With all the media attention on high cholesterol and heart health, it’s not surprising that some companies are preying on consumers with “natural” treatments like “red yeast rice products” that may contain prescription drugs without obtaining authorization from the US FDA. The FDA is now warning consumers about these products sold on the Internet as dietary supplements for high cholesterol:
Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics.
These products were found to contain lovastatin, an anti-cholesterol drug, yet the manufacturers do not warn consumers about the potentially dangerous side effects of products containing this chemical the way that pharmaceutical companies are required by law to warn consumers. The FDA has sent warning letters to these companies to stop selling these products. Source: FDA
By Robert Lamberts, M.D.
The supplement industry is a huge one – Over $14 Billion in US sales in 2004 (still small compared to the over $200 Billion spent on prescription drugs in the same year), but one study showed that 6 out of 10 Americans were taking a supplement of some kind.
A recent article in the Washington Post caught my eye, casting some questions about some of the more popular supplements:
Millions of Americans who regularly take vitamins and other popular dietary supplements have had their faith in those products challenged in the past year as the substances fared poorly in several large clinical trials and a federal panel’s scientific review.
The supplements tested are widely used but few had previously been put to large-scale, well-designed clinical trials. The findings showed that some of Americans’ most trusted supplements — including some, such as multivitamins and calcium, that doctors ave recommended for decades — failed to show the benefits they were believed to offer
The difference between drugs and dietary supplements lies mainly in how they are regulated by the FDA. While drug companies cannot make any claims that the FDA has not sanctioned, supplement manufacturers are able to be much more “creative” with their information. While they can’t make bold-faced lies, they can make claims that are unable to be disproven, such as “supports a healthy immune system,” or “supports prostate health.” The FDA has little say as to what claims are made (actually the Federal Trade Commission can step in for fraudulent advertising). The same is true for the content of the medications, which must meet stringent government requirements for prescription drugs, but can have a wide range of content in supplements. (more…)