The latest buzzword in the food industry is “neutra-ceuticals,” plant-derived substances added to foods to make them “healthier.” This is the food industry’s solution to the problem of sluggish growth and declining profit margins on processed foods. There’s more money in pills containing “phytonutrients” like indoles or isothiocyanates derived from broccoli, than in broccoli itself; and more profit from “functional foods” like “energy bars” with added soy isoflavones, touted as a panacea for everything from menopausal symptoms to osteoroposis, than from old-fashioned candy bars.
Recently the FDA allowed the industry the right to add plant-derived sterols to such pedestrian products as vegetable oil spreads, salad dressings, health drinks, health bars and yoghurt-type products. These phyto-sterols include beta-sitosterol, campesterol and stigmasterol, all estrogen-like compounds derived mostly from wood-pulp effluent. The products will carry a health label claiming cholesterol-lowering properties, thanks to FDA largesse, and consumers will pay highly inflated prices for the privilege of spreading these known toxins on their morning toast.
“My father died young,” says an earnest-looking man on a television commercial. “When I found out I had a cholesterol problem, I just thought, ‘Well, I’m not waiting around for it to happen to me.’ So I started using Flora ProActiv margarine which actually reduced my cholesterol absorption. With Flora ProActiv, I’m down from 6.5 to 4.5 in just three weeks. Now I can do anything I’ve been wanting to do for years.”
Not all consumers watch television. In fact, those consumers most concerned about their health don’t watch much television at all. They are likely to get their nutrition information from newspapers and magazines. Nutrition writers have been quick to comply with their advertisers’ wishes with articles on the virtues of functional foods. And the National Heart, Lung and Blood Institute’s “New Guidelines” for preventing heart disease recommend the consumption of cholesterol-lowering margarines and spreads providing 2 grams of sterols or stanols per day.
The cash registers are ringing up the dollars; cholesterol-lowering phytosterols are already big business. Recently, the pharmaceutical giant Novartis sold the licence for its phytosterol product, Reducol, to Forbes Meditech, Inc. of Canada for US $4 million despite the fact that these sterols are not even legal additives in Canada. Predictably, Forbes Meditech is now lobbying the Canadian government for permission to sell to Canadians, and on their website they say they are confident that they can soon build significant sales and can establish a wide and extensive customer base for these products.
Just what are phytosterols? They are hormone-like compounds from plants, and they are present in large numbers in the effluent from the wood pulp business. Canadian, UK and Scandinavian scientists have shown that water contaminated with phytosterols causes endocrine damage to fish downstream from wood-pulp plants. The fish become “sex-inverted” and hermaphroditic; fertility is also reduced.1,2,3,4 Phytosterols are a problem for wood pulp processors because they are difficult to remove. For a time, in the 1960s, they were able to cash in on them, as they were used as a basis for commercial human sex hormones.5 That use became obsolete as even cheaper sources of waste products, derived from lanolin in sheep’s wool became available! Phytosterols also have the classic estrogenic effect of stimulating the growth of uterine tissues, which may explain their folk-loric use as abortifacients.6
There is a remarkable similarity between the chemical structure of plant sterols and Diethylstilbestrol, the synthetic hormone associated with reproductive cancers in women.7 This is one reason scientists seriously considered them as natural anti-fertility agents in place of the modern synthetic contraceptive pill. This potential usage was abandoned when phytosterols were found to have similarly harmful side-effects.
The National Research Council of the US Academy of Sciences has warned about the potential of hormone exposure to humans from water downstream from paper-mill effluent outflows,8 noting that these compounds can induce feminization in male fish and cause the proliferation of breast cancer cells.9 Human studies have shown that phytosterols are also osteolytic,10,11, 12,13 meaning that they cause a breakdown of the organic bone matrix, and the subsequent leaching of the inorganic bone fraction.14 This can lead to a life-threatening condition called hypercalcemia, where the plasma level of calcium soars, an emergency situation that occurs in about 40 percent of cancer patients.11,15
Hypercalcemia manifests initially as anorexia, nausea, vomiting and abdominal pain. It is therefore no coincidence that Cytellin, a now-obsolete phytosterol-based cholesterol-lowering drug, caused similar adverse effects, listed in pharmaceutical texts as “anorexia, abdominal cramps, and diarrhea.”16 In its more severe manifestation, hypercalcemia results in emotional instability, confusion, delirium, psychosis, stupor and coma, muscle weakness, cardiac arrythmias and acute renal failure.
