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The public has until Nov. 9 to comment on the proposal, published by FDA in the Aug. 11, 1995, Federal Register. Written comments may be sent to: FDA Dockets Management Branch, HFA-305, Rockville, MD 20857.
Experts consistently recommend that the keys to reducing children's smoking are: reducing access and limiting the appeal for children. Under the new proposal, measures to achieve these goals include:
Reducing Easy Access by Children
Reducing Appeal to Children
The proposal maintains the legal status of cigarettes and smokeless tobacco products for adults.
The national Centers for Disease Control and Prevention estimated the health-care costs associated with smoking in 1993 to be $50 billion: $26.9 billion for hospital costs, $15.5 billion for doctors, $4.9 billion in nursing home costs, $1.8 billion for prescription drugs, and $900 million for home health-care expenditures.
The Office of Technology Assessment calculated the social costs attributable to smoking in 1990 to be $68 billion: $20.8 billion in direct health-care costs, $6.9 billion in lost productivity from disabilities, and $40.3 billion in lost productivity from premature deaths.
Preventing children from smoking is key to reducing the deadly toll of smoking. The Clinton administration's proposal is intended to reduce smoking by people under 18 by half. The proposal builds on previous actions taken by Congress and others, such as the ban on television advertising and state laws prohibiting the sale or use of tobacco by children. It follows recommendations by the American Medical Association and the Institute of Medicine.
Vending machines are a primary source of tobacco products for young smokers. A study by the vending machine industry found that 22 percent of 13-year-old smokers use vending machines, compared with 2 percent of 17-year-old smokers. The 1994 Surgeon General's Report found that young people could buy cigarettes in vending machines an average of 88 percent of the time.
Mail-order sales provide no sure way of verifying age. Current industry practice only asks the consumer to provide a birth date or check box to verify age.
Self-service displays allow children to easily obtain tobacco products. The Institute of Medicine, in its landmark 1994 report "Growing Up Tobacco Free," concluded that placing tobacco products "out of reach reinforces the message that tobacco products are not in the same class as candy or potato chips."
Free samples are obtained by children, including those in elementary school, despite industry code prohibiting distribution to anyone under 21. Free samples are distributed on street corners, in shopping malls, and at sporting events. A New Jersey survey found that one-third of high school students who were smokers or ex-smokers reported receiving free samples before age 16.
Advertising and promotional activities can greatly influence a young person's decision to smoke or use smokeless tobacco products. Awareness of tobacco products and messages is very high among even the youngest children. Studies show that 30 percent of 3-year-olds and 91 percent of 6-year-olds could identify "Joe Camel" as a symbol for smoking.
CDC recently reported that 86 percent of underage smokers who purchase their own cigarettes purchase one of the three most heavily advertised brands: Marlboro, Camel and Newport.
Tobacco products are among the most heavily advertised products in the United States. In 1993, the tobacco industry spent $6.2 billion on advertising and promoting cigarettes and smokeless tobacco. Tobacco advertising expenditures have increased more than 1,500 percent between 1970 (the year before television and radio advertising was banned) and 1992.
Promotion of tobacco products is reaching children through non-tobacco items such as T-shirts, hats, and gym bags and through sponsorship of events.
A 1992 Gallup Survey found that half of adolescent smokers and one-quarter of adolescents who do not smoke owned at least one tobacco promotional item, such as a T-shirt, cap, sports item, or lighter. Another report found that one out of four 12-and 13-year-olds owned one of these items. Used or worn by young people, these become "walking billboards," promoting the products in schools and other locations where tobacco advertising is usually prohibited.
Sponsorship of events such as tennis tournaments, car races, and rodeos associate tobacco products with excitement and glamour, and provide a way for tobacco brands to be advertised on television despite the broadcast advertising ban.
Each and every day, another 3,000 young people become regular smokers, and nearly 1,000 of them will eventually die as a result of their smoking. Currently, more than 3 million children and adolescents smoke cigarettes, and 1 million adolescent boys use smokeless tobacco.
Smoking by young people is rising sharply. Between 1991 and 1994, the percentage of eighth-graders who smoke increased 30 percent, and the percentage of tenth-graders who smoke increased 22 percent.
Children tend to vastly underestimate the likelihood that they will become addicted to these products. Although only 5 percent of daily smokers surveyed in high school said they would definitely be smoking five years later, close to 75 percent were smoking seven to nine years later. A survey conducted in 1992 found that about two-thirds of adolescents who smoked said they wanted to quit, and 70 percent said they would not start smoking if they could make that choice again.
FDA will hear information from scientists, clinical investigators, professional groups, trade groups, commercial enterprises, and consumers about living human cells intended for structural repair or reconstruction. This includes cells implanted at the site where cells or tissues were removed or at another site in or on the patient, and includes products such as cartilage, fat and skin that are used for cosmetic reconstruction and augmentation.
Not included for discussion are gene therapy products and autologous cell products intended for functional repair or reconstruction--such as autologous pancreatic cells to produce insulin following total removal of the pancreas, stem cells for functional replacement of muscle, and lymphocytes activated to induce immune function.
Further details regarding the public hearing will be announced in the Federal Register.
Living human cell and gene therapies must undergo the standard FDA application processes for investigational use and licensing of biologicals, which are described in the Oct. 14, 1993, Federal Register.
In July, FDA banned the sale of OTC theophylline-containing combination bronchodilators because evidence failed to show that the products are safe and effective. These products had been on the market for decades.
The agency cited data showing that the therapeutic dose for these drugs may be toxic to some people, causing life-threatening events and death. Studies also show no evidence that the ingredients in these OTC products contribute to the claimed therapeutic effects or that the dosage of each component is safe and effective for a significant number of patients.
