Inspections, Compliance, Enforcement, and Criminal Investigations
Nature's Way Products, Inc. 25-Jan-08
Department of Health and Human Services
Public Health Service
Denver District Office
January 25, 2008
RETURN RECEIPT REQUESTED
Dr. Dirk Reischig
President/Chief Executive Officer
Nature's Way Products, Inc.
76227 Karlsruhe, Germany
Ref. #: DEN-08-10
This letter is in reference to the inspection of your firm, Nature's Way Products, Inc., located in Springville, Utah, conducted by an investigator from the Food and Drug Administration (FDA) on September 10-14, 2007. During the inspection, FDA found that you manufacture the product Red Yeast Rice, and market or distribute the product on your web site, www.naturesway.com on other websites such as www.herbalremedies.com; via your retailer's guide magazine "Leaf Line"; and at various retail stores.
You promote your Red Yeast Rice product as a dietary supplement. A laboratory analysis conducted by the FDA determined bat your product contains significant levels of lovastatin. Lovastatin is the active ingredient in Mevacor® and its generic counterparts, which are FDA-approved drugs used to treat patients with primaryhypercholesterolemia. If consumed as directed, your product provides more than 14 mg lovastatin, which is approximately 4 mg more than the lowest recommended daily dose of lovastatin in Mevacor and its generic counterparts.
Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because your Red Yeast Rice product contains red yeast rice with enhanced or added lovastatin, it cannot be marketed as a dietary supplement. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(ff), specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act, 21 U.S.C. § 355, unless the article in question was marketed as a dietary supplement or food before its approval as a drug, 21 U.S.C. § 321 (ff)(3)(B). FDA approved Mevacor® as a new ding on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date. The Agency's determinations that lovastatin's approval as a new drug preceded its marketing as a food or dietary supplement and that lovastatin-enhanced red yeast rice is not a dietary supplement was upheld in litigation involving a product called Cholestin.
According to information on its labeling, your Red Yeast Rice product is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements in your labeling that document these intended uses include, but are not limited to, the following:
Red Yeast Rice, 120Vcaps® and Red Yeast Rice, 60 Vcaps®
• "Read Yeast Rice is a unique natural product used to support cardiovascular health."
• "Good for Hearts" under an image of a heart symbol with an arrow superimposed over the image illustrating a zigzagging downward trend.
Your Red Yeast Rice product is a drug as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man or other animals. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Red Yeast Rice without an approved application violates these provisions of the Act.
Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, your Red Yeast Rice's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(1)(1).
You should also be aware that your Red Yeast Rice product cannot be lawfully marketed as food, because it would be an adulterated food within the meaning of section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1), in that it bears or contains a poisonous or deleterious substance (lovastatin) which may render it injurious to health.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law, the Act, and its implementing regulations.
You should take prompt action to correct the violations cited in this letter, Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each stop being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
Address your reply to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
A description of the new drug approval process can be found on FDA's Internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Susan J. Miller
Acting District Director
Mr. Rory D. Mahony
Nature's Way Products, Inc.
1375 North Mountain Springs Pkwy
Springville, Utah 84663
 Pharmanex, Inc. v. Shalala, 221 F.3d 1151 (10th Cir. 2000), on remand at, 2001 U.S. Dist. LEXIS 4598 (D. Utah Mar 30, 2001)