Inspections, Compliance, Enforcement, and Criminal Investigations
Kosher Vitamin Express 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.koshervitamins.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 “Zahlers Kosher Abreve Advanced Cold & Flu Formula,” “Sunshine Health Kosher Cold & Flu Support,” and “Nutri-Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract” 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 uses described above include:
- The name of the product: “Zahlers Kosher Abreve Advanced Cold & Flu Formula 180 Capsules”
- “Powerful Cold and Flu Defense”
- “Zahler Abreve fights off both colds & flu by…acting as an anti-histamine …”
- “Zahler Abreve…should be taken at the very first sign of a cold or flu symptom. It can also be taken throughout the cold season as an effective preventative … tonic.”
- “Fights and reduces symptoms of*Colds *Flu *Pneumonia *Upper Respiratory Tract Infections”
- The name of the product: “Sunshine Health Kosher Cold & Flu Support 90 Vegetarian Capsules”
- “STRENGTHENING THE IMMUNE SYSTEM TO WARD OFF COLD & FLU VIRUSES AND OTHER VIRAL GERMS.”
- Sunshine Health’s all-in-one cold and flu capsule … ward[s] off colds and the flu. It … neutralize[s] the flu virus and other viral germs…”
- “To protect yourself from being the next cold or flu sufferer, here are some prevention techniques we encourage you to implement…Take Sunshine Health’s cold & flu capsules every day, as suggested. If you still get a cold or flu…Our cold & flu capsules will also help you heal and regain your strength more quickly.”
On the webpage titled, “Nutri-Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract”:
- The name of the product: “Nutri-Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract”
- “…Olive Leaf Extract[, an ingredient in -Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract, is] … one of the powerful natural cold remedies and flu treatments.”
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 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 working 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 Aaron E. Dotson at 240-402-1922.
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).
Very truly yours,
Division of Advertising Practices
Federal Trade Commission