WARNING LETTER
GOJO Industries Inc
MARCS-CMS 599132 —
January 17, 2020
Delivery Method:
UPS and Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Carey Jaros
Recipient Title
President and Chief Executive Officer
GOJO Industries Inc
3783 State Road
Cuyahoga Falls
,
OH
44223-2603
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
January 17, 2020
WARNING LETTER
Case # 599132
Dear Mses. Jaros and Kanfer Rolnick:
This letter concerns your firm’s marketing of the PURELL® Healthcare Advanced Hand Sanitizer product line that includes the over-the-counter (OTC) drug products “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gel,” “PURELL® Healthcare Advanced Hand Sanitizer Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam ES6 Starter Kit,” and “PURELL® Healthcare Advanced Hand Sanitizer ULTRA NOURISHING™ Foam.”
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On your websites, your firm markets these products individually as well as in combination with other PURELL products for use in various settings, such as athletic facilities, schools, and offices, under the title of “THE PURELL SOLUTION.” In this letter, we collectively refer to these products as “PURELL® Healthcare Advanced Hand Sanitizers.” Based on claims on your product websites, which also include links to webpages where these products may be purchased, the PURELL® Healthcare Advanced Hand Sanitizers are intended for use as consumer and healthcare antiseptics.
As currently formulated and labeled, PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). These violations are described in more detail below.
Unapproved New Drugs
Examples of claims observed on your product websites, www.gojo.com and www.purell.com, and social media accounts for PURELL® Healthcare Advanced Hand Sanitizers that provide evidence of the products’ intended uses (as defined in 21 CFR 201.128) include, but may not be limited to, the following:
On your PURELL® Healthcare Advanced Hand Sanitizer product pages:
“Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
On your webpage titled, “GOJO Blog What You Need to Know About Candida auris in the Healthcare Setting”:
“To help prevent transmission, hand hygiene with an alcohol-based hand sanitizer is recommended along with hand washing if hands are soiled. PURELL® Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness  against a drug resistant clinical strain of Candida auris in lab testing.”
On your webpage titled, “The PURELL SOLUTION™ for Athletic Facilities”:
“PURELL® Products Help Eliminate MRSA & VRE . . . 100% MRSA & VRE Reduction[] . . . A recent outcome study shows that providing the right products, in a customized solution, along with educational resources for athletes and staff can reduce MRSA and VRE by 100%[]”
On your webpage titled, “The PURELL SOLUTION™ for Education”:
“51% Reduced Student Absenteeism . . . PURELL® products have proven results in delivering positive health outcomes. Illness causes 144 million lost school days each year2 []. . . In a recent study, student absenteeism was reduced by 51% when PURELL hand hygiene products were used in conjunction with a curriculum to teach kids about good hand hygiene[] . . . 10% Less Teacher Absenteeism . . . PURELL® Products Help Teachers Stay Well[] . . . New teachers are particularly more susceptible to student borne illness[]. . . . In one study, schools that combined hand-hygiene education with PURELL® products reduced teacher absenteeism by 10%[]”.
On your webpage titled, “PURELL® Products are Proven to Reduce Absenteeism”:
“PURELL® Products are Proven to Reduce Absenteeism . . . On average, illness causes 144 million lost school days each year[] and missing school can have a significant effect on a student’s performance. . . . Research has shown that when used alongside a curriculum to teach students about hand hygiene, PURELL® products can reduce student absenteeism by up to 51%[].. . . Additionally, teachers who follow this program also experience a 10% reduction of absenteeism[].”
On your Facebook page at https://www.facebook.com/purell/:
“The PURELL SOLUTION™ has the products you need to help prevent the spread of infection this germ season. Visit GOJO.com for more information.”
In addition, you make statements within the “Frequently Asked Questions” on your website, www.gojo.com, that suggest that PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza.
Specifically, your website states:
Illness Outbreak
. . .
What Steps Can I Take to Prevent the Spread of Norovirus? Even though norovirus is highly contagious, there are ways you can reduce the risk of its spread. According to the Centers for Disease Control and Prevention, follow these steps to reduce the spread of the virus. 1. Practice good hand hygiene. Make sure to wash your hands with soap and water at key moments, especially after using the restroom since the virus can spread through stool. Alcohol-based hand sanitizers with at least 60% alcohol can be used in addition to handwashing . . .
Are PURELL® Hand Sanitizer products effective against the flu? The FDA does not allow hand sanitizer brands to make viral claims, but from a scientific perspective, influenza is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol. The World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending the use of alcohol-based hand sanitizer as a preventive measure for flu prevention”
Is PURELL® Advanced Hand Sanitizer Effective Against Ebola?. . . As of today, we are not aware of any hand sanitizers that have been tested against Ebola viruses, including PURELL® Advanced Hand Sanitizer. However, it is important to note that the Ebola virus is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol.
