Table of Contents
FDA Consumer magazine
January-February 2000
Under a rule recently proposed by FDA, the Nutrition Facts labels on vegetable shortenings and some cookies, crackers, margarines, and other foods may soon carry information about an ingredient called "trans fatty acids," or trans fats, which studies indicate may increase the risk of coronary heart disease.
Beyond requiring that some labels list the amount of trans fats in the food, the rule, as proposed, also defines the term "trans fat free" and limits the use of certain nutrient or health claims related to fat content, such as "lean" and "low saturated fat."
Scientific studies show that trans fats can raise the level of blood LDL (low-density lipoprotein, or "bad") cholesterol, which is associated with coronary heart disease and stroke. The American Heart Association estimates that about 500,000 Americans die each year from coronary heart disease, making it the number one cause of death in the United States.
The proposed rule was published in the Nov. 17, 1999, Federal Register and is available on the Internet at www.fda.gov/ohrms/dockets/98fr/111799c.txt. Comments may be submitted until Feb. 15, 2000, by writing to FDA's Dockets Management Branch, HFA-305, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
Certain foods containing soy protein may now carry a health claim about the role of soy in reducing the risk of coronary heart disease (CHD).
FDA is allowing the claim based on evidence that soy protein, when compared with other proteins such as those from milk or meat, can lower cholesterol levels when part of a diet low in saturated fat and cholesterol.
CHD, one of the most serious forms of cardiovascular disease, causes more deaths in the United States than any other disease. CHD risk factors include high total cholesterol levels and elevated amounts of low-density lipoprotein (LDL, or "bad") cholesterol.
Studies show that 25 grams of soy protein daily in the diet can lower both total and LDL cholesterol levels. To qualify for the approved health claim, foods must contain at least 6.25 grams of soy protein per serving.
Eligible foods include soy beverages, tofu, tempeh, and soy-based meat alternatives. Foods carrying the claim also must be low in fat, saturated fat, and cholesterol. Foods made with whole soybeans, however, may carry the claim if no other fat is present besides that found naturally in the whole bean.
FDA approved the claim last October in response to a petition by Protein Technologies International.
Mothers of children with Down syndrome show biochemical and genetic signs of impaired metabolism of the nutrient folate, according to a study by FDA's National Center for Toxicological Research.
In March 1996, FDA began requiring that folic acid be added to certain grain products, such as flour, breakfast cereals, and pasta. The agency based the move on evidence that an insufficient folic acid level in early pregnancy increases the risk of birth defects in the brain and spinal cord. The new study, published in the American Journal of Clinical Nutrition, further supports FDA's requirement, according to FDA Commissioner Jane Henney, M.D.
Down syndrome is a leading genetic cause of mental retardation that affects 1 out of 700 live births. Also called trisomy 21, it is caused by an extra copy of chromosome 21 that is usually maternal in origin.
While the FDA study provides some new insights into possible causes of the disease, larger clinical studies are necessary to confirm its findings and to determine definitively whether folic acid supplementation (at least two months before pregnancy) will reduce Down syndrome incidence.
"E" deficiencies found ... Nearly a third of Americans have low levels of vitamin E, says a study published by the national Centers for Disease Control and Prevention. Researchers found the low levels in 41 percent of African-Americans, 28 percent of Mexican-Americans, 26 percent of whites, and 32 percent of other groups. Data from a periodic federal government study focusing on the health of Americans were used in the study. Researchers were most concerned about how the information relates to the relatively high death rate from cardiovascular disease and cancer in the African-American population. Despite the important role vitamin E may play in preventing or controlling chronic disease, few population-based studies of distributions and correlates of blood concentrations of vitamin E have been performed. (American Journal of Epidemiology, August 1999)
Eat less, live longer? ... Genes that play a vital role in aging tend to stay healthier in response to a low-calorie diet, says a study by researchers at the University of Wisconsin, Madison. In mice fed a restricted diet, about 84 percent of the genetic alterations associated with aging were completely or partially suppressed. Scientists say this research may lead to drugs that could help slow aging in humans, although no studies have yet proven that a reduced-calorie diet will extend life in humans. (Science, August 1999)
New estimates on food-borne diseases ... Government data released last September says food-borne diseases sicken more people than previously thought but kill fewer. The national Centers for Disease Control and Prevention says that 76 million people are sickened, 325,000 are hospitalized, and 5,000 die each year from food poisoning, a revision of the previously reported 33 million sicknesses and 9,000 deaths. CDC says the data were revised because better information is now available on which to base the estimates, which should help guide food-borne illness prevention efforts and assess the effectiveness of food safety regulations.
