Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Pacific Region
Seattle District

 

22201 23rd Dr SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

June 20, 2001
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Richard J. Zhang, President
Rich Nature Nutraceutical Laboratories, Inc.
19011 36th Ave W #G
Lynnwood, WA 98036

Ref. No. SEA 01-63

Dear Mr Zhang:

This letter concerns your firm's marketing and distribution of "CholesCare." The label for "CholesCare," collected during the inspection of your firm on February 5-20, 2001, claims it "…naturally contains HMG-COA reductase inhibitors…" and "…lowers the body's LDL 'bad' cholesterol and triglyceride levels, it also raises the HDL 'good' cholesterol levels."

Promotional literature (labeling) for "CholesCare" contains drug/disease claims that include "My cholesterol, at that time, was 244. After taking CholesCare for one month, my cholesterol dropped to 186…," CholesCare contains red yeast, an exclusive strain of standardized Monascus Purpureus yeast (or Red Yeast) fermented on premium rice, which naturally contains HMG-COA reductase inhibitors (0.5% per capsule)." "…Monascus purpureus is the best strain of the yeast to produce metabolic agents that assist in the promotion of normal cholesterol levels," and "The effect of CholesCare is partially attributed to the presence of HMG-CoA reductase inhibitors…"

In addition, "CholesCare" contains lovastatin, a prescription drug that is not approved for over-the-counter (OTC) use, and requires monitoring by a physician. The presence of lovastatin in your product is demonstrated by the certificate of analysis provided at your request, by American Analytical Chemistry Laboratories Corporation. The certificate is specifically for lovastatin and indicates the concentration of this drug in the red yeast rice.

In its dismissal of the lawsuit brought against the Food and Drug Administration by Pharmanex, Inc., the US District Court for the District of Utah's decision of March 30, 2001, case number 2:97CV262K affirmed that red yeast rice products that contain lovastatin are subject to regulation as drugs and are not dietary supplements.

"CholesCare" is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). Moreover, "CholesCare" is a "new drug" [section 201(p) of the Act] because there is no evidence that this product is generally recognized as safe and effective for its intended uses. Since this drug product is a "new drug" it may not be legally marketed in the United States without an approved new drug application [section 505(a) of the Act].

This drug product is misbranded [sections 502(f)(1) of the Act] because its labeling fails to bear adequate directions for use for the conditions for which it is offered. The drug is also misbranded because the labeling is false and misleading as it suggests that the product is safe and effective for its intended use when this has not been established [section 502(a) of the Act].

This letter is not intended to be an all-inclusive review of all labeling and products your fhm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

We request that you take prompt action to comect these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice; The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within seven 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Dr SE, Bothell, WA 98021-4421. If you have any questions concerning any issue in this letter, please contact Lisa Elrand at 425-483-4913.

Sincerely,
/s/
Charles M. Breen
District Director

Enclosure:
21 CFR Parts 502 and 505

This page was posted on August 20, 2006.

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