UNIVERSITY OF CALIFORNIA
COOPERATIVE EXTENSION
NUTRITION PERSPECTIVES
Volume 25, No. 1
Jan/Feb 2000
TABLE OF CONTENTS
Soy Supplementation, Breast Cancer, and Menopausal Symptoms
The Dangers of DHEA
Should Food Stamps Be Used to Purchase Vitamins?
Pediatricians Should Counsel Patients, Moms on Need for Folic Acid
A New Study on Neural Tube Defects and Folic Acid
California Nutrition Council Responds to Accusations By Physicians
Committee for Responsible Medicine
State Health Director Warns Consumers about Prescription Drugs in Herbal
Products
The Food and Drug Administration Finalizes Rules for Claims on Dietary
Supplements
Medicare Coverage for Nutrition
A Calcium Summit: Developing a Public Health Strategy to Ensure
America’s Optimal Calcium Intake
Enjoying Carbohydrates with Diabetes
Carbohydrate Counting Hints for Diabetics
Pediatricians Can Help Win Support for Student Diabetes
Regimen
Consumer Attitudes towards Functional Foods
New Egg Safety Plan
Lead Test a Must for Medicaid Enrollees
Infant Colic and Cows’ Milk
Resources:
Internet Sources for Sound Nutrition and Health Information
Conferences:
Year 2000 California WIC Association Annual Conference
Subscription for NUTRITION PERSPECTIVES
Sheri Zidenberg-Cherr, PhD, Editor
University of California
Department of Nutrition
One Shields Ave.
Davis, CA 95616
NUTRITION PERSPECTIVES is prepared by Sheri Zidenberg-Cherr, PhD, Nutrition Specialist,
Cristy Hathaway, and staff. It is designed to provide research-based information on
ongoing nutrition and food-related programs. It is published bimonthly (six times
annually) as a service of the University of California Cooperative Extension and the
United States Department of Agriculture. Subscription to NUTRITION PERSPECTIVES is
available from UC Cooperative Extension, Department of Nutrition, University of
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PERSPECTIVES, University of California, Department of Nutrition, One Shields Ave., Davis, CA 95616-5270. Phone (530) 752-3387; Fax (530) 752-8905.
SOY SUPPLEMENTATION, BREAST CANCER, AND MENOPAUSAL SYMPTOMS
Soy has been a main component of the Asian diet for thousands of years and may be partially respons-ible for Asian countries’ low rates of cancer and other diseases. Nutritionists agree that soy as part of a well-balanced diet can promote good health. Preliminary research about the possible benefits of soy has increased the sale of soybeans and soy supplements. However, more research is needed to fully understand the physiological effects of soy and its components.
What are phytoestrogens?
Phytoestrogens are plant chemicals that are similar in structure to estrogen. There are various types of phytoestrogens, including isoflavones, lignins, and coumestans. Isoflavones can be found in high amounts in soy products such as soy beans, soy milk, tofu, miso, and tempeh. Isoflavones have received a significant amount of attention recently due to their potential role in the prevention of breast cancer, renal disease, osteoporosis, cardio-vascular disease, and in the alleviation of hot flashes in menopausal women.
What is hormone replacement therapy (HRT) and how does it relate to menopausal women?
Menopausal women who suffer from symptoms such as hot flashes, genital atrophy, insomnia, decreased libido, depression, anxiety, and mood fluctuations often seek help in the form of hormone replacement therapy (HRT). HRT entails the use of natural or synthetic hormones, such as estrogen and progesterone to alleviate menopausal symptoms.
Are there any dangers associated with hormone replacement therapy?
HRT may decrease a woman’s risk for cardiovascular disease and osteoporosis. However,
the treatment may also increase the risk for estrogen-induced cancers in the breast and
endometrium in some women (1).
What is the relationship between soy supplementation and post-menopausal symptoms?
A promising additional or alternative treatment to HRT may be supplementation with soy. There is limited evidence to suggest that soy, given as soy protein or soy flour in the diet, helps to alleviate hot flashes, while exerting a weak estrogenic effect (2,3).
What is the relationship between soy supplementation and breast cancer?
Isoflavones may compete with estrogen for estrogen receptor sites, thereby, decreasing the incidence of estrogen-induced tumor formation. Competition for estrogen receptor sites may be possible because isoflavones have a similar structure to estrogen. Another mechanism that may explain soy’s role in preventing breast cancer can be seen with genistein, a type of isoflavone. Genistein has been shown in animal studies to reduce the growth of tumors by interfering with cancer cells’ ability to communicate with other cells (4).
Why is it difficult to come to a definitive conclusion about the benefits of soy protein/soy isoflavones?
Results from studies exploring the role of isoflavones in affecting the number of hot flashes are inconsist-ent. Results range from mild decreases to moderately significant decreases in the incidence and/or severity of hot flashes. The inconsistency may be due to the fact that isoflavone doses provided through supple-mentation have varied in amounts among different studies. Some studies administered isoflavones as part of a whole soy product, which also included soy proteins. While others provided soy as a supplement. It is not clear whether isoflavones alone or as a component of soy protein is responsible for the decrease in the number of hot flashes experienced by some menopausal women. Studies examining the cholesterol-lowering effects of soy have shown that whole soy protein products containing isoflavones are effective, whereas the isoflavone supplement given by itself was not effective in lowering serum cholesterol.
Isoflavones have been shown, in some studies, to prevent excessive and uncontrolled growth of breast tissue. The proliferation of breast tissue may lead to breast cancer. However, some researchers do not feel that there is adequate justification for therapeutic use of isoflavones by postmenopausal women (5). In other stu-dies, soy isoflavones actually increased breast cell proliferation (4). Whether isoflavones stimulate or prevent breast cell proliferation may be dependent on individual differences, age, and/or if the woman is postmenopausal.
What are the current recommendations for soy and isoflavone supplements?
There is general agreement in the scientific community that soy protein helps to lower cholesterol, which can decrease the risk of heart disease. The Food and Drug Administration (FDA) has permitted the use of food labels expounding the health benefits of soy protein, not isoflavones. Low fat and low cholesterol foods that contain 6.5 grams of soy protein per serving are allowed to carry the label (5).