All authorities, including the FDA, should publicly and conspicuously warn consumers that phytosterol-containing products are unsuitable for pregnant or breastfeeding women, and for infants and children. This is because they accumulate in the fetus by transplacental transfer.17, 18 As they are fat-soluble, they can be found in breastmilk.Studies have shown that phyto- sterols have adverse effects in ovarian structures, and also alter follicular development;19 they work synergistically with the natural hormone estradiol to promote anabolic effects,20 and to alter the sexual balance of the neonate’s brain. It is an accepted axiom that “the hormonal environment during the critical period exerts permanent organizational effects that may affect the behavior in adult animals.”21
A recent Editorial in the British Medical Journal has re-examined the issue of “living in a sea of estrogens,” and suggests “that the apparent increases in the incidence of certain reproductive conditions may be due to exposure to chemicals in the environment.”22 There is agreement that the incidence of testicular and prostate cancer is increasing, and that semen quality is probably worsening in some regions of the world. The increasing incidence of cryptorchidism and hypospadias in men and endometriosis and polycystic ovaries in women is further evidence of the damaging effects of environmental estrogens. Plant sterols added to margarines will add to this load.
The effect of phytosterols on infants will be accentuated because they accumulate in blood and tissues at a rate three- to fivefold above that observed in adults.18 Once absorbed, they can affect not only the hormonal environment, but can also be deposited in aortic tissues of both infants and adults, resulting in atherosclerotic lesions.17
Of course, industry interests would rather we do not know about all this. Stan Correy of the Australian Broadcasting Corporation (ABC) comments, “the days of an apple-a-day to keep the doctor away are over, because the food companies have to move on from apples to make new profits. To give credibility to these new products, they use scientists, doctors and people from the legal professions to speak for them.”17a
New Zealand Fights Back
Not all government officials have bowed to the interests of the food conglomerates. Dr Mark Lawrence of Australia’s Deakin University, formerly head of the Australian Food Standards Committee, resigned from his post last September largely because of his concerns about the aggressive targeting of public officials and consumers by functional food promotions. “The Food Standards Committee is not able to be vigilant enough because it is dominated by food industry representatives,” he said. “I found the situation untenable. I and the other public health nutritionists could not feel confident that public health was going to take precedence over other dimensions.” Later, on Radio New Zealand, he explained that the Food Standards Committee was basically dominated by food industry interests, and that they were relaxing any kind of control over functional foods.
Last September, ABC devoted a full program to “The Twilight Zone: Medicalizing the Food Supply,” a program about the marketing of functional foods. Interviewer Stan Correy reported that the traditional food industry has “hit the proverbial brick wall. It simply cannot make extra profits by just selling plain grains, veggies and fruit; it has to find new ways to tempt consumers to their products. It is no longer credible for the food to be just delicious, especially if it is full of fat and bad things. There is nowhere to go but to make it full of supposedly good things. . . Think about it: fish oil in ice cream: it increases your memory; Brocco-bites, that’s broccoli in a pill; wood chips or cholesterol-lowering plant phytosterols in margarine; all part of the wonderful ‘healthy’ world of functional food and neutriceuticals.” And of corporate profit motivation.
Negative media coverage of functional foods spurred us to fight the introduction of sterol-added foods in New Zealand. We mounted an intense campaign of letter-writing and calls to the Australia/New Zealand Food Authority (ANZFA). As a result, ANZFA refused to allow a number of sterol-added foods to stay on the market, and permitted the continued sale of sterol-added margarines only on the condition that they carry mandatory warning statements. Their lengthy directive was condensed into a strong press release reported in the Australian and New Zealand media. (See sidebar.) In issuing the warning, Ian Lindermayer, ANZFA director, stated, “. . . we are certainly under those commercial pressures, that is true, but we have a statutory duty that we take very seriously, to put the protection of public health and safety at the very top of our priorities.”
The ANZFA action sent shock-waves not only through the Australasian food industries, but around the world, because food companies hype a positive decision in one country to other national food safety organizations. The industry initiated an extensive media campaign, lobbied government officials, and even made a formal complaint about ANZFA to the Australian Federal Senate. Despite industry efforts, ANZFA’s directive has become law in Australia and New Zealand, but because of the industry pressure the directive is only being partially enforced. The forbidden foods have gone from the market, but the industry has not conformed to the warning labels and is lobbying for the requirement to be waived.
