The U.S. Food and Drug Administration (FDA) is greatly concerned about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. The use of these products is associated with nephropathy. For more information visit the FDA web page titled Dietary Supplements: Aristolochic Acid. The FDA also has determined that colloidal silver products are unapproved drugs and not dietary supplements.

The FDA approved a shorter health claim for B-vitamins and vascular disease risk that reads "As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease.* *FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive." The FDA has also authorized manufacturers to make a health claim on labels about plant sterol and plant stanol esters and coronary heart disease. As noted in the March/April 2000 issue of the HIV ReSource Review, products with plant sterol and plant stanol esters can be helpful in reducing the risk of coronary heart disease by lowering blood cholesterol levels.

On the subject of cholesterol, the court upheld FDA’s ban on the cholesterol-lowering supplement Cholestin, which contains lovastatin, the active ingredient in Mevacor used to modify cholesterol levels. FDA is questioning the use of cholesterol- lowering supplements such as Cholestin without a physician's supervision.

Numerous studies using extended-release niacin (Niaspan) document that it can help decrease the risk of heart disease. Elam and others found that niacin is effective in treating lipid abnormalities and can be used safely by diabetics. (1) Wolfe and colleagues found that Niaspan at 1-2 grams decreased low-density lipoprotein cholesterol (LDL), triglycerides and total cholesterol and increased high-density lipoprotein cholesterol (HDL). (2) The 66 dyslipidemic men and women in this retrospective analysis were also treated with a statin drug. Reports from a multi-site double-blind study of 148 Type 2 diabetics that used either a placebo or Niaspan to treat lipid abnormalities revealed that diabetics can improve their lipid profile while maintaining blood sugar control. Both HDL cholesterol (mean increase 20-24%) and triglycerides (mean decrease 15-29%) improved after six weeks of treatment with 1-1.5 grams of Niaspan per day. Additional information on Niaspan is available for health professionals and patients.
Sources:
1. Elam MB, Hunninghake DB, Davis KB, Garg R, et al. Effect Of Niacin On Lipid And Lipoprotein Levels And Glycemic Control In Patients With Diabetes And Peripheral Arterial Disease: The ADMIT Study: A Randomized Trial. JAMA 2000;284(10):1263-70.
2. Wolfe ML, Vartanian SF, Ross JL, Bansavich LL, et al. Safety And Effectiveness Of Niaspan When Added Sequentially To A Statin For Treatment Of Dyslipidemia. Am J Cardiol 2001;87(4):476-79.