FDA Ruling on Dietary Supplement Claims
The U.S. Food and Drug Administration (FDA) recently finalized rules that define the types of statements that can be made about the effects of dietary supplements on the structure or function of the body. These rules follow the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, dietary supplements may make “structure/function” claims, which mean that the products affect the structure or function of the body, without previous review by the FDA. However, dietary supplements may not claim to prevent, treat, cure, mitigate or diagnose disease, without previous review by the FDA. The final ruling describes how the FDA will distinguish disease claims from structure/function claims and may affect how some products are labeled.
The final ruling will prevent labeling of dietary supplements with express or implied disease claims, such as those made through product name, a statement about the formulation of a product or through the use of pictures, vignettes or stories, without previous review by the FDA. The ruling permits claims that are unrelated to disease. These include health maintenance claims, other non-disease claims and claims for common, minor symptoms associated with stages of life.
The FDA has made several significant changes in the final ruling in response to concerns from the industry and consumers. These changes include revising the definition of “disease” in response to concerns that it was too broad and allowing structure/function claims about certain common conditions associated with aging, pregnancy, menopause and adolescence.
Under the DSHEA and existing regulations, manufacturers of dietary supplements are required to keep substantiation of any structure/function claims in their files. Their product labels must also include a disclaimer that the dietary supplements are not drugs and receive no FDA premarket approval. Within 30 days of marketing a given dietary supplement, manufacturers must also notify the FDA of the claims they are making.
Survey on Patient Knowledge of Insulin Resistance
Lack of knowledge about insulin resistance, an underlying cause of type 2 diabetes mellitus (formerly known as non–insulin-dependent diabetes mellitus), may be the main predictor of poor disease control among affected persons. According to a national survey released by the American Association of Diabetes Educators, nearly two thirds of patients with diabetes do not understand or have never heard of insulin resistance.
The association commissioned a telephone survey of more than 1,000 persons with type 2 diabetes who were more than 45 years of age. Survey participants were asked questions about their condition, current treatment regimen, hemoglobin A1c (HbA1c) and blood glucose levels, and sources of information about the disease. Of the patients surveyed, 88 percent reported that modified diet and exercise are part of their current treatment plan and 84 percent reported the current use of oral medication.
The survey found that patients who could not define insulin resistance have substantially poorer control of their blood glucose levels and HbA1c. The survey also revealed that 72 percent of patients want more information about the disease, but 75 percent do not seek support in coping with diabetes. While 92 percent of patients are aware of their current blood sugar level and 88 percent know their target goal for blood sugar level, 75 percent of participants do not know their HbA1c level and 77 percent do not know the recommended level for control. Ninety-seven percent of patients are being treated by a physician, but only 28 percent of patients have discussed insulin resistance with a physician.
The American Association of Diabetes Educators is a multidisciplinary organization that represents more than 10,000 health care professionals who provide diabetes education and care. More information on the association and the survey may be obtained by calling 800-TEAM-UP-4 (800-832-6874) or by visiting the association Web site at http://www.aadenet.org.
First Pneumococcal Vaccine for Infants and Toddlers
The U.S. Food and Drug Administration (FDA) has approved the first multivalent conjugate pneumococcal vaccine (Prevnar) for use in infants and toddlers. The vaccine prevents invasive diseases that are caused by the organism Streptococcus pneumoniae, including bacteremia and meningitis.
Each year in the United States, an estimated 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis occur among children less than five years of age. Children less than two years of age have the highest risk of infection. In up to 50 percent of children with meningitis, brain damage and hearing loss occur and about 10 percent die.
The new vaccine, pneumococcal 7-valent conjugate vaccine (Diphtheria CRM197Protein), targets the seven most common strains of pneumococcus. These strains account for about 80 percent of invasive disease in infants.
Prevnar is normally administered as a series of four inoculations given at two, four, six and 12 to 15 months of age. Alternative schedules are available for children who cannot receive the vaccine starting at two months of age. The vaccine is not indicated for use in adult patients or as a substitute for other approved pneumococcal polysaccharide vaccines that are approved for use in high-risk children more than two years of age. Side effects are generally mild and may include local injection site reactions, irritability, drowsiness and decreased appetite. In clinical trials, about 21 percent of the children had fevers higher than 37.9°C (100.3°F), compared with about 14 percent of children in the control group.
