The U.S. Food and Drug Administration (FDA) has issued a warning to the manufacturers of the weight-loss supplement Almased® that statements on the company's website, as well as in a "Weight Loss Program" booklet, are incorrectly and illegally promoting the weight-loss supplement as a drug to treat diabetes, high cholesterol and high blood pressure.
Diabetes, also known as diabetes mellitus, is a chronic health condition where the body is unable to produce enough insulin and properly break down sugar (glucose) in the blood. With Type 1 diabetes, the body does not make any insulin. With Type 2 diabetes, which is the more common type, the body does not make or use insulin properly. Without enough insulin, glucose stays in the blood and causes a condition called hyperglycemia, or high blood sugar levels. Diabetes is associated with long-term complications that affect almost every part of the body. The disease often leads to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage. Uncontrolled diabetes can complicate pregnancy, and birth defects are more common in babies born to women with diabetes.
High blood pressure over a sustained period of time is a condition referred to as hypertension (HTN). The American Heart Association estimates that nearly one in three American adults has high blood pressure. Approximately two-thirds of people over the age of 65 have high blood pressure. Of those people with high blood pressure, 71.8% are aware of their condition. Of all people with high blood pressure, 61.4% are under current treatment, 35.1% have it under control, and 64.9% do not have it controlled.
High cholesterol, or hypercholesterolemia, is a condition in which there are unhealthy high levels of cholesterol in the blood. It is also called dyslipidemia, hyperlipidemia, and lipid disorder. Too much cholesterol in the blood is a major risk for heart disease, which may lead to a heart attack, heart failure (cannot pump enough blood to the body), and death. High cholesterol levels are also a risk factor for stroke (lack of blood and oxygen to the brain), causing nerve damage.
Because Almased® is labeled as a dietary supplement, it cannot be advertised as a drug for curing or treating diseases such as diabetes, high blood pressure or high cholesterol according to section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Furthermore, Almased® cannot be reclassified as a drug because it has not been approved by the FDA as required in section 505(a) of the same act. Consequently, the FDA is requiring that Almased® USA, Inc. review the statements posted on its website or any other forms of product advertising. The company must remove any statements that suggest that the weight-loss supplement can be used to treat diabetes, high blood pressure or high cholesterol levels.
For more information about integrative therapies for diabetes, high blood pressure or high cholesterol levels, please visit Natural Standard's Comparative Effectiveness Database.