The innovative food safety projects of 11 state and local regulatory agencies will get a boost in the form of FDA grants totaling almost $500,000. The one-year grants, awarded as part of President Clinton's food safety initiative, apply to four key areas: inspection, regulation and compliance, information systems, and education and health information.
The following programs and agencies received grants:
Though multiple other antibiotics have been ineffective, a new antibacterial drug may prove victorious against a hardy infection that occurs most often in hospitalized patients and those with weakened immune systems.
Synercid (a combination of quinupristin and dalfopristin) was approved to treat infections associated with the Enterococcus faecium bacterium when there is no other effective treatment and an infection has even resisted treatment with the drug vancomycin, previously viewed as the last-resort medication.
Since 1989, when the first case of vancomycin-resistant Enterococcus faecium was reported, the U.S. incidence of this potentially life-threatening condition has increased rapidly.
Because Synercid is for such a serious condition, the drug was granted early approval based on its ability to clear the bloodstream of infection. A study is under way to verify the drug's beneficial effect at the specific site of infection.
In clinical trials of more than 2,000 patients, the overall effectiveness rate among those who could be fully evaluated was 52 percent. The drug's most common side effects were muscle and joint pain, nausea, diarrhea, vomiting, rash, and, when the drug was injected through a peripheral vein, reactions around the injection site such as pain and inflammation.
FDA's approval of Synercid in September 1999 made it the first drug in its "streptogramin" class to be approved in the United States for human use. The approval followed the recommendations of the Anti-Infective Drugs Advisory Committee.
Also approved to treat complicated skin and soft tissue infections, Synercid is marketed by Rhône-Poulenc Rorer, a French company with U.S. headquarters in Collegeville, Pa.
Flu sufferers have one more weapon in their fight against the miseries of influenza. The new oral drug Tamiflu (oseltamivir phosphate) can shorten the flu's troublesome symptoms, such as sore throat, congestion, cough, chills and fever, headache, body aches, and fatigue.
Tamiflu is approved for treatment of Type A and B influenza, the two most common types in the United States. Patients should start treatment with Tamiflu within two days of the first flu symptoms. The recommended dose is one 75-milligram capsule twice a day for five days, with or without food.
In clinical studies in more than 1,000 patients, those treated with Tamiflu reported that symptoms improved a little more than a day earlier than did those taking a placebo.
The most common side effects of the drug were nausea, vomiting, bronchitis, sleep disturbance, and dizziness. Tamiflu has not been shown to prevent flu infection or decrease the chance of transmitting it to others. It is not approved for use by children under 18 and has not been shown to be safe and effective for patients with chronic heart or lung disease.
Tamiflu was approved in October and is marketed by Roche Laboratories Inc., Nutley, N.J.
United States is nearly measles-free ... Only 100 cases of measles were recorded in the United States in 1998, virtually stamping out what was once a common childhood disease. The national Centers for Disease Control and Prevention said all but 29 of those cases involved people who were initially infected in other countries. The number suggests that measles has joined the ranks of smallpox, polio, diphtheria, and other diseases essentially wiped out in the United States, due mainly to immunizations. Just 10 years ago, there were over 27,000 domestic measles cases and 64 deaths.
For early-stage breast cancer that has spread to the lymph nodes under the arm, FDA has approved a new drug to treat the cancer after surgery has removed all known tumor.
