Red Yeast Rice, the FDA, and Treating Your High Cholesterol

For those whose cholesterol levels top the 200 mark, physicians often prescribe statins. While effective for many people with high levels of LDL, or bad cholesterol, a number of patients have suffered from side effects, the most notable being muscle toxicity or severe muscle pain.

The pharmaceutical family of statins includes such well-known names as Lipitor and Zocor. These drugs work by blocking the process that produces cholesterol. The core ingredient is lovastatin, a byproduct of yeast.

Red Yeast Rice is rice that has been fermented by the red yeast known as Monascus purpureus. Red Yeast Rice has been a part of Asian cultures since at least the 9^th century. It is thought to promote blood circulation and digestive health.

In 1977, Dr. Endo of Japan discovered a naturally occurring substance in Monascus yeast. Dr. Endo called this substance moncacolin K. Moncacolin K is a lovastatin, the same ingredient used in prescription statin drugs manufactured by pharmaceutical companies.

It is lovastatin that lowers cholesterol.

Red Yeast Rice capsules were available over the counter, and cost considerably less than prescription statins. Like their prescription counterparts, the supplements contained lovastatin. The ability to lower cholesterol became a marketing tool, and Red Yeast Rice was touted as a natural way to bring down cholesterol levels.

If sold as a dietary supplement, Red Yeast Rice goes unregulated by the Food and Drug Administration (FDA). But in 1999, when the FDA was alerted that the Red Yeast Rice products being sold over the counter contained lovastatin, the governmental agency sought to regulate it.

Lovastatin is a regulated substance, and so any product containing the substance needs to be regulated by the FDA.

In 2000, the 10^th US Circuit Court of Appeals ruled that Red Yeast Rice was to be regulated, and the FDA began investigating.