In March, FDA warned consumers not to buy or consume the supplement, known as Sleeping Buddha, which was marketed as an herbal alternative to prescription sedatives. The agency has never reviewed Sleeping Buddha or approved it for its promoted uses to treat insomnia and restlessness.
The prescription sedative ingredient, estazolam, is known to have serious side effects, including possible fetal damage if pregnant women take the drug. It also can pose a risk to consumers who drive, operate heavy machinery, or take other sedative drugs or drink alcohol while taking the drug.
Sleeping Buddha is marketed in capsule form as a product of China. Its distributor, Treasure Box Products Inc. of Burnaby, British Columbia, initiated the product recall in March, after FDA and Canadian testing identified the presence of estazolam.
FDA has received no reports of injuries from the product but advises consumers who have used Sleeping Buddha and have concerns to consult with their health-care providers.
The proposed rule, published in the April 29, 1998, Federal Register, specifically defines two types of potential claims: "structure-function" claims, which describe how a product may affect the body's structure or functioning, and disease claims, which relate the product to its role in the treatment, diagnosis, cure, or prevention of disease. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), structure-function claims are allowed, while disease claims are not.
FDA's proposal follows a report from the presidential Commission on Dietary Supplement Labels, an independent panel of experts charged under DSHEA with recommending measures for regulating dietary supplement claims. The proposal would not affect the availability of dietary supplements or consumers' access to them.
DSHEA allows manufacturers to use, without FDA authorization, structure-function claims that are truthful and not misleading. Under FDA's proposal, prohibited disease claims include those that imply or state that the product:
Also, manufacturers may not make or imply a disease claim in product names, graphics, citations, or other means.
If finalized, the proposed rule would require manufacturers to remove unacceptable disease claims from dietary supplement labels or meet the safety and effectiveness standards for drugs under the Federal Food, Drug, and Cosmetic Act.
The public has until Aug. 27 to send written comments on the proposed rule to FDA, Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857.
The Federal Register is available in some libraries and at www.fda.gov/ohrms/dockets/ on FDA's Website. The proposal can be viewed as a pdf file by clicking on the date 4/29, then Docket No. 98N-0044.
Since 1994, the agency has allowed the term "healthy" on foods that are low in total fat and saturated fat, meet limits for sodium and cholesterol, and contain at least 10 percent per serving of the recommended daily intake of at least one of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, and fiber.
Recognizing that raw fruits and vegetables can contribute significantly to a healthy diet, the rule specified that raw produce could be labeled "healthy" without the 10 percent nutrient contribution if it met the other requirements.
Under the new rule, published March 25, canned and frozen fruits and vegetables can also qualify nutritionally for the term without meeting the 10 percent requirement. However, they must not contain ingredients that would change their nutritional profile. Enriched grain products can also be labeled as healthy under similar conditions if they conform to standards of identity, which define certain required ingredients.
The new rule is intended to encourage people to eat more of the foods recommended for good health in the U.S. Dietary Guidelines.
The guide, published April 13 as part of President Clinton's initiative to make fresh fruits and vegetables safer, addresses key precautions in areas such as water quality, worker hygiene, field and facility sanitation, manure management, and transportation. Recommendations include teaching farm and plant workers proper hygiene and monitoring workers' health to reduce the risk that food-borne pathogens will be transmitted.
To view the draft guide, go to vm.cfsan.fda.gov/~dms/prodguid.html on FDA's Website.
If finalized, the first rule, proposed April 24, would require domestic and foreign processors of packaged fruit and vegetable juices that sell products in the United States to use the "Hazard Analysis and Critical Control Point (HACCP)" system to prevent contamination of their products. The HACCP program, already required at seafood, meat and poultry processing plants, is used to identify the steps during food production when contamination is most likely so preventive measures can be taken.
Processors could eliminate harmful microbes by pasteurizing the juice or by alternative methods, such as scrubbing or applying antimicrobial solutions.
The second rule, also proposed April 24, would require manufacturers of juices that are not pasteurized or otherwise treated to place the following warning label on the products: "Warning: This product has not been pasteurized and, therefore, may contain harmful bacteria which can cause serious illness in children, the elderly, and persons with weakened immune systems."
The public has until July 8 to comment on the HACCP proposal. Write to FDA, Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. The comment period on the labeling proposal closed May 26.
The Federal Register is available in some libraries and at www.fda.gov/ohrms/dockets/ on FDA's Website. The proposals can be reviewed as pdf files by clicking on the date 4/24, then on Docket No. 97N-0511 for the HACCP proposal or Docket No. 97N-0524 for the labeling proposal.
The Sahara Clinical Bone Sonometer, manufactured by Hologic Inc., Waltham, Mass., is the first device for diagnosing osteoporosis that does not require x-rays. It was approved on March 12 only for use on women at risk of bone fracture, not as a general screening tool.
Osteoporosis is a loss of bone strength, which affects an estimated 23 million American women, to some degree, most of them over age 60. The condition is much less common and usually not as severe in men.
