Update on Red Yeast Rice Products

Some customers have contacted us regarding negative publicity about red yeast rice products marketed under our Solaray®, Natural Balance® and VegLife® brands. This publicity originated with a ConsumerLab review.

We want to reassure you that our manufacturing and testing processes are designed to ensure that our products meet applicable safety standards in the United States. We believe that our products are safe when used as directed. The ConsumerLab review should not be construed as evidence that our products are unsafe.

REGULATORY BACKGROUND ON RED YEAST RICE

We sell traditional red yeast rice which is produced from the natural fermentation of the yeast, Monascus purpureus, on rice. Red yeast rice traditionally contains trace amounts of lovastatin - however, due to the regulatory status of red yeast rice, we focus our efforts on sourcing red yeast rice that has been manufactured according to traditional methods, which is the only kind of red yeast rice that meets FDA's regulatory requirements. Traditional red yeast rice has been consumed for centuries.

We think it is important to note that FDA has historically pursued regulatory action against manufacturers and products that have moderate to high levels of lovastatin or make claims about the presence of lovastatin on their labels. See for example these warning letters:

http://www.fda.gov/foi/warning_letters/s6692c.htm

http://www.fda.gov/foi/warning_letters/s6455c.htm

Consumers should be cautious about purchasing products that are manufactured using techniques that increase or concentrate the amount of lovastatin above what is found in traditional red yeast rice. Some manufacturers may even be adding lovastatin. In either case, FDA would take the position that such products should not be sold or purchased as they violate the law in numerous respects, including lack of assurance of safety.

CONSUMERLAB REVIEW

The ConsumerLab review contains some errors. One of the primary errors is its failure to note that among health food store brands tested by ConsumerLab, only Solaray®, Natural Balance® and VegLife® products contained levels of lovastatin within the range that FDA considers naturally occurring and safe. In fact, the ConsumerLab review suggests that consumers may wish to consider purchasing products with moderate to high levels of lovastatin - the very products that could be and have been subject to regulatory action and that FDA considers to be unacceptable and unsafe for dietary supplements.

We have made some suggestions to ConsumerLab regarding its approach to creating and publishing standards and some improvements to its business model. Here is a copy of our letter to them.

CITRININ SCREENING

We screen our red yeast rice using UPLC-MS (ultra performance liquid chromatography-mass spectrophotometer detection). Current detection capabilities are down to 1 ppm.

CITRININ SAFETY

ConsumerLab acknowledged in its review that there is no scientific basis to determine whether or not the levels of citrinin that ConsumerLab claimed to have found in our products and other products has any adverse health effects. We have consulted an independent toxicologist who has confirmed to us that the levels referenced in the ConsumerLab report do not raise a safety issue. Nevertheless, in order to continue to assure the highest level of quality for our products, we have expanded our screening program tests for citrinin in all red yeast rice raw material down to 1 ppm.

CONCLUSION

Nutraceutical has built its reputation as a superior quality supplement manufacturer by providing ingredients with guaranteed purity and potency. We are noted for having among the most stringent testing and quality control standards in the industry and are audited by an external auditor. Routine tests are performed for aluminum, lead and other heavy metals, more than 500 pesticides, herbicides and fungicides, microbial contaminants such as E. coli and salmonella, disintegration time and, of course, potency.

You can be confident that Nutraceutical products meet their stated label claims by being manufactured under strict quality control procedures, by being thoroughly screened for suspected contaminants and by using high quality ingredients.

FDA Re-evaluates Health Claims

On December 21, 2007, FDA announced that it intended to re-evaluate certain previously approved health claims and qualified health claims involving soy proteins, antioxidant vitamins and selenium. Read a copy of Nutraceutical's submission to FDA.

Kelp Products

A case report from the University of California - Davis reported that detectable levels of arsenic were found in kelp dietary supplement products and that an individual's adverse health symptoms may have resulted from the consumption of a kelp supplement. Subsequently, there were news and media reports on this case report and retailers and consumers expressed concerns regarding the consumption of kelp due to its potential arsenic content.

Below is some background information on this case report as well as arsenic generally, including its presence in food and the environment. This information is intended to help retailers and customers understand that Nutraceutical stands behind the safety of its dietary supplement products, including its kelp products, and uses laboratory testing guided by scientific expert input to help assure that its products are safe.

