UNIVERSITY OF CALIFORNIA
COOPERATIVE EXTENSION

NUTRITION PERSPECTIVES
Volume 25, No. 4
Jul/Aug 2000


TABLE OF CONTENTS    

Ephedra, A Weight Loss Supplement?
New Pediatric Growth Charts Provide Tool to Ward Off Future Weight Problems
The USDA Unveils New Nutrition Mascot for Children
Physical Activity Reduces Stroke Risk In Women
Dietary Reference Intakes: Applications In Dietary Assessment
Treating Hypertension In the Patient With Type 2 Diabetes
Blood Pressure-Lowering DASH Diet Also Reduces Homocysteine
The DASH Diet
Hormone Replacement Therapy’s Benefit for Coronary Heart Disease ..... Benefits of Diet and Lifestyle Modification
Zinc Acetate Lozenges Reduce Duration of Common Cold
Sugars and Health
Complementary & Alternative Medicine: What RDs Should Know
The American Academy of Pediatrics Promotes Good Nutrition in School
Well-Being Improves for Most Older People, But Not for All
The FDA Authorizes New Coronary Heart Disease Health Claims for Plant Sterols and Plant Stanol Esters
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 California, Davis, California. Cost is ten dollars ($10.00) for a one-year subscription. Subscriptions and questions or comments on articles may be addressed to: NUTRITION PERSPECTIVES, University of California, Department of Nutrition, One Shields Ave., Davis, CA 95616-5270. Phone (530) 752-3387; Fax (530) 752-8905.

EPHEDRA, A WEIGHT LOSS SUPPLEMENT?

            Weight loss seems to be a constant struggle for many Americans.   In the search for a thinner and more energetic body, individuals often opt for quick and convenient methods of weight loss rather than utilize more traditional means, i.e. exercise and balanced meals.  Herbal weight loss supplements, especially those containing ephedra, are the latest trend. It is estimated that 3 million doses of ephedra-containing products are taken per year.  Unfortunately, accompanying this trend is the possibility of health risks, even death.

What is Ephedra?

            Ephedra is also known as Ma huang, its Chinese name.  Ephedra is a shrub that contains the chemical, ephedrine.  Ephedrine acts as a stimulant similar to methamphetamine (1).

How is Ephedra used in traditional Chinese medicine?

            In traditional Chinese medicine, ephedra is used to alleviate the symptoms of colds and the flu.  Treatment with ephedra is recommended in small doses and for no longer than 2 weeks.

Is ephedrine related to pseudoephedrine?

            Psuedoephedrine is the man-made or synthetic version of ephedrine.  Psuedoephedrine can be found in various over-the-counter drugs such as Sudafed and Sinutab.  The active component in these drugs have been shown in clinical tests to alleviate cold symptoms with fewer side effects than ephedrine.

What popular formulations contain ephedra?

            The main active ingredient of many herbal-weight loss supplements on the market is ephedra.  One example of such a supplement is Metabolife 356.  This product contains 12 mg of ephedrine alkaloids in addition to “natural” caffeine.   Ephedra is found in more than 200 drinks, diet pills, liquid drops, powders, teas and supplements.

What is the presumed effect of ephedra-containing supplements?

            Proponents of these supplements claim that ephedra helps to increase a person’s metabolism.  An increase in metabolism would help an individual burn fat more efficiently, therefore leading to weight loss.  Ephedra is also touted as an energy booster and, thus is attractive to a variety of individuals.

Has research been conducted to test the efficacy of ephedra in reducing weight?

            Two studies consisting of an adequate number of subjects were conducted by a group in Denmark.  Ephedrine was combined with caffeine and given to subjects (2,3). Neither study demonstrated that ephedrine was effective as a weight loss supplement. Other studies have shown some beneficial effects, however, the studies had a small number of subjects and were poorly controlled.   More rigorous testing of ephedra is needed to determine its efficacy and risks (2,3,4).

Are ephedra containing products regulated by the Food and Drug Administration?

            Ephedra-containing products are regulated by the FDA as dietary supplements and, unlike pharmaceuticals, are not required by law to undergo strict tests for safety and efficacy.   A recent study found that ephedra doses varied tremendously among 20 products (1).  Values from 0.0 mg to 18.5 mg were found among the ephedra-containing products tested. There were also discrepancies between the actual content and what was reported on the label.  In some instances, the dose was greater than the label claimed to be in the supplement.

            In some of the products tested, ephedra was combined with a natural caffeine source.  Some reports have shown that ephedra, in combination with caffeine, could lead to serious side effects because of enhanced stimulatory effects.

What has the FDA done to ensure that ephedra products are safe?

            The FDA cannot remove a product from the market unless it can prove that the supplement is unsafe.  In 1997, the FDA proposed a regulation that would prohibit the marketing of dietary supplements containing more than 8 mg of ephedrine alkaloids in a six hour period, or 24 mg daily and would prohibit the use of other stimulant ingredients such as botanical sources of caffeine in such products (5).  Furthermore, the FDA warned that pregnant women and individuals who suffer from hypertension, heart conditions, and neurologic disorders should not consume ephedrine alkaloids.  The FDA also proposed to require a label to inform consumers to not take the product for more than 7 days and to state that taking more than the recommended serving may result in heart attack, stroke, seizure or death.  As a result of a 1999 Government Accounting Office (GAO) report calling for additional evidence to support the proposed limits and duration of use, the FDA has withdrawn that portion of the proposed regulation pending a reassessment.  In March, the agency made publicly available the evaluation of an additional 140 adverse event reports (6).  The Office of Women’s Health in the Department of Health and Human Services also recently held a public meeting to hear testimony on the risk assessment of products containing ephedrine alkaloids, and the FDA has reopened the comment period until September 30.

 Have there been any other attempts to regulate ephedra-containing products?

            A bill (AB2294) recently introduced in the California legislature would impose restrictions on dietary supplement products containing ephedrine group alkaloids sold in the state of California.  This bill passed the Assembly in May, 2000 and is currently in the Senate Committee on Appropriations.

Is ephedra safe to use?