As mentioned earlier, there is no consensus about the effects of isolated soy protein or isolated soy isoflavones in the treatment of menopausal symptoms. Thus, isolated soy isoflavone supplementation in the treatment of menopausal symptoms is not currently recommended (6). Eating soy as part of a healthy diet may have different physiological effects than the ingestion of isolated isoflavones (6).
Are there any concerns associated with soy isoflavone supplementation?
Consumers may interpret the approval of the food label claims regarding foods containing soy protein as a green light to take soy supplements. The problem with taking soy isoflavone supplements is that supplements are not regulated by the FDA (5). Furthermore, the supplement industry is under no obligation to disclose the inconsistencies found in various studies. Finally, the possibility of toxicity is greater with supplements since it is far easier to take excess quantities of soy isoflavones in a supplement form than from the diet (5).
References
1. Lee-Jane WL, Anderson KE, Grady JJ, Nagamani M. Effects of soya consumption for one
month on steroid hormones in premenopausal women. Implications for breast cancer risk
reduction, Cancer Epidemiology, Biomarkers and Prevention, 5:63-70, January 1996.
2. The Role of soy in preventing and treating chronic disease. Proceedings of a Symposium.
Brussels, Belgium, September 15-19, 1996, Am J Clin Nutr, 68(suppl):1531S-3S, 1998.
3. Albertazzi P. Pansini, F. Bonaccorsi, G. Zanotti, L. Forini, E. De Aloysio, D. The
effect of dietary soy supplementation on hot flashes, Obstetrics and Gynecology, 91(1):6-1
1, January 1998.
4. McMichael-Phillips DF, Harding C, Morton M, Roberts SA, Howell A, Potten CS, Bundred
NJ. Effects of soy-protein supplementation on epithelial proliferation in the
histologically normal human breast, Am J Clin Nutr, 68(suppl)-.1431S-6S, 1998.
5. Ginsburg J, Prelevic GM. Lack of significant hormonal effects and controlled trials of
phyto-oestrogens, Lancet, 355(9199):163-4, 2000.
6. Albertazzi P, Pansini F, Bottazzi M, Bonaccorsi G, De Aloysio D, Morton MS. Dietary soy
supplementation and phytoestrogen levels, Obstetrics and Gynecology, 94.229-31, 1999.
Caroline Kurtz
Doctoral Student
Department of Nutrition
UC Davis
Because Dehydroepiandrosterone (DHEA) turns into other hormones, including estrogen and testosterone, in the body, the risk of hormone-related cancers, such as endometrial, breast, and prostate cancers, may increase if DHEA supplements are used. If an individual already suffers from one of these cancers, it could cause it to grow more rapidly. Other ill-effects of taking this hormone may include acne, body hair growth, aggressive behavior, and liver enlargement. The FDA has received over 2,600 reports of adverse events that consumers say are linked with their use of DHEA.
Source: American Institute for Cancer Research Newsletter; Issue 66; p. 8; Winter 2000.
SHOULD FOOD STAMPS BE USED TO PURCHASE VITAMINS?
The 1996 Welfare Reform Act ordered the US Department of Agriculture (USDA) to examine its long-standing prohibition of food stamp recipients purchasing vitamin, mineral, and other dietary supplements, and to report its findings by December 1998. Almost one year later, the USDA has decided to continue its prohibition.
Noting that current food stamp policy does not prevent recipients from purchasing vitamin and mineral supplements with their own money, Secretary of Agriculture Dan Glickman concluded that "although changing current policy may have some small benefit for some households, I believe the potential gains resulting from a change are more than outweighed by other considerations."
Administrative and enforcement challenges comprised the bulk of those "other considerations." The USDA noted that distinguishing vitamin and mineral supplements from herbal, botanical, and other dietary supple-ments, many of which have little nutritional value, would be difficult and confusing. Also, the USDA believes that changing the current policy would create pressure to expand the categories of stores, such as vitamin stores, that would be allowed to accept food stamps. This would further strain the USDA’s ability to ensure compliance with current rules and pursue trafficking violations, the agency said.
Opponents of expanding the Food Stamp Program to include dietary supplements argue that participants would spend less money on food, and that the agricultural sector would suffer economically. One study found, however, that letting consumers buy supplements with food stamps would reduce food purchases by less than $0.94 a month per household. Furthermore, farmers would see their income reduced by approximately $5 to $19 million each year if recipients were allowed to use a portion of their benefits to purchase supplements.
Multi-vitamins are the most widely used supplements among all income groups. The USDA, using the 1994-96 Continuing Survey of Food Intakes by Individuals and the 1988-94 Third National Health and Nutrition Examination Survey, reported that vitamin and mineral intakes among low-income and high-income people are similar, and that 30 percent of all food stamp participants already make use of dietary supplements. Approxi- mately 42 percent of low-income persons not in the food stamp program, and 50 percent of high-income people, use some sort of supplement on a regular basis.
Proponents of the policy change argue that food stamp recipients should not be discriminated against purchasing vitamin or mineral supplements. "The current policy permits food stamp participants free choice in the food category, but disallows dietary supplements," said Annette Dickinson, vice president for scientific and regu-latory affairs at the Council for Responsible Nutrition (CRN). "As a result, low-income families in need of nutritional supplementation are prohibited from obtaining it. The time has come for food stamp recipients to have the same freedom of access enjoyed by other consumers."
The Council for Responsible Nutrition asserts that the food stamp authorizing legislation contains no ban on allowing recipients to use benefits to buy supplements. Both the Federal Food, Drug, and Cosmetic Act of 1988 and the Dietary Supplement Health and Education Act of 1994 define supplements as food. "The USDA had no legal or scientific basis for excluding nutritional supplements from the Department’s food framework," contin-ued Dickinson. "The Secretary of the USDA could take action immediately to reverse that arbitrary ruling. In the absence of corrective action by the Secretary, Congress can and should continue to pursue legislation to require the necessary changes."
Legislation has been introduced in both the Senate and the House of Representatives to permit house- holds to use food stamp benefits to purchase vitamin or mineral supplements. Senator Tom Harkin (D-IA), ranking member of the Agriculture, Nutrition, and Forestry Committee and the Agriculture Appropriations Subcommittee, called on his colleagues to support the legislation.
"It is a glaring inconsistency that food stamps may currently be used to purchase a variety of non-nutritious or minimally nutritious foods but not to purchase nutritional supplements. Incredibly, you can use food stamps to buy Twinkies, but not Vitamin C or a multivitamin, " Harkin said when introducing the Food Stamp Vitamin and Mineral Improvement Act.
No action was taken on the legislation before Congress adjourned in November. The Food Stamp Vitamin and Mineral Improvement Act is supported by the Alliance for Aging Research, the Spina Bifida Association of America, the National Osteoporosis Foundation, and the National Nutritional Foods Association.
Adapted from: Nutrition Week; Vol. XXIX No. 47; December 17, 1999; pp. 2-3.
PEDIATRICIANS SHOULD COUNSEL PATIENTS, MOMS ON NEED FOR FOLIC ACID
Despite the strength of available evidence, not enough women are following the recommendations of the Academy, the US Public Health Service (USPHS), and other groups to take 0.4 mg of folic acid each day. Because of their contact with adolescents and mothers, pediatricians are in a position to improve folic acid intake among the targeted populations.
Recommendations
Based on available evidence, in September 1992 the USPHS recommended that "all women of childbearing age in the United States who are capable of becoming pregnant consume 0.4 mg of folic acid per day for the purpose of reducing their risk of having a pregnancy affected with spina bifida or other neural tube de-fects (NTDs) (1)." Subsequently, the Food and Drug Administration issued a regulation requiring all enriched grain products to be fortified with folic acid. Fortification at the level of 140 m g per 100 g began in 1996.
Various health care organizations, as well as federal and state agencies, joined the Academy in recom-mending folic acid supplementation and food fortification. A revised policy statement from the American Academy of Pediatrics committee (AAP) of Genetics endorsing USPHS recommendations and addressing the need for public health programs, including supplementation, surveillance, and food fortification, was published in the August issue of Pediatrics (2).
The consensus among these groups about the use of folic acid follows:
Prevention of first occurrence
1. All women who are capable of becoming pregnant should take 0.4 mg of folic acid daily, because 95 percent of all NTD cases occur in children whose parents have no positive family history.
2. NTD prevention is best achieved by adequate daily folic acid intake by all sexually active women of childbearing age, whether or not they are contemplating a pregnancy, because neural tube closure occurs between days 26 and 28 following conception, which is before the recognition of pregnancy by most women, and in view of the fact that at least 50 percent of pregnancies are unplanned.
Prevention of recurrence
1. Women with a history of a previous pregnancy resulting in a fetus with an NTD should take 10 times the recommended dose, that is, 4 mg of folic acid daily, starting one month before conception and throughout the first three months of pregnancy.
2. These women should be advised to the use of a folic acid supplement to achieve these higher doses. Attempting to achieve them by taking multivitamins containing folic acid may result in the consumption of harmful levels of other vitamins, such as vitamin A.
3. It should be noted that 4 mg of folic acid did not prevent all NTDs in the Medical Research Council (MRC) study conducted in 1991. Therefore, high-risk women should be cautioned that folic acid supplementation does not preclude the need for counseling or consideration of prenatal testing for NTDs.
Dietary considerations
Higher levels of dietary folate intake also have been shown to decrease the occurrence of NTDs. For this reason, women of childbearing age should be encouraged to eat foods rich in folates. These include dark, leafy vegetables, citrus fruits, liver and organ meats, fortified cereals, and legumes. A large glass of orange juice and a bowl of fortified cereal provide about half the recommended daily amount of folic acid. However, since it is difficult to reach the desired plasma and red cell blood folate levels with a regular diet, women should not rely only on dietary folate and should be advised to take a daily supplement of folic acid.
Pediatricians have the opportunity to address nutrition and dietary behavior issues with the mothers of young patients, with adolescent patients, and as a routine part of prenatal consultations. Reinforcement about the preventive effects of folic acid, the need to take daily multivitamins containing the adequate amount of folic acid, and the importance of a healthy diet could be of enormous value in the prevention of NTDs and possibly other congenital malformations.
Adapted from: AAP News; Vol. 16 Number 1; January 2000; p. 36.
References:
1. Recommendations for the use of folic acid to reduce the number of cases of spina
bifida and other neural tube defects. MMWR. Sept. 11, 1992.
2. Folic acid for the prevention of neural tube defects. American Academy of Pediatrics.
Pediatrics, August 1999.
A NEW STUDY ON NEURAL TUBE DEFECTS AND FOLIC ACID
A study done in China showed that women who took folic acid supplements reduced their risk of having a baby with a neural tube defect (NTD) by 40 to 85 percent (1). Two regions of China were involved in the study, which was conducted by researchers from the US Centers for Disease Control and Prevention (CDC) and the Beijing Medical University. Almost 130,000 women took a folic acid supplement before becoming pregnant and during the first trimester. About 120,000 women did not take the supplement. In a northern region of China where there is a particularly high ratio of babies born with NTD, about 6.5 per 1,000 births, women who took a folic acid supple-ment reduced the risk of their baby having NTD by 85 percent. In two provinces in a southern region where the risk of NTD is lower, about one per 1,000 births, a folic acid supplement reduced the risk of a baby having NTD by 40 percent. The results show that folic acid supplements provided high protection from NTD in areas that had low rates of the defect, and even more protection in regions with high incidences.
NTDs are crippling defects that include spina bifida and anencephaly. Spina bifida can cause severe neurological disabilities. Babies born with anencephaly are missing all or most of the brain and do not survive past birth.
Adapted from: Nutrition Week; Vol. XXIX No. 45; December 3,1999; p. 7.
Reference:
1. Berry RJ Li Z, Erickson JD Li S, Moore CA, Wang H, et al. Prevention of neural-tube defects with folic acid in China. New Eng J Med, 1999 Nov 11, 341(20):1485-90.