Clarification of Case Report

The case report involves a single individual's experience with a kelp supplement consumed in quantities that are apparently at least up to four times the recommended daily amount. There are a number of inaccuracies in the case report. They include the following:

• The case report incorrectly implies that dietary supplements are not required by law to be safe. In fact, strict federal and state laws establish safety requirements for all dietary supplements, as is appropriate, and anyone who violates these requirements is subject to potential civil and criminal penalties.
• Contrary to the implications of the case report, dietary supplements have been widely consumed in the U.S for decades with a remarkable history of safety- in fact, the case report acknowledges that "only one case study has previously documented arsenic toxicity related to consumption of herbal kelp supplements."
• The case report fails to distinguish between organic and inorganic arsenic. Organic arsenic is less problematic than inorganic.
• The case report fails to acknowledge that arsenic is ubiquitous in our food and water and that safe levels of consumption were established long ago for vegetables, fish and herbs.
• Finally, there is no basis for the report's assertion that there is a growing number of reports of adverse effects from heavy metals in herbal supplements.

Additional critiques of the case report have been offered by both AHPA (the American Herbal Products Association)
and NPA (the Natural Products Association).

Dietary Sources of Arsenic

Arsenic is naturally occurring in the environment and is widely distributed throughout the earth's soil and oceans. Since arsenic is present in the environment, there are many dietary sources of arsenic, with seafood being the highest dietary source of arsenic. This means that arsenic is a naturally-occurring constituent in many foods, particularly those from the sea. Plants such as kelp absorb nutrients and minerals present in the environment during growth.

Arsenic is also present in drinking water. In 2002, the U.S. EPA established a federal drinking water standard of 10 ppb, which is equivalent to an ingestion of approximately 20 mcg/day from water alone. By comparison, the amount of arsenic per day that would be expected from a kelp supplement that is manufactured using appropriate controls would be approximately 0.1 mcg/day for a 45 mg kelp supplement.

Nutraceutical's Testing Procedures

Nutraceutical has one of the best product testing facilities in the industry, which includes the use of high-pressure liquid chromatographs (HPLC), gas chromatographs (GC), inductively-coupled plasma instruments (ICP), mass spectrometers (MS), ultraviolet visible spectrophotometers, infrared FTIR/NIR and other analytical instrumentation. In addition to its testing facilities, Nutraceutical also works with independent toxicology experts from time to time to assist with its product testing procedures for items such as pesticides, fungicides and heavy metals. Testing assistance is also provided by third-party laboratories. Nutraceutical's testing facilities are audited by an independent auditor and Nutraceutical has consistently received the highest compliance rating.

Kelp in Nutraceutical Products

The genus and species for the kelp used in Nutraceutical products include Laminaria digitata and Ascophyllum nodosum, which are both species of true kelp traditionally used as sources of iodine and other nutrients. Most of the kelp Nutraceutical purchases is sourced from the pristine seas around Iceland. The kelp is washed, chopped, dried, ground and screened before being made into tablets. Dried kelp has been used as a source of iodine since at least the beginning of the 19th century. Because kelp is a natural product, it absorbs nutrients and minerals present in the environment during its growth. These nutrients and minerals include iodine and may include other minerals, including very minute trace levels of arsenic absorbed from the environment.

Nutraceutical regularly tests and screens its kelp ingredients for arsenic content to assure safe levels when products are consumed according to label directions, and has had analyses performed by independent labs as well. Since kelp is a natural product, the arsenic content can vary from batch to batch but Nutraceutical has established its own testing standards and limits and rejects material that exceeds these limits. It is important in any such analysis to differentiate between inorganic and organic arsenic because organic arsenic is less toxic. Nutraceutical also periodically reviews alternative kelp suppliers to help ensure it is purchasing kelp with the lowest available arsenic levels.

The subject of the UC Davis case report has acknowledged taking significantly more than the recommended serving of kelp - up to four times the daily recommended amount. Eating too much of any type of food that contains naturally occurring arsenic could be a problem.

California and Proposition 65

To the extent there are minute levels of arsenic in kelp, Nutraceutical believes it is naturally occurring - meaning that it comes from the natural environment and not from man-made sources. The State of California has adopted a law known as Proposition 65 that requires warnings in certain circumstances, but does not require a warning for naturally occurring chemicals. However, in an over-abundance of caution and to make sure consumers are aware of the situation, Nutraceutical provides the Proposition 65 warning for all its kelp products to customers and retailers through notices on the product labeling, in product brochures (distributed by the retailers) and on its website at www.nutraceutical.com/notices.

