WARNING LETTER
Global Sanitizers LLC
MARCS-CMS 614124 —
November 08, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Ms. Kelly Ann Lewis-Bortman
Recipient Title
Manager/Co-Owner
Global Sanitizers LLC
175 E. Warm Springs Road
Las Vegas
,
NV
89119
United States
kelly@globalsanitizers.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
WARNING LETTER
November 8, 2021
Dear Ms. Lewis-Bortman:
The U.S. Food and Drug Administration inspected your drug manufacturing facility, Global Sanitizers LLC, FEI 3016413581, at 5979 S. Valley View Boulevard, Las Vegas, Nevada from February 23 to March 1, 2021.
This inspection followed an attempt to request records and other information from your firm pursuant to section 704(a)(4) of the Federal Food, Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4). This request was sent to your firm on December 31, 2020. You did not respond to this request or to a second attempt to request records. Refusal to permit access to any record as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act, 21 U.S.C. 331(e).
Your firm received bulk consumer hand rub drug product (also referred to as a consumer hand sanitizer), filled this into containers, and labeled the finished drug product. During the inspection, samples of labeled and unlabeled hand sanitizer drug products manufactured and labeled at your facility and distributed in the name of your represented business entity “SBL Brands LLC”, including MEDICALLY MINDED Antimicrobial Hand Sanitizer Gel with Vitamin E & Moisturizer were collected.
The results of the FDA laboratory testing of batches of these products collected from your facility and distributed by Global Sanitizers LLC under the business name “SBL Brands LLC” demonstrate that these drug products are adulterated within the meaning of section 501(d)(2) of the FD&C Act, 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
In addition, MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). 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).
Furthermore, MEDICALLY MINDED Hand & Surface Sanitizer Spray is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), and MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel and American Screening HAND SANITIZER are misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
FDA Tested Samples
Adulteration Violations: Substitution
Manufacturing operations at your facility included the receipt of bulk consumer hand sanitizer, which you filled into containers and labeled as the finished drug product. Based on information provided during the inspection, you received bulk hand sanitizer from several suppliers, including manufacturers located in Mexico.
MEDICALLY MINDED Hand Sanitizer Gel Antimicrobial Formula, collected at your facility, is labeled to contain 70% volume/volume (v/v) of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of a batch of this product collected during the inspection found that the drug product contained on average 0% ethanol and an average of 58% methanol v/v. Additionally, the drug product MEDICALLY MINDED Hand Sanitizer Gel Antimicrobial with Vitamin E & Moisturizer, purported to be manufactured at your facility, is labeled to contain 70% v/v of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of this batch of this product obtained from the commercial market found that the drug product contained an average of 32% ethanol v/v and an average of 7.4% methanol v/v. Therefore, these hand sanitizer drug products are adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.
Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects. Skin exposure to methanol can cause dermatitis, as well as transdermal absorption with systemic toxicity. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
On May 6, 2021, FDA held a teleconference with you and your legal counsel. We recommended you consider removing all of your firm’s hand sanitizer drug products currently in distribution to the U.S. market and within expiry. The FDA had previously notified the public on December 30, 2020 of the methanol contamination of your hand sanitizer drug products at the following website:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
On May 12, 2021, you issued a voluntary nationwide recall of two MEDICALLY MINDED hand sanitizer lots due to potential presence of undeclared methanol (wood alcohol), as noted on the following FDA website:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-sanitizers-issues-voluntary-nationwide-recall-medically-minded-hand-sanitizer-due-presence
After additional communication with the FDA, on May 20, 2021, you expanded the voluntary nationwide recall of MEDICALLY MINDED hand sanitizer to include three additional lots due to potential presence of undeclared methanol (wood alcohol), as noted on the following FDA website:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medically-minded-hand-sanitizer-nationwide-recall-expansion-due-presence-undeclared-methanol
In response to this letter, provide the following:
A detailed investigation into how the drug products described above, and which are labeled as containing 70% ethanol, in fact was substituted in part or in whole with methanol.
A list of all raw materials used to manufacture all of the hand sanitizer drug products you manufacture and/or distribute, including the suppliers’ names, addresses, and contact information.
