The low carbohydrate diet craze has hit the U.S., and consumers are scrambling to buy "low carb" food products. The food industry has asked the Food and Drug Administration (FDA), which regulates food, drugs, medical devices, and cosmetics, to clarify what carbohydrate claims can be made on food labels.
In a clinical study, human volunteers receive investigational drug therapy. The effects of the treatment are compared with a control group of human volunteers who receive either the standard treatment or a placebo (a sugar pill that has no therapeutic benefit). Researchers are able to conclude whether the experimental drug had a better outcome than the standard treatment. The experimental drug might produce a better outcome, but it might not work. It could prove dangerous or even deadly.
Most medical treatment uses some form of drug therapy. Consequently, most medical malpractice actions have a drug liability aspect. A physician has a duty to exercise the skill and care generally shown by competent physicians with similar training in diagnosing a condition and prescribing drugs or medical devices. If not, the physician can be held liable for professional negligence or medical malpractice.
Congress passed the Federal Food, Dug, and Cosmetic Act (FDCA) in 1938. The FDCA set up the Food and Drug Administration (FDA) to enforce the Act. The goals of the FDCA were to assure that foods are pure and safe to eat, that drugs and medical devices are safe and effective, and that cosmetics are safe. The FDCA banned adulterated and misbranded food from interstate commerce. The FDCA also regulates the labeling and packaging of foods, drugs, medical devices, and cosmetics. Under the FDCA, the FDA was given authority to adopt regulations dealing with food, drug, medical device, and cosmetic safety. This article discusses important amendments to the FDCA.
Cigarettes, cigars, and chewing tobacco are all tobacco products. Smoking has been linked to lung cancer, emphysema, heart disease, and other serious illnesses. Cigarette smoking by pregnant women increases the risk of birth defects, and exposure to second-hand smoke can lead to serious diseases. Chewing tobacco has been linked to oral cancer.
