Consumers were desperate to find hand sanitizer products during the early days of pandemic. Personal cleanser sales continued to soar through 2020 and into 2021.
On June 2, the CEO of PurePurge Inc., Rancho Dominguez, CA, was sent a letter related to its Medpure Hand Sanitizer product line after the agency reviewed its website on Feb. 11, 2021. Based on FDA’s review, Medpure Hand Sanitizer 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).
FDA noted intended uses (as defined in 21 CFR 201.128) of the products included, but may not be limited to, the following that were found on labels and websites:
“with PurePurge™ Technology . . . Drug Facts . . . Uses • Hand sanitizer to help reduce bacteria on the skin • Recommended for repeated use”
“Contains 70% Isopropyl Alcohol & 0.15% Hydrogen Peroxide as active ingredients
“The singlet oxygen technology within PurePurge™ provides a safe, proven, self-renewing, and sustainable source of disinfection.”
“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™”
“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”
“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.”
““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.”
“MedPure™ Hand Sanitizer, exclusive to PurgePurge Inc is shown to inactivate microoganisms (including bacteria and viruses).”
“MedPure Hand Sanitizer eliminates 99.99% of viruses and bacteria in as little as 15 seconds.”
According to FDA, these topical antiseptic products are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21, because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. FDA said it was unaware of any well-controlled clinical studies in the published literature that support a determination that Medpure Hand Sanitizers are GRASE for use under the conditions suggested, recommended, or prescribed their labeling.
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under this, 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, said FDA.
According to the agency, Medpure Hand Sanitizer does 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, the products contain the active ingredients isopropyl alcohol 70% and hydrogen peroxide 0.15%. Furthermore, the product websites that are considered labeling, make claims that included: “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. FDA said that although the company does 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.
Both websites noted by FDA in its letter, https://purepurge.com and https://www.medpure.store, were not active on June 11, 2021.
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, according to FDA. 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, nor are they consistent with the formulations described in FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.
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.
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.
Mexican Manufacturer Issued Warning Letter
In another recent instance, DMM Vission, S.A. de C.V. of Mexico was sent a US Warning Letter from the FDA following testing of consumer antiseptic hand rub drug products (hand sanitizers) labeled as SYP Health Hand Sanitizer Alcohol Gel and Cleaner By Crystalware Hand Sanitizer alcohol gel that were manufactured at the company’s facility. Following an attempt to import DMM Hand Sanitizer drug products into the United States, these products were detained and refused admission at the border.
The results of FDA laboratory testing of batches of these drug products detained at the border demonstrate that these drug products, labeled or declared to be manufactured at your facility, are adulterated. SYP Health Hand Sanitizer labeled to contain 70% of the active ingredient ethyl alcohol (ethanol) contained an average of 31% ethanol and an average of 2.3% methanol volume/volume (v/v), according to FDA. Cleaner By Crystalware Hand Sanitizer, which was labeled to contain 70% v/v of the active ingredient ethyl alcohol, contained an average of 22% ethanol and an average of 10% methanol v/v.