            There have been several case reports published linking ephedra use to high blood pressure, insomnia, anxiety, kidney damage, stroke, and heart and liver problems (1,7,8,9), while other studies show modest weight loss with few side effects. Given the conflicting information about the effectiveness of ephedra containing products, individuals should be cautious when consuming these dietary supplements.  In general, weight loss should entail safe methods such as exercise and calorie-reduction in the context of a healthy, balanced diet.  Therefore, the consumption of ephedra is not generally recommended by health professionals.  However, if one should choose to take dietary supplements, consult your doctor.

References:

1.   Gurley BJ, Gardner SF, Hubbard MA, Content versus label claims in ephedra containing dietary supplements, American Journal of Health-Systems Pharmacy, 2000, 57:963-969.

2.   Toubro S, Astrup A, Breum L, Quaade F.  The acute and chronic effects of ephedrine/caffeine mixtures on energy expenditure and glucose metabolism in humans. International Journal of Obesity and Related Metabolic Disorders, 1993 Dec, 17 Suppl 3:S73-7

3.   Toubro S, Astrup AV, Breum L, Quaade F.  Safety and efficacy of long-term treatment with ephedrine, caffeine and an ephedrine/caffeine mixture. International Journal of Obesity and Related Metabolic Disorders, 1993 Feb, 17 Suppl 1:S69-72.

4.   Breum L, Pedersen JK, Ahlstrum F, Frimodt-Muller J.  Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity. A double-blind multi-centre trial in general practice. International Journal of Obesity and Related Metabolic Disorders, 1994 Feb. 18(2):99-103.

5.   FDA Press Release: FDA Proposes Safety Measures for Ephedrine Dietary Supplements, June 2, 1997.

6.   FDA Press Release, FDA Announces the Availability of New Ephedrine and “Street Drug Alternative” Documents, March 31, 2000.

7.   Nadir A, Agrawal S, King PD, Marshall JB.  Acute hepatitis associated with the use of a Chinese herbal product, ma-huang. American Journal of Gastroenterology, 1996 Jul, 91(7):14368.

8.   White LM, Gardner SF, Gurley BJ, Marx MA, Wang PL, Estes M. Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults. Journal of Clinical Pharmacology, 1997 Feb, 37(2):116 22.

9.   Zaacks SM, Klein L, Tan CD, Rodriguez ER, Leikin JB.  Hypersensitivity myocarditis associated with ephedra use. Journal of Toxicology, 1999, 37(4):485-9.

Caroline Kurtz, Graduate Student

 

NEW PEDIATRIC GROWTH CHARTS PROVIDE TOOL TO WARD OFF FUTURE WEIGHT PROBLEMS

            The US Department of Health and Human Services (HHS) Secretary, Donna E. Shalala, announced the release of new Centers for Disease Control (CDC) pediatric growth charts that are not only updated and more representative of the US population, but which will now include a new assessment for body mass index (BMI). This key tool will help identify weight problems early on in children. These growth charts will be used by pediatricians, nurses, and nutritionists to monitor children’s growth.

            Secretary Shalala and Surgeon General David Satcher also announced that the Surgeon General will convene a workshop this fall to develop a national action plan to address weight problems and obesity.

            Most parents are familiar with the original growth charts used by pediatric health care providers since 1977 and adopted by the World Health Organization for international use since 1978. In fact, they are the most widely used tools to track growth and development in children and assist in signaling potential developmental problems. The charts consist of a series of curves called “percentiles” that illustrate the distribution in growth of children across the United States. The new BMI measure increases the usefulness of this tool significantly.

            “One of the first questions people ask new parents is `how much did your baby weigh?' From that moment on, growth charts are a reference point for parents as their children grow into adolescence and adult-hood,” said Secretary Shalala at the National Nutrition Summit in Washington, DC. “The new charts not only provide a more accurate gauge for pediatric health care providers, but the BMI information offers them a new tool that can identify kids who have the potential to become overweight down the road. The BMI is an early warning signal that is helpful as early as age 2. This means that parents have an opportunity to change their children’s eating habits before a weight problem ever develops.”

            The BMI is a single number that evaluates an individual's weight status in relation to height. BMI is generally used as the first indicator in assessing body fat and has been the most common method of tracking weight problems and obesity among adults. Health care providers now know that as early as age 2, children can demonstrate their propensity for future weight problems if they have a high ratio of body fat and a family history of weight problems.

            “Parents should partner with pediatricians to track their child’s growth,” Shalala said. Individual health care providers are in the best position to effectively evaluate growth and any possible development problems, especially because of information provided with the new CDC charts.”

            The revised pediatric growth charts more accurately reflect the Nation’s cultural and racial diversity and track children and young people through age 20. Additionally, there is considerable improvement in the infant growth charts where new data and improved statistical procedures have been useful in the revision process.

            CDC's new charts are based on data gathered through the National Health and Nutrition Examination Survey (NHANES), the only survey that collects data from actual physical examinations on a cross-section of Americans from all over the country. This survey showed that in the past two decades the number of overweight children and adolescents has doubled. Additionally, it showed that over one-half of all American adults are over-weight and that the number of obese adults has doubled. Health care providers hope that the new BMI charts will help address this nationwide problem. The growth charts indicate that, in general, children are heavier today than in 1977, but height has remained virtually unchanged.

            “Obesity is a condition that is difficult to treat clinically in children, so prevention is key,” said CDC Director Jeffrey P. Koplan. MD, MPH. “These new CDC charts are an important new tool to identify growth problems at an early age so we can better prevent excess weight gain.” The new charts are published in a report, “CDC Growth Charts: United States.” The report and the corresponding data will be available on the CDC Web site at: http://www.cdc.gov/growthcharts . A more comprehensive report will follow in the fall.

Source: Press Release; Advance Data 314. 28 pp. (PHS) 2000-1250; May 30, 2000.

 

 

THE USDA UNVEILS NEW NUTRITION MASCOT FOR CHILDREN

            Agriculture Secretary, Dan Glickman, introduced American kids to the great purple Power Panther, the USDA's new mascot to encourage children and their families to eat healthy and exercise.