Epirubicin hydrochloride injection (Ellence) is a member of the anthracycline class of anti-cancer medications. These are believed to work by interfering with a number of biochemical and biological functions within cancer cells, though their precise mechanism of action is not completely understood. These drugs are commonly used in combination with other medications to slow or halt the cancer's progression and potentially prolong some patients' lives.
FDA based its September 1999 approval on the results of two long-term, clinical studies in about 1,200 patients. The findings showed significant lengthening of the time without a relapse of the disease (recurrence of tumor) and increased five-year overall survival.
Adverse effects associated with the drug include nausea, vomiting, diarrhea, sores in the mouth, and hair loss. In addition, women have a slightly increased risk for treatment-related leukemia while taking the drug. Epirubicin may harm the fetus if given to a pregnant woman, and the drug may also cause premature menopause in premenopausal women. Also, men undergoing treatment with epirubicin should use effective contraceptive methods because therapy with the drug can cause chromosomal damage in sperm. Patients should be informed that there is a risk of irreversible heart damage associated with the drug.
The drug is manufactured by Pharmacia & Upjohn Company, N.J.
Cancer-shrinking protein found ... Scientists have identified another human protein that might starve tumors of their blood supply and shrink cancers with few or no side effects. One more in a growing list of "angiogenesis" inhibitors, this new protein halted the growth of blood vessels to human tumors in mice and caused them to shrink into small nodules. This research further supports a promising area of cancer research in the United States and Canada over the past two years. Twenty angiogenesis inhibitors are under study in cancer patients in the United States alone. (Science, September 1999)
Kidney transplant patients now have available to them a new drug that can bolster the effects of existing treatments in suppressing the immune system and helping to prevent rejection of transplanted kidneys.
The drug, Rapamune (sirolimus), is taken with two other immunosuppressants used to prevent tissue rejection--cyclosporine and corticosteroids--but works differently from other immunosuppressants and has few overlapping toxic effects.
Two clinical studies supported the drug's safety and effectiveness. Adverse reactions seen in some of the 1,300 study patients included increases in serum cholesterol and triglycerides (another type of fat found in the blood) as well as high cholesterol levels that required treatment with cholesterol-lowering drugs. Suppressing the immune system also increases the risk of infection and lymphoma.
Only doctors experienced in immunosuppression and managing organ transplant patients should prescribe Rapamune. If measures of kidney function indicate impairment, doctors should adjust the immunosuppression drugs as necessary.
Patients take Rapamune in liquid form mixed with water or orange juice. They should not drink grapefruit juice with Rapamune or use grapefruit juice to dilute the drug.
Rapamune, approved by FDA last September, is manufactured by Wyeth Ayerst Laboratories, Philadelphia.
Blood pressure warning ... New findings from the long-term Framingham Heart Study showing the dangers of not treating people with a type of hypertension called elevated systolic high blood pressure has prompted NIH to warn 250,000 U.S. health professionals that millions of Americans are at risk of dangerous complications. Systolic blood pressure is produced as the heart contracts and pumps blood to the body. Until recent years, the systolic reading had often not been considered a significant indicator of blood pressure problems. But NIH's advisory urges more aggressive treatment of the condition. An estimated 43 million people in the United States have high blood pressure, says the National Center for Health Statistics, and the prevalence rises with age. Left uncontrolled, high blood pressure significantly increases the risk of heart attack, stroke, and kidney disease, and is the leading cause of congestive heart failure.
Facilities that reprocess medical devices intended for single use would be regulated the same way as the original equipment manufacturer, under a strategy FDA recently proposed.
Reprocessing and reuse of these disposable devices--catheters, for example--have grown in recent years, heightening concern about patient safety, informed consent, and ethics of the practice.
