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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nutronix 6/23/09

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

5100 Paint Branch Parkway
College Park, MD 20740

 


TO: christyd@nutronix.com, BobBremner57@hotmail.com

 

Nutronix International
8529 Meadowbridge Rd, Suite 300
Mechanicsville, VA 23116


FROM: Food and Drug Administration

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


DATE: June 23, 2009


WARNING LETTER


This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://www.nutronix.com and http://www.silvernutronix.com, as well as Nutronix distributor websites hosted by http://www.silvemutronix.com (e.g., http://www.silvernutronix.com/bt14881.html) on June 18, 2009. The FDA has determined that your www.nutronix.com website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people, as evidenced by statements made on your distributor websites hosted by www.silvernutronix.com.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 The New Silver Solution. 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 Flu Virus.


Given that the various distributor websites hosted by www.silvernutronix.com are identical in
content and appearance (except for information about the individual distributor) and state that
they are "Copyright Nutronix Int'I," it appears that Nutronix International is responsible for the
promotional claims on the distributor websites. The statement on www.silvernutronix.com that
that site is "part of the Nutronix Marketing System" and the direct link from
www.silvernutronix.com to www.nutronix.com are further evidence of the business relationship
between www.nutronix.com and the distributor sites hosted by www.silvemutronix.com. Some
examples of the claims on your websites include:


• On your distributor websites hosted by www.silvernutronix.com: "A Smart Addition For
Those Who Believe in The 'Natural Approach' and want protection against the Swine Flu.
Be Prepared When You Need It and You Need It Now! Emergency special offer of $9.95


• On your www.nutronix.com website: "The New Silver Solution is a very potent and
effective nano-particulate solution that is non-toxic and yet lethal to ... some viruses....
The New Silver Solution(8) should be capable of killing any pathogenic microorganism.
This would include ... many viruses ...."


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 Flu 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 H1 N1 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 that have received warning letters from
FDA concerning marketing unapproved, uncleared, and unauthorized H1 N1 Flu Virus-related
products in violation of the FFDC Act. This list can be found at
www.accessdata.fda.gov/scriots/h1n1f1u. 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