Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing

By Kalah Auchincloss, Madeleine Giaquinto & Maura Norden

Since enactment of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938, the evolution and technological innovation of cosmetic products in the U.S. market have presented the Food and Drug Administration (FDA) with unique regulatory challenges. These challenges, along with commercial globalization and limited resources and enforcement authorities, created a need for a broader and more modern cosmetics regulatory framework.

To meet this need, in December 2022, Congress enacted and President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as part of the Consolidated Appropriations Act, 2023.^[1] This marked the first major update to FDA’s cosmetics oversight since 1938. MoCRA reforms reflected the challenges of regulating a modern cosmetics industry with increasingly diverse products, including a shift towards greater safety and quality for cosmetics, bringing cosmetics regulation more in line with FDA regulation of other types of regulated products. For example, MoCRA provides FDA with new authorities related to adverse event reporting, good manufacturing practices (GMPs), facility registration and product listing, labeling, recordkeeping, and mandatory recall authority. To implement these requirements, new FDA guidance and regulations for the cosmetics industry are forthcoming.

In that vein, FDA recently released two draft guidances to implement MoCRA, both of which are discussed in this Article.^[2]

I. Key Takeaways from FDA’s New Tattoo Ink Draft Guidance

In June 2023, FDA announced the availability of Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination (“Tattoo Ink Draft Guidance”).^[3] When finalized, the guidance will represent FDA’s current thinking on “insanitary conditions of tattoo ink preparation, packaging, or holding that may render the inks injurious to health because of microbial contamination.”^[4]

FDA regulates tattoo inks as cosmetics under the FDCA. The FDCA defines “cosmetic” by reference to a product’s intended use(s). The term “cosmetic” means “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance . . . .”^[5] Tattoo inks are cosmetics because they are articles intended to be introduced into or otherwise applied to the human body for beautifying, promoting attractiveness, or altering the appearance.^[6]

The FDCA prohibits the introduction of an adulterated cosmetic into interstate commerce.^[7] Under the FDCA, a cosmetic is deemed to be adulterated if it “has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”^[8] FDA issued the Tattoo Ink Draft Guidance to assist tattoo ink manufacturers and distributors in identifying situations in which a tattoo ink may become contaminated and potentially injurious to health, thus resulting in the adulteration of the tattoo ink.

While the draft guidance is intended for tattoo ink manufacturers and distributors, the cosmetic industry at large can benefit from reviewing the draft guidance. Key takeaways in the draft guidance for the larger cosmetic industry are discussed in more detail below.

FDA Is Preparing to Implement New Regulatory Requirements Applicable to Cosmetics Established by MoCRA

Issuing the Tattoo Ink Draft Guidance is among the first actions that FDA has taken to implement its new regulatory authorities under MoCRA. Indeed, FDA stated in the Tattoo Ink Draft Guidance that it “intend[s] to conduct rulemaking to establish good manufacturing practice regulations as part of the implementation of [MoCRA], which requires FDA to establish good manufacturing practice regulations that, to the extent practicable and appropriate, are consistent with national and international standards.”^[9] FDA also held a public meeting in June 2023 to receive input from stakeholders on topics related to cosmetic GMPs.^[10] In addition, FDA recently issued Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (“Cosmetic Registration & Listing Draft Guidance”), which “provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.”^[11]

As FDA’s recent guidance documents and its commitment to conduct rulemaking indicate, the agency has begun transitioning the cosmetic industry from a period of voluntary compliance, with regulatory controls designed to ensure the safety and quality of cosmetic products, to an era of mandatory compliance under the framework established by MoCRA.

FDA Is Still Attempting to Clearly Distinguish Between the Definitions of “Cosmetic,” “Drug,” and “Device”

Historically, FDA has struggled to draw a clear line between cosmetic and drug/device claims. This effort remains evident in the Tattoo Ink Draft Guidance.

The FDCA defines “cosmetic,” “drug,” and “device” by reference to the product’s intended use(s).^[12]

• As previously stated, “[t]he term ‘cosmetic’ means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance . . . .”^[13]
• “The term ‘drug’ means . . . articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . ; and . . . articles (other than food) intended to affect the structure or any function of the body of man . . . .”^[14]
• “The term ‘device’ . . . means an instrument, . . . implement, . . . or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man . . . , or . . . intended to affect the structure or any function of the body of man . . . .”^[15]

Because the regulatory requirements for cosmetics vary considerably from those for drugs and devices, accurately distinguishing between claims that reflect the intended use of a “cosmetic” versus a “drug” or “device” is critical.^[16] For example, cosmetics and cosmetic ingredients—with the exception of color additives—do not require FDA review or approval prior to marketing. In contrast, cosmetics marketed with drug or device claims are considered to be drugs or devices and may require approval or clearance prior to commercialization. However, the line between a “beautifying” (cosmetic) claim and a “therapeutic” or “structure/function” (drug or device) claim can often be ambiguous, given that many beautifying products affect the body to some extent.

To clarify this distinction, FDA has previously suggested that “products that are represented to have only ‘physical’ effects on the skin are cosmetics, while those for which a ‘physiological’ effect is asserted are drugs.”^[17] FDA has interpreted “physical” effects as “mechanical” changes that “cover” the skin (e.g., makeup) or affect “the outermost layers of the skin” (e.g., by softening or moisturizing).^[18] FDA has interpreted “physiological” effects as those which cause biochemical or deep-tissue changes, or which “influence the functioning of cells.”^[19]

In the Tattoo Ink Draft Guidance, however, FDA did not follow this approach. The Tattoo Ink Draft Guidance treats tattoo inks as a cosmetic, despite FDA historically treating such products as drugs and devices due to their deep insertion in the skin below the epidermis (affecting more than the outermost layers). Moreover, the Tattoo Ink Draft Guidance also contradicted FDA’s relatively recent application of this approach as set forth in Guidance for Industry and FDA Staff: Regulatory Considerations for Microneedling Products (“Microneedling Guidance”).^[20] Table 1 below compares the differing approaches in the Tattoo Ink Draft Guidance and Microneedling Guidance.

Table 1.

Tattoo Ink Draft Guidance

Microneedling Guidance

·       “Tattoo inks bypass the body’s primary physical barrier against pathogens, because they are inserted below the epidermis.”[21] ·       “Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis . . . .”[22]

“FDA considers claims or statements that indicate penetration or some effect beyond the stratum corneum into living layers of skin by such products to be evidence of a firm’s intent to affect the structure or function of the body. The stratum corneum is a dead layer of skin that is naturally shed through the desquamation process. Therefore, claims or statements regarding the removal of the stratum corneum are not considered an intent to affect the structure or function of the body. In contrast, explicitly or implicitly claiming or stating that a microneedling product penetrates living layers of skin (e.g., epidermis and dermis) would be considered an intent to affect the structure or function of the body.”[23]

Thus, the approach in the Tattoo Ink Draft Guidance is inconsistent with FDA’s approach in the Microneedling Guidance because the tattoo inks are injected well below the stratum corneum. According to the Microneedling Guidance, penetration beyond the stratum corneum would cause a product to be a drug or device.

II. Key Takeaways from Registration & Listing Draft Guidance

As discussed above, under MoCRA, certain owners and operators of facilities engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must now register their facilities (FDCA § 607(a)) and list their products (FDCA § 607(c)) (“Section 607 Requirements”). To help facilitate implementation of these requirements, FDA recently issued Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (“Cosmetic Registration & Listing Draft Guidance”).^[24]

The Cosmetic Registration & Listing Draft Guidance outlines elements of the Section 607 Requirements, including descriptions of who must register and list their products, what information must be submitted as part of registration and listing, and when registration and listing submissions must be made. The Cosmetic Registration & Listing Draft Guidance also provides information about how submissions can be made, whether combination drug/cosmetic products are subject to Section 607 Requirements, and the extent to which registration and listing information may be publicly disclosed. The comment period for initial feedback on the Registration & Listing Draft Guidance closed on September 7, 2023, but cosmetics industry stakeholders should remain engaged and look for future opportunities to provide input.^[25]

Registration & Listing Elements Look Familiar; They Are Not Dissimilar from the Now-Discontinued Voluntary Cosmetic Registration Program (VCRP)

As part of its development of the new registration and listing system, FDA ended the former Voluntary Cosmetics Registration Program (VCRP) earlier this year.^[26] The Cosmetic Registration & Listing Draft Guidance notes that information in the VCRP will not be transferred into the new system, and previous submissions will not satisfy the new Section 607 Requirements.^[27]

The VCRP was a voluntary program implemented via regulations found at 21 C.F.R. Parts 710 and 720. The new Cosmetic Registration & Listing Draft Guidance provides more detail than parts 710 and 720, but those who are familiar with the VCRP will notice similarities to the new, mandatory program and should not have trouble meeting the required registration and listing requirements.

