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  1. Warning Letters

WARNING LETTER

LCC Ltd. MARCS-CMS 688576 —

Delivery Method:
VIA UPS
Reference #:
320-25-19
Product:
Drugs
Recipient:
Recipient Name
Mr. Sung-chun Baik
Recipient Title
Chief Executive Officer
LCC Ltd.

738-13 Samyang-ro
Daeso-myeon
Eumseong-gun
Chungcheongbuk-do
South Korea

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-25-19

November 21, 2024

Dear Mr. Baik:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, LCC Ltd., FEI 3007255059, at 738-13 Samyang-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, from March 18 to 22, 2024.

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, “SOL, Mouthwash, zero alcohol, frosty mint” and “Oriox, Cool Breath, ORAL RINSE, Mild mint,” are unapproved new drugs in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). These products are also 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). These violations are described in more detail below.

We reviewed your April 12, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

CGMP Violations

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 contract manufacture over-the-counter (OTC) drug products such as anticavity mouthwash. You failed to conduct an adequate identity test on each shipment of each lot of components used in the production of your drug products. Additionally, you relied on the certificates of analysis (COA) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics at appropriate intervals.

Glycerin, Propylene Glycol, and (b)(4)

You failed to adequately test each shipment of each lot of glycerin, propylene glycol, and (b)(4) for identity, components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that glycerin, propylene glycol, and (b)(4) are ingredients used in your OTC mouthwash drug products. Identity testing for glycerin and certain other high-risk drug components include a DEG/EG limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.

In your response, you state that you will “take action” to have your customers “ship back” to your firm all OTC drug products exported to the United States (U.S.) market. You also indicated that you notified your customer, label owner (b)(4), to hold its remaining inventory and “explained the required recall procedure.” Furthermore, you provided documents showing that you performed identity testing on your current raw material lots of glycerin, propylene glycol, and (b)(4) for DEG and EG contamination.

Your response is inadequate. Identity testing performed on your current raw materials lots for DEG and EG contamination, failed to address potential impact on all drug product lots distributed to the United States that remain within expiry that were manufactured with untested components.

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 response to this letter, provide 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 component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (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.

2. 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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:

  • Adequate procedures describing roles and responsibilities of the QU, including the handling of vendor qualification, batch release, and complaints (21 CFR 211.22(a) and 211.22(d)).
  • Establishment of a 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)).
  • Adequate laboratory controls and specifications (21 CFR 211.160(b)).
  • Adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)).
  • Batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).

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:

    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.

3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Your laboratory records lacked complete and trustworthy data to support the analyses performed.
For example:

  • Our investigators observed original data (e.g., pH test records) discarded in the trash located in your in-process laboratory. A review of the discarded pH test records found discrepancies between the test dates, pH calibration data, and the final test report. Additionally, a discarded worksheet with test data (e.g., pH, specific gravity) was also found in the trash with different dates for testing compared to the reported worksheet.
  • During a walkthrough by the investigator, a full trash bin was observed in the high-performance liquid chromatography (HPLC)/gas chromatography (GC) equipment room of the quality control (QC) laboratory. Upon later returning to the room, the investigator observed that the trash bin was then empty, and then followed QC personnel to the outside dumpster where the employee retrieved the trash bag with discarded test data. The discarded test data included an HPLC assay calculation that failed acceptance criteria, but the reported result was found within specification. No out-of-specification (OOS) investigation was performed. Additionally, raw data for melting point were also found in the trash and did not completely match the data recorded.
  • Upon request to review the electronic raw data for your assay test results generated for drug products distributed to the U.S. market, your plant manager indicated the data was lost. In addition, you could not provide the microbiological test data for testing reported on your finished drug product COA upon request.

In your response, you acknowledge that your laboratory system lacks appropriate procedures and controls to ensure the integrity of your data. While we acknowledge your commitment to remediate your laboratory system, your response fails to fully consider the gaps and uncertainties in a retrospective review when there is a significant adverse pattern of data that is discarded, lost, or recorded non-contemporaneously. Additionally, your response did not consider plans to assess your manufacturing operation’s documentation system to determine where they are insufficient.

Reliability of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results, or conditions associated with all tests. Furthermore, the lack of reliable data compromises the QU’s ability to exercise its function of ensuring compliance to applicable standards.

