Import Alert 62-08
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 62-08
Published Date: 11/06/2023
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico"
Reason for Alert:
Alcohol-based hand sanitizers are drugs regulated by the FDA and are generally considered nonprescription, over-the-counter (OTC) drug products. For the purposes of this Import Alert "alcohol-based hand sanitizers" are those purported to contain ethanol (also known as "ethyl alcohol" or "alcohol") or isopropyl alcohol (also known as "2-propanol") as the active ingredient.
Nonprescription hand sanitizers without an approved application may be legally marketed in the U.S. under section 505G(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), if they conform with the relevant conditions of use outlined in the applicable monograph, including the active ingredient, and comply with all other applicable requirements for nonprescription drugs, including Current Good Manufacturing Practice (CGMP) statutory and regulatory requirements under 501(a)(2)(B) and 21 CFR 210 and 211, respectively. Concerning the applicable monograph, conditions for use for 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 the Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record," Proposed Rule, 80 FR 25166 (May 1, 2015); and the "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).
From early April 2020 through the end of December 2020, FDA collected 112 samples of alcohol-based hand sanitizer products from 53 different Mexican manufacturers who offered product for import into the United States. The manufacturers sampled account for 60.4% of the total lines of alcohol-based hand sanitizer products imported from Mexico during this time period. Of the 112 analyses that have been completed, 94 (84%) of the samples were found to be violative and 18 (16%) compliant. Further, of the 94 samples found to be violative, 74 were due to the presence of methanol and/or 1-propanol at unacceptable levels and 20 were due to insufficient levels of active ingredient (alcohol subpotency). This presents serious safety concerns, as the FDA is aware of at least 20 recent deaths associated with hand sanitizers, 16 of which involved methanol poisoning. Moreover, 7 of these cases were directly linked to hand sanitizers manufactured in Mexico. FDA sampled and tested shipments of the hand sanitizer products manufactured in Mexico and confirmed the presence of methanol in the products linked to each of these 7 deaths.
Evidence of methanol contamination, such as in those samples tested by FDA as described above, indicates a violation of current good manufacturing practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act, because it demonstrates that the quality assurance within the manufacturing facility is not functioning in accordance with CGMP.
Nonprescription hand sanitizers without an approved application may be legally marketed in the U.S. under section 505G(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), if they conform with the relevant conditions of use outlined in the applicable monograph, including the active ingredient, and comply with all other applicable requirements for nonprescription drugs, including Current Good Manufacturing Practice (CGMP) statutory and regulatory requirements under 501(a)(2)(B) and 21 CFR 210 and 211, respectively. Concerning the applicable monograph, conditions for use for 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 the Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record," Proposed Rule, 80 FR 25166 (May 1, 2015); and the "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).
From early April 2020 through the end of December 2020, FDA collected 112 samples of alcohol-based hand sanitizer products from 53 different Mexican manufacturers who offered product for import into the United States. The manufacturers sampled account for 60.4% of the total lines of alcohol-based hand sanitizer products imported from Mexico during this time period. Of the 112 analyses that have been completed, 94 (84%) of the samples were found to be violative and 18 (16%) compliant. Further, of the 94 samples found to be violative, 74 were due to the presence of methanol and/or 1-propanol at unacceptable levels and 20 were due to insufficient levels of active ingredient (alcohol subpotency). This presents serious safety concerns, as the FDA is aware of at least 20 recent deaths associated with hand sanitizers, 16 of which involved methanol poisoning. Moreover, 7 of these cases were directly linked to hand sanitizers manufactured in Mexico. FDA sampled and tested shipments of the hand sanitizer products manufactured in Mexico and confirmed the presence of methanol in the products linked to each of these 7 deaths.
Evidence of methanol contamination, such as in those samples tested by FDA as described above, indicates a violation of current good manufacturing practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act, because it demonstrates that the quality assurance within the manufacturing facility is not functioning in accordance with CGMP.
Guidance:
INSTRUCTION:
Divisions may detain without physical examination (DWPE) finished dosage alcohol-based hand sanitizer drug products offered for entry from the country of Mexico, except for the firms identified on the Green List to this alert.