            “This new character gets your attention for an important public service message. It teaches children the importance of balancing what you eat with what you do,” said Glickman, speaking to the American School Food Service Association (ASFSA). “The right behaviors now can prevent serious health problems later in life.”

            Dietary habits are established very early in life. More than 14 percent of children and 11 percent of adolescents are overweight, often as a result of poor nutrition. Healthy eating and physical activity are important life skills that help children grow and develop to their optimal potential.

            The national, healthy eating and physical activity campaign is designed to reach school-aged children (age 2 - 18 years) and their caregivers through materials and activities that incorporate the Power Panther and it's message, “Eat Smart, Play Hard.” Caregivers include parents, guardians, childcare providers, after school providers, and teachers.

            The campaign slogan EAT SMART, PLAY HARD and the Power Panther nutrition mascot will be used in Federal, State, and local nutrition program materials. Partnerships to distribute these educational materials will be developed with non-profit, corporate, and local cooperators. Health and nutrition group partners include: the American Dietetic Association, the American School Food Service Association, the National Association of WIC Directors, the President's Council on Physical Fitness and Sports, the Society for Nutrition Education, and the International Food Information Council. Dan Glickman's comments to ASFSA can be found at: http://www.usda.gov/news/releases/2000/07/0242.htm .

Source: Press Release: American School Food Service Association; July 18, 2000.

 

PHYSICAL ACTIVITY REDUCES STROKE RISK IN WOMEN

            Physical activity reduces cardiovascular risk via several mechanisms. This analysis of data from the Nurses’ Health Study suggests that physical activity's benefits extend to cerebrovascular disease as well (1). Researchers describe rates of stroke from 1986 through 1994 in 72,488 female nurses who completed detailed physical activity questionnaires in 1986, 1988, and 1992.

            Women who were more physically active tended to be leaner and less likely to smoke cigarettes. During the study period, there were 407 strokes: 258 ischemic strokes, 67 subarachnoid hemorrhages, 42 intracerebral hemorrhages, and 40 strokes of unknown type. There was a clear dose-response effect between physical activity and a lower risk for stroke. When the women were divided into quintiles on the basis of increasing physical activity, the age-adjusted relative risks for stroke were 1.00, 0.87, 0.68, 0.57, and 0.49, respectively (P<0.00I for trend). Statistical adjustment for other clinical variables did not change the relation between activity and stroke risk meaningfully. Although physical activity was associated with lower risk for ischemic stroke, it did not correlate with risk for hemorrhagic stroke. These findings provide yet another reason to encourage physical activity in the interest of reducing cardiovascular and cerebrovascular risk.

Reference:

1.   Hu FB et al. Physical activity and risk of stroke in women. JAMA 2000 June 14, 283.-2961-7.

Source: Journal Watch ; July 15, 2000, p. 11.

 

DIETARY REFERENCE INTAKES: APPLICATIONS IN DIETARY ASSESSMENT

            The Institute of Medicine is releasing Dietary Reference Intakes: Applications in Dietary Assessment, a report providing guidance on the interpretation and appropriate application of dietary reference intakes (DRIs): a set of reference values that can be used for assessing and planning diets. This report explains how each of the new DRIs, Estimated Average Requirements (EAR), Recommended Daily Allowances (RDA), Adequate Intakes (AI), and Tolerable Upper Intake Levels (UL), of nutrients can be used to assess and evaluate the nutritional adequacy of diets. Different approaches are outlined for dietary assessment of populations for public health purposes and individuals for nutrition counseling. The report also contains recommendations for research to improve estimates for nutrient requirements, the quality of dietary intake data, and statistical methods for using DRIs to assess intakes of individuals and groups. To access the report, go to the National Academy Press website at: http://www.nap.edu/   and select “Browse Categories.”  Then select the option “Food & Nutrition.”  You should see the title “Dietary Reference Intakes: Applications in Dietary Assessment” in the listed publications.

Source: Press Release; Institute of Medicine; August 18, 2000.

 

TREATING HYPERTENSION IN THE PATIENT WITH TYPE 2 DIABETES

            A new clinical advisory issued by the National High Blood Pressure Education Program (NHBPEP) recommends that physicians pursue a more aggressive treatment approach to lower the blood pressure of patients who have both hypertension and diabetes.

            Both diabetes and hypertension are independent risk factors for cardiovascular disease (CVD).  The advisory indicates that the coexistence of these conditions in a patient imposes a need for a significantly lower goal blood pressure (135/80 mm Hg) than the goal blood pressure recommended for a patient with hypertension who does not have diabetes  (140/90 mm Hg).  Over 5 million Americans have type 2 diabetes and high blood pressure.  Uncontrolled hypertension leads to stroke, heart failure, and kidney failure.  It is clear that the combina-tion of these two CVD risk factors has important public health implications.

            This new report is part of a series of clinical advisories being issued by NHLBI to raise health professional and consumer awareness of the health dangers posed by high blood pressure.  On May 4, 2000, NHLBI issued a clinical advisory to draw attention to the problem of high systolic blood pressure.  Systolic blood pressure measures the force exerted by the blood as it flows through the arteries when the heart contracts.  It is expressed as the top number of the blood pressure reading and now is recognized to be the most important indicator of heart disease risk in adults age 60 and older.

            The authors of the new advisory note results from several studies showing that efforts to lower high blood pressure in patients with type 2 diabetes produce dramatic results.  In one study, near optimal control of hyperten-sion (144/82 mm Hg) led to 44 percent fewer diabetes-related strokes, 37 percent fewer cases of small blood vessel damage due to diabetes (particularly diabetic retinopathy), and 32 percent fewer diabetes-related deaths.   Another study reported CVD deaths were reduced 76 percent in hypertensive patients who had type 2 diabetes and 13 percent in patients who had hypertension but no diabetes.

            The clinical advisory at http://www.nhlbi.nih.gov/hbp/health/diabetes_statement.html   is an update to the “Sixth Report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pres-sure” (JNC VI). The JNC VI was produced in 1997 by the NHBPEP, a federation of 45 professional, voluntary, and official agencies.

            To learn more about prevention and treatment of high blood pressure, visit NHLBI's new, interactive high blood pressure Web site for consumers and health professionals at http://www.nhlbi.nih.gov/hbp .