“This new vaccine is great news for parents and their children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children—those under two years of age,” said FDA Commissioner Jane Henney, M.D. “When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases.”
For more information on the pneumococcal vaccine for infants and toddlers, visit the FDA Web site at http://www.fda.gov
or call 888-INFO-FDA (888-463-6332).
The Commission on Clinical Policies and Research of the American Academy of Family Physicians (AAFP) has issued a policy statement recommending use of the vaccine in all children less than 24 months of age and children less than 60 months of age who have high-risk conditions. The AAFP commission will soon consider additions to this statement.
Information Packet for Women with Epilepsy
More than 1 million women in the United States have epilepsy and 75,000 women of all ages develop the condition each year, reports the Epilepsy Foundation. Recently, a new information packet that addresses the special concerns of women who have epilepsy has been compiled by the Epilepsy Foundation. The “Women and Epilepsy” packet contains two sets of information sheets, one for physicians and one for female patients.
According to Elizabeth Borda, director of the Women and Epilepsy Initiative, “The information sheets cover issues vital to women with seizure disorders but which are frequently overlooked by health care providers. Some women with the condition may themselves be unaware of the connection between epilepsy and what they experience.”
The physician information sheets address four topics of major importance: epilepsy and pregnancy, epilepsy and menopause, antiepileptic drug use in women with epilepsy and epilepsy in the female adolescent.
The packets are being mailed to more than 21,000 active, practicing family physician members of the American Academy of Family Physicians and are also being distributed to comprehensive epilepsy treatment centers, centers of Excellence in Women's Health and Planned Parenthood affiliates across the United States.
Copies of the new information packet may be obtained by calling the Epilepsy Foundation at 800-EFA-1000 (800-332-1000). Additional information about women and epilepsy can be found on the Epilepsy Foundation Web site (http://www.epilepsyfoundation.org
Morbidity and Mortality Related to Firearm Injuries
The overall annual rates of nonfatal and fatal firearm-related injuries in the United States declined consistently from 1993 through 1997, according to a recent report. The annual nonfatal rate decreased by 40.8 percent, from 40.5 per 100,000 persons in 1993 to 24.0 per 100,000 persons in 1997. The annual mortality rate also declined by 21.1 percent, from 15.4 per 100,000 persons in 1993 to 12.1 per 100,000 persons in 1997. The report appears in the November 19, 1999 issue of Morbidity and Mortality Weekly Report.
A firearm-related injury was defined as a penetrating injury or gunshot wound caused by a weapon that uses a powder charge to fire a projectile (e.g., handguns, rifles and shotguns). Data on nonfatal firearm-related injuries that were treated in the emergency departments of U.S. hospitals were obtained from the National Electronic Injury Surveillance System of the U.S. Consumer Product Safety Commission.
The declines in the rates of nonfatal and fatal firearm-related injury were generally consistent across all population subgroups. The decreases in the rates of nonfatal and fatal injury were similar in men and women. Declines in fatality rates in blacks and Hispanics were similar, and were both greater than the decline in non-Hispanic whites. In the rates of nonfatal injury, no consistent pattern was seen in the estimated decline across age groups, but in the rates of fatal injury, age and percentage change were inversely related.
To examine trends in the rates of nonfatal firearm-related injury, cases with unknown intent were allocated to one of three known categories: assault/legal intervention, intentionally self-inflicted and unintentional injury. Most of the nonfatal injuries occurred among men 15 to 44 years of age, were self-inflicted and were associated with hunting, target shooting and routine gun handling.
Numerous factors may have contributed to the decline in the rates of nonfatal and fatal assaultive firearm-related injury. These factors include: improvements in economic conditions; the aging of the population; the decline in the “crack” cocaine market; changes in legislation, sentencing guidelines and law-enforcement practices; and improvements associated with violence prevention programs.
