WARNING LETTER
Aqualex Co., Ltd.
MARCS-CMS 672292 —
June 12, 2024
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Gee Ho Jang
Recipient Title
CEO
Aqualex Co., Ltd.
RM 203, 27, Dunchon-Daero 457beon-Gil
Jungwon-gu
Seongnam-si
Gyeonggi-do
13219
South Korea
jangnoru@aqualex.co.kr
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Warning Letter
320-24-42
June 12, 2024
Dear Mr. Gee Ho Jang:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aqualex Co., Ltd., FEI 3010683345, at RM 203, 27, Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea, from October 16 to 20, 2023.
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 product is 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, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under sections 502(a), 502(b), 502(e), and 502(ee) of the FD&C Act, 21 U.S.C. 352(a), 352(b), 352(e), and 352(ee), respectively. Introduction or delivery for introduction of such product 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 November 9, 2023 response to our Form FDA 483 in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. 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)).
Your firm contract manufactures over-the-counter (OTC) sun protection factor (SPF) ultraviolet (UV) sunscreen protection drug product.
You failed to provide data to demonstrate that you have adequately validated your manufacturing processes used to manufacture your OTC drug product and to demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality. Specifically, you failed to provide evidence for the qualification of manufacturing equipment (e.g., tanks,
(b)(4)
, etc.).
In your response, you state that you plan to perform several corrective action and preventive action (CAPA) including establishing a procedure for qualifying your manufacturing equipment. Your response is inadequate as you did not assess the impact of unqualified equipment on the quality of drug products that you manufactured and commercially distributed to the U.S market. Additionally, you did not provide a detailed plan or supporting evidence (e.g., procedures and protocols) for validating your equipment or manufacturing processes.
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.
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 (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
• A timeline for performing appropriate PPQ for each of your marketed drug products.
• Include your process performance protocol(s), and written procedures for qualification of equipment and facilities.
2. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
Your firm uses
(b)(4)
water as a component to manufacture your OTC drug product. You failed to adequately design your
(b)(4)
water system to ensure that it was suitable for producing water used in the formulation of your drug product. For example, your
(b)(4)
water system has points of stagnant water (e.g., a dead-leg), including one located at a point-of-use in the production area. Stagnant water can foster the development of biofilms.
In your response, you state that you plan to implement a
(b)(4)
of the water system before production. Your response is inadequate. It did not demonstrate that your water system is of adequate design, control, maintenance, and monitoring, to consistently produce water suitable for its intended use as a component in your drug product. Your response also did not assess the impact of your inadequate water system design on the quality of the drug product you manufacture.
The
(b)(4)
Water System must be adequately designed and properly maintained to minimize and/or eliminate the potential for contamination.
(b)(4)
water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.
In response to this letter, provide:
• A comprehensive remediation plan for the design, control, and maintenance of the water system.
o Validation report for the water system obtained after all identified design issues have been fully corrected and any maintenance repairs have been completed (such as the modifications required to remove all dead-legs). Include the system validation protocol, the complete test results, and the final validation report.
• 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
(b)(4)
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.
3. 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) failed to ensure adequate control over CGMP records. For example, your QU failed to ensure there are adequate controls in place to assure that changes to CGMP records can be made only by authorized personnel, as employees were able to freely print out and discard documents without adequate QU or reconciliation. Our investigator also observed multiple original records (e.g., checklists associated with temperature and differential pressure monitoring) in a container marked for shredding.
Additionally, your QU does not adequately ensure the accuracy and integrity of data to support the quality of the drugs you manufacture. Notably, your laboratory employees indicated that laboratory data is routinely recorded on temporary records, and discarded, after later transcribing the data onto a final laboratory record.
In your response, you state that you will implement document controls and provide training to ensure activities are contemporaneously recorded. Your response is inadequate because it did not provide sufficient details to describe the process for managing and verifying that records are original, complete, and accurate, and you did not address the impact of inadequate document controls on the quality of your drug product.
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.
Your QU must review all the raw data generated during each test and all the completed laboratory control records when making batch release.
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.
o Also describe how top management supports quality assurance and reliable operations, including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
• A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
4. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b))
You failed to perform adequate release testing for each batch of your drug product prior to distribution. For example, your firm released multiple batches of your OTC SPF sunscreen drug product to the U.S. market without performing growth promotion testing on the media used for finished product (e.g.
(b)(4)
) total microbial count testing in accordance with USP monograph requirements. Furthermore, you failed to perform growth promotion testing on the media used for
(b)(4)
water (e.g.
(b)(4)
) and you failed to validate the test method for the determination of total microbial count in your
(b)(4)
water samples.
Your response indicates you will verify the suppliers’ certificate of analysis (COA) and rely upon their results for use. Your response is inadequate because you did not commit to perform growth promotion testing for each lot of media received. Growth promotion testing assures your ready-to-use microbiological media is suitable for determining the quality of
(b)(4)
water.
Drug product batches must be tested for identity, strength, quality, and purity prior to release. Testing is an essential part of ensuring the drug products you manufacture conform to all pre-determined quality attributes and are appropriate for their intended use, including microbiological specifications. Without adequate testing, you lack basic data to support that each drug product batch conforms to appropriate specifications before release.
