Yeast Infection News

Sunburst Organics, a Baldwin mail-order company, as the result of a Food and Drug Administration warning letter,  has removed a dietary supplement containing a specially concentrated red yeast rice extract from its stock.

Sunburst Organics took the action after the FDA said that a product the company was selling by mail and in its Baldwin store contained red yeast rice with enhanced or added lovastatin.

The label of the product, Cholestrix, claimed that the lovastatin, an active ingredient in certain prescription cholesterol drugs, provided “powerful cholesterol fighting” benefits.

In early August, the FDA said that lovastatin contained in certain red yeast rice products can cause muscle problems leading to kidney impairment.

The FDA informed Sunburst Organics that because Cholestrix made a cholesterol-fighting claim, it could not be marketed as a supplement that does not go through an agency approval process.

Because lovastatin had already been approved by the FDA as a drug, it cannot be marketed as a supplement, the agency told Sunburst Biorganics.

“Lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement, and your lovastatin-enhanced red yeast rice product is excluded from the dietary supllement definition,” the FDA letter said.

Jerry Reminick, vice-president of Sunburst Organics, said, “We’ve removed it from our Web site and we’re going to recall the products. We weren’t aware that lovastatin at that level was a drug.”

Source: Newsday