Inspections, Compliance, Enforcement, and Criminal Investigations

Innovative Biodefense Inc. 6/30/15

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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
SILVER SPRING, MD 20993

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
June 30, 2015
 
Dr. Colette Cozean, President/CEO
Innovative Biodefense Inc.
21581 Midcrest Drive
Lake Forest, CA 92630
 
Dear Dr. Cozean:
 
This letter concerns your firm's marketing of the Zylast antiseptic product line, including Zylast XP Antiseptic, Zylast XP Antiseptic Foaming Soap, and Zylast XP Antiseptic Lotion (collectively, the Zylast products). The United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed claims on Zylast product labels and on your website, www.zylast.com, which includes links to the Zylast social-media pages at Facebook and Twitter.
 
As currently formulated, labeled, and promoted, these products are unapproved drugs in violation of section 505(a) ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)]. Introduction of such products into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)]. These violations are described in more detail below. Please note that this is not inclusive of all the products your firm manufactures and/or distributes and may not represent all product violations.
 
Unapproved New Drug Charges
 
Although all three Zylast products have stated purposes as topical "antiseptics," the product labeling states intended uses that cause the products to be unapproved new drugs under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. This includes website labeling claims for effectiveness against specific serious-disease-related pathogens such as Ebola, Methicillin-Resistant Staphylococcus aureus (MRSA), H1N1 flu virus, and norovirus. Furthermore, Zylast XP Antiseptic product labeling indicates use as a leave-on product that is not rinsed off. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 CFR § 201.128. Labeling claims demonstrating such intended uses ofthe Zylast products include, but are not limited to, the following claims made on websites that offer these products for sale: www.zylast.com and www.zylastdirect.com:
 
Zylast products (Zylast XP Antiseptic, Zylast XP Antiseptic Foaming Soap, and Zylast XP Antiseptic Lotion):
 
• "Zylast products are specifically formulated to be effective against a broad spectrum of germs to include bacteria (including drug-resistant bacteria such as MRSA), viruses, molds, fungi, and more."
• "Zylast has been shown to be more than 100 times more effective than alcohol alone, killing 99.97% ofNorovirus on contact!"
• "Is Zylast effective against the Norovirus (stomach flu)? Yes! Zylast has been shown to be 100 times more effective than alcohol sanitizers against the Norovirus (stomach flu) killing 99.97% on contact."
• "Is Zylast effective against viruses? Yes! ... BZT and the Zylast actives have also been shown to kill more than 99% of the Rhinovirus (common cold), Rota virus (diarrhea, especially in children), H1N1, Influenza, HIV, and Herpes virus on contact."
• "Zylast kills more than 99% of Rhinovirus, the highly contagious 'common cold' on contact!"
• "Zylast kills influenza, 'the flu' and killed 99.99% of the H1N1 strain in 15 seconds!"
• "Zylast Reduces Illness Outbreaks in Schools by 87.5%!"
• "Zylast was tested against MRSA out to six hour after application, with both products destroying more than 90% of MRSA one hour after they had been applied"
• "Zylast Eliminates: Norovirus (The Stomach Flu) 99.97% ... E. coli 99% ... MRSA & VRE 99% ... Cold & Flu Viruses 99%"
 
Labeling claims found on Twitter at https://twitter.corn/zylastxp:
 
• "Zylast is more than 100 times as effective against the Norovirus as alcohol sanitizers ... "
• " ... #Zylast is the ONLY hand sanitizer effective in kill the #flu and #MRSA"
 
Labeling claims found on Facebook at https://www.facebook.com/ZylastXP/info?tab=page_info:
 
• "Zylast: New Antibacterial Cleanser May Help Knock Out Ebola"
• "New Zylast article picked up by Sound Medicine at NPR- a potential new tool in the fight against Ebola and disease. Powerful enough for Ebola, safe enough for your family!"
 
The Face book page (https://www.facebook.com/ZylastXP/info?tab=page_info) includes a link to a press release titled Zylast™ Wins USAID "Fighting Ebola Grand Challenge" (http://www.pmewswire.com/news-releases/zylast-wins-usaid-fighting-ebola-grand-challenge-300009163.html). Labeling claims found within the press release:
 
• "The persistence of Zylast is critical in fighting the spread of Ebola. If a healthcare worker comes into contact with an infected person- even one who has not been diagnosed, Zylast provides defense against infection."
• "Zylast kills any Ebola virus that comes into contact with Zylast-treated skin and will persist up to 6 hours after application."
• "Zylast is more than 100 times as effective against the Norovirus as alcohol sanitizers ... "
• " ... #Zylast is the ONLY hand sanitizer effective in kill the #flu and #MRSA"
 
Labeling claims found on Facebook at https://www.facebook.com/ZylastXP/info?tab=page_info:
 
• "Zylast: New Antibacterial Cleanser May Help Knock Out Ebola"
• "New Zylast article picked up by Sound Medicine at NPR- a potential new tool in the fight against Ebola and disease. Powerful enough for Ebola, safe enough for your family!"
 
The Facebook page (https://www.facebook.com/ZylastXP/info?tab=page_info) includes a link to a press release entitled Zylast™ Wins USAID "Fighting Ebola Grand Challenge" http://www.pmewswire.com/news-releases/zylast-wins-usaid-fighting-ebola-grand-challenge-300009163.html).
Labeling claims found within the press release:
 
• "The persistence of Zylast is critical in fighting the spread of Ebola. If a healthcare worker comes into contact with an infected person- even one who has not been diagnosed, Zylast provides defense against infection."
• "Zylast kills any Ebola virus that comes into contact with Zylast-treated skin and will persist up to 6 hours after application."
 
Zylast XP Antiseptic:
 
• The label for Zylast XP Antiseptic Lotion identifies benzethonium chloride 0.20% as the sole "Active Ingredient" and the "Directions" state "wet hands thoroughly with product and allow to dry without wiping."
 
Based on their labeling, the Zylast products are "drugs" as section 201(g)(l)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or any function of the body of man. Specifically, these products are intended as topical antiseptics.
 
Although the Zylast products are labeled as topical antiseptics and include the general use to reduce bacteria and microorganisms on the skin, the products, as demonstrated by the above referenced claims, are also specifically intended for effectiveness against specific serious-disease related pathogens, and for Zylast XP Antiseptic Lotion use as a leave-on product that is not rinsed off.
 
Zylast products are "new drugs" within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. As "new drugs," in order to ensure Zylast products are safe and effective for the uses demonstrated by its labeling, the Zylast products as currently formulated and labeled require FDA approved new drug applications in order to be legally marketed in the United States. Zylast products are not the subjects of approved new drug applications. As new drugs without approved applications, the current marketing of Zylast products violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Introduction of such products into interstate commerce is prohibited under § 301 (d) of the FD&C Act [21 U.S.C. § 331(d)].
 
We note that, in accordance with its announced compliance policy,1 FDA does not take enforcement action against the marketing of certain over-the-counter (OTC) drugs without approved new drug applications if they are covered by an ongoing OTC monograph rulemaking process. However, as explained in this letter, the Zylast XP products are being marketed for uses that are not part of any ongoing rulemaking.2 Specifically, the Zylast XP products deviate from OTC products subject to the OTC monograph rulemaking in two ways: They make pathogen-specific claims that were not, to our knowledge, made at the time the monograph process began and that are not being considered for this type of product. The Zylast XP Antiseptic Lotion is a leave-on product, and no such product has been shown to have existed at the time the OTC monograph process began and no such product is covered by the rulemaking.
 
Drug products intended for topical antiseptic general use to reduce bacteria and microorganisms on the skin such as the labeled purpose of the Zylast products are being evaluated under the ongoing rulemaking for OTC Topical Antimicrobial Drug Products within FDA's OTC Drug Review. OTC Topical Antimicrobial Drug Products include OTC healthcare antiseptics and OTC consumer antiseptics such as the Zylast products. Tentative final monographs (TFMs) for these products were first published in the Federal Register in 43 FR 1210 (January 6, 1978) and amended at 56 FR 33644 (July 22, 1991), 59 FR. 31402 (June 17, 1994), and 78 FR 76446 (December 17, 2013). These documents are available on FDA's website at:
 
Pending a final monograph,3 the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the relevant TFM or that are otherwise eligible for inclusion in the OTC Drug Review (see 68 FR 75585 at 75590-91 , Dec. 31, 2003). However, neither the Zylast products nor similarly formulated and labeled products for the specific intended uses demonstrated by the above claims are eligible for inclusion in the OTC Drug Review or otherwise generally recognized as safe and effective by qualified experts.
 
In particular, claims to the public, as referenced above, for effectiveness against specific pathogens, and any claims with respect to pathogens such as MRSA, E. coli, norovirus, H1N1, HIV, herpes, influenza, rhinovirus and rotavirus, go beyond merely describing the general intended use of a topical antiseptic as described in the relevant rulemaking. Moreover, such claims are not described in any OTC final monograph, tentative monograph, or any rulemakings being considered under the OTC Drug Review. Also, we are unaware of any evidence that a product so formulated and labeled for such uses was marketed in the United States on or before the inception of the OTC Drug Review.
 
Moreover, Zylast XP Antiseptic Lotion does not qualify for evaluation under the OTC Drug Review due to its formulation. Although benzethonium chloride at this concentration (0.20%) is covered under FDA's OTC Drug Review for certain uses, it is not covered by the OTC Drug Review when offered as a leave-on/no-rinse healthcare antiseptic cleanser. Furthermore, we are unaware of any evidence of a leave-on/no-rinse healthcare antiseptic cleanser formulated and labeled like Zylast XP Lotion that was marketed in the United States on or before the inception of the OTC Drug Review.
 