A list of all batches of all hand sanitizer drug products distributed in United States by your firm, and a full reconciliation of all material you distributed.
Copies of the complete batch records for all batches distributed to the U.S.
The substitution and contamination with methanol in a drug product purported to be manufactured in your facility also demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.
1
CGMP Violations
We have not received a response from your firm for corrective actions to the observations identified during the inspection in our Form FDA 483.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Failure to Establish an Adequate Quality Unit
Your firm lacked written procedures describing the responsibilities of the Quality Unit (QU). Likewise, you also lacked adequate personnel responsible for Quality oversight, and review of manufacturing and testing records to approve or reject finished drug product batches. For example, testing of labeled and unlabeled hand sanitizer drug products collected from your facility as well as released product in distribution were found to be contaminated with methanol, subpotent for the labeled ethanol, and/or contained elevated levels of acetaldehyde/acetal impurities. Failure to implement an adequate QU permitted the introduction of adulterated materials into interstate commerce.
Failure of the Quality Unit to Approve Production Procedures
You could not provide procedures, batch records, or other records to support the manufacturing operations performed at your facility. Likewise, you had no system for assigning and tracking unique batch numbers or for the control of labels. For example, unused labels for hand sanitizer drug products were found on a labeling machine when your facility was not in a state of operation. Additionally, the marketed drug products were not labeled with batch numbers and expiry dates. The QU is responsible for approving manufacturing procedures impacting the identity, strength, quality, and purity of the drug products and for reviewing production records to assure that no errors have occurred.
Failure of the Quality Unit to Establish Adequate Controls for Released Materials
Your firm received bulk hand sanitizer drug products, which was filled into consumer-sized finished dosage containers and labeled for distribution to the U.S. market. You could not provide any records of the lots distributed or the number of units entered into the U.S. market.
On a teleconference with your firm on May 6, 2021, to discuss a voluntary recall and through subsequent correspondence with the FDA, you could not immediately identify the volume of MEDICALLY MINDED hand sanitizer on the U.S. market. Ultimately, you determined that you needed to expand your original recall.
During the inspection and in subsequent teleconferences, you stated that your firm was discontinuing operations. However, your finished drug products were still stored on site in addition to the drug products currently distributed on the market. You are still responsible for the appropriate disposition of your drug products (whether distributed or not).
Failure of the Quality Unit to Establish Adequate Control for Incoming Components
You could not provide sufficient documentation of the quality of incoming bulk materials, including identity testing or physical inspection of your incoming component containers. In addition, you could not demonstrate that you evaluated the quality of your suppliers or the reliability of analyses received from suppliers. The QU is responsible for ensuring adequate laboratory resources for the testing and approval or rejection of components and for approving all procedures such as supplier qualification, that could impact the identity, strength, quality, and purity of the drug product.
In summary, the CGMPs assign responsibilities to the QU which include approving or rejecting incoming materials, in-process materials, and drug products; ensuring that controls are implemented and completed satisfactorily during manufacturing operations; and reviewing production records and investigating any unexplained discrepancies. You have not demonstrated that you have a QU capable of these responsibilities.
See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
In response to this letter, provide the following:
A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
Unapproved New Drug and Misbranding Violations
MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel, MEDICALLY MINDED Hand & Surface Sanitizer Spray, and MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel 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 MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel, MEDICALLY MINDED Hand & Surface Sanitizer Spray, and MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel product labels 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:
MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel
“200 MG CANNABINOIDS 100 MG CBD + 100MG CBD . . . Drug Facts…
Use:
Hand sanitizer to help reduce bacteria on the skin. . .
Directions:
Put enough product in your palm to cover hands and rub hands together briskly until dry.”
MEDICALLY MINDED Hand & Surface Sanitizer Spray
“Drug Facts . . .
Uses:
Hand and surface sanitizer to reduce bacteria on skin and surfaces. . .
Directions:
Wet hands thoroughly with product and allow to dry without wiping.”
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel
“Drug Facts . . .
Use:
Hand sanitizer to help reduce bacteria on skin . . .
