Cholestin recently has been reformulated with a unique proprietary blend of ingredients including Lipidol™. Lipidol™ is the result of 12 years of clinical studies. However, in February of , the manufacturer of Cholestin, Pharmanex Inc., a subsidiary of Utah-based Nu Skin Enterprises Inc., appealed the FDA’s ruling. Pharmanex Launches Next Generation Of Cholestin. Related CONTENT. Test Finds Varied Potency of Red Yeast Rice Supplements.

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Richard J Havel; Dietary supplement or drug? The Dietary Supplement Health and Education Act provides that any product marketed as a dietary supplement cannot contain an article that chooestin approved as a new drug unless the product was marketed before the drug’s approval.


Any component of the product may be considered pharmqnex be an article. Evidently, the law is intended to maintain the incentive for pharmaceutical companies to bring new drugs to market, a process that involves extensive and expensive preclinical and clinical evaluations. Red yeast rice has been used in China as a food colorant and flavor enhancer for centuries. Another related Chinese product, Xuezhikang, has been shown to lower plasma cholesterol concentrations.

Red Yeast Rice and Cholesterol

In the current double-blind clinical trial, 83 men and women with above average LDL-cholesterol concentrations were randomly assigned to receive Cholestin 4 capsules containing 2. Cholestin contains, by weight, 0.

Cholestin is currently sold in this country as a dietary supplement for healthy adults. The package insert instructs the user not to take more than 2 capsules twice daily 2. Pharmanex, Inc, the manufacturer of Cholestin, challenged this decision in Federal District Pbarmanex, which according to a press release issued a preliminary decision on June 16, l, stating that Cholestin is a dietary supplement and not a drug.


The case, which has broad implications for the regulation of the dietary supplement industry, remains under litigation at this time. Data provided in the report of Heber et phafmanex 2 indicate that Cholestin contains a large number of monacolins, ie, compounds of the statin class. Approximately three-quarters of the total complement of statins is monacolin K in its lactone or hydroxy-acid form, also known as lovastatin.

The remainder reportedly consists of other monacolins I—VIpresent in much smaller amounts. If the other statin compounds in Cholestin are equal in activity to lovastatin, the total complement of reductase inhibitors evidently accounts for most of the product’s cholesterol-lowering action. Cholestin and Xuezhikang differ from the traditional red yeast rice that is sold in Chinese groceries.

The latter contains undetectable or, at best, much lower amounts of lovastatin or other compounds of the statin class 5.

Red yeast rice is prepared by growing red yeast Monascus purpureus on rice to produce a red-colored product. According to Heber et al 2typical daily consumption is in the range of 14—55 g in many Asian countries. Consumption of statins from nonproprietary red yeast rice can nonetheless be presumed to be very low. Cholestin is manufactured by growing a single strain of M. The product, containing 0. The May 20,ruling of the Food and Drug Administration did not address the safety of Cholestin.

Heber et al 2 cite animal toxicity studies indicating no adverse effects of large amounts of Xuezhikang on liver function tests in rats treated for 90 d. However, no data are available on the short- or long-term toxicity of the individual statins contained in Cholestin except for lovastatin. Compactin, the first statin discovered by Endo 6 in Japan, was withdrawn by the manufacturer during phase 2 trials for unclear reasons. Compactin has one less methyl group than lovastatin.


Heber et al 2 call for a study of the long-term safety of Cholestin in a larger number of individuals. Meanwhile, the product is for sale in more than stores 7.

As indicated earlier, the outcome of the litigation surrounding Cholestin may have wide ramifications. Interested readers owe it to themselves to become informed about the issues under dispute and to address them in appropriate venues. Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide.

Pharmanex Wins Battle in Bid to Sell Cholestin

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Dietary supplement or drug? The case of Pnarmanex Richard J Havel. Dietary Supplement Health and Education Act of Cholesterol-lowering effects of a proprietary Chinese red yeast rice dietary supplement. Lovastatin Mevinolin in the treatment of heterozygous familial hypercholesterolemia: Pharmanex, Inc, administrative proceeding, Public Docket no. See corresponding article on Email alerts New issue alert.

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Pharmanex Wins Battle in Bid to Sell Cholestin – latimes

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