Pharmanex Challenges FDA "Drug" Ruling On Dietary Supplement Cholestin; Decision Could Have Far-Reaching Impact on Dietary Supplement Industry

The company will now revive its suit in Federal District Court in Utah to seek a ruling that will ensure the continued availability of the Cholestin product to consumers. FDA has agreed to an expedited court hearing, to occur on June 15, 1998, in Salt Lake City.

"Pharmanex continues to believe that Cholestin is a safe and beneficial dietary supplement," said Bill McGlashan, president of Pharmanex. "FDA’s far-reaching ruling today on Cholestin would restrict consumer freedom to choose among safe ways to promote and maintain health."

The FDA’s action does not question the safety or benefits of Cholestin as a dietary supplement. Rather, the agency reached the erroneous conclusion that the product is an unapproved "new drug."

If this decision is not overturned in court, it could deny consumers the ability to use Cholestin—a natural dietary supplement composed of ground red yeast rice—to promote and maintain healthy cholesterol levels. Red yeast rice is a natural food that is a traditional dietary staple in Asia.

FDA’s decision also has enormous implications for the dietary supplement industry. The decision directly calls into question the ability of dietary supplement companies to look to the existing food supply to provide consumers with standardized dietary supplement products that promote and maintain health.

Cholestin red yeast rice is used as part of an overall cholesterol maintenance program that includes regular exercise and a diet low in saturated fat. Nothing in Cholestin’s labeling or promotional material suggests the product treats, prevents or cures hypercholesterolemia or any other disease.

The future of this very popular, beneficial and relatively inexpensive supplement came into question Sept. 30, 1997, when the FDA told Pharmanex it considered Cholestin an unapproved drug rather than a dietary supplement and that the cholesterol information contained in the product’s packaging constituted a drug claim.

The FDA based its claim on the fact that Cholestin naturally contains mevinolin, a substance the agency equates with lovastatin, the synthesized active compound in Merck’s prescription drug Mevacor.

Cholestin contains at least 10 naturally occurring HMG-CoA reductase inhibitors, only one of which is mevinolin, as well as unsaturated fatty acids. All of these natural compounds contribute to Cholestin’s beneficial properties as a dietary supplement.

"This case undermines the very foundation of the Dietary Supplement Health and Education Act (DSHEA), which the FDA has long opposed," said McGlashan. "Dietary supplements such as Cholestin play a legitimate role in maintaining and promoting good health in a cost-effective manner. DSHEA makes that very clear."

Senator Dianne Feinstein (D-Calif.), in a letter to the FDA, stated: "I believe that it is important at this critical time in the interpretation of DSHEA, that as FDA works to protect consumers, the result is not seen as creating a chilling effect by equating Pharmanex’s effort at quality control, standardization and scientific research as the development of a drug."

And, Senator Tom Harkin (D-Iowa) stated in a letter to the FDA: "From a public health perspective, it is critical that as many of these individuals as possible have access to products that can promote and improve their health. One of the main purposes of DSHEA was to improve Americans’ access to and information about dietary supplements that can improve and promote health."

Sanford A. Miller, Ph.D., a leading national authority on food and former head of the FDA’s Center for Food Safety and Applied Nutrition, noted: "Whatever your view on the regulation of dietary supplements, Cholestin is, in my opinion, a dietary supplement. Pharmanex is doing exactly what Congress envisioned when it created DSHEA. It is simply producing red yeast rice, which for centuries has been used as a food, in a quality-controlled manner."

Founded in 1995, Pharmanex is a privately held manufacturer and marketer of natural health-care products. Based in Simi Valley, Pharmanex employs cutting-edge research and development techniques to assure the safety and efficacy of its line of natural products and strives to broaden acceptance of natural health-care products in mainstream America. Pharmanex’s product line includes BioGinkgo, Cholestin, CordyMax, Tegreen, EstroCare and Bio St. John’s.

Cholestin Fact Sheet

Description:

Cholestin is a natural dietary supplement composed of red yeast rice. Red yeast rice, a solid fermentation of yeast on rice, is a food product that has been used in China for thousands of years. Many red yeast rice products contain a range of naturally occurring HMG-CoA reductase inhibitors—including mevinolin—and unsaturated fatty acids.

Cholestin has been shown in numerous scientific studies, including one recently completed at UCLA, to help people with moderately elevated cholesterol maintain healthier cholesterol levels.

Cholestin does not pose safety or health concerns. The product bears proper labeling, including appropriate warnings, as permitted under the Dietary Supplement Health and Education Act (DSHEA). (This bullet may be deleted with mandated FDA changes.)

The product is available in more than 35,000 stores including GNC, Long’s Drug Stores, Vons, K-Mart, Wal-Mart, Walgreens, Sav-On, Rite-Aid, Fred Meyer, Giant Foods and CVS

What is mevinolin:

Mevinolin is a naturally occurring constituent of Cholestin, which is produced through the traditional Chinese red yeast rice fermentation process. As such, it is different from the synthetically isolated purified, crystallized substance called lovastatin found in Merck’s cholesterol-reducing drug, Mevacor.