Source: NIH News Release; Claude Lenfant, MD, Director National Heart, Lung, And Blood Institute; 23:32:51 -0400; May 31, 2000.

 

BLOOD PRESSURE-LOWERING DASH DIET ALSO REDUCES HOMOCYSTEINE

            The blood pressure-lowering DASH diet also reduces levels of the amino acid homocysteine, according to a National Heart, Lung, and Blood Institute (NHLBI)-funded study.  A high level of homocysteine appears to increase the risk of heart disease, stroke, and peripheral vascular disease (1).

            DASH stands for Dietary Approaches to Stop Hypertension. This new report is based on data from the DASH trial, which found that a diet rich in fruits, vegetables, and lowfat dairy foods and low in saturated fat, total fat, and cholesterol significantly and quickly lowers blood pressure. The diet also included whole grains, poultry, fish, and nuts. The DASH trial involved four sites and a coordinating center.  The homocysteine results come from the Johns Hopkins University site in Baltimore, MD.

            Homocysteine levels are affected by various factors, including intake of folic acid (or folate) and vitamins B6 and B12.  In the trial, participants followed one of three diets-a control diet similar to what most Americans eat, a diet rich in fruits and vegetables, and the DASH diet. Compared with homocysteine levels of those on the control diet, homocysteine levels of those on the DASH diet were significantly lower, with levels of those on the fruits and vegetables diet being intermediate. Changes in the homocysteine levels were significantly associated with changes in folate levels. NHLBI press releases and other materials are available online at: http://www.nhlbi.nih.gov .

Reference:

1.   Lawrence J. Appel, Edgar R. Miller, III, Sun Ha Jee, et al. Effect of Dietary Patterns on Serum Homocysteine: Results of a Randomized, Controlled Feeding Study; Circulation: Am J Heart Association; August 22, 2000 102: 852-857.

Source: Press Release; NIH News Advisory; August 21, 2000.

 

DASH DIET

            To compliment the previous article on the DASH diet we have re-printed the DASH diet described in greater detail in an earlier Nutrition Perspectives (Vol. 24 No. 2 p. 9 ). This meal plan is based on 2,000 calories a day. Depending on the calorie needs, an individual’s number of daily servings may vary from those listed. Consult your doctor or a registered dietitian to determine your calorie needs.

Food Group

Daily Servings

Serving Size

Grains and grain products

7 to 8

1 slice of bread

 

 

1/2  cup dry cereal

 

 

1/2 cups cooked rice, pasta, or cereal

 

 

 

Vegetables

4 to 5

1 cup raw leafy vegetables

 

 

1/2 cup cooked vegetable

 

 

6 oz vegetable juice

 

 

 

Fruits

4 to 5

6 oz fruit juice

 

 

1 medium fruit

 

 

1/4 cup dried fruit

 

 

1/2 cup fresh, frozen, or canned fruit

 

 

 

Low-fat or nonfat dairy foods

2 to 3

8 oz milk

 

 

1 cup yogurt

 

 

1.5 oz cheese

 

 

 

Meats, poultry, fish

2 or fewer

3 oz cooked lean meat, poultry (skinless

 

 

          white meat), or fish

 

 

3 oz tofu

 

 

 

Nuts, seeds and dry beans

4 to 5 per week

1/3 cup or 1.5 oz nuts

 

 

2 Tbsp or 1/2 oz seeds

 

 

1/2 cup legumes

 

 

 

Fats and oils

2 to 3

1 tsp. soft margarine or butter

 

 

1 tsp. regular mayonnaise or

 

 

          1 Tbsp low-fat mayonnaise

 

 

1 Tbsp salad dressing or

 

 

          2 Tbsp “light” salad dressing

 

 

1 tsp. oil (olive, corn, canola, safflower, or other)

 

 

 

Sweets

5 per week

1 Tbsp maple syrup, sugar, or jelly

 

 

1/2 cup sherbet

 

 

3 pieces of hard candy

 

 

 

Source: National Heart, Lung, and Blood Institute, http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/folldash.htm   and http://dash.bwh.harvard.edu/dashdietservings.html

 

HORMONE REPLACEMENT THERAPY'S BENEFIT FOR CORONARY HEART

      DISEASE AND BENEFITS OF DIET AND LIFESTYLE MODIFICATION

            According to a recent study, postmenopausal hormone therapy is not beneficial in the short term to either prevent the progression of or induce the regression of atherosclerosis in coronary arteries in women with estab-lished coronary heart disease (CHD) (1). The results extend the debate on the role of hormone replacement therapy (HRT) in preventing CHD.

            In the study, 309 women with diagnosed coronary disease were randomly assigned to receive either placebo, 0.625 mg of conjugated estrogen alone, or 0.625 mg of estrogen in combination with 2.5 mg medroxy-progesterone acetate (MPA). The researchers found that both the single and combined hormone therapies had an important impact on atherosclerosis risk factors.  However, neither estrogen alone nor estrogen plus MPA affected the progression of coronary atherosclerosis in women with established coronary heart disease.

            The Estrogen Replacement and Atherosclerosis (ERA) trial has some important limitations.  The study lasted only 3 years, while HRT's benefits for heart disease may not be evident for several years following initiation of therapy.  Also, it is possible that HRT has beneficial effects on the coronary arteries that are not seen on the angiogram.  More studies of women with pre-existing heart disease may provide a more definitive answer on HRT's benefits in this population.

            Furthermore, the results of the ERA study cannot be generalized to all postmenopausal women.  Women in the ERA study were approximately 65 years old, and therapy was initiated an average of 23 years after meno-pause.  It remains to be seen whether the study results apply to women of all ages, and to HRT started soon after the beginning of menopause.  Again, more studies of postmenopausal women with pre-existing heart disease are needed.

            Additional information from trials studying HRT's effects on women without heart disease is currently be-ing obtained from NHLBI's ongoing Women's Health Initiative (WHI), one of the largest prevention studies ever conducted in the United States.   The WHI is examining the effect of HRT in preventing heart disease in more than 27,000 postmenopausal women aged 50-79.

