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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ecologic 11-Dec-03

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

Public Health Service
Food and Drug Administration

 

5100 Paint Branch Parkway
College Park, Maryland 20740


 

DEC 11 2003

WARNING LETTER

VIA CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Ms. Christine Beanan
Ecologic
6 Main Street
Guffey, CO 80820

Dear Ms. Beanan:

The Food and Drug Administration (FDA) has reviewed your web sites at the following address: www.ecoloeicshop.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act(the Act) in the labeling of your product Oil of Oregano. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. Your web site claims that your product is useful in the prevention and treatment of diseases, including Severe Acute Respiratory Syndrome (SARS). The labeling of your product bears the following claims:

  • "Oil of oregano has been touted as an immune booster to help fight SAR [sic]."

  • ""Oil of Oregano is a potent antiseptic, meaning it kills germs. Research proves that it is highly effective for killing a wide range of fungi, yeast, and bacteria as well as parasites and viruses."

These claims cause your product to be a drug as defined in section 201(g)(1)(B) of the Act. Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). This drug is also misbranded within the meaning of section 502(a) of the Act because its labeling is false and misleading in that it suggests that this drug is effective for the prevention of SARS,when, in fact, these claims are not supported by reliable scientific evidence. This drug is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be addressed to Shelly L. Maifarth, Compliance Officer, Food and Drug Administration, Denver Federal Center, 6th and Kipling, Building 20, Entrance W-10, Denver, Colorado, 80225-0087.

Sincerely,

/S/

 

Director
Office of Compliance
Center for Food Safety and Applied Nutrition