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

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: 312-353-5863

September 21, 2006

WARNING LETTER
CHI-7-06

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Joseph M. Mercola, D.O.
Optimal Wellness Center
1443 West Schaumburg Road, Suite 250
Schaumburg, IL 60194

Dear Dr. Mercola:

The Food and Drug Administration (FDA) conducted an inspection at your facility at the above address on April 24, 2006. During that inspection, the investigator collected various product labels including, but not limited to, the following products: Vibrant Health Research Chlorella XP, Fresh Shores Extra Virgin Coconut Oil, Momentum Health Products™ Vitamin K2™, and Momentum Health Products™ Cardio Essentials™ Nattokinase NSK-SD. In addition, we reviewed labeling on your website at http://www.mercola.com. A review of this labeling found that the products listed above are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.321 (g)(1)(13)]. These claims on your labeling, including your website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.

Examples of disease claims observed in your products' labeling, including your website and product labels, include:

Vibrant Health Research Chlorella XP

The following are examples of reference citations on your website that are used to promote Vibrant Health Research Chlorella XP for treatment or prevention of various diseases:

Fresh Shores Extra Virgin Coconut Oil

Momentum Health Product™ Vitamin K2™

Momentum Health Products™ Cardio Essentials™ Nattokinase NSK-SD

"Therapeutic dose (e.g., person under medical supervision w/high blood pressure, risk factors for coronary artery disease, high risk for blood clots, DVT). 4,000 fibrin units per day.

Ischemic strokes (e.g., person at risk for ischemic, "dry" stroke, or who is recovering from a stroke, transient ischemic attack, RND {reversible ischemic neurologic deficit], etc. 6,000 fibrin units per day.

These claims cause your products to be drugs, as drug, as defined in Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective.

These products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].

Please note that similar therapeutic claims on you web site were brought to your attention in a letter from FDA's Center for Food Safety and Applied Nutrition dated February 16, 2005. In that letter, we notified you hat claims for several of your firm's products, including chlorella and coconut oil products, caused those products to be unapproved new drugs within the meaning of the Act. A copy of the February 16, 2005, letter, which also provides additional information elated to the Dietary Supplement Health Education Act, is enclosed for your reference.

This letter is not intended to be an all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that yo will explain the reason for your delay and state when you will correct any remaining deviations.

Your reply should be sent to the Food and Drug Administration, Attention: Patrick J. Brown, Compliance Officer, 550 W. Jackson Blvd , 15th Floor, Chicago, Illinois 60661-5716.

Sincerely,

/S/

Scott J. MacIntire
District Director

Enclosure: Ref. No. CL-04-HFS-810-134, Dated February 16, 2005.

This page was posted on October 11, 2006.

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