The Physicians Committee for Responsible Medicine (PCRM) has attacked the Dietary Guidelines Committee, accusing its members of being unduly influenced by the meat, dairy, and egg industry. According to PCRM, these foods have caused unprecedented increases in the rates of heart disease, diabetes, stroke, cancer, hypertension, and obesity. This is a strange accusation to make since human beings have been eating meat, drinking milk from a wide range of animals, and consuming eggs of various kinds of poultry for thousands of years. Surely the members of the PCRM are aware of the fact that the average life span has increased dramatically in the last 100 years even though we have continued to eat these foods. Defaming both the members of the Dietary Guidelines Committee and selected foods is both unjustified and unfair.
Dietary guidance in this country has been in the hands of nutrition scientists who have devoted their entire careers to studying how the human body uses the nutrients found in food for growth, repair, and health. All of the individuals on the Dietary Guidelines Committee are affiliated with academic institutions that have excellent repu-tations, and these individuals are notable for their nutrition expertise. They understand that the human body must obtain almost 50 different nutrients from food in order to sustain itself. These nutrients are not found in any one food, or even any one food group; they are found in a wide variety of foods. Restricting the diet with regards to variety increases the risk of nutrient deficiencies.
The PCRM's attack on selected foods is motivated by their goal of revolutionizing the American diet to conform to veganism, that is, a total dependence on plant foods. For the average American, that would not only mean giving up hamburgers, steak, pork chops, and milk shakes, it would also mean no more macaroni and cheese, scrambled eggs, nachos, and milk with dry cereal or in coffee. To replace these foods, the PCRM would have us drink fortified soy milk, eat brown rice and brown bread, and lots of leafy green vegetables. This kind of dietary restriction would make it very difficult for Americans to obtain adequate amounts of nutrients.
The Food Guide Pyramid was designed to help Americans make food choices that provide recommended amounts of nutrients necessary for growth and health. It is the first food guide developed using computer data-banks containing information on food consumption, the nutrient composition of food, and the Recommended Diet-ary Allowances. The food pyramid includes meat, fish, poultry, and eggs because these foods contribute signif-icant amounts of protein, iron, zinc, niacin, and vitamins B-6 and B-12 to the diet. Milk, yogurt, and cheese are the primary sources of calcium in the US diet.
The PCRM appears to take a great deal of pride in smearing the nutritional reputation of milk asking that its become an "optional beverage" in school meal programs. Perhaps they are gratified by the fact that soft drinks are replacing milk as the beverage of choice in the diets of children and teenagers in this country. This is being aided and abetted by schools that sign exclusive beverage contracts with Coke and Pepsi. Any parent who thinks this is a positive trend should compare the nutrition label on a bottle of soft drink and a carton of milk to see who is get-ting shortchanged. If the majority of the members of the Physicians Committee for Responsible Medicine were in fact physicians, according to PCRM's website only 5% of their members are physicians, perhaps they would be more worried about an impending epidemic of osteoporosis than about lactose intolerance. It is a lot easier (and less expensive) to prevent an upset stomach than deal with a broken hip.
The US Dietary Guidelines and the Food Guide Pyramid provide the foundation for nutritional guidance for the public. The nutrition scientists who developed them are dedicated, knowledgeable, and responsible individuals whose foremost concern is the public's nutritional well-being.
Source: Joanne Ikeda MA RD, Rita Mitchell RD, President, California Nutrition Council.
STATE HEALTH DIRECTOR WARNS CONSUMERS ABOUT PRESCRIPTION DRUGS IN HERBAL PRODUCTS
Consumers should immediately stop using five herbal products because they contain two prescription drugs not listed as ingredients that are unsafe without monitoring by a physician, State Health Director Diana Bontá, RN, DPH, said January 18, 2000. The products are Diabetes Hypoglucose Capsules, Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Hypoglycemic Capsules and Zhen Qi Capsules. The products claim to contain only natural Chinese herbal ingredients. However, an investigation by the California Department of Health Services Food and Drug Branch determined that they contain the prescription drugs glyburide and phenformin, which can be used to treat diabetes.
The investigation was launched after a diabetic patient in Northern California suffered from several epi-sodes of low blood sugar after consuming one of the products, Diabetes Hypoglucose Capsules. The patient has fully recovered. Consumers should stop using these products and seek medical advice, especially if they are currently being treated with other anti-diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of extremities. Consumers who use these products can receive a dangerously high amount of glyburide and phenformin.
These products are available from mail order and can be purchased by telephone or via the Internet:
Diabetes Hypoglucose Capsules are sold by Chinese Angel Health Products Inc., also known as Chinese Herbal Health Products, 2118 Wilshire Blvd, PO Box 498, Santa Monica CA 90403. These capsules, which are green and white, are available in 70-capsule bottles. The label has green and black English printing with a picture of a plant. The UPC number is 6-923174-911016.
Pearl Hypoglycemic Capsules, imported by Sino American Health Product Inc., 2421 W. 205th St., Suite D103, Torrance CA 90501, are sold by the importer and Chinese Angel Health Products Inc. Chinese Angel Health Products also re-labels the product. Capsules, available in 60-capsule bottles, are blue and white with Chinese characters imprinted on one side of the capsule. The red, green, and black English label is placed over the Chinese manufacturer's label that contains black and green Chinese characters and a red logo.
Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules and Tongyi Tang Diabetes Angel Hypoglycemic Capsules are available in 60-capsule bottles. The capsules are blue and white with Chinese characters imprinted on one side of the capsule. The label has red, green, and black English printing and Chinese characters. The UPC number is 6-920555-319966.
The Zhen Qi Capsules are available in 60-capsule bottles. The capsules are clear. The green label has silver English printing with a picture of a leaf. The product is manufactured for Sino American Health Products Inc. of Torrance CA 90501. The UPC number is 7-63052-31148.
Consumers should return these products to the seller or dispose of them safely to prevent exposure to children. The Food and Drug Branch is working closely with the US Food and Drug Administration to stop importation of the products into the United States and remove them from sale.
Source: Press Release, January 18, 2000; State Health Director Diana Bontá, RN, DPH.
