WARNING LETTER
Creative Essences, Inc.
MARCS-CMS 710658 —
September 25, 2025
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Reference #:
320-25-116
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Alex D. Daliva
Recipient Title
President
Creative Essences, Inc.
15320 Cornet Street
Santa Fe Springs
,
CA
90670-5532
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-25-116
September 25, 2025
Dear Mr. Daliva:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Creative Essences, Inc., FEI 3006349554, at 15320 Cornet St., Santa Fe Springs, from March 19 to 25, 2025.
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 Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
In addition, the “
(b)(4)
” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Additionally, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of a misbranded drug product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
We reviewed your April 15, 2025, response to our Form FDA 483 in detail.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Your firm is a manufacturer of over-the-counter (OTC) drugs for oral, nasal, rectal, and topical use. Your firm’s investigations into unexplained discrepancies are inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product batches and components associated with unexplained discrepancies. When an investigation was performed, you failed to identify the root cause(s), implement appropriate corrective action and preventive action (CAPA), and expand the investigation to evaluate the impact on other batches or products. For example:
Your QU did not investigate an out-of-specification (OOS) identification test for an incoming lot of active pharmaceutical ingredient (API), benzocaine, that was subsequently used to manufacture
(b)(4)
released
(b)(4)
drug product lots.
Your QU failed to adequately investigate multiple microbial OOS results from your
(b)(4)
water system which is used as a component in your drug products.
Your QU failed to adequately investigate multiple OOS stability failures (pH and viscosity) for a released batch of Nutrascreen Color Balanced SPF30 sunscreen.
In your response, you state you will ensure that QU personnel provide the disposition for each component per the raw material specification sheet. You also state that there was a sampling error by the technician and because there were no OOS results in the finished product, you did not investigate the water system failures any further. Although your response indicates you opened a CAPA for the sunscreen stability failures, it does not appear you have initiated an investigation or actions to address the deficiency.
Your response is inadequate. The completed investigations in your response are not sufficiently thorough and lack sufficient scientific justification to support your identified root cause. You also fail to provide supporting documentation or sufficient details about the CAPAs to ensure they will be effective in resolving the deficiency. Additionally, you fail to provide a retrospective review of all manufacturing and laboratory investigations.
In response to this letter, provide:
A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure that all phases of investigations are appropriately conducted.
An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigation trends, improves the CAPA program when needed, implements final QU decisions, and is fully supported by executive management.
2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
You lacked appropriate sampling and testing to ensure your drug products conform to appropriate standards of identity, strength, quality, and purity. For example, you failed to establish adequate procedures for finished drug product sampling to ensure adequate representation of each batch. Also, there were multiple instances where required finished drug product samples were either not taken or taken but not appropriately tested.
Furthermore, your firm failed to demonstrate that your microbiological test methods were appropriate. Specifically, you could not provide evidence to demonstrate method suitability for microbiological tests used to test samples from your water system and finished drug products.
In your response, you state that the laboratory technician pulled samples primarily based “by memory” and that you will send retains for testing. You also state your “investigation is underway” and due to resource issues, you will address this after implementing related CAPA regarding the microbiological testing deficiencies.
Your response is inadequate. You do not provide sufficient detail or adequate evidence of corrective actions (e.g., protocol or procedure). You also do not provide a timeline for verification of the methods or describe your plans for testing in the interim. Furthermore, you do not address whether a retrospective impact assessment would be performed for previously distributed drug products that are still within expiry.
The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established and validated. Results generated using unverified or unvalidated methods may put consumers at risk.
In response to this letter, provide:
A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.
An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You failed to conduct adequate identity testing on incoming components, including APIs, used in the manufacture of your drug products. For example, you failed to adequately test each shipment of each lot of glycerin and propylene glycol for identity, components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing for glycerin, propylene glycol, and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform adequate identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in manufacture of your drug product.
The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.
In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals.
In your response, you state you have validated the suppliers’ COA for some of your active ingredients and you will submit samples of your glycerin and propylene glycol raw material in stock for testing.
Your response is inadequate because it does not indicate you will perform the required testing for each lot of incoming raw materials, nor does it provide sufficient details on how you will establish the reliability of your component suppliers’ COAs at appropriate intervals. Furthermore, your response lacks a retrospective review, analysis, and risk assessment for previously distributed drug products that are within expiry.
Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components or drug products conform to appropriate specifications prior to use in the drug products you manufacture.
In your response to this letter, provide:
A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the components and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B. and C of the USP monograph.
The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
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 summary of your program for qualifying and overseeing contract facilities that test the components you use to manufacture your drugs.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
You lacked process validation data to demonstrate you have adequately validated your manufacturing processes used to manufacture your OTC drug products and to demonstrate your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.
In your response, you acknowledge that no actions or solutions have been implemented for this deficiency.
Your response is inadequate. You did not provide a timeframe for completion of process validation activities for each of your drug products, nor did you provide your interim plans for any drugs distributed before validation activities are completed to ensure you produce drug products of acceptable quality.
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,
Process Validation: General Principles and Practices
for general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.
Additionally, based on inspection findings, it is unclear whether you had the ability to demonstrate that your water system was in a state of control due to inadequate qualification, inadequate sanitization, and inadequate monitoring. You use water as a component in your drug products and for equipment cleaning.
Water for pharmaceutical purposes must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate validation provides no assurance the system performs as intended and subsequent use of deionized water in pharmaceutical manufacturing can adversely affect drug product quality and patient safety.
In response to this letter, provide:
A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
A timeline for performing process performance qualification for each of your marketed drug products.
Process performance protocol(s), and written procedures for qualification of equipment and facilities.
A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.
