton

Libby Moulton is a 2L at Columbia Law School
  • rBST labeling « Revenge of the Nerd: The Sequel
  • Ella Baker

    rBGH milk is legal in the United States it is 90% banned in Canada, Japan, the
    European Union, Australia and New Zealand. In the EU, both meat and dairy
    products from the US are banned from import.

  • Anonymous

    Im just aware of this believe it or not but the truth of  this is if it”s  safe or better to drink.


    I don’t support anything that contains something manufactured by Monsanto chemicals, period.
    If EU and other first world countries banned this product is for a reason.
    Big corporations are killing us.

  • Jim Mooney

    So why is the FDA able to Force small milk producers to advertise for Monsanto by putting a claim on their cartons that rBST is just fine? I don’t see other natural food producers having to pimp for artificial flavors, colors, or sweeteners.  This is obvious corruption.

  • Anonymous

    If there is really no significant difference in cows treated with rbst and those that are not, then why ever do it? hmmm?

  • Increase Possibility of Twins – TTCKit

    [...] be the growth hormones in the milk that is consumed. So opt for the dairy that does not have the “Not from Rbst-treated cows” label on [...]

  • Peter Borten

    Thanks for the informative article. Unfortunate that this labeling requirement (“no material difference”) remains.
    @oblio9090: the point isn’t that the cows are the same; the milk is the same, and therefore it’s safe (which we now know to be untrue). for sure, the cows are NOT the same, and that’s why they use it (for more milk).

  • professor chaos

    Canada, Japan, the European Union, Australia and New Zealand are the bastion of liberal thinking (not reality). None of these countries, have found rBST or rBGH harmful to humans (because it isn’t). They do it so they can ban imports from the U.S. thus appeasing their dairyman who don’t want competition. So the nanny states capitulate because they don’t want the loonies like animal rights activists (it does increase diseases that are found in non treated cows by 12%) marching around their offices. The problem with that is that when you give into them the anti-rBST activists cry see there, they banned it so it must be bad. You have to suspend all logic to follow that conclusion. Those countries all state that milk from rBGH or rBST treated cows is safe. They ban it because of the health risks to THE COWS not humans. MILK IS MILK.

  • professor chaos

    wow enrico, the hatred is palpable. what in the world did they do to you. college student eh? maybe a journalist? how about knee jerk liberal? your logic is insane. again, those countries didn’t ban rBST or rBGH because it was killing us. Canada still allows USA hormone treated milk and dairy products to be sold there. it’s safety is no different than organic milk, and Canada says so. they banned it elsewhere to destroy the competition to their dairy producers and pressure from the increasing liberal activists who hate everything man made. the other countries can’t stand protestors so they found a back door to ban it, because of an increase of sick cows. organic cows have the same diseases and their milk is safe and so is the hormone treated cows. the hormone increases yields thus giving farmers increasing revenue and consumers lower milk prices. (scary stuff). spare me all the talking point lies which are so predictable. big corporations aren’t killing us, they produce jobs and essential products (i know what hackneyed response you’ll come up with). the liberal agenda and the BIG BANKS are killing us. if monsanto developed a drug that would make you 21 again and immortal would you boycott it? i’m guessing you would, after you got your dose. have you even hit 21 yet?

  • Aparna Ganapathi

    The article is clear that milk produced is different when cows are treated with rBST. Man made is surely wonderful when it works with the natural intelligence, however man’s greed is the spoiler. Monsanto is epitome of mans greed not man’s intelligence. Atleast can we spare basic things like food air and water ?

  • Aparna Ganapathi

    have you even thought about what goes into making milk ? its the cows strength vitality and life energy which we get as milk. Cows are not just resources but another life form. Is exploitation of a life form the only intelligence we have ? Sometimes its the colonies, sometimes its chained human slaves sometimes its cows …

  • kyle
  • kyle
  • kyle

    CINCINNATI, Ohio — The Kroger Company announced today they will stop selling and processing genetically modified milk by February 2008. That means the Kroger chain will by February, be selling only milk from cows that are rBST-free.
    hey professor ” Monsanto pays my bills” chaos . Is the Kroger Company full of ” knee jerk liberals?”

  • Juanita Randall

    You are probably right about that, after H, Sandy when there was no choice about to buy, I tried milk without rBST, just to have milk for my cereal. Milk usually gives my gas, but that milk did not. I was surprised and purchased more just to see if it was a fluke, no reaction again, when given no choice the expensive good stuff was what my system needed. Who knew!!!

  • Juanita Randall

    Obesity is being blamed on fast foods, foods that probably have growth hormones in them. Why have many of our poorer citizens become so bloated? Never in the history of the human condition, has there been a population of so many overweight people. The fashion designers could no longer ignore the oversized people because we out number the so-called ideal image of the perfect body type. If you have an undiscriminating appetite, chances are you are overweight. Kyle, thank you for that video clip, I would not have seen it if I had not been looking for a reason why my fav rSBT free milk was not being stocked in my fav supermarket. One of the clerks even dummied up (actually sounded stupid and unaware of the product) when I asked when they were going to restock the product. I found the product in a another chain, it only carries the small size, the brand has been downsized. The higher price will kill future sales from the penny wise super shoppers.

  • Nalf

    Drinking milk is just plane weird shit anyway.

  • Mauricio Cortes

    Evidence of negative long term affects on human consumption of rbst/rbh tainted dairy: devolvition; resorting to name calling low intelligence blows like “looney” as exemplified by professor chaos. His phd was well earned from some no name community college, TX.

  • Mauricio Cortes

    rape is a disgusting act of human indecency, letting a carnal act of desire lead one to defile another just for human pleasure. Our taste buds should not fall slave to the “pleasure” pushed on us by the milk conspirators who rape thousands of cows daily to keep them incessantly pregnant and producing puss from their swollen over-worked utters. Fact:humans are the only species to consume another species lactation.
    Weird indeed Nalf. Non-gmo organic soy/almond/rice milk is way more beneficial and less harmful both on our bodies and environment.

  • Got rBST?

    [...] A good short background on Monsanto, FDA, and labeling here. [...]

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