Inspections, Compliance, Enforcement, and Criminal Investigations
Zone Of Natural Remedies
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Silver Spring, MD 20993-0002|
From: FDA Center for Drug Evaluation and Research
Date: May 21, 2010
14953 NE 95th St.
Redmond, WA 98052
Zone of Natural Remedies, LLC
6531 Park of Commerce Blvd., Suite C-160
Boca Raton, Florida 33487
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
Silver Spring, MD 20993-0002
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.zoneofnaturalremedies.com on May 18, 2010. The FDA has determined that your website offers products for sale that are intended to diagnose, mitigate, prevent, treat (including to treat the symptoms of) or cure the H1N1 Flu Virus in people. These products have not been approved or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment (including treatment of symptoms), or cure of the H1N1 Flu Virus. These products are “FluGo” and “BaniFlu.” Further, “BaniFlu” is a biologic as defined in section 351(i) of the Public Health Service Act (PHS Act). The marketing of these products violates the Federal Food, Drug, and Cosmetic Act (FFDC Act) and/or the PHS Act. 21 U.S.C. §§ 331, 352, 355, 42 U.S.C. §351(a).
We request that you immediately cease marketing unapproved or unauthorized products for the diagnosis, mitigation, prevention, treatment (including treatment of symptoms), or cure of the H1N1 Flu Virus.
Some examples of the claims for the products on your website include:
“Homeopathic remedy temporarily relieves symptoms of the swine flu, avian flu or cold like cough, runny nose, fever, sore throat and fatigue.”
“Homeopathic Flu Vaccine – remedy temporarily protects against flu virus, swine flu, and germs ....”
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 (including to treat the symptoms of) or cure H1N1 Flu Virus in people.
We recognize that the labeling for your products listed above identifies them as homeopathic drug products with active ingredients measured in homeopathic strengths – FluGo: Ferrum phosphoricum D6, Belladonna 30C, Alium cepa 30C, Arsen iod 30C and Baniflu: Influenzinum 30C, Bacillinum 30C, Gelsemium 30C, Nux Vomica 30C. Nothing in the FFDC Act or the regulations issued under it exempts homeopathic drugs (including homeopathic biological products) from the regulatory requirements of the FFDC Act or its implementing regulations. We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval or authorization under enforcement policies set out in the FDA's Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). The enforcement discretion set forth in the CPG is not unlimited, however. The CPG states that it "delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S." (emphasis added). The qualifying word "ordinarily" indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.
As stated above, the Secretary of Health and Human Services 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. A homeopathic drug product (including a homeopathic biological product) marketed without approval or authorization is not subject to the enforcement discretion set forth in the CPG when there is a nationwide public health emergency involving the disease that the product is intended to be used to diagnose, mitigate, prevent, treat (including to treat the symptoms of), or cure. Under these circumstances, the enforcement discretion set forth in the CPG does not apply to an unapproved or unauthorized product, regardless of its homeopathic status.
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 (including to treat the symptoms of) 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, or 352. Within 48 hours, please send an email to FDAFLUTASKFORCECDER@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://www.accessdata.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.
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECDER@fda.hhs.gov or by contacting Elisabeth Walther, Pharmacist at (301)796-3913.
Deborah M. Autor, Esq.
Office of Compliance
Center for Drug Evaluation and Research