Directions:
Put enough product in your palm to cover hands and rub hands together briskly until dry.”
American Screening HAND SANITIZER
“Drug Facts . . .
Use:
Hand sanitizer to help reduce bacteria on skin . . .
Directions:
Put enough product in your palm to cover hands and rub hands together briskly until dry.”
MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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 other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this drug product is an unapproved new drug 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, MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel 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, notably because its active ingredient CBD is not an active ingredient in any applicable final monograph or TFM described above.
Although cannabidiol (CBD) and cannabigerol (CBG) are labeled as inactive ingredients on the label of your MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel drug product, the labeling for this product clearly represents CBD and CBG as active  ingredients.
2
Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists, “MedicallyMindedCBD.com,” a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph or TFM, for purposes of establishing eligibility for lawful marketing without an approved application under section 505G of the FD&C Act.
Furthermore, even if CBD or CBG could be considered an inactive ingredient in MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel, that product would still need an approved new drug application to be legally marketed because the product would not be eligible for marketing under section 505G of the FD&C Act. In particular, such product would not meet the conditions under section 505G(a)(3), insofar as it would not conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable.
3
A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance).
4
CBD or CBG has no known functional role as an inactive ingredient in a finished drug product. Additionally, an inactive ingredient should not exert pharmacological effects
5
and must be safe when used at the intended dosage.
6
CBD, however, has a known pharmacological activity with demonstrated risks.
7
It is unknown whether the levels of CBD or CBG used in your MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel drug product has pharmacological activity or pose any concern for safety events. Accordingly, CBD or CBG cannot be considered a safe and suitable inactive ingredient as required under 21 CFR 330.1(e). Moreover, as explained above, your MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel drug product is ineligible for marketing without an approved application under section 505G of the FD&C Act. Such a product does not conform with the TFM or the applicable requirements, nor is it consistent with the formulations described in the guidances setting forth FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.
8
MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
Furthermore, MEDICALLY MINDED Hand & Surface Sanitizer Spray is misbranded under section 502(c) of the FD&C Act, 21 U.S.C 352(c), because the product’s Drug Facts panel contains extraneous information that goes beyond the indications described in the TFM, nor is it consistent with the indications described in the guidances setting forth FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency described above. Specifically, 21 CFR 201.66(d)(7) states that additional information not described in the content requirements for OTC drug products should not appear in the Drug Facts panel. However, the “Uses” section of the Drug Facts panel for MEDICALLY MINDED Hand & Surface Sanitizer Spray includes extraneous information, such as under the Uses section, “. . . surface sanitizer . . . surfaces.” Conformance with general requirements for nonprescription drugs, such as 21 CFR 201.66(d)(7), is necessary in order for MEDICALLY MINDED Hand & Surface Sanitizer Spray to meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505 (See section 505G(a)(3)(A)(ii)(III) (21 U.S.C. 355h(a)(3)(A)(ii)(III)).
Additionally, MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel and American Screening HAND SANITIZER are packaged in containers that resemble drinking water bottles customarily purchased by U.S. consumers.9 Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” As such, your clear, colorless hand sanitizers that fill 8oz bottle containers that resemble plastic bottles ordinarily used to package drinking water are misbranded under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).
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).
Establishment Registration and Drug Listing Violations
Based upon the information obtained from the inspection, Global Sanitizers LLC (FEI 3016413581) has been identified as a repacker. Under section 510(i)(1) of the FD&C Act (21 U.S.C. § 360(i)(1)), Global Sanitizers LLC is required to submit registration information annually by electronic means for each establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is in commercial distribution in the United States. Global Sanitizers LLC has not fulfilled the registration requirement. As a result, all drugs manufactured in this establishment are misbranded under Section 502(o) of the FD&C Act [21 U.S.C. 352(o)].
