Carta sobre rBGH

Sheldon T. Bradshaw, Chief Counsel July 14, 2007

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20957

Mary K. Engle, Associate Director

Division of Advertising Practices

Federal Trade Commission

600 Pennsylvania Avenue, NW

Washington, D.C. 20580

Dear Mr. Bradshaw and Ms. Engle:

This letter is in response to the letters you received from Brian Robert Lowry of the Monsanto Company dated February 22, 2007 regarding labeling of milk labeling practices with respect to recombinant bovine growth hormone (rBSTor rBGH).

In these letters, Mr. Lowry claimed that consumers are being misled by the labeling of dairy companies that refrain from the use of rBGH. Oregon Physicians for Social Responsibility disputes the accuracy of many of Mr. Lowry’s statements and strongly disagrees. We contend that most consumers are very clear on the labeling and are making their buying decisions based on well-founded concerns about rBGH.

Our organization has studied the science and history of rBGH in depth for the past four years and has led a national public education campaign urging consumers to buy rBGH-free products. We would like to add our comments as you consider this issue.

rBGH and rBGH-free milk are not the same

Mr. Lowry claims that there is no difference between rBGH and rBGH-free milk: “Put simply, milk from cows supplemented with rBST is equivalent in all respects to other milk.” This is incorrect.

As Dr. Michael Hansen of Consumers Union pointed out, Monsanto’s Posilac® adds one amino acid (methionine) to the cow’s natural growth hormone molecule. It has been demonstrated that even small differences in this molecular structure can significantly change immunogenic properties.¹ Therefore, rBGH is different than the cow’s natural BGH and can be detected by the immune system.

Moreover, it is not in dispute that rBGH significantly increases the levels of another powerful growth hormone, IGF-1, in cows’ milk. In neither letter did Mr. Lowry even mention IGF-1, which as will be pointed out, is highly significant.

There is no consensus on the safety of rBGH to human health

Mr. Lowry claims there is a scientific consensus that rBGH is safe for human health: “. . . for well over a decade the safety of milk from animals supplemented with rBST has not been a scientific issue.” This is also incorrect.

There are three major problems associated with rBGH, including the most controversial, the suspected links between this drug and human cancer.

Increased cancer risk: IGF-1 is present and identical in both cows and humans and is necessary for growth and development. However, both laboratory and epidemiological studies have demonstrated that elevated levels of IGF-1 are associated with increases in several types of cancers in humans.²

There have been many studies establishing IGF-1’s promotion of breast cancer, including one showing the influence of tamoxifen on the hormone.³A prospective epidemiological study, using data from the Nurses’ Health Study at Brigham and Women’s Hospital/Harvard, demonstrated a positive relation between circulating IGF-1 levels and risk of breast cancer in premenopausal women.⁴

There have also been numerous studies linking IGF-1 to other common cancers. One prospective study showed that men with higher levels of the hormone are over four times more likely to develop prostate cancer than men with lower levels.⁵ Several other studies have linked IGF-1 with promoting metastasis and increasing colon cancer rates.⁶

IGF-1 in milk was originally thought to be destroyed by digestion, unable to reach the bloodstream where it could affect cancer rates. Although IGF-1 by itself doesn’t survive digestion, studies conducted after 1993 indicate that casein, the main protein in milk, protects most IGF-1 from digestion.⁷

Some argue that rBGH-induced IGF-1 is not a cancer risk because the body produces far more IGF-1 than can be taken in by dietary sources. However, even very small amounts of hormones can have major implications for human health, especially if consumed over long periods of time or at critical stages of growth and development (infancy, puberty, etc.). Moreover, several studies have shown that dietary intake of IGF-1 can indeed have an effect on human health.⁸

The precise ways that IGF-1 increases cancer rates are quite complex and involve far more than levels in the blood. The half-life and effects of binding proteins play crucial roles, and there are other mechanisms not totally understood.⁹ While it’s not possible to declare with certainty that rBGH use increases cancer rates, there are significant scientific data pointing in that direction.

Antibiotic resistance: The FDA acknowledges that cows given rBGH experience a statistically higher rate of mastitis, a painful udder infection.¹⁰ It is treated with antibiotics such as penicillin, amoxicillin and erythromycin, which are also used to treat infections in humans. Bacteria resistant to these antibiotics are selected out and end up in the milk, air, soil and water, which can contribute to increased antibiotic resistance in humans, a major health problem.

Numerous scientists in Canada and the European Union¹¹ cited cancer and antibiotic resistance risks. The Codex Alimentarius, the U.N.’s main food safety body, considered rBGH twice, in 1997 and 1999.¹² Both times, it concluded there was NO consensus that rBGH was safe for human consumption. It has not been brought up since.

Health Care Without Harm, an international coalition of over 440 organizations dedicated to health and safety in hospitals, issued a position statement in 2005 opposing the use of rBGH based on health risks to cows and humans.¹³ Hospitals all over the country are turning to rBGH-free dairy products.