DWPE may be appropriate for finished dosage drugs in final packaged units and bulk containers only. Active Pharmaceutical Ingredients and inactive pharmaceutical ingredients are not included in this Import Alert. ***Personal Importation Policy (PIP) exemptions will not supersede import alert guidance for products found to be subject to IA.***
In order to secure release of an individual shipment subject to DWPE under this Import Alert the importer and/or another responsible party to the shipment may provide evidence that the shipment does not contain hand sanitizer products that appear to be adulterated as a result of CGMP non-compliance. Such evidence may include:
- Records from the manufacturer regarding the active ingredient used in the hand sanitizer products subject to DWPE. (Note that under the monograph, only ethanol or isopropyl alcohol are active ingredients in legally marketed alcohol-based hand sanitizers, and only at the applicable concentration specified);
- Full formula of all hand sanitizers currently subject to DWPE;
- Records from the manufacturer providing information about all physical manufacturing sites, from active pharmaceutical ingredient (API) manufacture through to finished product manufacture and packaging, for each drug product offered for import;
- Information from the manufacturer demonstrating that the facility and hand sanitizer product are manufactured and distributed in full compliance with all applicable statutory and regulatory requirements of CGMP. This would include documents supporting compliance with all 210 and 211 regulations applicable to hand sanitizer drug product manufacture.
For different products/firms, some of the above-listed items may not be needed to demonstrate that the alcohol-based hand sanitizer is produced in conformity with CGMP requirements. If a firm believes an item is not needed to demonstrate their compliance with CGMP, they should provide a detailed rationale and supporting documents. CDER/OC/ODSIR/DGDDP/IECB will evaluate all evidence on a case-by-case basis.
To facilitate review of the submissions, FDA strongly recommends that evidence be submitted in English (original documents should be translated and both the translation and original should be provided). Documents not submitted in English will delay FDA reviews.
Requests for Removal from Detention Without Physical Examination Under This Import Alert:
Firms that wish to be removed from DWPE (added to the Green List of this Import Alert) should provide information to FDA to adequately demonstrate that they have in place appropriate measures to overcome the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. Examples of such information may include:
- Records from the manufacturer regarding the active ingredient used in the hand sanitizer products subject to DWPE. (Note that under the monograph, only ethanol or isopropyl alcohol are active ingredients in legally marketed alcohol-based hand sanitizers, and only at the applicable concentration specified);
- Full formula of all hand sanitizers currently subject to DWPE;
- Records from the manufacturer providing information about all physical manufacturing sites, from active pharmaceutical ingredient (API) manufacture through to finished product manufacture and packaging, for each drug product offered for import;
- Information from the manufacturer demonstrating that the facility and hand sanitizer product are manufactured and distributed in full compliance with all applicable statutory and regulatory requirements of CGMP. This would include documents supporting compliance with all 210 and 211 regulations applicable to hand sanitizer drug product manufacture.
If a firm/product is subject to DWPE on this Import Alert and is also subject to DWPE for the same underlying violation on another Import Alert, then a request can be made that the firm or product be removed from DWPE for both Import Alerts based on the same information. If the firm/product is subject to DWPE on another Import Alert based on a different violation, importers should consult the other Import Alert for information about the procedures for removal from DWPE under the other Import Alert.
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert (i.e., Addition to the Green List), all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
FDA strongly recommends firms interested in petitioning for removal from DWPE under this Import Alert provide relevant information prior to shipping products subject to this Import Alert into the U.S. This may help facilitate review and avoid delays at the time of import.
Requests for removal from DWPE (Addition to the Green List) will be referred by DIO to CDER/OC/ODSIR/DGDDP/IECB for evaluation.
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)".
A firm would be removed from the Green List if the FDA has information indicating that the firm is no longer in compliance with the FD&C Act, such that future shipments may appear violative.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
For questions regarding performance standards or other compliance issues regarding drug products subject to this Import Alert, please contact CDER/OC/ODSIR/DGDDP/IECB Branch via email: CDERImportsExports@fda.hhs.gov.
Divisions may detain without physical examination (DWPE) finished dosage alcohol-based hand sanitizer drug products offered for entry from the country of Mexico, except for the firms identified on the Green List to this alert.
DWPE may be appropriate for finished dosage drugs in final packaged units and bulk containers only. Active Pharmaceutical Ingredients and inactive pharmaceutical ingredients are not included in this Import Alert. ***Personal Importation Policy (PIP) exemptions will not supersede import alert guidance for products found to be subject to IA.***
In order to secure release of an individual shipment subject to DWPE under this Import Alert the importer and/or another responsible party to the shipment may provide evidence that the shipment does not contain hand sanitizer products that appear to be adulterated as a result of CGMP non-compliance. Such evidence may include:
- Records from the manufacturer regarding the active ingredient used in the hand sanitizer products subject to DWPE. (Note that under the monograph, only ethanol or isopropyl alcohol are active ingredients in legally marketed alcohol-based hand sanitizers, and only at the applicable concentration specified);
- Full formula of all hand sanitizers currently subject to DWPE;
- Records from the manufacturer providing information about all physical manufacturing sites, from active pharmaceutical ingredient (API) manufacture through to finished product manufacture and packaging, for each drug product offered for import;
- Information from the manufacturer demonstrating that the facility and hand sanitizer product are manufactured and distributed in full compliance with all applicable statutory and regulatory requirements of CGMP. This would include documents supporting compliance with all 210 and 211 regulations applicable to hand sanitizer drug product manufacture.
