Inspections, Compliance, Enforcement, and Criminal Investigations
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Vitalmax Vitamins 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: Alan Serinsky
info@vitalmaxvitamins.com
www.vitalmaxvitamins.com
www.vitalmaxvitamins.com
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
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 websites at the Internet addresses www.vitalmaxvitamins.com and www.healthyanswers.com in January 2013. The FDA has determined that your website www.vitalmaxvitamins.com offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the Flu Virus in people. This product has not been approved or cleared by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the Flu Virus. This product is called BodyGuard and is labeled as a dietary supplement. The marketing of this product 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 www.vitalmaxvitamins.com that evidence that the product you offer is intended for the use(s) described above include:
On the webpage titled, “Body Guard”:
- “Boost Your Immune System and Fight Cold and Flu - Naturally!”
On the webpage titled, “Why In the World Are You STILL Catching Cold and Flu Bugs?” (http://www.vitalmaxvitamins.com/lp/2012/bodyguard/?utm_source=prweb&utm_medium=BGLP1PR#order2), which offers the Body Guard product for sale, we note the following claims:
- “Why in the World Are You STILL Catching Cold and Flu Bugs?
Just recently I was … astounded by the amount of wheezing…sniffling…and coughing that I had to endure during my airplane flight! One year ago I would have walked off that plane certain that within days I would succumb to some sort of virus or flu. But today, it’s a whole new story.
Now available to the general public is a revolutionary immune booster … This all-natural remedy contains a combination of nutrients so potent, it can help shield you from a variety of bacteria, germs and viruses that would normally put you out of commission.
This miraculous remedy is called BodyGuardTM and it happens to be the single most powerful formula to help guard your health! … This unique formula sends germs packing in a way that antibiotics and drugs never could.
In fact, the healing nutrients in these tiny tablets [BodyGuardTM] can help you:
o Fight colds, infections and respiratory problems.
o Safeguard you from deadly flu viruses.
o Relieve you from stuffy noses, chills, hoarseness and other cold symptoms!”
- “BodyGuard™ also contains nutrients such as … Pau d’Arco extract. This South American rainforest herb has superior antiviral properties that virtually wipe out cold and flu bugs! What’s more, BodyGuard™ even contains Elderberry extract—a nutrient proven to help clobber most flu and viruses.
And scientific studies prove it’s true:
One study published in the winter 1995 issue of the Journal of Alternative and Complementary Medicine showed that 93% of influenza-B flu patients given elderberry extract in supplement form were almost completely symptom-free within two days!
In a second study published in the International Journal of Medical Research, 90% of the study participants had influenza A. Patients who took this extract recovered in an average of 3 days, versus 7 days for the placebo group!”
- “All you need to do is simply take a couple capsules of BodyGuard™ everyday and you can freely travel anywhere without thinking twice about what germ…bacteria…virus…or flu that might invade your body! I’m so sure you’ll be spending fewer days in bed and more days playing golf or cards that I’m committed to offering you this 100% money-back risk-free guarantee!”
- “ [F]or just pennies per day, you’ll protect yourself from nasty germs, bacteria and viruses that can … leave you unprotected against deadly viruses and flu or worse!”
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 product listed above to be an unapproved or uncleared product 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 Katrina L. Dobbs at 240-402-5163.
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 healthproducts@ftc.gov, 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,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
Associate Director
Division of Advertising Practices
Federal Trade Commission
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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