The FDA’s approval of rBGH was one of the most controversial decisions it has ever made, with widespread criticism from government leaders, farmers and numerous scientists, including several within the FDA. Scientific evidence accumulated since then only reinforces the human health concerns with this drug. Enclosed with this letter is a copy of Oregon PSR’s Know Your Milk brochure, which lists extensive scientific documentation of the human and animal health concerns of rBGH, much of it discovered after the FDA approved the drug in 1993.

rBGH harms cows

Mr. Lowry claims that “. . . the use of rBST has no harmful effects on cows . . .” This is also incorrect. Monsanto’s own package insert for Posilac® lists 16 different harmful conditions that this drug increases in cows, including reduced pregnancy rates, decreases in birth weight of calves, increases in somatic cell counts and mastitis, increases in body temperature, increases in indigestion, bloat and diarrhea, increased numbers of enlarged hocks and lesions and more disorders of the foot region.

Virtually every major animal protection agency in the country, including the Humane Society of the U.S., Humane Farming Association, Farm Sanctuary and Animal Protection Institute, opposes the use of rBGH. And in addition to human health concerns, the governments of Canada and all 25 nations of the European Union formally cite physical harm to cows as justification for their banning of rBGH.

Consumers don’t want rBGH

Monsanto and its supporters have also claimed that rBGH is not a significant factor in consumer dairy buying habits. This is not only incorrect, it is simply denying the obvious.

It’s common knowledge that sales of organic milk have increased by approximately 20% per year for the last decade. It’s also well known in the dairy industry that most of this increase has been driven by the desire of consumers to avoid rBGH.

This aversion to rBGH is backed up by other studies. The Washington (State) Dairy Products Commission conducted a survey in 2006 that recorded that 64% of respondents were aware of rBGH and of those, 31% altered their dairy consumption accordingly. Both figures were the highest since the annual survey was launched in 1998. Blair Thompson, the organization’s spokesman, said “More than any other issue, rBST use is driving changes in dairy consumption behaviors.”¹⁴

In 2004, Tillamook County Creamery Association noted that fully 8% of all consumer contacts were about rBGH, up from 4% in 2003 and 3% in 2002.¹⁵ These consumer concerns were a major factor in the company declaring their cheese rBGH-free in April 2005. The consumer trend was obvious.

In the past two years, companies all over the country have cited consumer preference as the major driver in going completely or partially rBGH-free. Processors such as California Dairies, Inc., Southeast Dairies, Inc., Hood, Garelick, Darigold, Sinton and Wilcox; supermarket chains such as Publix Super Markets and Price Chopper; and retailers such as Starbucks and Chipotle Mexican Restaurants have all reported that significant numbers of customers have asked them to go rBGH-free. They simply listened to their customers and acted accordingly.

Consumers aren’t misled by labels

Mr. Lowry claims that consumers are misled by rBGH-free labeling: “. . . current advertising practices mislead consumers by falsely claiming that there are health and safety risks associated with milk from rBST-supplemented cows.” This is also incorrect, on two counts – there are health risks and consumers aren’t misled.

First, please note we agree with the decision to disallow inaccurate “hormone-free” labels, since all milk has hormones. However, it should be noted that the vast majority of dairy processors don’t say this and make no health claims whatsoever. The most commonly used labels are these phrases or statements, or wording very similar:

• “rBST- (or rBGH-) Free”
• “Our farmers pledge: No artificial hormones”
• “This milk comes from cows not treated with the growth hormone rBST (or rBGH)”

Moreover, even Mr. Lowry admits that most companies include the FDA-suggested disclaimer that there is no significant difference between rBGH and rBGH-free milk.

The labels are quite clear and most consumers know what they mean just as much as they know what “No preservatives,” “No artificial flavors,” “No artificial colors,” etc. mean when they read them on other labels. Consumers simply don’t believe Monsanto and the FDA when they say there are no significant differences in the milk and no human health concerns.

As we’ve pointed out above, they have solid, scientific justification for these beliefs. Moreover, many consumers are very well aware of the well-documented harm done to cows and refuse to buy rBGH dairy products based on animal welfare grounds.

Companies have the right to tell consumers how their products are produced and what is NOT in them

It’s helpful to compare labeling of non-dairy products to see what is legally established practice in American business. Enclosed are photos of a small sample of foods that label what is not in their products:

DeBoles rice: “Gluten free – all natural ingredients – no preservatives or chemicals added”

Applegate Farms bacon: “Vegetarian grain-fed with no animal by-products – No nitrites added – No antibiotics used”

Sunrise Fresh eggs: “Cage free – certified humane raised & handled – vegetarian diet”

Ranger chicken: “All vegetarian diet – no animal by-products, antibiotics or growth promoting hormones are given to our Ranger Birds”

Back to Nature pickles: “No artificial preservatives, flavors or colors”

Ian’s fish sticks: “No wheat – no gluten – no casein – no milk – no eggs – no nuts – no soy”

This is only a small sample. The most widespread use of labeling to inform consumers, of course, is organic products. Whether stated or not on the label, organic by definition means that no antibiotics, pesticides or hormones are allowed.