            Hu and colleagues reported on the benefits of lifestyle modification for the prevention of CHD in women with no existing coronary heart disease (2).  The authors evaluated the effects of risk factors on the incidence of CHD in nearly 85,000 women aged 34-59 who were participating in the Nurses' Health Study. The scientists found that over 14 years of follow-up, between 1980 and 1994, positive lifestyle patterns resulted in significant declines in the incidence of coronary disease in women who had no previously diagnosed cardiovascular disease (CVD).

            During the 14 years, the incidence of coronary heart disease declined by 31 percent, after adjustment for age.  Smoking declined by 41 percent, the rate of HRT use among postmenopausal women increased by 175 percent, and diet improved considerably.  Taken together, the changes in these variables explained a decline of 21 percent in the incidence of CHD.  Read individually, the reduction in smoking explained a 13 percent decline in the incidence of CHD, improvement in diet explained a 16 percent decline, and an increase in postmenopausal hormone use accounted for a 9 percent decline.

            Conversely, during the same follow-up period, the proportion of women in the study who were overweight (defined as a body mass index, BMI, of at least 25) increased by 38 percent. BMI measures weight relative to a person's height and is a key indicator of overweight and obesity, major risk factors for CHD.  An increase in BMI in the Nurses' Health Study cohort explained an 8 percent rise in the incidence of coronary disease.

            These two studies highlight critical research and public health education needs. According to NHLBI, we must aggressively pursue clinical trials to determine how best to prevent coronary heart disease.  In addition, as noted by NHLBI's Scientific Director of Clinical Research, Dr. Elizabeth Nabel, we must exert greater efforts to educate the public about the importance of lifestyle behaviors in the prevention of coronary disease (3). NHLBI  materials on heart health are available online at: http://www.nhlbi.nih.gov

Reference:

1.   Herrington DM MD, et al. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Eng J Med; August 24, 2000.

2.   Hu FB, Stampfer MJ, et al. Trends in the incidence of coronary heart disease and changes in diet   and lifestyle in women; N Eng J Med; 343 (8):530

3.   Nabel EG. Coronary heart disease in women -- an ounce of prevention. N Eng J Med; 343 (8):572 2000 - Editorial  Adapted from: NHLBI news release; Statement by Claude Lenfant, MD; August 23, 2000.

 

ZINC ACETATE LOZENGES REDUCE DURATION OF COMMON COLD

            Use of zinc acetate lozenges is associated with a reduction in severity and duration of cold symptoms, according to the results of a randomized, double-blind, placebo-controlled trial (1).

            The previous evidence supporting the use of zinc to treat the common cold is mixed, the authors note, with five studies finding that it reduces the duration of colds and another five failing to demonstrate any benefits.

            In the current study, Dr. Prasad, of Wayne State University Health Center, in Detroit, Michigan, and colleagues randomized 50 patients within 24 hours of the onset of cold symptoms to take zinc acetate (12.8 mg) or placebo every 2 to 3 hours while awake.

            The researchers report that the average duration of cold symptoms was 4.5 days in the zinc group versus 8.1 days in the placebo group. Half of the participants taking zinc were well within 3.8 days, while half of those taking placebo were well within 7.7 days. The authors also report that by the fourth day of the study, “the average severity score in the zinc group was half that in the placebo group.”

            Adverse effects were similar in both groups, although patients taking zinc reported more constipation and dry mouth.

            Dr. Prasad and colleagues note that patients in the zinc group received an average of 80 mg of zinc each day. While this is more than five times higher than the recommended daily intake, short-term use of zinc should not lead to copper deficiency, according to the report.

            “We recommend that if a person does not show clear evidence of improvement after 3 days of zinc treatment, he or she should be investigated for other respiratory tract disorders or allergy and receive appropriate treatment,” they write.

            In an editorial that accompanies the study, Dr. Norman Desbiens, of the University of Tennessee College of Medicine, in Chattanooga, concludes, “The effect of zinc on the common cold is still questionable.”

            He points out that the participants were asked to guess whether they were taking placebo or zinc, but the study was not large enough to see whether these guesses affected the results. “It would be helpful to repeat the present study using a larger group of patients and adjusting for the guess,” he writes.

Reference:

1.   Prasad, AS; Fitzgerald, JT; Bao, B; Beck, FW; Chandrasekar, PH.  Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine, Aug 15, 2000,133(4):245-52. Source: Press Release; Reuters Health; August 15, 2000.

 

SUGARS AND HEALTH

            Sugars have been extensively studied for possible cause-and-effect relationships to chronic diseases and health problems such as hyperactivity in children, obesity, diabetes, heart disease and dental caries. Several scientific reviews have shown that sugar consumption is not associated with development of any chronic disease or health problem, except for dental caries (1,2).

Dental Caries: Dental caries is a bacterial, plaque-dependent disease. Bacteria allowed to amass on dental plaque metabolize any fermentable carbohydrate. Lactic acid produced by the bacteria demineralizes the enamel and underlying tissues. Data show that many factors must converge to form dental caries. Prevention should focus on fluoridation of water, regular dental care and proper dental hygiene.

Hyperactivity: Many people think sugar consumption is linked to hyperactivity in children. However, scientific evidence does not support an association between sugar intake and hyperactivity or impaired learning in children, even in those who reportedly are sensitive to sugar (3,4).

Nutrient Dilution: The amount of added sugars in the diet is often assumed to predict its nutrient adequacy. This hypothesis was tested using dietary intake surveys from the United States and Europe. The data showed no con-sistent or nutritionally meaningful variation in micronutrient intakes across a wide range of sugar consumption (1).

Obesity: Assertions continue that increased sugar intake, particularly intake of added sugars, is associated with the rise in obesity. However, obesity is a multi-factorial condition. One important factor is positive energy balance, that is, an imbalance between energy intake and energy expenditure.

            The Centers for Disease Control and Prevention (CDC) report that in 1997, approximately 55 percent of adults, II percent of adolescents, and 14 percent of children were overweight, many were further classified as obese (5). The National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health has developed guidelines to identify overweight and obesity (6), using body mass index (BMI). NHLBI guidelines classify a person with a BMI between 25 and 29.9 as overweight, and one with a BMI > 30 as obese.