Specifically, and according to the records obtained at the time of inspection, Global Sanitizers LLC (FEI 3016413581) repackages drugs for commercial distribution in the United States which have not been properly listed with FDA as required by the law. These drugs include:
MEDICALLY MINDED Hand & Surface Sanitizer Spray (2 fl oz and 4 fl oz bottles)
MEDICALLY MINDED Hand Sanitizer Gel 2,4,8, and 16.9 fl oz bottles (containing isopropyl alcohol 70% v/v)
MEDICALLY MINDED Hand Sanitizer Gel with Aloe Vera 8 fl oz bottles (containing ethyl alcohol 70%v/v)
MEDICALLY MINDED Hand Sanitizer Gel 200 MG Cannabinoids
Advanced Formula Hand Sanitizer Gel H2One Premium Hand Sanitizer 8 fl oz
MEDICALLY MINDED Hand Sanitizer Gel ANTIMICROBIAL FORMULA 8 fl oz
There are no drug listing submissions under the name of or labeler code for Global Sanitizers LLC. Under section 510 of the FD&C Act as amended and 21 CFR (21 U.S.C. 360(j)(1), 21 CFR 207.17 and 207.41), all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with FDA. Failure to properly list drug products is prohibited and will render the drugs misbranded (21 U.S.C. 331(p) and 352(o)).
Drug Production Ceased
We acknowledge your commitment to cease production of drugs at this facility. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility or another in the future.
If you plan to resume manufacturing drugs, ensure that adequate corrective actions are in place and notify this office to schedule a meeting before resuming your operations.
Based upon the nature of the violations we identified at your firm, if your firm intends to resume manufacturing drugs for the U.S. market, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in your facility. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence of other violations.
Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.
FDA may also withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer until the above violations are corrected. We may re-inspect to verify that you have completed your corrective actions.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot do so within 15 working days, state your reasons for delay and your schedule for completion.
Your response should refer to unique identifier CMS 614124 and be sent electronically to ORAPHARM4_Responses@fda.hhs.gov or mailed to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food and Drug Administration
19701 Fairchild Road
Irvine, CA 92612
If you have any questions regarding this letter, please contact William V. Millar, Compliance Officer, at (503) 671-9711 Ext. 30, or by email at william.millar@fda.hhs.gov.
Sincerely,
/S/
CDR Steven E. Porter, Jr
Director, Division of Pharmaceutical Quality Operations IV
Cc: SBL Brands, LLC
175 E. Warm Springs Road
Las Vegas, NV 89119
______________________________
1
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 for CGMP violations under section 501(a)(2)(B) of 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. In addition to the violative sample results detailed above that demonstrate the contamination of hand sanitizer products manufactured and/or distributed at your facility, a review of the purported formulations on the drug products’ labeling further indicates that such products are not prepared consistent with FDA’s temporary policy set forth in the guidance. Therefore, these products do not fall within the Agency’s temporary policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.
2
Under 21 CFR 201.66(b), an active ingredient is a component of a drug 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 function of the body.
3
21 CFR 330.1(e) requires that "the product contains only suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity."
4
See e.g., "
Using the Inactive Ingredient Database
" Guidance for Industry (July 2019), p. 1 at https://www.fda.gov/media/128687/download, and "
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
" Guidance for Industry (May 2005), pp. 1-2 at https://www.fda.gov/media/72260/download.
5
See e.g., 21 CFR 314.3(b) and 21 CFR 210.3(b)(7), which define an active ingredient as “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 man.” All other components of a finished drug product are considered inactive ingredients (see CFR 314.3(b), 21 CFR 210.3(b)(8)).
6
See 21 CFR 330.1(e).
7
For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf.
8
See, e.g., Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Because MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is not consistent with the formulations described in these guidances, it 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.
9
FDA is concerned that OTC hand sanitizer drug products packaged in containers that resemble drink containers commonly used by adults and children may confuse or mislead consumers and, thereby, increase the risk of accidental ingestion. Please refer to the August 27, 2020 news release titled, “COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers,” see https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-handsanitizer-packaged-food-and-drink-containers, that warns consumers about alcohol-based hand sanitizers packaged in containers that resemble food or drink containers customarily purchased by U.S. consumers may put consumers at risk of serious injury or death if ingested.
Content current as of:
11/16/2021
Regulated Product(s)
Drugs