Amazingly, the industry has touted the ANZFA directive around the world as a “success.” Unilever launched an advertising blitz in the UK about the “big news” of the approval to sell its ProActiv product. However, this then got Unilever into trouble at the UK’s Advertising Standards Authority. In a bitter dispute about which margarine lowers the most cholesterol, Unilever and Johnson & Johnson, another multi-national, complained about each other’s advertising. The UK Advertising Standards authority ruled against them both, stating that both corporations had exaggerated how much their margarines could lower cholesterol
In contrast with this international activity, the US FDA, a law unto itself, has not limited the sale and promotion of these “tumor sterols.” The FDA has a unique procedure. It was designed by industry, which lobbied for its substitution in place of normal GRAS requirements. It is called “self-determination,” meaning that a manufacturer provides its own evaluation of the “safety” of its product. The FDA then advertises in the Federal Register, which is not really a widely read document. If no citizen objects, the FDA rubber stamps its approval and a multi-million-dollar win is showered on the applicant. This then becomes the benchmark for every other promotion of similar products. The US Center for Food Safety and Applied Nutrition (CF-SAN ) does not investigate for itself, and there rarely is an objection because the ultimate consumer does not have a clue about the procedure. The Weston A. Price Foundation joined us in writing to the FDA to protest the inclusion of plant-sterol toxins in the food supply, but the approval was granted anyway. The file reference for the phytosterol approval is GRN 000061.
Dangerous and Also Useless
In 1990, Dr Petr Skrabanek of Dublin University commented in the prestigious medical journal The Lancet on the dogma that cholesterol reduction could extend life.23 He wrote: “There is not a scrap of evidence that it is capable of changing the risk of dying from coronary heart disease, but there is reasonable evidence that it does not. The oldest consensus among the vendors of health, and other traders along the valley of the shadow of death, is that people want to be deceived and should be pleased accordingly. In the past, mountebanks were distinguishable from their more respectable colleagues at least in appearance and manners, if not by the effectiveness of their cures. Nowadays, the convergence of medicine and its ‘alternatives’ is an ominous foretaste.” Dr Skrabanek recommends that “people should temper their faith in experts–particularly when they see them coming in droves–with their own informed scepticism.”
The food industry believes it has found the Midas touch of turning dross into gold, but for the trusting consumer sterol-added products are nothing but fools’ gold.
Feeding Cattle at the Pulp Mill
Scientists in Finland have developed another use for wood pulp–the manufacture of single-cell protein (SCP) animal feed using the spent liquor of sulfite pulp mills. Called the Pekilo process after the commercial name of the product, the process uses microfungi to derive SCP from wood sugars. Manufacturers claim that the process will contribute significantly to eliminating problems of water pollution from sulfite spent liquors and that the product is nontoxic to animals. The question is, has the product been tested for the presence of sterols and over the long term for its effect on animal reproduction?
Warning to Be Put on Anti-Cholesterol Spread
Wellington, June 6, 2001: Margarines containing ingredients touted as reducing cholesterol must carry an advisory message warning some people against consuming them, health authorities have decided. The Food Standards Ministerial Council of Australia and New Zealand last week approved vegetable oil-derived plant sterol esters as a food ingredient in margarines but said other foods containing them would be banned.
Products containing the ingredient are marketed as margarines and spreads on both sides of the Tasman as a simple and natural way to lower blood cholesterol levels.
The council accepted the advice of the Australia New Zealand Food Authority (ANZFA) that the sterol esters should be allowed in margarines.
However, the products must carry an advisory warning that they may not be appropriate for infants, children, pregnant or breast-feeding women and that people on cholesterol-reducing medication should seek medical advice before using them, Anzfa said in a statement.
The food lines being targeted are those containing a natural plant ingredient known as phytosterol esters.
Anzfa told the Australian Parliament it was concerned consumption of large quantities of phytosterol esters could reduce the body’s levels of substances known as carotenoids and antioxidants.
Deficiencies in such substances were linked to increased risks of some cancers, especially in babies, children, and pregnant or breast-feeding women, Anzfa warned.
While there was enough evidence the quantity consumed through margarines was safe, no such evidence about higher intakes that could come through a broader range of foods had been supplied by manufacturers, Anzfa said.
In New Zealand, Goodman Fielder’s anti-cholesterol margarine is sold as Logicol by Meadow-Lea Foods.