World Health Organization (WHO)
and the
Center for Disease Control and Prevention (CDC)
are recommending the use of alcohol-based hand sanitizer as a preventive measure during this outbreak . . .
These statements, made in the context of the Frequently Asked Questions section, clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza. As such, the statements are evidence of your products’ intended uses. However, FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.
Based on the above claims, PURELL® Healthcare Advanced Hand Sanitizers are drugs as defined by section 201(g)(1)(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. Further, your PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, are intended for use as both consumer antiseptic rubs and health care antiseptic rubs. Although the individual products claim to be “designed for healthcare environments,” consumers can buy these products from the websites linked to the “Where to Buy” tabs listed on your product website.
Furthermore, PURELL® Healthcare Advanced Hand Sanitizers are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA approved applications pursuant to section 505 of the Act, 21 U.S.C. 355, are in effect for your PURELL® Healthcare Advanced Hand Sanitizers, nor are we aware of any adequate and well controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are generally recognized as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
We note that your website suggests that PURELL® Healthcare Advanced Hand Sanitizers are marketed under the OTC Drug Review and that they are formulated with ethyl alcohol. For OTC drug products intended for use as consumer antiseptic rubs, on April 12, 2019, FDA published the Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020). FDA deferred consideration of benzalkonium chloride, ethyl alcohol, and isopropyl alcohol in the 2019 Consumer Antiseptic Rub Final Rule (for additional information, see Docket No. FDA–2016–N–0124 at https://www.regulations.gov).
For OTC drug products intended for use as health care antiseptics, on December 20, 2017, FDA published the Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (82 FR 60474, December 20, 2017). In the 2017 Final Rule for Health Care Antiseptics, FDA announced it had deferred rulemaking on six active ingredients for specific OTC Health care antiseptic uses. Included in those six active ingredients are alcohol (also referred to as ethanol or ethyl alcohol) for use in a health care personnel hand rub or surgical hand rub (for additional information, see Docket No. FDA-2015-N-0101 at https://www.regulations.gov).
Until FDA promulgates final rules establishing whether ethyl alcohol, as one of the deferred ingredients listed in the two rules above, is generally recognized as safe and effective (GRASE) for the antiseptic uses described above, the agency generally does not intend to object to the marketing of products, provided they meet the proposed formulation and labeling conditions described in the relevant tentative final monograph (TFM) and each general condition in 21 CFR 330.1 and provided that a particular product does not constitute a hazard to health. Such marketing, however, is subject to the risk that a final rule may require reformulation, relabeling, and/or FDA approval under section 505 of the FD&C Act, 21 U.S.C. 355.
Your PURELL® Healthcare Advanced Hand Sanitizer products do not comply with the relevant TFM.
Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Furthermore, the claims on your product websites suggest that PURELL® Healthcare Advanced Hand Sanitizers are effective in reducing illness or disease-related student and teacher absenteeism also go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Such claims are not described in any OTC final rule, the above-referenced TFM (see 59 FR 31402, June 17,1994), or any rulemakings being considered under the OTC Drug Review. Additionally, we are unaware of any adequate and well-controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are GRASE for the above-described intended uses. Furthermore, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.
Therefore, as formulated and labeled, the PURELL® Healthcare Advanced Hand Sanitizer 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. Moreover, no product intended to prevent disease or infection from specific pathogens, such as MRSA, VRE, norovirus, flu, and Candida auris; intended to prevent the spread infections; or intended to reduce illness or disease-related student and teacher absenteeism, is being considered under FDA's OTC Drug Review. Furthermore, we are not aware of evidence demonstrating that the PURELL® Healthcare Advanced Hand Sanitizer products as formulated and labeled are generally recognized by qualified experts as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. Please be aware that 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.
Within fifteen working days after you receive this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not drugs or unapproved new drugs or otherwise may be legally marketed, please provide your reasoning and any supporting information for our consideration. 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.
Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.
Attn:
Nicholas F. Lyons
Director of Compliance
U. S. Food and Drug Administration
Division of Pharmaceutical Quality Operations III
Refer to the Unique Identification Number (Case# 599132) when replying. If you have questions regarding the contents of this letter, please contact me at (312) 596-4220.
Sincerely,
/S/
Nicholas F. Lyons for Art O. Czabaniak
Program Division Director
Division of Pharmaceutical Quality Operations III
__________________________________
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These products are marketed in different sizes and package configurations and are designed to be used with various push-style or hands-free dispensers.
Content current as of:
01/21/2020
Regulated Product(s)
Drugs