The ban does not include theophylline-containing OTC inhalers.
At the same time, FDA proposed banning OTC bronchodilators containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride because of abuse and misuse. According to the U.S. Drug Enforcement Administration, ephedrine is being used to make illegal drugs. And, FDA has found that some drug manufacturers promote ephedrine for unapproved uses, such as weight control and muscle enhancing.
People with asthma who have been using ephedrine will have several OTC alternatives containing other drugs, including epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. These are sold as metered-dose inhalers. Prescription options exist, as well.
FDA approved Coverject Sterile Powder (alprostadil, or prostaglandin E-1 hormone) for treatment of erectile dysfunction due to neurologic, vascular, psychological, or mixed causes, and to supplement other tests in diagnosing erectile dysfunction.
The patient injects the drug into the side of the base of the penis. It usually induces an erection within 5 to 20 minutes by relaxing smooth muscle and dilating the major blood artery in the penis.
Impotence support organizations estimate that 30 million men in the United States are impotent. One in three men over age 60 is affected.
Dosage is determined in the doctor's office, where patients must be properly instructed and trained in injection techniques. Most men will achieve optimal results with doses of 20 micrograms or less, and dosage should not exceed 60 micrograms. The drug should be used no more than three times a week and no more than once in 24 hours.
Potential side effects are mild to moderate pain at the injection site, local formation of excessive fibrous tissue, and an abnormally prolonged erection, or priapism. If erection persists longer than six hours, patients should immediately call their doctors or seek other emergency medical assistance.
Patients with sickle cell anemia or trait, multiple myeloma, leukemia, anatomical deformation of the penis, or penile implants should not use Coverject Sterile Powder. Also, underlying treatable medical causes of impotence should be diagnosed and treated before beginning this treatment.
Coverject Sterile Powder is manufactured by Upjohn Corporation, Kalamazoo, Mich.
(For more about impotence treatment, see "Inflatable Penile Implants Under Scrutiny" in the January-February 1994 FDA Consumer.)
Marketing with the new use was approved by FDA last June. Zocor was first approved in 1988 as an adjunct to diet to reduce elevated total and low-density lipoprotein cholesterol in patients with high cholesterol. Other drugs in its class include Lescol (fluvastatin), Mevacor (lovastatin), and Pravachol (provastatin).
Approval of the new use was based on results of the Scandinavian Simvastatin Survival Study, also known as the 4S study. The study assessed 4,444 patients with coronary heart disease and cholesterol levels of 212 to 309 milligrams per deciliter of blood over an average of 5.4 years. Zocor reduced overall deaths by 30 percent. Specifically, the drug reduced coronary heart disease deaths by 42 percent and reduced the occurrence of hospital-verified, nonfatal heart attacks by 37 percent.
Side effects associated with Zocor were generally mild and included: headache, abdominal pain, constipation, flatulence, and diarrhea.
Zocor is manufactured by Merck & Co. Inc., Whitehouse Station, N.J.
(For more information on cholesterol, see "Lowering Cholesterol," in the March 1994 FDA Consumer.)
The test system consists of a patch applied to the skin to collect sweat and an assay to detect drugs. The Sudormed Sweat Specimen Container is manufactured by Sudormed, of Santa Anna, Calif. The SolarCare Technologies Corporation EIA Micro-Place Assay is made by SolarCare Technologies Corporation, Bethlehem, Pa.
The patch is a waterproof, adhesive pad about the size of a playing card. It can be worn up to seven days on the back, upper arm, or lower chest and will collect drugs of abuse used during that time. A tamper-proof feature restricts it to a single application, so that it cannot be removed and reapplied later.
Currently, most drug abuse screening programs use urine tests, which only detect drug use up to 36 hours before the urine collection.
FDA cleared the patch test for marketing July 14. The agency based this decision on its review of Sudormed's clinical studies on effectiveness, its consideration of the scientific, medical and social issues concerning drug abuse testing, and the recommendation last April of the Medical Devices Advisory Committee's Clinical Chemistry and Clinical Toxicology Panel.
Results of a study show that women with polyurethane-coated breast implants are at negligible risk for cancer. In 1991, an FDA analysis showed that polyurethane could break down under human body conditions and form a chemical called TDA, which can cause cancer in animals. The manufacturer, Surgitek, a former subsidiary of Bristol Myers Squibb Co. of New York, immediately stopped selling the implants.
The study, designed by FDA and Bristol-Myers Squibb, showed the risk of cancer from exposure to TDA in women with these implants is only one in a million over a lifetime. About 110,000 women have the polyurethane-coated implants. FDA does not recommend removing the implants, as the agency considers the health risk connected with surgical explantation to be far greater than the risk of developing cancer.
Information that doctors must give to women considering saline breast implants has been revised. Saline implants are the only type still on the market for general use. These devices are composed of a saline (salt water)-filled solid silicone envelope. The most common risks of the devices are deflation or rupture, interference with mammography, and capsular contracture (formation and hardening of scar tissue around the implant). FDA advises women considering the implants to read all the information before surgery and discuss the possible benefits and risks with their doctors.
The revised information was reviewed by consumer groups, health professionals, and industry. It was published in the June 28 Federal Register.
FDA, the U.S. Department of Agriculture's Food Safety and Inspection Service, and the national Centers for Disease Control and Prevention, working with state health departments, will collect data from five locations around the country to learn more about risk factors for transmission of E. coli, Salmonella, and other harmful bacteria in food. The data will be used to help track the effectiveness of new federal food safety programs and regulations.