|Subject:||Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus|
|Issuer:||Center for Food Safety and Applied Nutrition|
|Issued:||Jan. 26, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
House No. 921 Sector 7
Andaman and Nicobar India 134109
FROM: Food and Drug Administration
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
Date: January 26, 2010
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.ayurvediccure.com on January 20, 2010. 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 Guduchi Satya (Tinospora Cordifolia) Capsules, Tulasi (Holy Basil) Capsules, and Sunthi (Ginger) Capsules. The marketing of these products violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352, and/or 355. 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 a webpage titled "Swine Influenza (H1N1 flu, Swine flu, Hog flu and Pig flu)", under the subheading "Herbs for swine flu treatment":
• " Holy Basil, [and] Ginger ... are used in the treatment of flu ... since ancient times. Regular uses of these medicines are helpful in controlling the signs and symptoms of deadly swine flu and help in early treatment of influenza. '" [R]egular use of these herbs prevent[s] further spread of swine flu and help[s] in early treatment of influenza."
• "The most common herbs which can be used in the treatment and prevention of swine flu are
or Holy basil
2. Sunthi or Ginger
3. Giloy 2
Under the subheading "Swine Flu Remedies", "BUY NOW links appear for holy basil supplements, ginger supplements, and Tinospora supplements. These links take the user to order pages for the Tulasi (Holy Basil) capsules, Sunthi (Ginger) Capsules, and Guduchi Salva (Tinospora Cordifolia) Capsules, respectively. Near each of the "BUY NOW links is a "Read more" link for the product that opens a separate, product-specific webpage with information on the uses of the product. These product-specific pages also bear claims about treatment of the H1N1 Flu Virus:
• "Holy Basil is also recommended as a
Remedy for Swine Flu
• "Ginger Is also recommended as a Remedy for Swine Flu "
• "Tinospora Cordifolia Is also recommended as a Remedy for Swine 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 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 end 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's 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
FDAFLUTASKFORCECFSAN@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 action. 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 Slates, 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 unapproved, uncleared, or unauthorized products that cannot be legally sold to consumers in the United states.
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Kathleen Lewis at 301-436-2148.
Roberta F. Wagner
Office of Compliance
Center tor Food Safety
and Applied Nutrition
1 Your website uses "Tulsi" and "Tulasi" interchangeably as synonyms. See http://www.ayurvediccure.com/tulasi.htm.
According to your website, "Giloy" is an altemate name for Guduchi Satva (Tinospora Cordifolia). See http://www.ayurvediccure.com/tinospora.htm.