In response to this letter, provide:
• A list of chemical and microbiological test specifications, including test methods, used to analyze each batch of your drug products before a lot disposition decision.
o 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.
o 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.
• 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.
5. Your firm failed to establish and follow an adequate 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)).
You did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their assigned shelf-life. For example, there was no data available from long-term storage conditions (at 25°C, 60% relative humidity) to support the labeled 3-year expiry.
Your response indicates you will implement a written testing program to assess the stability characteristics of your drug product. However, you indicate that the stability test sample to be utilized will be bulk drug in a container closure that is not the same as or simulates the packaging proposed for distribution. Your response is inadequate as you did not demonstrate or provide scientific rationale that the proposed bulk container would be representative of the container closure system in distribution.
In response to this letter, provide:
• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
o Stability-indicating methods.
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.
o Detailed definition of the specific attributes to be tested at each station (timepoint).
o All procedures that describe these and other elements of your remediated stability program.
Products Containing Glycerin
You manufacture a drug that contains glycerin. The use of ingredients contaminated with diethylene glycol (DEG), or ethylene glycol (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.
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 if your firm intends to resume manufacturing drugs for the U.S. market. 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.
Unapproved New Drug Violations
“DBH Beverly Hills, EGF FGF DNA, UV Shield” 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 “DBH Beverly Hills, EGF FGF DNA, UV Shield” product label and labeling,
1
including the website product page at www.dermaestheticsusa.com (URL printed on the label),
2
that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but are not limited to, the following:
“DBH Beverly Hills, EGF FGF DNA, UV Shield . . . UVA UVB Sunscreen Protection . . .
DRUG FACTS . . . Uses
-Helps prevent sunburn – If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun . . .” [from the product label]
“New Advanced Formula with EFG, FGF, and DNA growth factors – active anti-aging peptides to help repair sun damage!” [from the website https://dermaestheticsusa.com/collections/best-sellers/products/uv-shield-dna-egf-fgf]
“WHY JUST PROTECT WHEN YOU CAN CORRECT AT THE SAME TIME? . . . the UV Shield: EFG FGF DNA sun protection is formulated with epidermal growth factors (EGF) for multi-active defense against aging and cell damage, Fibroblast Growth Factors (FGF) for multi-chain amino acid and nutrient delivery throughout the skin layers, and Sodium Deoxyribonucleic acid (DNA) for cell recovery and rehabilitation. . . .” [from the website https://dermaestheticsusa.com/collections/best-sellers/products/uv-shield-dna-egf-fgf]
“BREAKTHROUGH INGREDIENTS . . . Cell Renewal – Sh-Oligopeptide-1 (EFG), Advanced defense against aging and cell damage . . . Cell Growth – Sr-Rainbow Trout Oligopeptide-1 (FGF), Multi-chain amino acids for deeper nutrient delivery . . . Cell Health – Sodium Deoxyribonucleic Acid (DNA), Boost cellular recovery and rehabilitation” [from the website https://dermaestheticsusa.com/collections/best-sellers/products/uv-shield-dna-egf-fgf]
Based on the above labeling claims, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is intended for use as an OTC sunscreen drug product. As described below, 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).
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; and in general, 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product identified above.
The “DBH Beverly Hills, EGF FGF DNA, UV Shield” product is a sunscreen drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. With respect to OTC sunscreen drug products, such products are deemed to be GRASE and not a new drug if, among other things, they conform to the conditions of use specified in the Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter referred to as “M020” or the “sunscreen drug products monograph”).
3
As described below, the “DBH Beverly Hills, EGF FGF DNA, UV Shield” drug product is an unapproved new drug marketed in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
The active ingredients in “DBH Beverly Hills, EGF FGF DNA, UV Shield” are not consistent with the active ingredients and combinations of active ingredients permitted in sunscreens subject to M020. Specifically, the product labeling for “DBH Beverly Hills, EGF FGF DNA, UV Shield” represents the ingredients, ethylhexyl methoxycinnamate
4
, titanium dioxide, ethylhexyl salicylate
5
, sodium deoxyribonucleic acid (DNA), sh-oligopeptide-1 (EGF – epidermal growth factor), and sh-polypeptide-1 (FGF – fibroblast growth factor), as active ingredients. Under 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Although the product label does not specifically list DNA, EGF, and FGF as active ingredients in the Drug Facts panel for “DBH Beverly Hills, EGF FGF DNA, UV Shield,” the website claims for these specific ingredients, quoted above, for anti-aging treatment of skin and damaged skin cell repair/recovery/rehabilitation, along with the prominent featuring of these substances on the principal display panel of the product label, represent them as “active ingredients” as defined in 21 CFR 201.66(b)(2) because they are intended to furnish pharmacological activity. Neither DNA, EGF, or FGF is a permitted active ingredient in M020.10 or M020.20, alone or in combination.
Further, the “DBH Beverly Hills, EGF FGF DNA, UV Shield” product labeling online includes indications that are not consistent with the permitted indications in the sunscreen drug products monograph. For example, the website claims quoted above for anti-aging treatment of skin and damaged skin cell repair/recovery/rehabilitation do not conform with M020.50(c)(3).
For the reasons described above, “DBH Beverly Hills, EGF FGF DNA, UV Shield” does not comply with M020: Sunscreen Drug Products for Over-the-Counter Human Use, as set forth in final administrative order OTC 000006, nor does it comply with any other final order.
6
Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an FDA-approved application. Thus, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Accordingly, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is an unapproved new drug 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 such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Misbranded Drug Violations
Additionally, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is misbranded under sections 502(a), 502(b), 502(e), and 502(ee) of the FD&C Act, 21 U.S.C. 352(a), 352(b), 352(e), and 352(ee), respectively.
“DBH Beverly Hills, EGF FGF DNA, UV Shield” is misbranded under section 502(a) because its labeling is false or misleading. On the website product page at www.dermaestheticsusa.com, it states that this product is “OCTINOXATE FREE”. Conversely, the product label’s Drug Facts panel lists ethylhexyl cinnamate, otherwise known as octinoxate, as one of its active ingredients. Because the assertions about the composition of this product in these two pieces of its labeling are contradictory, at least one is false or misleading, and makes the drug product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
Moreover, “DBH Beverly Hills, EGF FGF DNA, UV Shield” is misbranded under section 502(e) because the product label does not include the established name for two (2) of the active ingredients listed, ethylhexyl methoxycinnamate and ethylhexyl salicylate. Specifically, 21 CFR 201.66(c)(2) states that the Drug Facts panel must include the established name
7
of each active ingredient(s). However, the product label identifies ethylhexyl methoxycinnamate and ethylhexyl salicylate as active ingredients in the Drug Facts panel. Although ethylhexyl methoxycinnamate and ethylhexyl salicylate are synonyms for octinoxate and octisalate, respectively, these are not the established names of these active ingredients as listed in an official compendium. The United States Pharmacopeia (USP), an official compendium, lists octinoxate
8
and octisalate
9
in its compendium. Because octinoxate and octisalate are the names listed in the USP compendium, they are considered to be the established names for these active ingredients and must be identified as such in the Drug Facts panel in accordance with 21 CFR 201.66(c)(2).
“DBH Beverly Hills, EGF FGF DNA, UV Shield” is also misbranded under section 502(b)(1) because the product label does not contain the name and place of business of the manufacturer, packer, or distributor. The product label collected from your firm only includes the product website, (www.dermaestheticsusa.com).
“DBH Beverly Hills, EGF FGF DNA, UV Shield” is misbranded as well 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).
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 February 9, 2024.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Aqualex Co., Ltd., FEI 3010683345, at RM 203, 27, Dunchon-daero 457beon-gil into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
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 Aqualex Co., Ltd., FEI 3010683345, at RM 203, 27, Dunchon-daero 457beon-gil 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 3010683345 and ATTN: Frank Wackes.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
CC (U.S. Agent via email):
J.S. CHEM INTERNATIONAL CO.
ahn3060@naver.com
CC (U.S. Consignee / Own Label Distributor via email):
Dermaesthetics Beverly Hills Formula of U.S.A. Inc.
Email Contact Information: Ann Lee (Most Responsible) at consult@e-zra.com
Firm customer service: INFO@DERMAESTHETICSUSA.COM
_______________________
1
Referenced as “UV Shield: EGF FGF DNA Sun Protection” on firm’s website product page.
2
This website offers the product for sale in the United States without a prescription.
3
Sections 505G(a)(1) & (2) of the FD&C Act specify criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs.” In the case of sunscreens, the criteria include conformance with “the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.”
Section 505G(a)(1)(A)(i) and 505G(a)(2) of the FD&C Act. Applicable requirements from these documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. (See Order ID OTC000006, available at FDA’s website OTC Monographs @ FDA, https://dps.fda.gov/omuf, ); see also section 505G(m)(2) of the FD&C Act, effects of which are discussed in OTC 000006.
4
For further discussion of the labeling regarding this active ingredient, please see the misbranding violations portion of this letter.
5
For further discussion of the labeling regarding this active ingredient, please see the misbranding violations portion of this letter.
6
FDA is also not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “DBH Beverly Hills, EGF FGF DNA, UV Shield” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.
7
Section 502(e)(3) of the FD&C Act defines “established name” as: (A) the applicable official name designated pursuant to section 508, or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium (C) if neither clause (A) or (B) applies, then the common or usual name, if any, of such drug or of such ingredient. See also 21 CFR 201.66(b)(5).
8
https://online.uspnf.com/uspnf/current-document/1_GUID-5BA0A497-1386-4B81-981B-318235094FA1_5_en- US?source=emailLink&highlight=octinoxate%20
9
https://online.uspnf.com/uspnf/current-document/1_GUID-25E75D2A-5F8F-482A-9DE1-7A3C090C7839_5_en-US?source=emailLink&highlight=octisalate
Content current as of:
06/18/2024
Regulated Product(s)
Drugs