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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

University of Berkley 2/7/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448

CBER-13-01

Date: February 7, 2013
 
To: director@berkley-u.edu
 
Subject: Urgent Message from the Food and Drug Administration Regarding 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.berkley-u.edu/flu-prevention / director@berkley-u.edu
 
FROM:      Food and Drug Administration
 
RE:          Unapproved products related to the 2012/2013 flu season
 
Date:               February 7, 2013
 
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.berkley-u.edu/flu-prevention  on January 11, 2013.  The FDA has determined that your website offers products for sale that are intended to diagnose, mitigate, prevent, treat or cure the 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 Flu Virus. This product is Berkley-Body-Immune Flu Prevention. 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 Flu Virus. 
 
Some examples of the claims on your website include: 
 
  • "The most effective alternative to the flu shot” (emphasis added).
 
  • “Health experts at Berkley recommend Homeopathic/Naturopathic treatment to prepare for the upcoming flu season due to shortage in flu vaccines” (emphasis added)
 
  • “Natural health and strength can still be yours without Flu Shots or an office visit” (emphasis added)
 
  • Protect yourself with the “Body-Immune Flu Prevention” (emphasis added)
 
  • “Flu prevention is possible”
 
  • “Berkley – Body - Immune Flu Prevention”
 
  • “Body – Immune Flu Prevention”
 
The marketing and sale of unapproved or uncleared Flu Virus -related products 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 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 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 fifteen working days of receipt of this email, please send an email to FDAFLUTASKFORCECBER@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. 
 
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECBER@fda.hhs.gov or by contacting the Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality at 301-827-6201. 
 
 
Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
From: FDA Center for Biologics Evaluation and Research
(FDAFLUTASKFORCECBER@fda.hhs.gov)