Goodman Fielder’s chief operating officer Doug McKay welcomed the decision on margarines.
He said the company would not market any other products with sterol after the June 16 cut-off until its own studies were completed and it had won Anzfa approval.
“Goodman Fielder has initiated independent scientific and clinical research on using plant sterols in a range of foods to show they are safe and effective,” he said in a statement. – NZPA/AAP
(This press release was issued by the Australian/New Zealand Food Authority, January 2002)
- MacLatchy et al, “The Phyto-Estrogen B-Sitosterol Alters the Reproductive Endocrine Status of Goldfish,” Toxicology & Applied Pharmocology 1995 134:305-312.
- Mellanen et al, “Wood-Derived Estrogens: Studies in Vitro with Breast Cancer Cell-lines, and in Vivo in Trout,” Toxicology and Applied Pharmocology 1996 136:381-388.
- Howell et al, “Gonopodial Morphogenesis in Female Mosquito-Fish Masculinised by Exposure to Degradation Products from Plant Sterols,” Environmental Biology of Fishes 1989 24:43-51.
- Denton et al, “Masculinisation of Female Mosquito Fish by Exposure to Plant Sterols and Micobacterium Spegmatis,” Bulletin of Environmental Contaminant Toxicology 1995 35:627-632.
- Rydholm, Pulping Processes, Interscience Publishing, 1965, pp 226-227 & 826-827.
- Farnsworth et al, “Potential Value of Plants as Sources of New Anti-fertility Agents, Part 1,” Journal of Pharmaceutical Sciences 1975 64(4):583-587.
- Farnsworth et al, “Potential Value of Plants as Sources of New Anti-Fertility Agents, Part 2,” Journal of Pharmaceutical Sciences 1975 64(5):737.
- “Hormonally Active Agents in the Environment,” National Research Council of the American Academy of Sciences, National Academy Press 1999, pp 78 & 85.
- Makela et al, “Estrogen-Specific 17B-hydroxysteroid Oxireductase Type 1C as a Possible Target for the Action of Phytoestrogens,” PSEBM 1995 208:51-59.
- Gordan et al, “Osteolytic Sterols in Human Breast Cancer,” Science 1966, 131:1226-1228.
- “Tumor Sterols” Day et al in Metabolism (18) (8) pp 646-650 1969.
- “Identification of Osteolytic Sterols in Human Breast Cancer” Gordan et al in Transactions of the Association of American Physicians (53) pp 183-189 (1967)
- “Significance of Dietary Plant Sterols in Man and Experimental Animals” Subbiah et al in Mayo Clin Proc (46) pp 549-559 (1971).
- Taber’s Cyclopedic Medical Dictionary, 18th ed, 1997, pp 1367.
- Merck Manual, 17th ed, 1999, pp 145-151.
- Martindale, The Extra Pharmocopaeia, 28th ed, 1982, pp 411.
- Mellies et al, “Phytosterols in Aortic Tissue in Adults and Infants,” Journal of Laboratory and Clinical Medicine 1976 88(6):914-821.
17a. “Drugs or Dinner: Marketing Functional Foods”, Stan Correy, 30 Sept 2001 http://www.abc.net.au/rn/talks/bbing/stories/s381313.htm
- Mellies et al, “Plasma and Dietary Phytosterols in Children,” Pediatrics 1976(57):60-67.
- Samannoudy et al, “Adverse Effects of Phytoestrogens–Effect of B-Sitosterol Treatment on Follicular Development of Ovarian Structure and Uterus in the Immature Sheep,” Cellular and Molecular Biology 1979 26:255-266.
- Mallini et al, “Effect of B-Sitosterol on Uterine Biochemistry: Comparative Study with Estradiol and Progesterone,” Biochemistry and Molecular Biology International 1993 31(4):659-668.
- Register et al, “Effect of Neonatal Exposure to Diethylstilbestrol, Coumestrol and B-Sitosterol on Pituitary Responsiveness and Sexually Dimorphic Nucleus Volume in the Castrated Adult Rat” PSEBM 1995 208:72-77.
- Harrison, “Endocrine Disrupters and Human Health” (Editorial), British Medical Journal 2001 323:1317-1318.
- Skrabanek, “Nonsensus Consensus,” The Lancet 1990 335:1446-1447.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly magazine of the Weston A. Price Foundation, Spring 2002.