THE FOOD AND DRUG ADMINISTRATION FINALIZES RULES FOR CLAIMS ON DIETARY SUPPLEMENTS
The Food and Drug Administration (FDA) published its final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Under the DSHEA, dietary supplements may bear "structure/function" claims, claims that the products affect the structure or function of the body, without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate, or diagnose disease (a disease claim). This final rule describes how the FDA will distinguish disease claims from structure/function claims. While this rule should not affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under the DSHEA and therefore may result in some labeling changes for these products.
The final rule precludes express disease claims ("prevent osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains aspirin), or through the use of pictures, vig-nettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims ("maintains a healthy circulatory system"), other non-disease claims ("for muscle enhancement," "helps you relax"), and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes").
In response to comments from industry and consumers, the FDA made several significant changes in the final rule. These changes, which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of "disease" in response to comments that it was too broad and permitting structure /function claims about certain common conditions associated with aging, pregnancy, menopause, and adoles-cence. Serious conditions associated with aging, pregnancy, menopause, and adolescence, such as toxemia of pregnancy, and osteoporosis, will continue to be treated as diseases.
Under the DSHEA and existing regulations, dietary supplement manufacturers are already required to have, in their files, substantiation of any structure/function claims they make. They must also include a disclaimer on their labels that the dietary supplements are not drugs and receive no FDA pre-market approval. Finally, they must notify the FDA of the claims they are making within 30 days of marketing a given dietary supplement.
The FDA believes that this rule, which clarifies appropriate structure/function claims, will ultimately provide consumers with better information on dietary supplement labeling that will help them select appropriate products. The issuance of this rule is an important part of the FDA's overall dietary supplement strategy, which was ann-ounced on January 5, 2000, and which is aimed at providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.
The rule was published in the January 6, 2000 Federal Register and will become effective 30 days after the date of publication. Any product that is marketed for the first time after the date of publication and any new claims made for an existing product for the first time after publication will be expected to comply with the rule beginning 30 days after publication. Small businesses that marketed a product as of the publication date will have an additional 17 months to bring existing claims into compliance and all other products that were on the market as of the publication date will have an additional 11 months to bring existing claims into compliance.
Source: Press Release, January 5, 2000; The Food and Drug Administration (FDA).
MEDICARE COVERAGE FOR NUTRITION
A new report released by the National Academy of Sciences’ Institute of Medicine (IOM) recommends expanding Medicare benefits to cover nutrition therapy in outpatient and home settings if a doctor approves the counseling and a registered dietician provides the service. Regardless of the cost, which is estimated at $1.4 billion over five years, the IOM recommends covering nutrition therapy for Medicare beneficiaries because of "reason- able evidence of improved patient health."
Currently, Medicare routinely covers nutrition therapy for patients admitted to hospitals, but not in out-patient or home care settings. Because nutrition therapy is an effective tool for the management of diabetes, high cholesterol, and hypertension, at least one of which affects 86 percent of elderly Americans, IOM recommends that nutrition counseling be a reimbursable Medicare benefit.
IOM completed its study "The Role of Nutrition in Maintaining Health in the Nation’s Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population" upon the request of Congress as part of the 1997 Balanced Budget Act.
Supporters of the Medicare Medical Nutrition Therapy Act, which has received widespread support in Congress needs to finally pass the bill.
"The Institute of Medicine has clarified the need for Medicare to cover these invaluable services," said Ann Gallagher, president of the American Dietetic Association. "This is good for patients and their families as well as the entire Medicare program. Now it’s up to Congress to make it happen."
Source: Nutrition Week; Vol. XXIX No. 47; December 17, 1999; p. 8.
A CALCIUM SUMMIT: DEVELOPING A PUBLIC HEALTH STRATEGY TO ENSURE AMERICA’S OPTIMAL CALCIUM INTAKE
Calcium deficiency is epidemic in the United States, in large part because of the three-decade decline in consumption of milk, a major source of this nutrient. A diet low in calcium may contribute to osteoporosis, hyper-tension, colon cancer, and other chronic diseases. Improving the nation’s calcium status could have a positive impact on Americans health and the nation’s escalating healthcare costs.
To develop a public health strategy to ensure Americans’ optimal dietary calcium intake, the first-ever Calcium Summit was held on June 25, 1999, in Washington, DC. During the event, which was attended by nearly 250 leading health professionals, researchers, and government officials, leaders from more than 30 nutrition and health organizations signed on to the Calcium Coalition. Coalition leaders are committed to "optimizing the calcium intake of Americans to help improve health and reduce chronic disease risk."
National and international authorities in the fields of calcium, public health, and consumer behavior presented information on the following:
¨ Americans’ low calcium status beginning in childhood.
¨ Challenges related to increasing calcium intake.
¨ Why calcium from foods such as dairy foods is the preferred source of this nutrient.
¨ Why we need calcium throughout life.
¨ How calcium may help protect against major chronic diseases including osteoporosis, hypertension, and possibly colon cancer.
¨ How programs involving collaborations among educators, health professionals, the media, and the private and public sectors can reach all segments of the population to increase dietary calcium intake.
The Calcium Summit participants identified new strategies for educators, government, health profes-sionals, and industry to help them increase the public’s awareness of dietary calcium and close the calcium gap. Included among the suggestions were to:
¨ Educate teachers, coaches, mothers, and targeted health professionals (e.g., physicians, allied health providers) who, in turn, could be role models.
¨ Encourage pediatricians and family physicians to be proactive in suggesting consumption of dairy foods as a source of calcium and vitamin D to their patients.
¨ Include questions related to calcium and dairy food intake in nutrition screening tools.
¨ Communicate simple, consistent, positive dietary calcium messages such as "drink at least 3 glasses of milk a day."
¨ Increase the public’s access to calcium-rich foods such as milk.
¨ Build and strengthen partnerships among Coalition members and others.
¨ Make the Calcium Summit the starting point for a dialogue among leading health organizations.
The Calcium Summit was sponsored by the National Dairy Council and the Milk Processor Education Program (MilkPEP).
If you are interested in obtaining copies of the complete summary, please call 1-800-WHY-MILK (Please note limited quantities are available). You can also log onto www.nationaldairycouncil.org to download a reproducible copy of the Calcium Summit Summary.