The Antiretroviral Pregnancy Registry Interim Report
The Antiretroviral Pregnancy Registry Interim Report summarizes the findings of the ongoing Antiretroviral Pregnancy Registry, a collaborative project that monitors all reported exposures to antiretroviral medications, such as saquinavir, lamivudine and zidovudine, during pregnancy. The registry is managed by the PharmaResearch Corporation with the assistance of an advisory committee consisting of members from the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the National Institutes of Health and various subspecialists in maternal and fetal medicine, teratology, infectious disease and epidemiology. The registry data are an important source of information about drug safety in pregnancy. The purpose of the registry is to detect any major teratogenic effect of antiretroviral drugs when administered inadvertently or intentionally to pregnant women.
The Antiretroviral Pregnancy Registry began as the Zidovudine in Pregnancy Registry in January 1989. It became the Antiretroviral Pregnancy Registry in January 1993. This report covers all data collected by the registry from January 1, 1989 through July 31, 1999. The report is updated semiannually and is sent to health care professionals who request information.
The Interim Report provides summaries of the prospective and retrospective case studies, methods of registration and follow-up, treatment regimens taken during the earliest trimester of exposure, list of birth defects as reported to the registry and background information on the various antiretroviral medications. The report also includes forms for physicians to use in registry and patient enrollment.
The Antiretroviral Pregnancy Registry welcomes all reports of exposure during pregnancy but encourages physicians to report exposures as early as possible in the pregnancy to avoid potential selective-reporting biases introduced from retrospective data. Patient confidentiality is strictly guarded in this anonymous registry.
For answers to questions about the Antiretroviral Pregnancy Registry or to contribute to the registry, call 800-258-4263; fax 800-800-1052; or write to 115 N. 3rd St., Ste. 306, Wilmington, NC 28401.
Causes and Treatment of Exercise-Induced Asthma
The American College of Sports Medicine (ACSM) recently released an official statement on exercise-induced asthma. The statement covers the causes of exercise-induced asthma, methods of diagnosis, and the prevalence and treatment of the disorder. The statement appears in ACSM's Current Comments, January 2000.
According to the ACSM, the term “exercise-induced asthma” describes acute lung airway narrowing that occurs during and/or after physical activity. The underlying causes of exercise-induced asthma are not clearly understood. Changes in airway temperature, changes in airway dryness and congestion of the bronchial arteries, which results in bronchial mucosal vascular engorgement, are thought to be possible causes. Currently, the relationship between bronchial blood flow and bronchial heat exchange is thought to influence the development of airway narrowing following over-breathing related to exercise.
The method of detection of exercise-induced asthma is important in estimating the prevalence of the disorder. Although measurement with the peak flow meter is adequate in highly reactive and symptomatic persons, it is relatively insensitive in mildly affected persons or elite athletes in whom small reductions in bronchial airflow may lead to a significant decrease in athletic performance. Because peak flow measurements are effort-dependent, this diagnostic technique is not completely reliable. Spirometric measurements and maximal mid-expiratory flow rates are accurate and reproducible, because effort variation is detectable from the configuration of the tracings.
Depending on the study population, exercise protocol, detection method and environmental conditions, the prevalence of exercise-induced asthma ranges from 10 to 50 percent. In the general population, an incidence of 10 to 15 percent is a reasonable figure.
According to the ACSM, medications that modify or prevent the occurrence of exercise-induced asthma include bronchodilators, anti-inflammatory compounds and a variety of medications, such as antihistamines, calcium channel blockers and inhaled heparin. More recently, immune system modifiers are also available.
Current Comments are official statements by the ACSM concerning topics of interest to the public at large. More information may be obtained by calling 317-637-9200 or by writing the ACSM at P.O. Box 1440, Indianapolis, IN 46206-1440.
Report on Refractive Eye Surgery for Myopia
The Health Technology Advisory Committee (HTAC) has published a report on refractive eye surgery for the treatment of myopia. HTAC was established in 1992 by the Minnesota state legislature. It is an independent, non-partisan advisory body that evaluates new and emerging health care technologies based on existing scientific research and technology assessments.
The report provides information on the safety and effectiveness of four types of refractive eye surgery: radial keratotomy, photorefractive keratectomy, laser in situ keratomileusis (LASIK) and intraocular lenses. Recently, interest in refractive eye surgeries has grown, mainly by word of mouth. While studies on the short-term effects of these surgeries have shown promising results, the long-term effects are still unknown. The report discusses safety considerations and the possible complications associated with each surgery, in addition to the cost of the various procedures and questions patients should consider when evaluating refractive eye surgery.