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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Natren, Inc. 6/18/2009

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  5100 Paint Branch Parkway
College Park, MD 20740

 

TO: websales@natren.com

Natren, Inc.
3105 Willow Lane, Suite 100
Westlake Village, CA 91361


FROM: Food and Drug Administration


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


DATE: June 18, 2009


WARNING LETTER


This is to advise you that the United States Food and Drug Administration (FDA) reviewed your
websites at the Internet addresses www.natren.com and www.truthaboutprobiotics.com on June
17, 2009. The FDA has determined that your www.natren.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 on your www.truthaboutprobiotics.comwebsite.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 Natren Healthy Trinity. 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.


Some examples of the claims on your www.truthaboutprobiotics.com website include:


• Under the heading "Swine Flu Outbreak and What Can Probiotics Do?": "An article came
out today ... suggesting that taking a daily probiotic a day will prevent swine flu -- clearly
stating that strong immunity begins with a balanced GUT! ... So, what can you do to
protect yourself that is all natural and works with your body's immune system? Natren's
Healthy Trinity, a powerful and potent probiotic, is the only probiotic that TAP recognizes
to increase your natural immunity because over 70% of your body's immunity lies in your
gut! Not to mention, having a potent probiotic strain(s) in your gut, prevent [sic] the bad
bacteria and viruses from taking hold and making you ill."


• "Another unique aspect of swine flu is that it is marked by acute gastro-intestinal
symptoms: nausea, diarrhea, vomiting, etc. These reasons are all the more evidence to
take probiotics to support your body's GI tract during any ... flu issues. Other
precautions to take include: ... Most importantly, continue taking your Natren's Healthy
Trinity at least one capsule three times a day for the maximum protection!"


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 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 that 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/scripts/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 Standra Purnell at 301-436-1613.

 

Sincerely,

 

/S/


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