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Enforcement Actions

Flu & Cold Defense LLC 1/24/13

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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
WASHINGTON, D.C. 20740

WARNING LETTER

January 24, 2013


Mr. Todd Whidden
Flu and Cold Defense LLC
3939 NE 5 Ave., A102
Boca Raton, FL 33431


Flu and Cold Defense LLC
2234 N Federal Hwy
Box 487
Boca Raton, FL 33431
Info@GermBullet.com


Dear Mr. Whidden:


This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your firm's marketing of your product GermBullet on your websites, www.germbullet.com and www.nsaroma.com. According to information on your websites, GermBullet is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on your websites that document these intended uses include, but are not limited to, the following:


• The graphic appearing on your website and product labeling of a germ inside of a target with the words "COLD & FLU VIRUSES" and "BACTERIA FUNGI."


• "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and fungi."


• "[GermBullet] gives your body defenses a higher probability of effectively combating germs, so that you remain healthy."


• "Nova Southeastern University laboratory testing confirmed that GermBullet® inhalation blend has a broad spectrum potential capability to kill illness-causing bacteria, mold, and fungi."

• "I use GermBullet whenever I feel that I am coming down with something or having a stuffy nose. So far, it has been working for me."


• "I am an airline pilot and I was getting sick all the time, at least once every few weeks.
Once I started using GermBullet I'm not getting sick anymore."


• "It is truly amazing. I wouldn't be without it! Especially during this cold and Flu season!"


• "I love GermBullet; amazing product and REALLY WORKS! I have major allergies and this has made a huge difference. In addition, I have a low immune system, so when my folks get sick, I normally do too. BUT this time, when I used GermBullet, I didn't get sick when they did. This stuff is amazing."


• "Inhale before, during or after exposure to airborne germs or when you first suspect a cold."


• The Fox News report linked from your website of"how to beat the cold and flu symptoms with a bullet."


• The Wall Street Journal article entitled "Keeping Cold, Flu Germs Out."


In addition, your January 15, 2013, PR Newswire press release entitled, "Flu and Cold Defense's GermBullet® May Help Protect You so Your Immune System Is Not Overwhelmed as Flu Reaches Epidemic Levels," further demonstrates the intended use of your product.


GermBullet is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man or other animals. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of GermBullet without an approved application violates these provisions of the Act.


Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, GermBullet's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).


Additionally, you make false and misleading promotional statements on your website regarding the product. In particular, www.germbullet.com states, "An FDA recognized virology lab independently tested GermBullet® inhalation blend and confirmed that it has the potential capability to kill cold and flu viruses." However, FDA has not "recognized" any virology lab that has independently tested your product. Thus, your product is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).
 

* * *


The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you and your firms comply with all requirements of federal law and FDA regulations. Please note that FDA may contact distributors listed on www.germbullet.com and provide a copy of this letter.


You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.


Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Address your reply to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Attention: Sarah Burrell.


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.pdf), 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.


Sincerely,

/S/
Howard Sklamberg
Director
Office of Compliance
Center for Drug Evaluation and
Food and Drug Administration
 

/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission