Alli is an over the counter (OTC) weight-loss medication. It is manufactured by GlaxoSmithKline, based in England. Alli is the first OTC, weight-loss drug approved by the Food and Drug Administration. According to Phentermine website, Alli is intended for use by overweight individuals over the age of 18 years, with a BMI (Body Mass Index), a number calculated from a person’s weight and height, of 25 or above. Alli contains the following active and inactive ingredients.
An active ingredient, according to the Food and Drug Administration website, is the part of a drug that creates pharmacological effects by its action on the body function of humans or animals as a cure, diagnosis or treatment, or the mitigation or prevention of a disease. Orlistat is a generic drug and the active ingredient in Alli. Orilistat blocks the action of the enzyme in the body that normally breaks down fats. This makes it easier for the body to absorb fats, and the fat that’s not broken down and absorbed is excreted, undigested, from the body, preventing it from being stored as body fat. Alli contains 60 mg of Orlistat; this is 50 percent less Orlistat than other weight-reducing prescription drugs, making Alli safe to be an OTC drug.
An inactive ingredient, according to the Food and Drug Administration website, is any part of a drug content other than the active ingredient. Inactive ingredients are used in pharmaceutical products to improve appearance, stability and bioavailability, and the taste as well as consistency, or as a stabilizer or a preservative. Inactive ingredients are usually referred to as inert. These ingredients do not affect the action of the active component in the drug. The inactive ingredients in Alli includes, FD and C Blue No. 2, edible ink and gelatin as well as iron dioxide, microcrystalline cellulose and povidine, sodium lauryl sulfate, sodium starch glycolate and talc.
In 1985, the FDA, on the recommendation of the Committee on Drugs, mandated labeling of OTC and prescription formulas to include a qualitative list of inactive ingredients. This recommendation was the result of an increasing number of reports regarding adverse reactions due to inactive ingredients in these pharmaceutical products. The FDA has approved 773 inactive ingredients for use in pharmaceutical drug products .