The presence of mevinolin in a food product like red yeast rice is not unusual. Mevinolin is also found in oyster mushrooms (the second-largest-selling variety of mushrooms in the world). Pharmanex does not add, enhance or maximize this natural constituent; it merely employs quality controls to ensure consumers get the most consistent and highest-quality product.

Cholestin’s labeling:

Since Cholestin became available to consumers in early 1997, Pharmanex has emphasized in labeling that it is intended for use only by people with moderately elevated cholesterol and that the dietary supplement can play a role in maintaining healthy blood lipid levels in the context of an overall healthy diet combined with regular exercise.

Pharmanex does not make claims about Cholestin with respect to persons with a disease such as hypercholesterolemia, or dangerously high cholesterol levels (240 mg/dl or higher) and does not state a disease benefit.

DSHEA:

DSHEA is a law enacted in 1994 to regulate the growing dietary supplement industry. At the center of the FDA’s examination of Cholestin has been the position taken by the FDA that DSHEA does not permit statements of nutritional support relating to cholesterol and that all such statements are drug claims rather than structure/function statements of nutritional support authorized by DSHEA. FDA has since imposed rules that acknowledge the legality of statements of nutritional support regarding the promotion and maintenance of healthy blood cholesterol levels.

Pharmanex Inc. Facts-at-a-Glance

A science-based, privately held developer and marketer of natural, proprietary and preventative health-care products, based in Simi Valley.

A pioneer in phytotechnology; employs cutting-edge research and development of techniques to assure the safety and functionality of natural, traditional health products.

Employs cutting-edge biochemical research to "fingerprint" the molecular compositions of every natural substance present in its products to achieve unparalleled product reliability.

Has raised a total of $34 million in venture funding, believed to be the single largest pool of venture capital ever raised by a company in the dietary supplement industry. Investors include the interests of the Pritzker family, Chase Venture Partners, J. H. Whitney & Co., Fidelity Capital Management, Generation Ventures, Post Advisors and Canyon.

Research team includes more than 40 M.D.- and Ph.D.-level scientists, many with extensive pharmaceutical industry experience.

Products consist of naturally occurring, plant-based substances that have been proven safe and effective through extensive scientific research.

Management team led by:

Henry Burdick, chairman and chief executive officer; former CEO and co-founder of Pharmavite Corp., maker of NatureMade, the leading vitamin brand in the United States.

William McGlashan Jr., president; co-founder and former CEO of Generation Ventures, specialists in funding and building Sino-American business ventures; co-founder and president of Trade Inc.

Michael Chang, Ph.D., chief scientific officer and senior vice president, research and development; prior positions include director of medicinal chemistry, Rhone-Poulenc Rorer; and associate director of Medicinal Chemistry, Merck; he holds 29 patents and has authored 40 publications.

The Pharmanex Scientific Advisory Board (SAB) is composed of world-renowned scientists who have made major contributions to the development of natural products. The SAB is chaired by Stanford University Professor of Chemistry Dr. Carl Djerassi, winner of the National Medal of Science and the National Medal of Technology; author of more than 1,200 research articles and seven books on natural product chemistry.

The Pharmanex Medical Advisory Board (MAB) is an advisory panel that counsels the company on medical issues related to its business. Members of the MAB illuminate health issues that could be addressed by natural products marketed under DSHEA, and propose new areas for product development. The MAB is chaired by James Rippe, M.D., the Center for Clinical and Lifestyle Research; and David Heber, M.D., Ph.D., director, UCLA Center for Human Nutrition.

The company has launched a $20 million marketing program; national and major market advertising, public relations and direct marketing efforts targeted to consumers 40+, physicians and pharmacists.

Products, all of which are dietary supplements under the Dietary Supplements and Health Education Act of 1994 (DSHEA), include:

Cholestin, made from Monascus purpureus Went yeast fermented on rice, which has been clinically proven to promote and maintain healthy cholesterol levels.

CordyMax Cs4, a fermented product derived from the Tibetan Cordyceps sinensis mushroom, long used for its qualities as a vitality- and stamina-enhancer.

BioGinkgo 25/6 and BioGinkgo 27/7 Extra Strength, standard and extra-strength compositions of Ginkgo biloba leaf extract, used to improve memory and blood circulation to the brain and extremities.

Tegreen 97, a cell protectant containing the highest levels (97%) of antioxidant-rich green tea polyphenols available in any dietary supplement.

Bio St. John’s, a combination of St. John’s wort extract and Tibetan Cordyceps sinensis mushroom used to maintain healthy emotional balance.

EstroCare, a combination of the Black Cohosh extract and Tibetan Cordyceps sinensis mushroom, which provides women with nutritional support for a smooth transition through menopause.

Corporate Mission:

Develop and mass market proprietary, natural, complementary health-care products, all clinically proven to be safe and effective.

Educate policy makers, medical professionals and consumers in order to broaden acceptance of natural health-care products in mainstream America.

Clearly defining the role of Pharmanex brands as complements to, rather than substitutes for, other components of the health-care system, including OTC and pharmaceutical drugs.

Pharmanex products are available in more than 35,000 mass-market and health food stores nationally, including GNC, Long’s Drug Stores, Vons, K-Mart, Wal-Mart, Walgreens, Rite-Aid, Fred Meyer and CVS.