| UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION WASHINGTON, D.C. 20740 |
TO: marge@naturesgift.com
www.naturesgift.com
316 Old Hickory Blvd. East
Madison, TN 37115
FROM: The Food and Drug Administration and the Federal Trade Commission
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1
Flu Virus; and
Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure
the H1N1 Virus
DATE: February 16, 2010
WARNING LETTER
This is to advise you that the United States Food and Drug Administration ("FDA") and the United States Federal Trade Commission ("FTC") reviewed your website at the Internet address www.naturesgift.com on November 2, 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 include, but are not limited to, Flu Foil Synergy, Flu Foil Synergy with Inhaler, Ravensara, and Ravintsara. The marketing of these products violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. Your website contains blog entries that promote several of your products for H1N1 or Swine Flu. 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.
In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a product can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.
Some examples of the claims on your website include:
• On a webpage entitled, “Nature’s Gift September 2009 Newsletter,†with the subtitle “Nature’s Gift September Newsletter:â€
“Natural methods to aid your defense against the H1N1 and Swine Flu virus… Sales on Ravensara, Ravintsara and Flu Foil Synergyâ€
• On a blog webpage entitled, “Saturday, October 31, 2009,†with the blog subtitle “There’s a Mouse in The House:â€
“The CDC says some recent research has shown has shown H1N1 can travel & infect others . . . so I immediately moved away & pulled out my Flu Foil Inhaler.â€
• On a blog webpage entitled, “Saturday, August 29, 2009,†with the blog subtitle “More on Swine Flu H1N1:â€
“As the news of the threat of the H1N1 virus becomes more and more frightening . . . I decided to repost a case study . . . with 5% Ravensara or Ravintsara . . . [t]hree times a day . . . absenteeism in that one classroom was dramatically lower than that of the school as a whole.â€
• On a blog webpage entitled, “Thursday, August 20, 2009,†with the blog subtitle “Health Care Provider seeking Swine Flu (H1N1) guidance:â€
“I suspect others might be pondering the use of Essential Oils to protect themselves and their families against the promised H1N1 epidemic . . . [f]or the two year old I would definitely use the ravINTsara . . . [f]or the whole family . . . I would diffuse Flu Foil . . . or even use inhalers on a regular basis . . ..â€
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 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 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.
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 to FDA at FDAFLUTASKFORCECDER@fda.hhs.gov or by contacting Andrea Vincent at 301-796-3751.
It is also your responsibility to ensure that the products you market are in compliance with the FTC Act. FTC staff strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. The FTC also asks that you notify it via electronic mail at flu@ftc.gov within 48 hours of the specific actions you have taken to address the agency's concerns. If you have any questions regarding compliance with the FTC Act, please contact Karen Jagielski at 202-326-2509.
Sincerely,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
/S/
Deborah Autor
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
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