Data Integrity Remediation

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We acknowledge that you are using an independent third-party consultant to perform data integrity (DI) training. However, we strongly recommend that you retain an independent third-party qualified consultant to audit your operation and assist in your DI remediation in meeting FDA requirements. In response to this letter, provide:

  • A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:

    o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
    o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
    o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.
    o A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.

  • A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
  • A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:

    o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
    o A comprehensive description of the root causes of your data integrity lapses, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
     o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
    o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.
    o A commitment to have a qualified consultant conduct extensive annual audits, for at least 2 years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
    o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).
    o A status report for any of the above activities already underway or completed.

Unapproved New Drug Violations

“SOL, Mouthwash, zero alcohol, frosty mint” and “Oriox, Cool Breath, ORAL RINSE, Mild mint” products 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.

Examples from the product labels and labeling from the website, www.soloralcare.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) for these products include, but may not be limited to, the following:

SOL, Mouthwash, zero alcohol, frosty mint
    “helps prevent plaque build-up, protects against cavities, fights gum disease…”
    [from product label]

    “Experience a multitude of benefits designed to cater to your oral health needs. Our mouthwash helps prevent plaque build-up, safeguarding your teeth against cavities. It fights gum disease, promoting healthy gums for a confident smile.” [from website www.soloralcare.com]

Oriox, Cool Breath, ORAL RINSE, Mild mint
    “Helps prevent and reduce plaque and gingivitis” [from product label]

    “Active Ingredients                             Purpose
     Allantoin 0.10%.........................................Antigingivitis” [from product label]

Based on the above labeling evidence, the “SOL, Mouthwash, zero alcohol, frosty mint” product is intended for use as both as an anticaries drug product and an antigingivitis/antiplaque drug product;1 your “Oriox, Cool Breath, ORAL RINSE, Mild mint” product is intended for use as an antigingivitis/antiplaque drug product. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug 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 it is lawfully marketed under section 505G of the FD&C Act. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.

SOL, Mouthwash, zero alcohol, frosty mint
Some of the claims excerpted above are for anticaries use, and others are for antigingivitis use. Because it is unclear whether you intend for your product to be used as an anticaries or an antigingivitis/antiplaque oral healthcare drug product, we address both below.

With respect to nonprescription (OTC) anticaries drug products, such products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in an applicable final administrative order. Nonprescription (OTC) anticaries drug products are addressed in the OTC monograph M021: Anticaries Drug Products for OTC Human Use.2 Your “SOL, Mouthwash, zero alcohol, frosty mint” product is not formulated in accordance with M021. Specifically, your product does not include either of the acceptable active ingredients listed in M021 for the reduction or prevention against caries in treatment rinses: sodium fluoride or stannous fluoride.

Antigingivitis/antiplaque oral healthcare drug products for OTC use are also subject to section 505G of the FD&C. Pursuant to section 505G(a)(3),3 these drug products are not required to have an approved application in order to be marketed, as long as they conform to the conditions set forth in the advanced notice of proposed rulemaking (ANPR) entitled “Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph”, 68 FR 32232 (May 29, 2003) (hereinafter “2003 ANPR”), and comply with all other applicable requirements. The “SOL, Mouthwash, zero alcohol, frosty mint” product is not formulated consistent with the conditions in the 2003 ANPR. Specifically, under the 2003 ANPR, an antigingivitis/antiplaque product is formulated with menthol, eucalyptol, methyl salicylate, and thymol in a hydroalcoholic vehicle within the specified concentrations. Your “SOL, Mouthwash, zero alcohol, frosty mint” product is not formulated with methyl salicylate and thymol, nor does it contain alcohol.

Thus, to the extent you intend to market your “SOL, Mouthwash, zero alcohol, frosty mint” as an anticaries product, it does not meet the conditions in the final administrative order for anticaries drug products (OTC000034/M021). To the extent you intend to market this product as an antigingivitis/antiplaque drug product, it does not meet the conditions described in the 2003 ANPR nor with any other final order or proposed rulemaking.4 Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application.

Oriox, Cool Breath, ORAL RINSE, Mild mint
Based on the labeling claims identified above for “Oriox, Cool Breath, ORAL RINSE, Mild mint,” this product is intended for use as antigingivitis/antiplaque oral healthcare drug product. As previously mentioned, antigingivitis/antiplaque oral healthcare drug products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. These drugs are not required to have an approved application under section 505G(a)(3) of the FD&C Act in order to be marketed, as long as they conform to the conditions set forth in the 2003 ANPR, including labeling conditions, and comply with all other applicable requirements.

