Quake Kare, Inc NEVE BUY FROM QUAKE KARE, INC. PLEASE BEWARE!!! Moorpark California

Quake Kare, Inc. 5/12/09 From: FDAFLUTASKFORCE-CDRH@fda.hhs.gov

Date: May 12, 2009

To: sherryh@quakekare.com; info@quakekare.com

Subject: Urgent Message from the Food and Drug Administration Regarding 2009 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.quakekare.com / sherryh@quakekare.com; info@quakekare.com

FROM: Food and Drug Administration

RE: Unapproved/Uncleared/Unauthorized Products Related to the 2009 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.quakekare.com/index.asp?PageAction=VIEWCATS&Category=52 on May 5, 2009. The FDA has determined that your website offers products for sale that are intended to diagnose, mitigate, prevent, treat or cure the 2009 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 2009 H1N1 Flu Virus. These products are the Basic Pandemic Swine Flu Kit, the Standard Pandemic Swine Flu Kit, and the Deluxe Pandemic Swine Flu 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 2009 H1N1 Flu Virus.

Some examples of products on your website with claims include:

"Basic Pandemic Swine Flu Kit":

o Emergency swine flu kit containing the basic supplies for protection from the spread of the pandemic swine flu. Recommended by the U.S. Centers of Disease Control and World Health Organization to prevent the swine or bird flu virus.

"Standard Pandemic Swine Flu Kit" and "Deluxe Pandemic Swine Flu Kit":

o Emergency Accessory Kit to the Home Survival Kit containing the most effective supplies for protection from the spread of the pandemic swine flu. Recommended by the U.S. Centers of Disease Control and World Health Organization to prevent the swine or bird flu virus.

Be Prepared with Swine Flu Supplies

Kits and Supplies for Protection from Swine Flu Pandemic

"Especially pertinent right now are our Pandemic Swine Flu Kits containing preparedness supplies specifically designed for protection from the swine flu or H1N1 influena virus."

"You should also have a pandemic flu emergency kit for each member of your family in your home. This emergency kit contains emergency supplies specifically designed to protect against the outbreak of a pandemic swine or avian flu."

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 2009 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 2009 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 the 2009 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 2009 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 2009 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 2009 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 2009 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.

I am a very happy customer of Quake Kare and have been ordering from them for a while now.  I have ordered and received multiple packages from Quake Kare.  They are a reputable company and sell great products.  I urge every American to prepare themselves for emergencies and order from Quake Kare.  I am writing this to rebut the complaint that I inadvertently found on the internet on this website  The complaint of the consumer that the kits are cheap and can be bought at the Dollar Store are completely unfounded.  You can put together your own kit by purchasing items at any Dollar Store or CVS, Walmart or what have you.  Or you can purchase from Quake Kare a kit already put together for you.  Sure you pay them postage and handling which is what anyone is going to charge you who packages up any product on the internet, for your convenience, and takes it to the post office and mails it for you.  What does this person think the $4 packing fee is?  This company has to pay for the box that the product is mailed to you in, the styrofoam they use to make sure the product doesn't break in shipment, etc.  I have ordered many items from Quake Kare.  I could run around from store to store looking for each of these items, or I could order direct from them and have it shipped to my door. 

I urge all Americans to protect themselves and their families and order these products.  I am rebutting this unfair complaint as a consumer who uses Quake Kare on a regular basis to protect my family.  They sell quality products, and if were not for Quake Kare, I wouldn't even know what to put in an emergency package.