            Obesity is an important risk factor for diabetes, coronary heart disease, other degenerative diseases and certain types of cancer. According to the FAOIWHO, “there is little scientific support for the commonly held perception that consumption of high amounts of simple sugar contributes to obesity. There is no evidence that simple sugars are used with a different efficiency than complex carbohydrates (other than dietary fiber and resistant oligosaccharides). While there are substantial data suggesting that high levels of dietary fat intake are associated with high levels of obesity, at present, there is no reason to believe that high intake of simple sugar is associated with high levels of obesity” (7). The report emphasizes that excess energy in any form will promote body fat accumulation and may lead to obesity if energy expenditure is not increased.

Diabetes: Sugars do not cause diabetes. Rather, genetic factors predispose individuals to develop diabetes. Also, certain individuals and populations appear to have a strong predisposition to obesity and diabetes when diet and lifestyle changes (i. e., lack of physical activity) lead to positive energy balance. Thus, management of Type II diabetes relies on weight loss by balancing physical activity with eating a healthful diet.

Insulin Resistance: Recently, some diet books have popularized the term insulin resistance, which means that insulin is less able to stimulate uptake of glucose from the blood by muscle and other tissues that require it. Obesity, heredity and a sedentary lifestyle are risk factors for development of insulin resistance. Misleading assertions that insulin resistance leads to obesity have reversed the true association. Moreover, insulin resistance has been identified as a risk factor for heart disease. Individuals with this condition should be counseled to lose (or avoid gaining) weight using a prescribed eating plan tailored to provide an appropriate macronutrient profile. They should also be advised to exercise appropriately.

Heart Disease: While some researchers have proposed that sugar intake contributes to risk of heart disease, subsequent studies have not substantiated this (8). The FAO/WHO report finds: “...no evidence for a causal role of sucrose in the etiology of coronary heart disease” (7).

Conclusion

            Rising obesity rates are of great concern because of the subsequent serious health problems. But focusing on only one component of the diet is unlikely to solve the problem. For most people, the best advice continues to be, eat a variety of foods in appropriate portion sizes and engage in at least 30 minutes of physical activity every day. Those with nutrition-related health conditions should seek the advice of a nutrition professional.

References:

1.   Anderson GH. Sugars and health: A review. Nutrition Research. 1997; 17:1485-1498.

2.   Public Health Service, US Department of Health and Human Services. The Surgeon General’s Report on Nutrition and Health. Washington, DC: US Government Printing Office; 1988. DHHS(PHS) Publication No. 88-50210.

3.   Wolraich M, Lindgren S, Stumbo P, Stegink L, Appelbaum M and Kiritsy M. Effects of diets high in sucrose or aspartame on the behavior and cognitive, performance of children. New England Journal of Medicine. 1994;330:301-307.

4.   Kanarek R. Does sucrose or aspartame cause hyperactivity in children? Nutrition Reviews. 1994; 52.-173-175.

5.   Centers for Disease Control and Prevention. http:/Iwww.cdc.gov/nchs/fastats/overwt.htm

6.   National Heart, Lung, and Blood Institute. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. http://www.nhlbi.nih.gov/guidelines/obesity/ob_home.htm  

7.   Food and Agriculture Organization/World Health Organization. FAOIWHO Expert Consultation on carbohydrates in human nutrition. Carbohydrates in Human Nutrition. 1998; pp. 1-1 29.

8.   National Research Council. Diet and Health: Implications for Reducing Chronic Disease Risk. National Academy of Sciences. 1989; pp., 273-290.

Source: Nutrition Updates; Spring/Summer 2000.

 

COMPLEMENTARY & ALTERNATIVE MEDICINE: WHAT RDS SHOULD KNOW

            The American Dietetic Association, (ADA), is aware of recent mailings to its members by American Specialty Health Network and other Complementary and Alternative Medicine (CAM) providers, such as Landmark Healthcare Inc., Alignis, Consensus Health, American WholeHealth Networks, Inc., soliciting RDs to join their net-works. ADA's Health Care Financing Team prepared a CAM background for members. The excerpt below should provide readers with sound information regarding CAM.

Business impact: Will business opportunities increase through CAM referrals? For example, network referrals may come from physicians and other non-physician providers. However, the number of patients who choose to pay for CAM services out-of-pocket may be minimal and an RD’s business may not experience any substantial growth.

Flexibility: Depending on the CAM contract and legal obligations, RD’s may or may not be able to participate in more than one CAM network. If restrictions are noted, this may limit the number of potential referrals and business growth.

Negotiated fees: If fees offered through the CAM provider network are not optimal, it may counteract the RD’s business plan, profits, and overall reason for participating. If an RD is trying to establish a practice and is seeking new patients, the individuals referred from the CAM network may help advance the business plan. Managed care organizations and private insurers may consider payment schedules negotiated by CAM provider networks.                            

Networking opportunities: Once an RD is part of the network, they may be invited to attend seminars and workshops with other providers. This may increase the RD's knowledge of other specialties as well as increase multidisciplinary quality of patient care. However, if patients are primarily self-referred, interaction with other CAM providers may be minimal.                   

Ability to adapt quickly to healthcare trends: Inclusion of nutrition services within CAM networks is a relatively new consumer benefit. The number of CAM networks seems to be growing. Participating in CAM networks may provide RD’s with a competitive advantage in the CAM arena. Since the programs are new, it is unclear whether consumers will utilize the benefits, since many require direct payment by the patient. Some insurers have made CAM a covered benefit, and others plan to do so in the future. Some RDs have parlayed their CAM provider status into provider status for medical nutrition therapy as a covered benefit.

Documentation and Advertisement: Some CAM network providers may offer resources, e.g. web pages and directories, to help advertise and promote network providers. Depending on the type of practitioners who are listed in the directory, this may or may not provide beneficial publicity. Also, some CAM networks assist providers by completing reimbursement paperwork on behalf of the provider.

Company values: CAM networks may or may not “credential” individuals who meet the Commission on Dietetic Registration's requirements for Registered Dietitians. Consequently, RD’s may participate in a network(s) that includes other individuals with less training than RDs. As RD’s consider participating in CAM networks, ADA suggests RD’s consult with an attorney to discuss contract details. It may also be helpful to contact local practitioners who are enrolled in the network as well as the CAM network directly. For complete information about CAM networks, visit ADA's website at wwweatfight.org/gov/camnetworks.html.

Adapted from: The Bulletin; Dorothy Michalczyk, Manager Communications, July/August 2000, p. 1.

 

THE AMERICAN ACADEMY OF PEDIATRICS PROMOTES GOOD NUTRITION IN SCHOOL

            The American Academy of Pediatrics (AAP) and US Department of Agriculture (USDA) have collaborated with four other leading medical associations to call upon schools and communities to recognize the health and educational benefits of healthy eating for children.

            In a new statement, Promoting Healthy Eating Behaviors: The Role of the School Environment, the groups focus on the importance of making good nutrition for children a priority in every school.

            According to the statement, many of today’s children and youth have unhealthy eating patterns that can have negative consequences for their health and education. The USDA hopes to promote knowledge, attitudes, and behaviors among schoolchildren that will help them develop healthy eating patterns throughout their lives. To achieve this change, the statement says, students, parents, teachers, school officials, and community leaders must be actively involved in ensuring that school environments promote healthy eating patterns.

            The statement includes a call to action, encouraging pediatricians and other health care professionals to promote the recommendations, titled Prescription for Change: Ten Keys to Promote Healthy Eating in Schools, in their local communities.

            Childhood obesity has reached epidemic proportions, with 4.7 million children, ages 6 to 17 now overweight or obese, according to the statement. A new USDA report found less than 15 percent of school-children eat the recommended servings of fruit and less than 20 percent eat the recommended servings of vegetables each day.

            Because of the significant risks these poor eating habits can pose, the statement recommends changing the health behaviors of children though their physical and social environments. It goes on to assert that the challenge of improving students’ eating patterns is a shared responsibility by schools, families, and communities.

            The groups believe schools can be the cornerstone of change and are most likely to be successful in improving students’ eating patterns by:

·          helping them learn skills needed to practice lifelong healthy eating;

·          giving them repeated opportunities to practice healthy eating skills;

·          ensuring consistent messages in the classroom and school cafeteria;

·          providing nutrition education activities that are fun; and

·          implementing the USDA nutrition plan throughout the school community.

            These efforts will signal to students, parents, and the community that schools recognize healthy eating as an important life skill and are committed to making it part of a total education program.

            In addition to the Academy, other endorsers of the recommendations are the American Academy of Family Physicians, American Dietetic Association, National Hispanic Medical Association, and National Medical Association.

            Academy members are encouraged to promote the Prescription for Change: Ten Keys to Promote Healthy Eating in Schools, in their local schools and communities. To download a copy of the statement, visit the USDA’s Food and Nutrition Service Web site at: www.fns.usda.gov

Source: AAP News; Vol 16 No 6; June 2000, p. 4.

 

WELL-BEING IMPROVES FOR MOST OLDER PEOPLE, BUT NOT FOR ALL

            Older Americans are living longer and living better than ever before. But many of those age 65 and older face disability, chronic health conditions, or economic stress, according to a new federal indicators report that describes the status of the nation's older population. This is the first in a continuing series planned by the Federal Interagency Forum on Aging-Related Statistics, a consortium of US government agencies working together to improve the quality and usefulness of data on older Americans.

            The global population is aging at a rate unprecedented in history.   In the US, the population age 65 and older is expected to double by 2030. The Forum developed the report, “Older Americans 2000: Key Indicators of Well-Being,” to regularly track trends as society and individuals look for ways to address the aging boom. Today's report, which brings together information from more than a dozen national data sources for the first time, will serve as a baseline for future updates.

            “Americans age 65 and older are an important and growing segment of our population. While many federal agencies provide data on this diverse population, it is sometimes difficult to understand how this group is faring. For the first time, the federal statistical system has come together to provide a unified picture of the overall health and well-being of older Americans,” says Katherine K. Wallman, Chief Statistician, US Office of Management and Budget.

            The 128-page report covers 31 key indicators carefully selected by the Forum to portray aspects of the lives of older Americans and their families.  The report is divided into five subject areas: population, economics, health status, health risks and behaviors, and health care.

Highlights include:

Population:

            The number and proportion of older people in the US population have grown and generally will continue to grow at a very rapid pace. Aging in the 21st century will be characterized by a steep rise in the population age 85 and older and increased racial and ethnic diversity.

Economics:

            The economic picture for most older Americans is improving. But there are also significant disparities in income and wealth. Poverty has dropped dramatically, but rates are still very high for some groups. Social security benefits and pensions have taken on greater importance. Overall, the net worth of older Americans also has increased over time.

Health Status:

            Older Americans are living longer and feeling better. An overwhelming majority rate their health as good or excellent.  Men and women report comparable levels of well-being. Disability rates are declining as well. But large numbers of older people find their health threatened by memory impairments, depression, chronic conditions, and disability, especially at very advanced ages, which can substantially diminish quality of life.

·          Americans born at the beginning of the 21st century are expected to live almost 30 years longer than those born at the turn of the 20th century. In 1997, a newborn baby girl could expect to live 79 years and a boy 74 years, compared to 51 years for a girl and 48 years for a boy born in 1900. Life expectancy varies by race, however. The average life expectancy for a white baby born in 1997 was 6 years higher than for a black baby born in the same year.

·          Chronic disease, memory impairment, and depressive symptoms affect large numbers of older people, and the risk of such problems often increases with age. In 1995, almost 60 percent of people age 70 and older report having arthritis, up slightly from the proportion reporting arthritis in 1984. The prevalence of arthritis and other chronic diseases, such as hypertension, heart disease, cancer, diabetes, and stroke are also reported, and vary by race and ethnicity. Increases in memory impairment and depressive symptoms occur with advancing age: one-third or more of men and women age 85 and older have moderate or severe memory impairment and 23 percent of this group experience severe depressive symptoms.