The current action/alert limits for total counts and objectionable organisms used for your purified water system. Ensure that the total count limits for your
(b)(4)
water are appropriately stringent in view of the intended use of each of the products produced by your firm.
A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces water that meets
(b)(4)
Water, USP monograph specifications and appropriate microbial limits.
5. 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).
Your firm failed to establish an adequate QU with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:
Establishment of procedures describing roles and responsibilities of the QU including, but not limited to, batch release, investigations, change control, and periodic (i.e., at least annual) product reviews (21 CFR 211.22(d)).
Establishment of an adequate equipment cleaning and maintenance program for your equipment (21 CFR 211.67(b)).
Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Your firm’s quality systems are inadequate. 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 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:
A determination of whether procedures used by your firm are robust and appropriate
Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
A complete and final review of each batch and its related information before the QU disposition decision
Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
Unapproved New Drug and Misbranding Drug Violations
“
(b)(4)
” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body.
Examples of claims observed on the “
(b)(4)
” product labeling, including from the “
(b)(4)
” website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:
(b)(4)
(b)(4)
(b)(4)
(b)(4)
Unapproved New Drug Violations
Based on the above labeling evidence, “
(b)(4)
” is intended for use as
(b)(4)
topical antiseptic drug product. This product 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 an approved application from FDA in effect, 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 the “
(b)(4)
” drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this 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).
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application—commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. Under section 505G(a)(3) of the FD&C Act, drugs that (prior to enactment of section 505G) were classified as Category III
1
for safety or effectiveness in the preamble of a tentative final monograph (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 indication, and comply with all other applicable requirements.
Consumer topical antiseptics, such as your
(b)(4)
product, were addressed in a 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) (hereinafter “1994 TFM”), as 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) (hereinafter “Consumer Topical Antiseptics Proposed Rule”).
2
In the preamble of the 1994 TFM
3
as well as the preamble of the Consumer Topical Antiseptics Proposed Rule (the most recent amendment of the 1994 TFM with respect to such products), three active ingredients (benzalkonium chloride—the active ingredient in your
(b)(4)
product—ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products.
4
However, “
(b)(4)
” does not meet the conditions under section 505G(a)(3) for legal marketing without an approved application because this product does not conform to conditions applicable to consumer topical antiseptic products under the 1994 TFM, as amended by the 2016 Consumer Topical Antiseptics Proposed Rule with respect to such products. Specifically, according to the product labeling, “
(b)(4)
” is intended to be applied
(b)(4)
. Under the 1994 TFM as amended by the 2016 Consumer Topical Antiseptics Proposed Rule, only consumer topical antiseptic products intended for use on the hands without water are included in the scope of consumer topical antiseptic products covered by the TFM.
5
Thus, consumer topical antiseptic products with the active ingredient benzalkonium chloride intended for administration
(b)(4)
do not conform to the conditions for consumer topical antiseptic products under the 1994 TFM, as amended by the Consumer Topical Antiseptics Proposed Rule. Accordingly, your
(b)(4)
product does not meet the criteria under section 505G(a)(3) for legal marketing without an approved application and thus cannot be legally marketed as an OTC monograph drug under section 505G of the FD&C Act.
The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Additionally, “
(b)(4)
” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product 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.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Additionally, we also note that conflicting information for the
(b)(4)
has been provided to the Agency based on the information collected by our investigator during the inspection and the labeling submitted to FDA for drug listing in the agency’s Electronic Drug Registration and Listing System (eDRLS) in accordance with section 510 of the FD&C Act. Specifically, nonprescription oral anesthetic products containing benzocaine or butacaine sulfate as active ingredients that are marketed under section 505G of the FD&C Act are required to bear the warning, “Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine' anesthetics” on the Drug Facts panel. See section M022.52(c)(4) of Over-the-Counter Monograph M022: Oral Healthcare Drug Products for Over-the-Counter Human Use. However, the labeling provided to the investigator for the
(b)(4)
fails to include this required warning on its labeling. Please ensure that your OTC drug products have the required warnings and statements and comply with all applicable labeling requirements.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.
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.
Cosmetics Manufactured for Distribution in the United States
In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.
We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
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 complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3006349554 and ATTN: Christopher M. Jenner.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
/S/
Brad Pace, J.D.
Associate Director
Office of Unapproved Drugs and Labeling Compliance
Signed on behalf of:
/S/
Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
_____________________
1
As used under the OTC monograph system prior to enactment of section 505G (and as stated at 81 FR 42912, 42915), “
[t]he OTC drug procedural regulations in § 330.10 use the terms ‘Category I’ (generally recognized as safe and effective and not misbranded), ‘Category II’ (not generally recognized as safe and effective or misbranded), and ‘Category III’ (available data are insufficient to classify as safe and effective, and further testing is required)
”, 81 FR 42912, 42915.
2
As stated in the Consumer Topical Antiseptics Proposed Rule, “
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective
(GRAS/ GRAE)”, 81 FR 42912.
3
The initial 1994 TFM included but did not distinguish between and separately address consumer antiseptic washes and rubs, and health care hand washes and rubs. The Consumer Topical Antiseptics Proposed Rule amended the 1994 TFM with respect to its treatment of consumer antiseptic rubs specifically. See 81 FR 42916.
4
81 FR 42912, 42918. The Category III designation for these active ingredients means 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 topical antiseptic product.
5
As stated in the Consumer Topical Antiseptics Proposed Rule, “
we refer to the group of products covered by this proposed rule as ‘consumer antiseptics.’ Consumer antiseptic drug products addressed by this proposal include consumer antiseptic hand rubs (commonly called hand sanitizers) and antiseptic wipes
”, 81 FR 42912, 42915.
Content current as of:
10/07/2025
Regulated Product(s)
Drugs
Over-the-Counter Drugs