However, the “Oriox, Cool Breath, ORAL RINSE, Mild mint” product is not formulated consistent with the conditions in the 2003 ANPR. Specifically, the “Oriox Cool Breath ORAL RINSE, Mild mint” product lists allantoin as the active ingredient for the prevention and reduction of dental plaque and gingivitis. Allantoin is not recognized as an acceptable active ingredient, when used in combination or as a sole ingredient, for OTC antigingivitis/antiplaque drug products under the 2003 ANPR.

Thus, as formulated and labeled, the “Oriox, Cool Breath, ORAL RINSE, Mild mint” oral healthcare drug product does not meet the conditions described in the 2003 ANPR for Antigingivitis/Antiplaque Drug Products nor any other final order or proposed rulemaking.4 Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application.

Therefore, as described above, both “SOL, Mouthwash, zero alcohol, frosty mint” and “Oriox, Cool Breath, ORAL RINSE, Mild mint” are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Because there is no approved application in effect for these products, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

The introduction or delivery for introduction of these unapproved new drug products 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, the oral healthcare products, “SOL, Mouthwash, zero alcohol, frosty mint” and “Oriox, Cool Breath, ORAL RINSE, Mild mint” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products 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.

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).

Disparities in Records Submitted to the Agency

FDA placed your firm on Import Alert 66-40 on May 3, 2023, as information you provided in your response to an FDA request for records pursuant to section 704(a)(4) of the FD&C Act, 21 U.S.C. 374(a)(4), did not appear to conform to CGMP. Specifically, your response to the FDA records request demonstrated a lack of identity testing for each shipment of each lot of incoming components at high-risk of DEG or EG contamination, as required under 21 CFR 211.84(d)(1). Subsequent to your placement on Import Alert, you submitted additional data to the agency that included DEG and EG test results purported to be for drug products you distributed to the United States. Additionally, you committed to perform identity testing on your components at high-risk for DEG and EG contamination.

To evaluate the records provided and commitment to identity testing, and in part to evaluate if your firm should be removed from import alert, FDA conducted an inspection of your facility. However, upon physical inspection of your facility, the test data related to your submitted test results could not be identified with any lot distributed to the U.S. market. Furthermore, you failed to conduct identity tests on your components after your written commitment to do so for finished drug products released in February 2024 to the U.S. market. Your firm will remain on import alert until FDA is satisfied that the appearance of violations observed have been resolved.

Repeat Violations at Facility

In a previous warning letter (#320-23-24), dated August 3, 2023, FDA cited similar significant CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

Drug Production Ceased

If you plan to resume any drug manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. Should you resume manufacturing drugs, 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 corrective actions and preventive actions 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.

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.

FDA placed your firm on Import Alert 66-40 on May 3, 2023, after your response to our 704(a)(4) Request for Records sent to you on March 3, 2023, demonstrated CGMP violations related to controls for DEG/EG in high-risk components used in your drugs.

The inspectional findings detailed above further demonstrate your firm’s noncompliance.

Your firm remains on Import Alert 66-40.

Correct any violations promptly. 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 any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at LCC Ltd., 738-13 Samyang-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) and are misbranded under section 502 of the FD&C Act, respectively.

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 3007255059 and ATTN: Bill Fowler.

Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

/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

CC:(b)(4)

_________________________

1 We need not address in this letter whether it is permissible to market a product as both an anticaries and antigingivitis/antiplaque drug product; as discussed below, your SOL, Mouthwash, zero alcohol, frosty mint does not comply with the conditions for marketing either anticaries or antigingivitis/antiplaque products for non-prescription use without an approved new drug application in effect.

2 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs;" notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330 prior to enactment of the CARES Act. In the case of anticaries drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M021: Anticaries Drug Products for OTC Human Use. (See Order ID OTC000034, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)

3 Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category I for safety and effectiveness in an ANPR that is the most recently applicable proposal or determination issued under 21 CFR Part 330 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 ANPR, including labeling conditions, and comply with all other applicable requirements.

4 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that the above referenced oral healthcare products are GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.

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