Adverse Event Reporting

On December 6, 2006 Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act that will treat supplements like drugs for adverse event reporting.

What many people didn't realize in considering this bill is that there was already an adverse event reporting system for dietary supplements. See how you can already report adverse events to the FDA. We remain concerned that this new system that treats supplements like drugs - and supplement manufacturers like drug manufacturers - will not help consumers. Nutraceutical led the fight to protect the rights of consumers and health food stores to continue to sell safe and effective dietary supplements. For more information, click on any of the links below.

Brochures and Information

• Adverse Reactions to Foods and Dietary Supplements: Answers to Common Questions. In the Fall of 2005, we printed and continue to distribute 1,000,000 copies of this brochure to health food stores and health food store customers around the country!
• Legislative Update. In May 2006, we distributed this brochure to health food stores around the country
• Letter to A Private Label Manufacturer. We recently sent this letter to a private label manufacturer to point out errors in a letter they had sent to their retail customers about the legislation. The name and address of the recipient has been removed.
• A recent memo and three alternative approaches we have proposed: a 1-800 number, adding foods or fixing significant problems with the legislation as written.
• Concerns and issues we raised about an earlier version with trade associations and numerous senators and congressmen.
• A letter we sent to members of the House Energy & Commerce Committee.
• An informative "Legal Tips" article appearing in the September 2006 issue of Whole Foods Magazine (reprinted with permission of Scott Tips and Whole Foods Magazine).

Expert Opinions

• A letter from a product liability defense lawyer, Dan Gerber, analyzing the potential effects of the Act.
• A letter from a well-known FDA lawyer, Jonathan Emord, analyzing the potential effects of the Act.
• The cost estimate of this legislation prepared by Congress.

 

The Ephedra Decision: The Real Story

On April 14th, 2005, a Federal District Court in Utah ruled against FDA's ban on low-dose ephedra products. The plaintiffs were Nutraceutical Corporation and its subsidiary Solaray. We sued not just to protect our ephedra product, but to protect your access to other supplements. The FDA subsequently appealed the decision to the 10th Circuit Court of Appeals and on August 17th, 2006, the 10th Circuit Court of Appeals reversed and remanded. Nutraceutical subsequently petitioned for a rehearing but its petition was denied. Nutraceutical subsequently filed a petition for a writ of certiorari to the U.S. Supreme Court. On May 14, 2007, Nutraceutical's petition was denied.

In the meantime, Nutraceutical filed a motion for summary judgment with the Federal District Court in Utah, and FDA responded with a cross-motion for summary judgment. On March 16th, 2007, the Federal District Court in Utah ruled in favor of FDA. However, in its decision, the District Court held that the risk-benefit test announced in FDA's decision only applied to dietary supplements containing ephedrine alkaloids. Neither Nutraceutical nor FDA appealed this decision.

• Read the District Court Ruling
• Read the 10th Circuit Ruling
• See Our Petition for Rehearing
• See the 10th Circuit's Denial of Our Petition
• See Our Petition for a Writ of Certiori to the U.S. Supreme Court
• See our Motion for Summary Judgment Filed with the District Court
• See FDA's Cross-Motion for Summary Judgment Filed with the District Court
• See our Reply in Support of Our Motion for Summary Judgment and in Opposition to FDA's Cross-Motion for Summary Judgment Filed with the District Court
• Defendants' Reply to Plaintiffs' Opposition to Defendants' Cross-Motion for Summary Judgment
• Read the District Court's Subsequent Ruling
• See the U.S. Government's Opposition Brief to Nutraceutical's Petition for a Writ of Certiorari
• See NNFA's Amicus Curiae Brief in Support of Nutraceutical's Petition for a Writ of Certiorari
• See Our Reply Brief Before the U.S. Supreme Court

See the Food and Drug Administration's Responses to Questions about Codex and Dietary Supplements

See the Council for Responsible Nutrition's Myths and Facts on Codex and WTO

See the National Nutritional Foods Association Position Paper as well as its Codex Alimentarius Resource Center.