Inspections, Compliance, Enforcement, and Criminal Investigations

Ip-6 International Inc. 4/23/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-10
April 23, 2014
 
Mr. Thomas P. Sokoloff
President
IP-6 International Inc.
270 East Dr., Ste A
Melbourne, FL 32904-1038
 
Dear Mr. Sokoloff:
 
Between August 26 and August 29, 2013, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement distribution facility located at 270 East Drive, Suite A, Melbourne, Florida. As a distributor that contracts with manufacturers to produce dietary supplements that your firm releases for distribution under your firm’s name, you have the ultimate responsibility for the products that you introduce or deliver for introduction into interstate commerce. Based on a laboratory analysis of your Red Yeast Rice Gold product and a review of its labeling, FDA has determined that Red Yeast Rice Gold is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)] and is a misbranded drug under section 502 of the Act [21 U.S.C. § 352], as detailed below.  
 
Although you label and promote Red Yeast Rice Gold as a dietary supplement, a laboratory analysis conducted by the FDA determined that this product contains a significant level of lovastatin, approximately 1 mg per capsule. Lovastatin is the active ingredient in Mevacor® and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. If taken at the maximum dose recommended on the label, your product would provide 4 mg lovastatin per day, which is almost half of 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 Gold product contains red yeast rice with enhanced or added lovastatin, it cannot be marketed as a dietary supplement. Section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)] specifically excludes from  the dietary supplement definition articles that are approved as new drugs under section 505, unless the article was marketed as a dietary supplement or food before its approval as a new drug. FDA approved Mevacor® as a new drug 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. FDA’s conclusions that lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement and that a lovastatin-enhanced red yeast rice product is not a dietary supplement were upheld in litigation involving a product called Cholestin.[1]
 
In addition to analyzing your product, we reviewed your website at the Internet address www.OrganicRedYeastRice.com in March 2014 and determined that you take orders there for Red Yeast Rice Gold, which the website and product label promote for conditions that cause the product to be a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and 321(g)(1)(C)]. The claims on your website and product label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the human body. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the website and product label claims that provide evidence that your product is intended for use as a drug include:
 
  • “Cholesterol Support”
  • “Low cholesterol is not a magic answer to heart health. We believe that addressing…inflammation in your arteries is where prevention begins. Maintaining healthy cholesterol levels contributes to reducing inflammation.”
 
In addition, when scientific references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The home page of your website provides links to the following publications reporting the results of studies pertaining to the use of red yeast rice for prevention and treatment of colon cancer, hypercholesterolemia, and coronary heart disease, and/or to the effects of red yeast rice on the structure or function of the body, such as lipid levels and endothelial function:
 
    • “Lipid-lowering efficacy of red yeast rice in a population intolerant to statins.”
    • “Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial.”
    • “Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement.”  
    • “Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study.”
    • “Anticancer effects of Chinese red yeast rice versus monacolin K alone on colon cancer cells.”
    • “Combined nattokinase with red yeast rice but not nattokinase alone has potent effects on blood lipids in human subjects with hyperlipidemia.”
 
Your Red Yeast Rice Gold product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your Red Yeast Rice Gold product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded under section 502(f)(1) of the Act in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. 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 ensure that your firm complies with all requirements of federal law and FDA 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.
 
Within fifteen (15) 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 step 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.
 
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding this letter, please contact Ms. Norris at (407) 475-4730.
                                                                       
 
Sincerely,
/S/ 
Ruth P. Dixon
Acting Director, Florida District


[1] Pharmanex, Inc. v. Shalala, 221 F.3d 1151 (10th Cir. 2000); 2001 U.S. Dist. LEXIS 4598 (D. Utah Mar. 30, 2001) (district court opinion on remand).

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