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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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NZYMES.COM 5/18/09

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, MD 20740

TO: NZYMES.COM - A Division of Biopet, Inc., nzymes.com

FROM: Food and Drug Administration

RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

DATE: May 18, 2009

WARNING LETTER 

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http:llnzymes.com on May 18, 2009. The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus. This product is Ox-E-Drops. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Fiu Virus.

Some examples of the claims on your website include:

• "Every few years, there comes along some new strain of the FLU, such as the recent Swine Flu, that threatens an epidemic.... That being said, we think everyone should know how effective the NZYMES Ox-E-Drops can be in either the preventive or healing realms for this type of illness. Though a doctor can normally provide no pharmaceutical that can deal with viral infection, that does not mean there are not other alternatives; OxE- Drops is busy proving itself as an effective option every day."

• "In the case of the current Swine Flu ... There is no specific proof that the Ox-E-Drops can diffuse this type of virus; but, since the virus is acquired via airborne transmission and acquired in the respiratory areas, these factors give a strong clue that the Ox-EDrops could possibly wage an effective defense. The solid track record of using the OxE-Drops in a dual approach, internally + vaporizer, in dealing with similar infections (including pneumonia) makes the case for this product likely being very helpful in the case of a Swine viral infection."

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Fiu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus -related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.

You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.

FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites thai have received warning letters from FDA concerning marketing unapproved, uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at www.accessdata.fda.gov/scriptslh1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.

If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission.

We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.

Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Quyen Tien at 215-717-3705.

Sincerely,

/S/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition