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
TO: Reinaldo Carvalho
FROM: The Food and Drug Administration and the Federal Trade Commission
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:
On the main page of your website, with the heading “Tis the Season…For Influenza and Other Viruses”:
- “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 (40 mg and 250mg)
- “Resveratrol has also been studied as . . . an antiviral, inhibiting . . . certain flu and respiratory viruses.”
Garlic 90 (500mg)
- “[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 . . . .”
Ashwagandha (aka Indian Ginseng, Winter Cherry) 500 mg
- “Ashwaganda has long been used to . . . fight colds, flu . . . .”
Astragalus Immune System Support 500 mg
- “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.
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
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 clearance 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 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.
If you are not located in the United States, please note that unapproved and uncleared products intended to diagnose, mitigate, prevent, treat, or cure the 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 products listed above to be unapproved or uncleared 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 Anam Pasha at 240-402-1563.
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), aff'd, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff'd, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at * 11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, consumer testimonials, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) (http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf1), pet. for review den., 2010 WL 5108600 (D.C. Cir. Dec. 10, 2010).
The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at firstname.lastname@example.org, within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.
Very truly yours,
Mary K. Engle
Division of Advertising Practices
Federal Trade Commission
Division of Advertising Practices
Federal Trade Commission
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition