WARNING LETTER
PurePurge Inc.
MARCS-CMS 613194 —
June 02, 2021
Product:
Drugs
Recipient:
Recipient Name
Gordon Wood
Recipient Title
Chief Executive Officer
PurePurge Inc.
2630 Homestead Place
Rancho Dominguez
,
CA
90220
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
June 2, 2021
Dear Mr. Wood:
This letter concerns your firm’s marketing of the MEDPURE HAND SANITIZER product line
1
. The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://purepurge.com on February 11, 2021 where you direct consumers to the website, https://www.medpure.store, to purchase your products. In this letter we collectively refer to these products as “MEDPURE HAND SANITIZERS.”
Based on our review, MEDPURE HAND SANITIZERS are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and are misbranded under sections 502(ee) and (o) of the FD&C Act, 21 U.S.C. 352(ee) and (o). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranding Violations
MEDPURE 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 use in 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. Specifically, these products are intended for use as consumer topical antiseptics.
Examples of claims observed on the MEDPURE HAND SANITIZERS products’ labels, and labeling including your product website https://purepurge.com where consumers can click on the banner “MEDPURE™ SANITIZER – BUY NOW!” that links to the website https://www.medpure.store, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:
“with PurePurge™ Technology . . . Drug Facts . . . Uses • Hand sanitizer to help reduce bacteria on the skin • Recommended for repeated use” (product label)
“Contains 70% Isopropyl Alcohol & 0.15% Hydrogen Peroxide as active ingredients (from your website https://purepurge.com)
“The singlet oxygen technology within PurePurge™ provides a safe, proven, self-renewing, and sustainable source of disinfection.” (from your website https://purepurge.com)
“PurePurge™ Inc. has perfected its' [sic] process to commercially manufacture large quantities of singlet oxygen and successfully blend it with a variety of modern and traditional anti-microbials into its' [sic] proprietary photo-sensitizing organic dye, PurePurge™” (from your website https://purepurge.com)
“PurePurge™ oxidizes the entire cell instead of poisoning or puncturing a specific site. There is no known resistance to PurePurge™ which has been clinically proven to kill: •Gram Positive Bacteria •Gram Negative Bacteria •Enveloped Viruses •Non-Enveloped Viruses •Fungi •Mold •Spores” (from your website https://purepurge.com)
“In the presence of LIGHT, this proprietary organic dye - PurePurge™ - acts as catalyst to generate highly reactive singlet oxygen molecules, which attack and destroy any microbes present on the material or substrate.” (from your website https://purepurge.com and the website https://www.medpure.store)
““PurePurge™ patented oxygen reactive technology is integrated into MedPure™ branded products and has been shown through independent lab tests to neutralize microorganisms like viruses and bacteria, while providing a comfortable level of protection for the user.” (from the website https://www.medpure.store)
“MedPure™ Hand Sanitizer, exclusive to PurgePurge Inc
is shown to inactivate microoganisms (including bacteria and viruses).” (from the website https://purepurge.com)
“MedPure Hand Sanitizer eliminates 99.99% of viruses and bacteria in as little as 15 seconds.” (from the website https://www.medpure.store)
These topical antiseptic products 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 (GRASE) 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), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or under other exceptions not applicable here. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your MEDPURE HAND SANITIZERS are GRASE for use under the conditions suggested, recommended, or prescribed their labeling. Accordingly, these drug products are an 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 over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016)(Consumer Antiseptic Rubs Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.
However, MEDPURE HAND SANITIZERS do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rub proposed, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
According to the products’ labeling, MEDPURE HAND SANITIZERS contain the active ingredients isopropyl alcohol 70% and hydrogen peroxide 0.15%. Furthermore, the product websites, https://purepurge.com and https://www.medpure.store that are considered labeling, make claims that include, but are not limited to, “The singlet oxygen technology within PurePurge™ provides a safe, proven, self-renewing, and sustainable source of disinfection,” and “In the presence of LIGHT, this proprietary organic dye - PurePurge™ - acts as catalyst to generate highly reactive singlet oxygen molecules, which attack and destroy any microbes present on the material or substrate.” According to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Although you do not specifically list PurePurge™ as an active ingredient, the website claims described above for this specific ingredient demonstrate that it is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity. Moreover, the ingredient PurePurge™ is prominently featured on the principal display panel (PDP) of the products’ label, which, combined with the website claims described above, further suggests that PurePurge™ is intended as an active ingredient. Neither hydrogen peroxide nor PurePurge™ is permitted as an active ingredient for use as consumer antiseptic hand rub drug products under the 1994 TFM. Such products do not conform to the TFM
2
, nor are they consistent with the formulations described in FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency
3
.
In addition, the labeling of MEDPURE HAND SANITIZERS indicates that the products eliminate more than 99.99% of viruses in as little of 15 seconds and are proven to kill enveloped viruses, non-enveloped viruses, fungi, mold and spores. These labeled, intended uses go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, and FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.
4
These products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because MEDPURE HAND SANITIZERS are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
MEDPURE HAND SANITIZERS are further misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). On your company website (https://medpure.store.com) you state that “PurePurgeTM Inc. is a manufacturer and global distributor of cutting-edge photo-dynamic, disinfection products” and you offer multiple “MEDPURE HAND SANITIZERS” for sale in the United States. A review of FDA’s establishment registration and drug listing database confirms that PurePurgeTM, located at 2630 Homestead Place, Rancho Dominguez, CA 90220, is not registered as a drug manufacturing facility and MEDPURE HAND SANITIZERS are currently not listed with FDA as required by section 510 of the FD&C Act. Under section 510(i)(1) of the FD&C Act, 21 U.S.C. 360(i)(1), your firm failed to submit and maintain its establishment registration with FDA (see 21 U.S.C. 360(i)(1) and 21 CFR 207.17). In addition, under section 510 of the FD&C Act, as amended, and 21 CFR Part 207, all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with FDA (see 21 U.S.C. 360(j)(1) and 21 CFR 207.41). Your firm’s failure to fulfill its registration and drug listing obligations misbrands the products under section 502(o) of the FD&C Act.
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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 any 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these violations may result in legal action, 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 address any violations. 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 in violation of the Act, 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.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
___________________________________
1
Your MEDPURE HAND SANITIZER product line includes, “MEDPURE HAND SANITIZER 2oz Bottle,” “MEDPURE HAND SANITIZER 1 Gallon Refill Bottle,” and “MEDPURE HAND SANITIZER 32oz Refill Bottle.”
2
The use of more than one active ingredient for such products is not consistent with the applicable TFM for consumer and health care personnel antiseptic hand rubs. Therefore, MEDPURE HAND SANITIZERS go beyond the conditions outlined in their applicable TFM and as such they are not eligible for marketing without an approved application.
3
Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry:
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms violations of section 505 the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Because MEDPURE HAND SANITIZERS are not consistent with the formulations described in these guidances, they does not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.
4
The 1994 TFM covers health care antiseptics that are indicated for use to help reduce bacteria that potentially can cause disease and health care and consumer antiseptics that are indicated for use to decrease bacteria on the skin. Id. At 31443.
Content current as of:
06/08/2021
Regulated Product(s)
Drugs