Source: National Dairy Council; Calcium Summit; June 25, 1999, Washington DC
ENJOYING CARBOHYDRATES WITH DIABETES
Planning an eating strategy for diabetes? You don’t need special foods or a rigid meal plan. You don’t need to avoid certain foods, either. In fact, there’s no single meal plan for diabetes. Instead, a personalized, flexible approach works best: one your healthcare professional helps you create to match your nutrition needs, health, treatment goals, tastes, and lifestyle!
Good nutrition principles, variety, balance, and moderation apply to diabetes management. So carbo- hydrate-rich foods fit right in. Focus on those low in fat and high in complex carbohydrates (starches), other nutri-ents, and fiber. Keep your blood glucose and blood lipid levels, as well as weight goals, in mind as you make food choices.
Ins and Outs of "Carbs"
¨ Diabetes affects how your body uses food energy. What’s the link to carbohydrates? "Carbs," your body’s primary energy source, come from a variety of foods: complex carbohydrates from grain products, vegetables, legumes, and fruit; and sugars from fruit, milk, some vegetables, and sweets.
¨ Eventually all carbohydrates break down into glucose, which is carried in your blood as "blood sugar." Insulin, a hormone, lets blood sugar enter your body cells where it’s used for energy.
¨ People with diabetes may not produce enough insulin, or perhaps their bodies can’t use it properly. As a result, carbohydrates and other energy nutrients aren’t used normally. That causes swings in blood sugar levels, and affects their health and how they feel.
¨ For many individuals with diabetes, carefully managed eating, physical activity, and weight control are enough to control blood sugar levels. Others need diabetes pills or insulin injections.
Truths Behind "Carb" Myths
Myth: Eating sugar or too much carbohydrate causes diabetes.
Truth: Diabetes is a complex condition, related to health status, genetics, obesity, and aging.
Myth: People with diabetes can’t eat foods with sugar.
Truth: People with diabetes can eat any food, in moderation, with careful planning. Total carbohydrates, not their sources, affect blood sugar levels. In fact, complex "carbs" and sugars increase blood sugar levels at about the same rate. Bottom line: look at the total "carb" picture, not just sugar content, for diabetes management!
Fitting Carbohydrates In
For many individuals with diabetes, the Food Guide Pyramid and the Dietary Guidelines for Americans provide enough menu-planning guidance for fitting in carbohydrate-rich foods and keeping blood sugar levels normal. Others may use the diabetic exchange system or carbohydrate counting.
The Food Guide Pyramid
The Pyramid shows a range of nutrient-rich servings from five food groups. Although each has its unique nutrient profile, each group supplies at least some foods with carbohydrates: complex "carbs," mostly from the Bread Group, Vegetable Group, and from legumes in the Meat Group; and sugars, mostly from the Fruit and Milk Groups.
¨ Find out how many Pyramid servings match your energy needs and help keep your weight within a healthful range.
¨ Pick your "carbs" wisely, mostly with foods that deliver complex carbohydrates, other nutrients, and fiber, without too much fat or added sugars.
¨ Go easy on sugary and high-fat foods from the Pyramid tip (Fats, Oils, and Sweets).
The Diabetic Exchange System
This approach puts foods into groups that are based on similar amounts of carbohydrates, protein, fat, and calories. For the right amount and balance of energy nutrients, your health professional can recommend a daily plan that includes exchanges from each group.
Carbohydrate Counting
This approach helps you track how many carbohydrate grams you consume daily. You adjust your menu plans, depending on your blood sugar levels.
Whatever your approach, include a variety of nutrient-rich foods, with the percent of calories from carbo-hydrates that your health professional recommends for you. Let’s say that you’re advised to eat 60 percent of your calories from carbohydrates. In a 2,000-calorie daily eating plan, that’s 1,200 calories from total "carbs" or 300 carbohydrate grams. (One carbohydrate gram provides 4 calories.) Your own calorie needs depend on your age, activity level, and body size.
Food Labels: Use the Facts
Nutrition Facts on food labels make menu planning for diabetes easier.
¨ Serving sizes: In managing diabetes, serving sizes are important. Eating too much or too little affects blood sugar levels and body weight. Be aware: label servings may differ from Pyramid or exchange list servings. A one-cup label serving of oatmeal counts as 2 bread group servings or 2 starch exchanges. Use label serving sizes to compare "carbs," other nutrients and calories in similar foods.
¨ Daily Values (DVs): Use % DVs to see how much you consume in one serving. Your needs may be higher or lower than 100% DV; Nutrition Facts are based on a 2,000-calorie daily plan. Because heart disease risk goes up with diabetes, look for foods with low DVs for fat, saturated fat, and cholesterol, and with high DVs for fiber.
¨ Total Carbohydrates: For carbohydrate counting, check the grams of total carbohydrate, not just sugars, in one serving.
Keeping Blood Sugar Levels Steady
For people with diabetes, keeping blood sugar at a steady level means planning and regular "refueling" stops.
¨ Plan Today for Tomorrow. Meal planning requires forward thinking, perhaps making breakfast and sack lunches before bedtime. Remember: stick with your plan!
¨ Eat Regularly. Have some carbohydrates in each of your meals and snacks, about every four hours. Meal skipping can lead to ravenous hunger and overeating or to an eating pattern that’s not in tune with managing diabetes.
¨ Carry Snacks Along. Graham snacks, crackers, pretzels, and fruit make quick, easy snacks when you need to eat.
¨ Trade Off. If you eat starchy foods at one meal or snack, cut back on sugary foods, and vice versa. If you want both, consider sugar substitutes and sugar-free alternatives, such as sugar-free jelly, beverages, or desserts.
With good nutrition, you can manage diabetes, delay its complications, and, perhaps, prevent obesity-related diabetes. If you have diabetes, ask a registered dietitian or diabetes educator to help you devise a workable, enjoyable plan for healthful eating and physical activity. The time you spend learning pays off in the long run.
Source: Nutrition Update; Fall/Winter 1999.
CARBOHYDRATE COUNTING HINTS FOR DIABETICS
You may have counted fat grams. Carbohydrate counting is similar! Just count the total grams of carbohydrate in your food and beverages. This helps you predict where your blood sugar level is going if you have diabetes. A rule of thumb: the more carbohydrates you consume, the higher your blood sugar level.
