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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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LifeSecure 5/12/09

From: FDAFLUTASKFORCE-CDRH@fda.hhs.gov


Date: May 12, 2009


To: dscott@lifesecure.com


Subject: Urgent Message from the Food and Drug Administration Regarding H1N1 Flu Virus-
Related Products Marketed by Your Firm


UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES


FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20855


TO: http://www.lifesecure.com/dscott@lifesecure.com/info@lifesecure.com


FROM: Food and Drug Administration


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


DATE: May 12, 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://www.lifesecure.com/pandemicFlu.asp on May 4, 2009. The
FDA has determined that your website offers products for sale that are intended to diagnose,
mitigate, prevent, treat or cure the H1N1 Flu Virus in people. These products have not been
approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation,
prevention, treatment, or cure of the H1N1 Flu Virus. These products are the On-The-Go Swine
Flu Personal Infection Protection Kit, the Family Swine Flu Infection Protection Kit, and the
Extended Swine Flu Infection Protection Kit. The marketing of these products 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 website include:


• On-The-Go Swine Flu Personal Infection Protection Kit:
o “The kit […] includes infection protection supplies recommended by the U.S.
Centers for Disease Control (CDC) in the event of a pandemic (e.g. swine flu,
bird flu) outbreak.”


• Family Swine Flu Infection Protection Kit:
o “This kit provides expert-recommended essentials for basic protection against
infectious germs in the event of a pandemic (e.g. swine flu, bird flu) outbreak.”


• Extended Swine Flu Infection Protection Kit:
o “This kit provides an extended supply of products to protect you, your family, and
others against infectious germs such as those during a pandemic (e.g. swine flu,
bird flu) outbreak.”


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
FDAFLUTASKFORCE-CDRH@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 http://accessdatatest.
fda.gov/scripts/h1n1flu/
. 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(s) listed above to be unapproved, uncleared, or
unauthorized products that cannot be legally sold to consumers in the United States.


Please direct any inquiries to FDA at FDAFLUTASKFORCE-CDRH@fda.hhs.gov.