Happi Staff01.23.20
Gojo Industries Inc. has been sent a warning letter by the US Food and Drug Administration (FDA) regarding marketing statements related to its Purell Health Healthcare Advanced Hand Sanitizer product line, including products such 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 Utra Nourishing Foam.
According to FDA’s letter dated Jan. 17, Gojo’s websites are marketing 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 the letter, FDA collectively refers to these products as Purell Healthcare Advanced Hand Sanitizers.)
Based on claims on 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, the products 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).
FDA said examples of claims observed on Gojo 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:
• “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
• “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.”
• “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%[]”
• “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%[]”.
• “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, Puell® products can reduce student absenteeism by up to 51%[].. . . Additionally, teachers who follow this program also experience a 10% reduction of absenteeism[].”
“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, FDA contends that the company makes statements within the “Frequently Asked Questions” on its website 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. Based on those claims, FDA said 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, 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, FDA states 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), said FDA in its letter.
FDA also said that Gojo’s 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).
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).
The agency said that 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 it 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.
FDA said it contends that Purell Healthcare Advanced Hand Sanitizer products do not comply with the relevant TFM.
FDA noted that Gojo’s 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, FDA said it is 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.
In the letter, FDA said “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.”
According to FDA’s letter dated Jan. 17, Gojo’s websites are marketing 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 the letter, FDA collectively refers to these products as Purell Healthcare Advanced Hand Sanitizers.)
Based on claims on 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, the products 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).
FDA said examples of claims observed on Gojo 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:
• “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
• “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.”
• “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%[]”
• “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%[]”.
• “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, Puell® products can reduce student absenteeism by up to 51%[].. . . Additionally, teachers who follow this program also experience a 10% reduction of absenteeism[].”
“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, FDA contends that the company makes statements within the “Frequently Asked Questions” on its website 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. Based on those claims, FDA said 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, 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, FDA states 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), said FDA in its letter.
FDA also said that Gojo’s 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).
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).
The agency said that 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 it 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.
FDA said it contends that Purell Healthcare Advanced Hand Sanitizer products do not comply with the relevant TFM.
FDA noted that Gojo’s 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, FDA said it is 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.
In the letter, FDA said “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.”