Who Must Register and List

The Registration & Listing Draft Guidance adopts statutory definitions of terms relevant to Section 607 Requirements^[28] (i.e., “cosmetic product,”^[29] definitions for “facility,”^[30] “responsible person,”^[31] and “small businesses”^[32]), but also sets forth new definitions^[33] for several terms/phrases not defined by the statute (i.e., “contract manufacturer,” “manufacturing or processing of a cosmetic product,” and “DUNS number”).

Generally, every person that owns or operates a facility engaged in the manufacturing or processing of a cosmetic product must register with FDA, pursuant to Section 607(a)(1). The Cosmetic Registration & Listing Draft Guidance defines cosmetic manufacturing or processing as “engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.”^[34] An entity that “solely performs” (re)labeling, (re)packaging, holding, and/or distributing of cosmetics,^[35] is excluded from the statutory definition of facility, and from the registration requirements restated in the draft guidance. “Packaging” and “repackaging” do not, however, include filling a product container, and thus, product filling would necessitate facility registration.^[36] Additionally, beauty shops, salons, and retailers are excluded from the statutory definition of facility, and do not need to register with FDA unless they also manufacture or process a cosmetic product.^[37]

With respect to a contract manufacturer’s obligation to register their facility, the Cosmetic Registration & Listing Draft Guidance notes (consistent with the statute) that only a single registration is required per facility, even for those that manufacture cosmetic products for more than one responsible person and/or those that manufacture cosmetic products of their own.^[38] Alternatively, a responsible person whose products are manufactured or processed at a contract manufacturing facility may also submit the facility registration on behalf of that facility, alleviating the contract manufacturer’s need to register their own facility. In other words, either the contract manufacturer or the responsible person (i.e., the entity whose name appears on the product label) must register a single manufacturing facility, but not both.^[39]

For product listing, the responsible person must submit the required information, pursuant to Section 607(c)(1). As defined in Section 604(4), the responsible person is the manufacturer, packer, or distributor whose name is on the label of the product.^[40] Additionally, certain small businesses, as defined in Section 612(b), are not required to register facilities and list cosmetic products.^[41] However, four exceptions to this exemption may apply, depending on the nature of the cosmetic product.^[42]

What Information Must Be Submitted

The first step in a facility’s registration submission process involves obtaining a facility registration number (i.e., the FDA Establishment Identifier (FEI)).^[43] Facility owners or operators can request a new FEI number, or determine whether a facility has an existing FEI number through the “FEI Search Portal”^[44] available on FDA’s website. Once they obtain an FEI number, facility owners must provide FDA with the following data as part of a registration submission, pursuant to Section 607(b)(2) and as outlined in the Cosmetic Registration & Listing Draft Guidance:^[45]

• Name of the owner and/or operator of the facility;
• Facility’s name, physical address, email, telephone number (for foreign facilities, the contact information for the U.S. agent);
• FEI number;
• All brand names of cosmetic products manufactured or processed at the facility;
• Applicable cosmetic category;^[46] and
• Type of submission being made (i.e., initial registration, content update (annual), or abbreviated renewal).

The Cosmetic Registration & Listing Draft Guidance also restates language from the statute as to the data that must be included in a product listing submission, including:^[47]

• All relevant FEI numbers (i.e., facilities where the responsible person’s cosmetic products are manufactured or processed);
• Name and contact information of the responsible person;
• Name of the cosmetic product as it appears on the label;
• Applicable cosmetic category;
• List of ingredients in the cosmetic product (including fragrances, flavors, or colors);
• Product listing number (if any) assigned by FDA; and
• Type of submission being made (i.e., initial, content update, or abbreviated renewal).

Although Section 607 requires that the “applicable cosmetic category” be included in both registration and listing submissions, the statute does not describe more precisely what those categories are. In the Cosmetic Registration & Listing Draft Guidance, FDA has developed an initial list of various cosmetic product categories, included in Appendix A.^[48] The appendix includes many recognizable categories of cosmetic products, such as lotions, sprays, oils, and serums, but also contains other less standard products, such as “nail extenders.”^[49]