·          Despite the prevalence of illness or chronic conditions, the proportion of Medicare beneficiaries age 65 and older with a chronic disability was 21 percent in 1994, down from 24 percent in 1982. During this time period, the older population grew significantly, and the number of older people estimated to have functional limitations increased by 600,000. This was considerably fewer, however, than the 1.5 million increase projected had disability rates not declined.

Health Risks and Behaviors:

            Social and behavioral aspects of life can make a difference in health and well-being. Most older people describe themselves as socially active, which may enhance their physical and emotional health. But others report choices and behaviors, such as the failure to engage in physical activity or to keep up with vaccinations, that could interfere with health and independence.

·          A large majority of older people report social contacts with friends, neighbors, and relatives or engaging in activities, such as going out to restaurants. The proportion of older Americans engaged in physical activity is increasing:  between 1985 and 1995 the percentage who were sedentary decreased from 34 percent to 28 percent for men and 44 percent to 39 percent for women.

·          From 1989 through 1995, the proportion of older people who were vaccinated against influenza and pneumonia increased, but reached the 60 percent coverage target set by Healthy People 2000 for only one group, non-Hispanic whites vaccinated against influenza. An increasing trend also holds true for older women getting mammograms; 55 percent of older women in 1994 reported having had a mammogram in the previous two years, compared with 23 percent in 1987.

Health Care:

            Older people report being generally satisfied with health care quality and access. Average costs have not risen steeply during the 1990’s. The cost of health care and use of services is closely associated with age and institutional status, with higher expenditures incurred by the oldest Americans and those living in long-term care facilities.

·          Between 1992 and 1996, there was a slight increase in average inflation-adjusted annual health care expenditures (both public and private) for older Americans. In 1996, the average annual expenditure was $5,864 for people age 65 through 69, rising to $16,465 at age 85 and older. In 1996, 69 percent of non-institutionalized Medicare beneficiaries had some type of private or public coverage for prescription drugs, while 31 percent did not. Out-of-pocket expenditures for prescription drugs were 83 percent higher for those not covered than for those with coverage.

·          People age 85 and older are the most likely Americans to live in nursing homes. In 1997, only 11 people per 1,000 age 65 through 74 lived in a nursing home, compared with 192 people per 1,000 among those age 85 and older. About three-fourths of nursing home residents are women, roughly equal to their representation in the population age 85 and older. People in nursing homes today are more functionally impaired than their counterparts in previous years. The percentage of nursing home residents who were incontinent, who needed help with eating, or who were dependent on others for mobility increased slightly between 1985 and 1997.

·          For those who receive home care, the nature of assistance may be changing. Most home care is provided informally by family, friends, and the community, as it has been for quite some time. But since the 1980s, the use of informal support as an exclusive means of help appears to be declining. The percentage of older people receiving only informal care dropped from 74 percent in 1982 to 64 percent in 1994, while the use of combined formal and informal care increased from 21 percent to 28 percent during the same time period.

            Beyond the specific indicators, the Forum's report also examines areas where research and data efforts need to be improved. Among the recommendations are extending age reporting categories to more specifically incorporate upper age ranges in federal data collection efforts, improving the way data are collected to measure income and wealth, strengthening measures of disability, and gathering information to understand the reasons for improvements in life expectancy and function.

            The public may view copies of the report on the web site http://www.agingstats.gov. Single printed copies of “Older Americans 2000: Key Indicators of Well-Being” are available from the National Center for Health Statistics, at (301) 458-4636 or by sending an e-mail request to nchsquery@cdc.gov  Anyone wishing multiple printed copies of the report should contact Forum Staff Director Kristen Robinson at (301) 458-4460 or send an

e-mail request to: kgr4@cdc.gov

Adapted from: NIH News Release; August 10, 2000.

 

THE FDA AUTHORIZES NEW CORONARY HEART DISEASE HEALTH CLAIM FOR PLANT STEROL AND PLANT STANOL ESTERS

            The FDA has authorized use of labeling health claims about the role of plant sterol or plant stanol esters in reducing the risk of coronary heart disease (CHD) for foods containing these substances. This interim final rule is based on FDA's conclusion that plant sterol esters and plant stanol esters may reduce the risk of CHD by lowering blood cholesterol levels.

            Coronary heart disease, one of the most common and serious forms of cardiovascular disease, causes more deaths in the US than any other disease. Risk factors for CHD include high total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol.

            This new health claim is based on evidence that plant sterol or plant stanol esters may help to reduce the risk of CHD. Plant sterols are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, and other plant sources. Plant stanols occur naturally in even smaller quantities from some of the same sources. For example, both plant sterols and stanolsare found in vegetable oils.

            Foods that may qualify for the health claim based on plant sterol ester content include spreads and salad dressings. Among the foods that may qualify for claims based on plant stanol ester content are spreads, salad dressings, snack bars, and dietary supplements in softgel form.

            Foods that carry the claim must also meet the requirements for low saturated fat and low cholesterol, and must also contain no more than 13 grams of total fat per serving and per 50 grams. However, spreads and salad dressings are not required to meet the limit for total fat per 50 grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content. In addition, except for salad dressing and dietary supplements, the food must contain at least 10% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or fiber. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol.

            Scientific studies show that 1.3 grams per day of plant sterol esters or 3.4 grams per day of plant stanol esters in the diet are needed to show a significant cholesterol lowering effect. In order to qualify for this health claim, a food must contain at least 0.65 grams of plant sterol esters per serving or at least 1.7 grams of plant stanol esters per serving. The claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods.

An example of a health claim about the relationship between plant sterol esters and reduced risk of heart disease is:

·          Foods containing at least 0.65 grams per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams of plant sterol esters.

An example of a health claim about the relationship between plant stanol esters and reduced risk of heart disease is:

·          Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___ grams of plant stanol esters.

            This new health claim interim final rule responds to petitions submitted to the FDA by Lipton (plant sterol esters) and McNeil Consumer Healthcare (plant stanol esters). The FDA is issuing this rule as an interim final rule. It is effective immediately with an opportunity for the public to comment. The final rule on this health claim may differ from this interim rule, and manufacturers would be required to revise their labeling to conform to any changes adopted in the final rule.

Source: FDA Press Release; September 5, 2000.

 

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