FDA's proposal covers:
The agency also proposes categorizing the reprocessed devices as "low," "moderate," or "high" risk based on potential hazards to patients. Devices posing the most significant public health risks after reprocessing would be classified as high risk and be required to comply with all relevant regulatory requirements, such as applying for premarket approval. Reprocessors of moderate-risk devices would have to assure FDA that the devices are as safe and effective as the original product. Low-risk devices, which pose little or no public health risk, would be a low agency priority and would be exempt from any premarket submission requirements.
FDA also may require original equipment makers to label their single-use products to alert users and reprocessors to the potential risks associated with reprocessing the devices.
Full details of the proposed policy are available at www.fda.gov/ohrms/dockets/98fr/110399i.txt.
A shocking success ... A device that delivers lifesaving shocks to victims of cardiac arrest is the latest trend in airport safety, says the Airports Council International, a trade group. The effort is part of the Chicago HeartSave program that provides publicly accessible defibrillators within one minute of any location in the O'Hare and Midway airport terminal buildings. Emergency defibrillators installed in one airport saved four lives in less than five weeks. Now other airports are considering equipping their facilities with the easy-to-use devices. The latest defibrillators automatically detect erratic heartbeats and decide when a shock is needed, proving beneficial even in the hands of people with little training.
Based on a number of reports of human illnesses in Canada, FDA recently warned U.S. consumers about the potential risk from contact with dog chew products made from pork or beef.
According to FDA, dog chew products, including pig ears, beef jerky treats, smoked hooves, and pig skins, may pose a risk of bacterial infection, such as Salmonella infantis. In normally healthy people, these infections can cause flu-like symptoms (nausea, vomiting, abdominal pain, and diarrhea, for example), but in those with weakened immune systems the infection can be more serious--even life-threatening.
FDA is urging pet owners to wash their hands with hot water and soap after coming into contact with these pet chews. Elderly people, young children, and those with weakened immune systems should avoid contact with the treats altogether.
FDA is working with other U.S. and Canadian health officials and has issued an import bulletin on products that have been directly linked to illnesses. Also, the agency is examining the manufacturing processes for products containing pig ears to determine how this product and similar ones can be made safely.
Doctors fail to discuss concerns ... Physicians counseling women on the use of hormone therapy do not address patient fears, says a Harvard University study. Women identified an average of 15 factors that were important to them as they decided to use prescription hormones to ease menopause symptoms, but these were not addressed by their doctors. Nearly every woman said that her doctor's opinion was critical to her decision. The researchers found that the guidelines for physicians on hormone replacement therapy that are issued by the American College of Physicians, the American College of Obstetricians and Gynecologists, and the U.S. Preventive Services Task Force may not reflect patient concerns. New methods for promoting shared decision making with patients are being considered. (Annals of Internal Medicine, August 1999)
Breast milk may help reduce allergies ... Breast-feeding babies for their first four months may protect against asthma and allergies. A study by Australian researchers examined 2,187 newborns from birth until 6 years, and those who are exclusively breast-fed for the first four months of life were significantly less likely to develop asthma and allergies at 6 than children who began drinking other types of milk before 4 months of age. The findings are consistent with other studies showing breast-feeding benefits. Breast milk appears to contain important nutritional, anti-inflammatory or other substances that may help guard against asthma. (British Medical Journal, September 1999)
Don't mix herbs and standard drugs ... Users of prescription drugs and alternative remedies could place themselves at risk if they don't tell their doctors they are combining these substances, say researchers from George Washington University and the National Institutes of Health. One in every five prescription drug users also takes alternative medicines, setting the stage for potentially serious drug interactions. Little is known to date about herb-drug, herb-herb, and nutrient-drug interactions. Consumers should discuss these medications and combinations with their doctors. (Psychosomatic Medicine, September 1999)
To order single copies of the following publications, use the contact information listed after the title. To order 2 to 50 copies, write to FDA, HFI-40, Rockville, MD 20857.
On page 11 of the article "FDA & Y2K" in the November-December 1999 FDA Consumer, an incorrect number was listed for the Food Marketing Institute. The correct number is (202) 452-8444.
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