Carbohydrates counting allows flexibility in your food choices. If you eat about the same number of carbohydrate grams at the same time each day, "carbs" may come from any type of food. Food group foods, such as: breads, crackers, and cereals; pasta, rice, and grains; legumes and peanut butter; vegetables; milk and yogurt; and fruit and juice, are all good choices because they supply plenty of vitamins and minerals, too. Sweets have "carbs" but fewer minerals and vitamins.
"Carb" counting also accommodates your eating schedule, your lifestyle, medications, and changes in your normal routine. If you choose carbohydrate counting as your approach to managing diabetes:
¨ Have a registered dietitian or diabetes educator help you determine how many "carbs" you need at each meal and snack, and when. Discuss your typical eating habits and figure out how many "carbs" you consume. Together make an eating plan that meets your carbohydrate, nutrition, and health needs.
¨ On packaged foods, find the number of total carbohydrate grams per serving on the Nutrition Facts label. Remember that the food’s serving size (gram weight) usually isn’t the same as its grams of carbohydrate. For example, a serving of food weighing 30 grams may contain just 15 grams of carbohydrate.
¨ Use measuring cups or a food scale to weigh and measure portions. Compare these to label serving sizes. Figure how many grams of total carbohydrate are in your portions.
¨ For un-packaged foods, get a book with carbohydrate facts. Ask for nutrition information from restaurants. Learn how many "carbs" one serving provides. You’ll need practice with mixed foods, such as pizza and lasagna, too.
¨ To make carbohydrate counting easier and more accurate, get to know serving sizes for Exchanges Lists. Practice measuring! One carbohydrate choice, starch, fruit, milk and "other carbohydrates" exchange, contains about 15 carbohydrate grams.
¨ Keep your total carbohydrate intake at any meal or snack within 5 grams of your target.
Source: Nutrition Update; Fall/Winter 1999.
PEDIATRICIANS CAN HELP WIN SUPPORT FOR STUDENT DIABETES REGIMEN
The treatment of diabetes mellitus in children and youth has intensified over the past few years as a result of the findings of the Diabetes Control and Complications Trial (1). This landmark study showed that controlling blood glucose levels markedly lessens the complications of diabetes. Consequently, children with diabetes are experiencing more hypoglycemia because of the approach to keep blood glucose levels in the near-normal range. Improved technologies designed to control diabetes (e.g., new insulin analogues, new delivery methods such as the insulin pens, and the insulin pump) are making the management of diabetes more effective, but not less complicated for the inexperienced person.
Every child with diabetes must be able to follow a specific diabetes treatment plan if one hopes to decrease the risk of long-term complications of this disease. This plan, as agreed upon by the parents and diabetes team, should be communicated in writing to the school and should include a release allowing the school to communicate directly with the child’s physicians. Schools must be aware that they have the responsibility to help all children achieve academic success and to be as physically healthy as possible without regard to their dis-ease or disability. As outlined by the American Diabetes Association Position Statement on the Care of the Child with Diabetes in School, it is imperative that all schools allow children to:
1. Test their blood glucose level before lunch, and at other times if indicated. This should ideally occur in the classroom so the child’s learning is not disrupted. Also, asking a child who might be hypoglycemic to go from the classroom to another part of the school (e.g., the nurse’s office) subjects the child to potentially dangerous and life-threatening delay in treatment;
2. Administer insulin according to the child’s routine schedule or at other times, if indicated, to correct abnormal blood glucose levels; and
3. Treat hypoglycemia with oral glucose in the classroom or with the emergency action of parenteral glucagon by school personnel.
To further ensure safety, each school site must have specific personnel with appropriate knowledge, attitude, and skills who are responsible for assisting the child when necessary and for contacting the diabetes team, and all children require that someone at the school be able to administer glucagon to treat severe hypo-glycemia (2).
Pediatricians should advocate for their patients’ needs by helping families of children with diabetes obtain all necessary support while the child is at school. This includes informing the school about the child’s diabetes regimen, working with the child’s school personnel’s questions (on a general and urgent basis), assisting the school with management and emergency plans, and changing school board policies, if needed. Improving the long-term outcome for children with diabetes is possible, but only with the help and collaboration of medical providers and the schools.
Adapted from: Kaufman F and Taras H. AAP News 15(12), December 1999.
References:
1. Lasker RD. The diabetes control and complications trial. Implications for policy and practice.
New Eng J Med, 1993, Sept 30, 329(14):1035-6.
2. Matyka KA, Crowne EC, Havel PJ, et al. Counterregulation during spontaneous nocturnal hypoglycemia in prepubertal children with type 1 diabetes. Diabetes Care, 1999 Jul, 22(7):1144-50.
CONSUMER ATTITUDES TOWARDS FUNCTIONAL FOODS
The International Food Information Council (IFIC) has been directing a four-year research effort on "functional foods" (foods that may provide health benefits beyond basic nutrition) to find out how consumers obtain, process, and use information to make decisions about their diet. Specifically, IFIC research explores consumer attitudes toward the concept of functional foods using both qualitative and quantitative methods.
The most recent focus groups, conducted in the spring of 1999, compared how two different consumer segments responded to the same information on functional foods. The two segments included unmotivated consumers who were aware of the connection between diet and health but had not made significant changes to their diet. The second segment consisted of motivated consumers who were aware of the diet and health connec-tions and had changed their diet based on such information.
Interestingly, the unmotivated consumers expressed a high degree of skepticism about news media and other sources of information on diet and health. They cited numerous excuses for not changing their diets: they "don’t have the time to prepare the right foods"; they "don’t like the taste of many foods thought to be beneficial"; and "there’s no convincing evidence that diet makes a difference." Even those consumers who cited having close relatives become victims of heart disease or cancer would not sacrifice taste or convenience to improve their diet. The good news is that many did say that they might be open to consuming a beneficial component that had been added to a food they already liked. Calcium-fortified orange juice was a popular example.
Motivated consumers, on the other hand, regularly absorb and believe in a tremendous amount of infor-mation on diet and health. These consumers, empowered by knowledge from multiple, credible sources, really believe they have control over their own health. Unlike the unmotivated, these consumers want to avoid repeating the experience of a close relative who contracted disease. Some were also influenced to make changes by a warning from a physician about their own state of health. Others could cite a positive personal experience or had always been conditioned to recognize the positive impact of food on health.
Learning more about consumer motivaters for choosing functional foods is increasingly important. This year has been a real crossroads in terms of realizing their promise. Foods and dietary supplements containing soy protein or plant sterols to reduce the risk of cardiovascular disease will continue to be at the center of atten-tion. Uncertainties about regulatory boundaries will provide challenges. Responsibly communicating the benefits of functional foods may be the key to advising consumers about this new and exciting opportunity to optimize diet and health.
Adapted from: International Food Information Council Foundation Food Insight; September/October 1999; pp. 6-7.
President Clinton announced a new safety plan last week that he hopes will cut in half the number of eggs contaminated with Salmonella by 2005, and eliminate Salmonella contamination in eggs entirely by 2010. The President’s Council on Food Safety identified eggs as a food that poses a risk to children, the elderly, and people with compromised immune systems.
Americans consume an average of 234 eggs a year per person. While it is estimated that only one in 20,000 eggs is contaminated with Salmonella, this involves over 3.3 million eggs a year. "Every year, Salmonella bacteria causes about 300,000 cases of illness," Clinton said in his weekly radio address. And when infected eggs still make it from the farm to the table, we know we have more work to do."
The President’s "aggressive action plan" is composed of two strategies. The first strategy involves rigor-ous agricultural practices on the farm, including extensive testing for Salmonella. The second strategy incorpor-ates the use of new technologies like in-shell pasteurization at packing plants.
The plan also consolidates egg safety oversight between the Food and Drug Administration, the US Department of Agriculture’s Food Safety and Inspection Service (FSIS), and the Centers for Disease Control and Prevention. The FSIS plans to implement the Hazard Analysis and Critical Control Points inspection system (HACCP) for egg products.
Clinton also announced new initiatives in safeguarding imported food, including stronger efforts to prevent "port shopping," which occurs when a shipper takes a rejected product from one port to another.
Source: Nutrition Week; Vol. XXIX No. 47; December 17, 1999; p. 7.
LEAD TEST A MUST FOR MEDICAID ENROLLEES
It is a legal requirement that children enrolled in Medicaid be tested for lead poisoning. While children enrolled in Medicaid in some states ultimately may be shown to be at low risk, no waivers of this legal requirement now exist. The Health Care Financing Administration (HCFA) has not yet set criteria for such waivers.
These children enrolled in Medicaid have a greater chance of having elevated blood lead levels than other children, according to a study released by the US General Accounting Office (GAO) in January.
Using national data on children’s blood lead levels from 1991 through 1994, the GAO showed that 60 percent of all children with blood lead levels above 10 µg/dL were enrolled in Medicaid. Of those above 20 µg/dL, at least 83 percent were enrolled in Medicaid.
In addition, only 20 percent of children enrolled in Medicaid during the same years had been tested for lead poisoning. About one-third of all children are enrolled in Medicaid.
Since 1989, federal law has required that children enrolled in Medicaid be screened for lead poisoning. HCFA policy calls for children enrolled in Medicaid to have their blood lead measured at 12 and 25 months of age, while children ages 36 to 72 months should be tested if they were missed (1).
The Health Center Program administered by the Health Resources and Services Administration also requires that primary health services provided by its centers include screening for elevated blood lead levels. The program provides primary care services in medically under-served areas.
Source: AAP News 15(12), December 1999.
Resource: State Medicaid Manual. September 1998. Paragraph 5132.2.
Colic is an incompletely understood condition involving intermittent, unexplained excessive crying, usually occurring in the first four months of life. It occurs in both breast-fed and formula-fed infants. Some cases of severe colic are related to sensitivity to proteins in cows’ milk. Thus, some formula-fed babies with colic will improve if switched to a milk-free formula. In breast-fed babies, some cases of colic may be related to the mother’s diet. Maternal intake of cruciferous vegetables, cows’ milk, onion, and chocolate has been associated with colic symp-toms in breast-fed infants.
Colic in breast-fed infants may improve if the mother avoids certain foods. Dietary changes (for the infant or the nursing mother) are worth trying under the guidance of the infant’s health care provider. However, it is certainly not necessary to eliminate dairy products from the diets of all nursing mothers or to recommend milk-free formulas for all formula-fed infants.
Source: The American Council On Science and Health Presents Much Ado About Milk; Second Edition; October 1999; pp. 16-17.
INTERNET SOURCES FOR SOUND NUTRITION AND HEALTH INFORMATION
¨ Tufts University Nutrition Navigator: http://navigator.tufts.edu
¨ The American Dietetic Association: http://www.eatright.org
¨ The International Food Information Council Foundation: http://ificifo.health.org
¨ Medline: http://www.nlm.nih.gov/databases/freemedl.html
¨ National Institutes of Health: http://www.nih.gov
¨ The US Food and Drug Administration: http://vm.cfsan.fda.gov
¨ Mayo Health Oasis (of the Mayo Clinic): http://www.mayohealth.org
¨ John Hopkins Health Information: http://intelihealth.com/IH/ihtIH
¨ World Health Organization: http://www.who.int
¨ Food & Agriculture Organization: http://www.fao.org
¨ Government health finder: http://www.healthfinder.gov
Adapted from: Food Insight, IFIC Foundation. May/June 1999.
YEAR 2000 CALIFORNIA WIC ASSOCIATION ANNUAL CONFERENCE
Monday March 27, 2000 — Wednesday, March 29, 2000
Anaheim Hilton Hotel, Anaheim, CA
The California WIC Association (CWA) invites you to its 2000 Annual Conference entitled, "CLICK on WIC: Serving Communities in the New Millennium." In addition to highlighting the latest programs and services for women, infants, and children, this year’s conference will focus on the technology that will enhance the WIC programs to help better serve women, infants, and children in the new millennium.
For more information, contact the CWA: Tel: 916.448.2280 Fax: 916.448.7826 Email: cwa@tomatoweb.com
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