Therefore, as formulated and labeled, the Zylast products are not covered under any OTC monograph or ongoing rulemaking that sets forth conditions for general recognition of safety and effectiveness for such uses. Nor are products intended specifically for effectiveness against specific serious-disease related pathogens, such as MRSA, E. coli, norovirus, H1N1, HIV, herpes, influenza, rhinovirus and rotavirus, being considered under FDA's OTC Drug Review. Additionally, products intended as a nonrinse, leave-on product, such as Zylast XP Antiseptic, are not being considered under FDA's OTC Drug Review. Furthermore, we are not aware of evidence to show that Zylast products as formulated and labeled are generally recognized by qualified experts as safe and effective for their labeled uses.
 
Additionally, we note claims for the Zylast products include assertions that the products provide six hours of extended efficacy against serious-disease related pathogens such as Ebola, Methicillinresistant Staphylococcus aureus (MRSA), H1N1 flu virus, and norovirus and other microorganisms. Time-specific extended efficacy claims especially when related to serious-disease related pathogens may lead to a false sense of security for the general public by resulting in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms and cross-contamination.
 
Misbranding Charge
 
The following labeling claim was included on your website, www.zylastdirect.com:
 
• "The active ingredient in Zylast, BZT ... and is considered safe and effective in concentrations of 0.1-0.2% by the FDA."
 
FDA has not established nor proposed BZT (benzethonium chloride) to be safe and effective at any concentration when used as a leave-on antiseptic such as Zylast XP Antiseptic Lotion. Thus, this claim is false and misleading, and Zylast XP Antiseptic Lotion is misbranded under section 502(a) of the Act [21 U.S.C. §352(a)]. Additionally, we note that even the rinse-off uses of BZT, which have been evaluated for under the rulemaking, have only been proposed as safe and effective for such uses, so the phrase "is considered" in the above quotation is inaccurate and misleading.
 
Unsubstantiated Advertising
 
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 POM Wonderful LLC v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015), reh 'g denied, 2015 U.S. App. LEXIS 8946 (D.C. Cir. 2015) (en bane); FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), affd, 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), affd, 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, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, 2009 WL 516000 at *17-19 (F.T.C. Dec. 24, 2009), affd, 405 Fed. Appx. 505 (D.C. Cir. 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.
 
Next Steps
 
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products, nor are the arguments raised here regarding them exhaustive. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of Federal law and FDA regulations.
 
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 15 working days of receipt of this letter, please notify the applicable FDA and FTC offices specified below in writing of the specific steps that you have taken to correct the referenced 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 15 working days, state the reason for the delay and the time within which you will complete the correction. If your firm no longer manufactures or markets any of the Zylast products, your response should indicate this along with the reasons for discontinuation, as well as the date your firm ceased production.
 
With regard to the advertising claims discussed in this letter, please notify Gregory W. Fortsch of the FTC via electronic mail at gfortsch@ftc.gov within fifteen 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 Mr. Fortsch at 202-326-3617. With regard to the FDA related violations described in this letter your reply should be directed to the attention of Mr. Raymond Brullo, Compliance Officer, Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Road, Irvine, CA 92612-2506. If you have questions regarding any issue in this letter, please contact Mr. Brullo at (949) 608-2918 or via electronic mail at raymond.brullo@fda.hhs.gov. You can find guidance and information regarding regulations through links at FDA's website at http://www.fda.gov/oc/industry.
 
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District Office
U.S. Food and Drug Administration
 
/S/
Cynthia Schnedar, J.D.
Office Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
 
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
 
__________________________________________________ 
1 FDA's Compliance Policy Guidance 450.200 sets forth our regulatory policy with respect to products being marketed under ongoing OTC monograph rulemaking. We note that, even if the products were covered by the rulemaking, they would warrant FDA enforcement action under that policy because some of their claims are for effectiveness against serious disease related viruses which could preclude obtaining proper medical attention.
2 Because so few OTC drugs are the subject of new drug applications (NDAs), in 1972, FDA decided to review all OTC drugs for both safety and efficacy. A review on a drug-by-drug basis would have been impractical since there are an estimated 250,000 OTC drugs on the market. Therefore, FDA announced that the OTC Drug Review would occur on an ingredient and therapeutic-category basis. To accomplish this, FDA convened special review panels. The review procedure for drug products studied by these panels is set forth in 21 CFR Part 330.
 
Upon review of the recommendations made by the subject panel, FDA publishes a Federal Register announcement containing the Proposed Monograph (i.e., an Advanced Notice of Proposed Rule). After a period of review and comment, the agency then publishes a Tentative Final Monograph (Proposed Rule). Finally, after an additional review and comment period, the agency publishes a Final Monograph (Final Rule). The Final Monograph concerns general recognition of safety and efficacy for the class of OTC drugs that it covers. OTC drugs that deviate from a final monograph are not generally recognized as safe and effective and require approved new drug applications before they can be marketed. But OTC drugs that comply with a Final Monograph do not need approved new drug applications.
 
3 Once a final monograph becomes effective, it may be necessary to reformulate and/or relabel such products to conform to its requirements, or, in the alternative, to seek FDA approval of a new drug application (NDA) under section 505 of the FD&C Act [21 U.S.C. § 355].
 

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