It seems to us that Monsanto is asking the federal government to restrict fair competition to try to save its dying product. After four years of this campaign in which we’ve made over 150 public presentations all over the country presenting both sides of this issue, one fact stands out: the more consumers know about rBGH, the more they’re likely to oppose it. Moreover, we know that most consumers that go rBGH-free never go back to accepting rBGH products. This is highly significant in a very competitive business. Knowledge about the science-based concerns with rBGH is rapidly spreading and consumers are increasingly “voting with their dollars.” This fact is not lost on business leaders, who are making perfectly logical decisions to discontinue rBGH to preserve and enhance their profits.

Companies should have the right to continue to tell consumers in straightforward language how their products are produced and what is not in them. This is accepted advertising practice and dairy producers should not be subject to restrictions that do not affect all other food manufacturers.

Companies should also have the right to respond to market conditions and do what is best for profitability. If they are hearing from their customers that they don’t want something, they should have every freedom to eliminate it and give these customers the information they need to make an educated purchasing decision.

Finally, consumers should have the right to know how their food is produced and what ingredients are and are not in them. This can only be accomplished by labeling.

We urge you to preserve fair competition by not further restricting labeling of rBGH-free products.

Moreover, based on a significant body of scientific research conducted since 1993, we urge the FDA to remove rBGH from the market immediately.

Sincerely,

Rick North, Project Director – Campaign For Safe Food

Martin Donohoe, MD – Chief Scientific Advisor

Oregon Physicians for Social Responsibility

¹ Erhard, M.H. et al, Identification of antigenic differences of recombinant and pituitary bovine growth hormone using monoclonal antibodies. Journal of Immunoassay, 15(1):1-9, 1994.

² Yu, H, Rohan, T, Role of the insulin-like growth factor family in cancer development and progression, Journal of the National Cancer Institute, Sept. 20, 2000, 92(18):1472-1481.

³ Colletti, RB, Roberts, JD, Devlin, JT, Copeland, KC, Effect of tamoxifen on plasma insulin-like growth factor I in patients with breast cancer, Cancer Research, 1989, 49:1882-1884.

⁴ Hankinson, S, Willett, W, Colditz, G, Hunter, D, Michaud, D, Deroo, B, Rosner, B, Speizer, F Pollak, M, Circulating concentrations of insulin-like growth factor-I and risk of breast cancer, The Lancet, May 9, 1998,

⁵Chan, JM, Stampfer, MJ, Giovannucci, E, Gann PH, Ma, J, Wilkinson, P, Hennekens, CH, Pollak, M, Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study, Science, Jan. 23, 1998, (279):563-566.

⁶Giovannucci, E, Insulin, insulin-like growth factors and colon cancer: a review of the evidence, Journal of Nutrition, Nov. 2001, 131:3109S-3120S.

⁷ Kimura, T, Murakawa Y, Ohno M, Higaki K, Gastrointestinal absorption of recombinant human insulin-like growth factor-1 in rats, Journal of Pharmacology and Experimental Therapeutics, July 1997, 283:611-618.

Xian, CJ, Shoubridge CA, Read LC, Degradation of IGF-1 in the adult rat gastrointestinal tract is limited by a specific antiserum or the dietary protein casein, Journal of Endocrinology, 1995, 146:215-225.

⁸ Heaney R, McCarron D, Dawson-Hughes B, Oparil S, Berga S, Stern J, Barr S, Rosen C, Dietary changes favorably affect bone remodeling in older adults, Journal of the American Dietetic Association, October 1999, 99:1229-1233.

Holmes M, Pollak M, Willett W, Hankinson S, Dietary correlates of plasma insulin-like growth factor 1 and Insulin-like growth factor binding protein 3 concentrations, Cancer Epidemiology, Biomarkers and Prevention, September 2002, 11(9):852-861.

Steinman G, Mechanisms of twinning:VII: Effect of diet and heredity on the human twinning rate, Journal of Reproductive Medicine, May 2006, 51(5):

⁹ Moschos, S, Mantzoros, C, The role of the IGF system in cancer: from basic to clinical studies and clinical applications, Oncology, Nov. 4, 2002, 63(4):317-332.

¹⁰ Kronfeld, D, Recombinant bovine somatotropin and animal welfare, Journal of the American Veterinary Medical Association, June 1, 2000, 216(11):1719-1720.

¹¹The European Commission, Scientific Committee on Veterinary Measures Relating to Public Health, Report on Public Health Aspects of the Use of Bovine Somatotropin, March 15-16, 1999, Section 2.4.2.1.

rBST Gaps Analysis Report, Internal Review Team, Health Canada, April 21, 1998.

¹² Codex Alimentarius Commission, Report – Twenty-third Session, Consideration of Draft Maximum Residue Limits for Bovine Somatotropin (BST), Rome, June 28-July 3, 1999, p. 13-14.

¹³ Health Care Without Harm, www.noharm.org,, Position Statement on Recombinant Bovine Growth Hormone.

¹⁴ Mateusz Perkowski, “rBST controversy gives dairy farmers marketing advantage,” Capital Press, March 2, 2007.

¹⁵ Hilary Parker, “Knowing agendas of consumer advocate groups key for dairy,” Cheese Market News, March 4, 2005.