Inspections, Compliance, Enforcement, and Criminal Investigations
Supplementality LLC 2/11/13
|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
SILVER SPRING, MD 20993
RE: Unapproved Products Related to the 2012/2013 Flu Season; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure Flu Virus
DATE: February 11, 2013
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.supplementality.com in January 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 or cleared by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the Flu Virus. These products are called Resveratrol (40mg and 250mg), Garlic 90 (500mg), Echinacea, Elderberry, Ashwagandha (aka Indian Ginsing, Winter Cherry) (500mg), and Astragalus Immune System Support (500mg) and are labeled as dietary supplements. The marketing of these products violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 352. We request that you immediately cease marketing unapproved and uncleared products for the diagnosis, mitigation, prevention, treatment, or cure of the Flu Virus.
Some examples of the claims on your website that evidence that the products you offer are intended for the use described above include:
- “Help fight off influenza and other viruses and their symptoms naturally with this selection of herbs and other products.”
- “The products listed below [including your Resveratrol (40mg and 250mg), Garlic 90 (500mg), Echinacea, Elderberry, Ashwagandha (aka Indian Ginsing, Winter Cherry) (500mg), and Astragalus Immune System Support (500mg) products] can help to reduce the length of time that [flu] symptoms persist, the severity of symptoms, or both.”
- “Resveratrol has also been studied as . . . an antiviral, inhibiting . . . certain flu and respiratory viruses.”
- “[Garlic] is used historically in treating . . . flu . . . .”
- “Used for colds and flu . . . .”
- “Echinacea appears to help reduce the symptoms of colds and flu as well as the duration of the sickness. A 2008 review of 14 different clinical trials of echinacea use found that taking the supplement . . . helped people get over cold and flu symptoms a day and a half earlier than those who didn't take it.”
- “Elderberry is historically used for . . . flu, bacterial and viral infections . . . .”
- “Ashwaganda has long been used to . . . fight colds, flu . . . .”
- “Astragalus is used to strengthen the immune system against colds or flu . . . .”
- “Traditional Chinese medicine has used Astragalus as a remedy for . . . respiratory infections . . . . Medical journals suggest the herb may stimulate the immune system and the body’s ability to resist and combat various diseases.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
You should take immediate action to ensure that your firm is not distributing, and does not distribute in the future, products intended to diagnose, mitigate, prevent, treat or cure the Flu Virus that have not been approved or cleared 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 the products you distribute, including the claims made for those products in websites, product labels, and other labeling and promotional materials, to ensure that the products you distribute are not intended for uses that render them misbranded in violation of the FFDC Act. 21 U.S.C. §§ 331, 352. Within 15 days, 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.
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Anam Pasha at 240-402-1563.
Very truly yours,
Division of Advertising Practices
Federal Trade Commission