FDA is regulating red yeast rice manufacturers, say ABC & NPA, as scientists question safety and labels

According to a paper in the Journal of Clinical Lipidology​​, a review of 101 products containing red yeast rice found that “no products passed any independent laboratory verification testing”​.

In addition, 42.6% of the product labels contained statin-related warnings, said the researchers, led by Matthew Ito, PharmD.

The ingredient ​

Red yeast rice is the product of yeast grown on rice. It is a dietary staple in some Asian countries, and reportedly contains several compounds that inhibit cholesterol production, including monacolin K – also known as lovastatin and used in Merck’s Mevacor pharmaceutical.

The scientific support for red yeast rice (RYR) includes a positive opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) that red yeast rice can maintain normal blood LDL-cholesterol concentrations​.

Commendable intent, but…​

Commenting on the paper, Mark Blumenthal, Founder & Executive Director of the American Botanical Council (ABC), told NutraIngredients-USA that the paper “appears to contain a reasonably concise review of some of the clinical literature showing the beneficial activity of various red yeast rice preparations in lowering LDL cholesterol and other blood lipids in human clinical trials. ​

“With respect to the authors’ attempt to determine the extent of RYR dietary supplement products’ contents, label warnings, and manufacture under GMP rule, the authors are to be commended for their intent​ to conduct an extensive review and analysis of their data. ​

“However, there are some limitations to this paper, one of them being that the authors appear to have obtained much of their information via searches on the Internet.” ​

FOIA​

The Oregon State researchers also filed a Freedom of Information Act (FOIA) request with the FDA with several questions about the identity of red yeast rice supplement manufacturers, and which of these are in compliance with FDA cGMP regulations.

The FDA responded that it had “no information on the identity or numbers of firms currently manufacturing or distributing dietary supplements containing red yeast rice [because], under current law, dietary supplement firms are not required to register products or dietary supplement ingredients with the FDA.”​ As such, the agency has no information that would enable it to identify those that have been inspected to date under current CFR 111.

Making a significant leap for their conclusions, the researchers wrote: “Currently, the FDA is not regulating manufacturers of RYR products and as a result, many of these products may contain monacolin K and toxins such as citrinin.”​

“Erroneous”​

ABC’s Blumenthal said such a conclusion was “erroneous”​.

Cara Welch, PhD, Sr VP of scientific & regulatory affairs at the Natural Products Association (NPA), told us: “As far as I can tell, the inaccurate conclusion goes something like this: FDA doesn’t collect information on identity of firms manufacturing RYR products so can’t tell you if they’ve been inspected under 21 CFR 111 – the authors thus conclude GMPs haven’t been followed regarding RYR product manufacturing.  ​

“As a matter of fact, I know RYR manufacturers are regulated by the FDA and, in some cases, have been inspected under 21 CFR 111. ​

“These authors don’t understand the reality of dietary supplement regulation.”​

“Misleading”​

Blumenthal added that, “even though many experts will no doubt support their concerns about the variability of monacolin K (the primary active statin-like compound in RYR) and the possible inclusion of the potentially nephrotoxic contaminant compound citrinin in some RYR raw materials and products, to write that these products are not regulated is inaccurate and misleading​

“The authors might have been more aware of regulatory realities with respect to their concerns regarding the lack of FDA requirement for a standardized level of monacolin in commercial RYR dietary supplement products, and the possibility that the contaminant citrinin may be present. ​

“While both of these items are of reasonable concern to health professionals and others, it is possible, perhaps probable, that from a regulatory perspective, the very act of declaring a standardized level of monacolin in RYR extracts may trigger a regulatory action by the FDA, per the Cholestin case, thereby making it unfeasible for a company to do so,”​ he added.

NPA’s Dr Welch said: “The authors imply red yeast rice products can’t be marketed if they contain any amount of monacolin K but NPA believes you can market traditional RYR products as long as you aren’t enhancing and promoting the monacolin K concentration.”  ​

Traditional production methods​

Marc Ullman from NY law firm Ullman, Shapiro & Ullman confirmed that if a dietary supplement company standardizes its product for monacolin content, FDA will consider it an unapproved new drug. 

“Red yeast rice can still be legally marketed as a dietary supplement only when fermented in the traditional manner of production.  Manufacturers cannot target statin content or manipulate for it.​

“Similarly, while it is legal to market red yeast rice, it is not legal to sell the product while promoting monacolin or statin content,” ​added Ullman.

Source: Journal of Clinical Lipidology​​
March 2013, Volume 7, Issue 2, Pages 117-122, doi: 10.1016/j.jacl.2012.09.003
“Review of red yeast rice content and current - Food and Drug Administration oversight”​
Authors: L. Childress, A. Gay, A .Zargar, M.K. Ito

Supporting documents from the study can be found here​.