The sonometer measures bone strength by transmitting high frequency sound waves through the patient's heel for 10 seconds. The device then automatically analyzes and prints out the results. It was shown to be as effective as x-rays for predicting risk of fracture.
Pap smears are the primary method for detecting cervical cancer, which annually affects more than 13,000 American women and leads to 4,500 deaths. Successful treatment depends on early detection.
FDA approved the AutoPap system May 5, after evaluating data from a multicenter clinical study involving more than 31,500 Pap smear slides.
The screening system, marketed by Neopath Inc., Redmond, Wash., is approved for use on conventionally prepared Pap smear samples of patients not considered to be at high risk. Trained professionals will re-evaluate any slides on which the device detects signs of cancer.
The oral treatment Xeloda (capecitabine) was approved April 30 for patients with advanced breast cancer for which no acceptable alternative treatments are available. Specifically, the drug is for patients whose tumors are resistant to Taxol (paclitaxel) with an anthracycline or for those who should not have anthracycline therapy.
Xeloda was granted accelerated approval, an early approval process applied to some drugs that are used to treat life-threatening conditions. In studies, the drug measurably shrank some patients' tumors. The most common side effects of Xeloda include diarrhea, nausea, vomiting, fatigue, painful inflammation of the mouth, and painful rash and swelling of the hands and feet.
As a condition of approval, FDA is requiring the manufacturer, Hoffmann-La Roche Inc., Newark, N.J., to conduct further studies of the drug's clinical benefits.
Urinary incontinence affects about 10 million Americans, mostly women. Most of these women have stress urinary incontinence, experiencing urine leaks from physical stress such as coughing, laughing, or lifting heavy objects.
The patch, manufactured by UroMed Corp., Needham, Mass., is about the size of a quarter and has an adhesive coating on one side. Placed over the urinary opening, it forms a seal to help reduce leakage. It is not designed to control heavy urine leakage and may not always control moderate leakage, so women may need additional protection, such as panty liners or pads.
The patch is usually worn for two to three hours at a time during the day and can be worn through the night. To urinate, the woman peels off the patch and puts on a new one afterward.
Irritation was one of the main side effects in clinical studies, occurring in about 8 percent of patients. The long-term effects of using the product are not yet known. The patch should not be used during sexual intercourse or by women with urinary tract infection, vaginal infection, or local irritation. Also, it is not intended for women with types of incontinence other than stress incontinence and is less effective in women who have had previous surgical treatment for the condition.
Approved March 27, Viagra (sildenafil citrate) leads to an erection by increasing the blood flow to certain areas of the penis.
Viagra was studied in men with various conditions often associated with impotence, such as prostate problems, hypertension, and coronary artery disease, as well as in men with no identifiable physical cause. The studies indicated that men with diabetes or radical prostate surgery experienced less improvement than others.
Viagra is taken one hour before sexual activity and should be taken in the recommended dose, not more than once a day.
Viagra's most common side effects include headache, flushing and indigestion. In some cases, men experienced vision changes, mostly in their color perception.
The drug is manufactured by Pfizer Pharmaceuticals, New York City. Viagra's labeling and other information can be found on FDA's Website at www.fda.gov/cder/consumerinfo/viagra/viagra.htm.
Men who are currently using medicines that contain nitrates, such as nitroglycerin, should not use Viagra because taken together the drugs can lower blood pressure too much. In addition, men who have medical conditions that may cause a sustained erection, such as sickle cell anemia, leukemia or multiple myeloma, or who have an abnormally shaped penis may not be able to take Viagra.
Viagra has not been studied with other treatments for impotence, so use in combination with other treatments is not recommended.
A "high intensity" sweetener that is about 600 times sweeter than sugar, sucralose is made from a process that begins with sucrose, or table sugar. Like sugar, the new product is a free-flowing, water-soluble, white crystalline powder.
FDA approved sucralose April 1 for use in baked goods, baking mixes, nonalcoholic beverages, chewing gum, coffee and tea products, confections and frostings, fats and oils, frozen dairy desserts and mixes, fruit and water ices, gelatins, puddings and fillings, jams and jellies, milk products, processed fruits and fruit juices, sugar substitutes, sweet sauces, toppings, and syrups. It also can be a "table-top sweetener" that is added directly to foods.
FDA reviewed more than 110 studies in humans and animals in deciding on sucralose's safety.
Sucralose is manufactured by McNeil Specialty Products, a subsidiary of Johnson & Johnson, New Brunswick, N.J.
The Extension Adapter for a Tesio catheter is part of a kit made or distributed by Medcomp, Harleysville, Pa., and sold between October 1997 and February 1998 in 11 states and nine foreign countries.
The deaths and injuries resulted from severe blood loss when the adapters disconnected from the implanted dialysis access catheters while the patients were asleep.
FDA urges all patients on chronic dialysis to contact their dialysis centers immediately to see if they have the defective adapter. If so, it will have to be replaced. FDA also is urging all hemodialysis centers across the United States, particularly in California, Florida, Michigan, Minnesota, Missouri, New Jersey, Tennessee, Texas, Utah, Virginia, and Washington, where the adapters were known to have been distributed, to stop using the defective adapter and notify their at-home hemodialysis patients of the risk.
Medcomp announced in a March 24, 1998, letter to its distributors that it is recalling all of the 7,000 defective Tesio Extension Adapters, which were also distributed in nine foreign countries.
Medical facilities have long used unoccupied TV broadcast channels for the operation of telemetry devices. But as television stations have begun converting to the digital systems that will broadcast new high-definition TV formats, they have started using these formerly unoccupied channels, which could create a disruption in the operation of the devices. At press time, no patients had been significantly affected by interference, according to a statement by the two agencies.
Fibrin, approved by FDA May 1, is made from fibrinogen, a human blood protein that forms a clot when combined with thrombin, another blood-clotting protein. The product forms a flexible material over the oozing blood vessel that can often control bleeding within five minutes.
Fibrin is manufactured in Austria and distributed by Baxter Healthcare Corporation, Glendale, Calif., under the brand name Tisseel.
Sterilization System, FDA warns, due to reported injuries involving ophthalmic surgical instruments sterilized with the system. The device has not been cleared by FDA.
The agency has received reports of at least 10 serious corneal injuries involving vision damage with at least two cases requiring corneal transplants.
The device appears to form toxic salts when used on surgical tools made of copper, brass or zinc.
The device's maker, Abtox Inc., Mundelein, Ill., recalled the device in April from its 155 customers worldwide. At press time, FDA was monitoring the recall.
Spraying away Salmonella ... Running newly hatched chicks through a shower of 29 beneficial bacteria can reduce or eliminate Salmonella in those birds. The bacteria are in a spray called Preempt, which FDA approved in March. The bacteria, which the chicks ingest when they peck at their wet feathers, take up residence in the chicks' intestines and shut out Salmonella. In tests on 80,000 chicks, Salmonella presence was eliminated with only one application.
Early labor test ... Pregnant women can find out if they are at risk for premature labor with a new saliva test that gauges levels of the hormone estriol. Approved by FDA in April, SalEst, made by Biex Inc., Dublin, Calif., is intended for women between the 22nd and 36th weeks of pregnancy. Of the 4 million annual births in the United States, about 11 percent are premature. These babies are at greater risk of dying and having conditions such as cerebral palsy and mental retardation.
Reducing "awareness" during surgery ... A device designed to eliminate the potential that a patient might remain partially conscious after receiving anesthesia was approved by FDA in March. The Bispectral Index monitor measures the brain's response to anesthesia, allowing doctors to administer the precise amount of drug needed to ensure the patient is completely unconscious. Johns Hopkins University researchers estimate that "awareness" during surgery occurs in four out of every 10,000 cases.
Stroke signs ... Many people can't identify even one symptom of stroke, says a new survey sponsored by the National Institute of Neurological Disorders and Stroke. Only slightly more than half of those surveyed could name at least one stroke symptom, and only 68 percent could name one stroke risk factor. Stroke is the main cause of disability and the third leading cause of death in this country. Researchers say knowing symptoms increases the odds that stroke's effects can be lessened, even reversed.
Here are the warning signs. If you have any of these symptoms, call, or have someone call, 911 immediately:
For more on stroke, see "New Success Against Stroke" in the March-April 1998 FDA Consumer.
Soy story ... Genistein, a chemical found in tofu and other soybean-based foods, may suppress proteins that allow cancer cells to survive. Researchers at the University of California at Los Angeles say certain Asian cultures, whose diets are high in genistein, have a low risk of cancers such as breast and prostate. (Journal of the National Cancer Institute, March 1998)
Drop goes the measles ... Now at the lowest level ever in the United States, domestic measles cases last year numbered only 135, down from 488 in 1996, according to the national Centers for Disease Control and Prevention. Elsewhere in the Western Hemisphere, however, the childhood disease was more prevalent, reports CDC. For example, Brazil's densely populated state of Sao Paulo had 20,186 cases.
Risky fats ... Elevated blood levels of triglycerides, the most prevalent fat in food, can indicated a heart attack risk for middle-aged and elderly men, says a study in Denmark. Researchers studied 2,906 white men, ages 53 to 74, who had no heart disease history, and found that over eight years the men with the highest triglyceride levels appeared to have the most heart attack risk, regardless of factors such as total cholesterol. (Circulation, March 24)
Caffeine lowdown ... A new brochure that highlights information on caffeine and health is available from the International Food Information Council (IFIC). Included are "quick facts" and historical notes about caffeine consumption, as well as topics such as caffeine during pregnancy, questions about addiction, and osteoporosis. For a free copy, send a stamped, self-addressed envelope to "Everything You Need to Know About Caffeine," IFIC, P.O. Box 65708, Washington, DC 20035. Or visit IFIC's Website.
FDA Consumer magazine (July-August 1998)
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