For different products/firms, some of the above-listed items may not be needed to demonstrate that the alcohol-based hand sanitizer is produced in conformity with CGMP requirements. If a firm believes an item is not needed to demonstrate their compliance with CGMP, they should provide a detailed rationale and supporting documents. CDER/OC/ODSIR/DGDDP/IECB will evaluate all evidence on a case-by-case basis.
To facilitate review of the submissions, FDA strongly recommends that evidence be submitted in English (original documents should be translated and both the translation and original should be provided). Documents not submitted in English will delay FDA reviews.
Requests for Removal from Detention Without Physical Examination Under This Import Alert:
Firms that wish to be removed from DWPE (added to the Green List of this Import Alert) should provide information to FDA to adequately demonstrate that they have in place appropriate measures to overcome the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. Examples of such information may include:
- Records from the manufacturer regarding the active ingredient used in the hand sanitizer products subject to DWPE. (Note that under the monograph, only ethanol or isopropyl alcohol are active ingredients in legally marketed alcohol-based hand sanitizers, and only at the applicable concentration specified);
- Full formula of all hand sanitizers currently subject to DWPE;
- Records from the manufacturer providing information about all physical manufacturing sites, from active pharmaceutical ingredient (API) manufacture through to finished product manufacture and packaging, for each drug product offered for import;
- Information from the manufacturer demonstrating that the facility and hand sanitizer product are manufactured and distributed in full compliance with all applicable statutory and regulatory requirements of CGMP. This would include documents supporting compliance with all 210 and 211 regulations applicable to hand sanitizer drug product manufacture.
If a firm/product is subject to DWPE on this Import Alert and is also subject to DWPE for the same underlying violation on another Import Alert, then a request can be made that the firm or product be removed from DWPE for both Import Alerts based on the same information. If the firm/product is subject to DWPE on another Import Alert based on a different violation, importers should consult the other Import Alert for information about the procedures for removal from DWPE under the other Import Alert.
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert (i.e., Addition to the Green List), all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
FDA strongly recommends firms interested in petitioning for removal from DWPE under this Import Alert provide relevant information prior to shipping products subject to this Import Alert into the U.S. This may help facilitate review and avoid delays at the time of import.
Requests for removal from DWPE (Addition to the Green List) will be referred by DIO to CDER/OC/ODSIR/DGDDP/IECB for evaluation.
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)".
A firm would be removed from the Green List if the FDA has information indicating that the firm is no longer in compliance with the FD&C Act, such that future shipments may appear violative.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
For questions regarding performance standards or other compliance issues regarding drug products subject to this Import Alert, please contact CDER/OC/ODSIR/DGDDP/IECB Branch via email: CDERImportsExports@fda.hhs.gov.
Product Description:
Alcohol-Based Hand Sanitizer Drugs
Charge:
For finished dosage drug products that appear to be adulterated due to Current Good Manufacturing Practice violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). [Adulteration, Section 501(a)(2)(B)]
OASIS Charge Code - DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). [Adulteration, Section 501(a)(2)(B)]
OASIS Charge Code - DRUG GMPS
Countries
MEXICO
-
(61 H - - 99) Anti-Bacterial, N.E.C.Desc: Anti-Bacterial
-
(62 F - - 23) Isopropyl Alcohol (Anti-Infective, Topical)Desc: Isopropyl Alcohol (Anti-Infective
-
(62 F - - 99) Anti-Infective, Topical N.E.C.Desc: Anti-Infective
-
(62 H - - 05) Ethyl Alcohol (Anti-Microbial)Desc: Ethyl Alcohol(Anti-Microbial)
-
(64 A - - 99) Disinfectant N.E.C.Desc: Disinfectant N.E.C.
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)
MEXICO
Cyan Labs S.A. de C.V.
Date Published : 02/25/2021
Anillo Periferico Km. 37 , Col. Moises Saenz, Apodaca
, Ciudad Apodaca,
Nuevo Leon MEXICO
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 02/25/2021
Desc: Alcohol-Based Hand Sanitizers