Quite frequently we are asked why we do not produce a supplement containing Red Yeast Rice Extract which is effective in many people for lowering cholesterol.
The answer is always the same. Simply that it has a similar action to that of a statin drug and as a result carries the same risk which we will not expose our customers to.
A number of supplement companies in the US have got into trouble with the FDA for marketing this product, and some of them are facing possible law suits from consumers for the same reasons as that of some of the manufacturers of statin drugs.
The law suits are based on the damage these drugs (and supplements) inflict on the body.
The following is an article by David A Mark, PhD, who is president of dmark consulting. I thought you may find it interesting.
Red yeast rice: Market it at your own peril
BACKGROUND: Monascus purpureus is a type of yeast grown on rice, traditionally used in China to generate a safe reddish food colouring (hence ‘red yeast rice’). In the 1990s, Chinese scientists working with the M. purpureus Went strain, using specific and carefully monitored growing conditions, were able to make powdered red yeast rice (RYR). A 2006 meta-analysis of 93 published, randomised, controlled clinical trials reported that, when taken orally at 1,200-2,400mg/day, it can lower total cholesterol by 35mg/dL, LDL cholesterol by 28mg/dL, and triglycerides by 36mg/dL, and increase HDL cholesterol by 5.8mg/dL.3 The active compounds in red yeast rice include monacolins, one of which, ‘monacolin K,’ is identical to the drug lovastatin (Mevacor).
FIRST ACT: The FDA moved to ban RYR products in 1998. The FDA position was that the products were unapproved new drugs. A protracted legal effort ended in March 2001, and the products disappeared from the market.
SECOND ACT: Red yeast rice products began to reappear in the US market in 2003. A reasonable guess is that those RYR products were not necessarily cultured or extracted to maximise monacolin content. Comparative laboratory analysis showed a 10-fold range in monacolin content. Most labels and websites said no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications.” Some labels made no statements related to cholesterol or heart health.
THIRD ACT: By 2007, there were at least 25 RYR products on the market. Label language ranged from specifying a monacolin content >> and claiming cholesterol-lowering activity to no mention of content or function. A few were coy about content or function, but inferred the same by having cautionary language similar to that of ’statin’ drugs, or were co-formulated with coenzyme Q10, a liver compound depleted by statin drugs.
The FDA responded in August 2007. One warning letter noted a company’s website that specified a lovastatin content and was a “cholesterol-fighting formula.” Another warning letter to a different company was more interesting because nothing about the product went beyond typical structure/function language — but analysis of the product by an FDA laboratory discovered that the product did contain lovastatin in more than trace amounts — hence a drug and forbidden. Neither company markets the products anymore.
The FDA also issued a press release warning consumers “…not to buy or eat red yeast rice products … that may contain an unauthorized drug that could be harmful to health.” The rationale for “harmful to health” was that consumers might not understand that the dangers of monacolin-containing RYR could be the same as those of prescription statin drugs. There are at least two case report studies in the literature of patients who developed muscle weakness and damage from consuming a red yeast rice product.4,5
Of importance to companies that continue to market RYR products, the FDA’s action became a catalyst to law firms seeking as potential clients people who consumed a RYR product and believe that they suffered an illness as a result. These legal activities will expand to include any RYR product claiming monacolin content, having warning statements alluding to health risks similar to those seen with statin drugs, or if the products have a measurable monacolin content without stating so on the label.
An RYR product that:
• Contains monacolins and says so: subject to FDA action (and lawsuits)
• Contains monacolins and does not say so: subject to FDA action (and lawsuits)
• Does not contain monacolins but says so: subject to FDA action
• Does not contain monacolins and does not say so: Caveat emptor, or at least exercise cautrion until the FTC decides that the term ‘red yeast rice’ constitutes false advertising, even if no further advertising claims are made for function or content
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