Significantly, the system for categorizing types of cosmetic products laid out in Appendix A is similar to the system that FDA’s Center for Devices and Radiological Health (CDRH) now uses for organizing various device types—medical device classification product codes.^[50] FDA likely will use these cosmetic categories for some of the same purposes for which it uses device product codes. CDRH has explained that it uses product codes “to obtain quality and reliable data, and perform analyses that are often reported to Congress, the Government Accountability Office (GAO), the general public, the media, and industry.”^[51] Device product codes also have several other important uses, including tracking medical device adverse event reports, imports and exports, and recalls.^[52] Therefore, aside from purposes related to registration and listing, FDA could use cosmetic product categories for many of the same reasons, including tracking adverse event reporting, imports/exports, and recalls. Given the many possible uses for these cosmetic product categories, industry feedback on them will be essential to ensuring that the organizational system for cosmetics is appropriate and effective. FDA seems to recognize the importance of this feedback and specifically requested comments on these product categories.^[53]

Through the Cosmetic Registration & Listing Draft Guidance, FDA also requests various optional data be submitted as part of registration and listing submissions, beyond what is required under Section 607 Requirements.^[54] These items include the parent company name, the facility Data Universal Numbering System (DUNS) Number, Unique Ingredient Identifiers (UNIIs), and any additional contact information relevant to the specific submission, among others.^[55]

When Must Registration and Listing Submissions Occur

The statutory deadline for fulfilling Section 607 Requirements is December 29, 2023; this applies to owners and operators of facilities engaged in the manufacturing or processing of cosmetic products prior to December 29, 2022,^[56] and to responsible persons engaged in the marketing of cosmetic products prior to December 29, 2022.^[57] However, in November 2023, FDA announced in Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“Cosmetic Registration & Listing Compliance Policy”) that it would delay enforcement of Section 607 Requirements for six months, or until July 1, 2024.^[58] This delayed enforcement also applies to owners and operators of facilities engaged in manufacturing or processing of cosmetic products after December 29, 2022, as well as for responsible persons engaged in the marketing of cosmetic products after December 29, 2022; they too now have until July 1, 2024 to meet registration and listing requirements.^[59]

The Cosmetic Registration & Listing Draft Guidance also describes timing requirements, consistent with those in Section 607, for submitting amended facility registration information (i.e., within 60 days of a change), as well as updated listing information (i.e., annually).^[60] Distinct from the statute, the draft guidance recommends that submissions involving updated information include changes resulting in a registration cancellation or a discontinued product.^[61] For purposes of renewals, the draft guidance again adheres to the statutory language and calls for facilities to renew their registration with FDA on a biennial basis (i.e., every two years), even if registration information remains unchanged since their most recent past submission (FDA intends to provide an abbreviated renewal registration submission option for unchanged renewals).^[62]

The Draft Guidance Continues to Emphasize That the Cosmetic Registration & Listing Requirements Do Not Apply to Cosmetic Products That Are Also Drugs

The Cosmetic Registration & Listing Draft Guidance notes that Section 607 Requirements do not apply to cosmetic products that are also drugs, nor do they apply to the facilities that manufacture such products (unless the facility also manufactures or processes a product that is solely a cosmetic).^[63] This is partly consistent with Section 613 of the FDCA, which states that “a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from” Section 607 Requirements.^[64]

Interestingly, subchapter V in the statute sets forth regulatory requirements applicable to both drugs and devices, indicating that “a cosmetic product or facility that is also subject to the requirements” applicable to drugs or devices “shall be exempt from” Section 607. However, the Cosmetic Registration & Listing Draft Guidance only mentions drugs, stating that certain requirements do not apply to cosmetic products that are also drugs.^[65] That being said, this may be an area where clarity is needed as to FDA’s expectations with respect to registration and listing exemptions for cosmetics that are also devices.

In addition, the same electronic submission process used to register an establishment and list a drug will be available for cosmetic facility registration and product listing. The consistency between these processes is intended to streamline the submission of registration and listing information for cosmetics facilities and products for entities that also submit drug establishment and listing information.^[66]

FDA is developing an electronic portal for submitting cosmetic facility registration and product listing information, called Cosmetics Direct.^[67] Additionally, pursuant to the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, cosmetics facility registrations and product listings are now included within the SPL framework, and Cosmetics Direct will be an FDA-provided SPL authoring tool.^[68] The Cosmetic Registration & Listing Draft Guidance notes that a paper form (i.e., Forms FDA 5066 and 5067)^[69] will also be accepted as an alternative submission method; however, FDA is “strongly” encouraging electronic submissions for more efficient data management.^[70] Both submission tools (i.e., use of the electronic portal and the paper form) will be accessible on FDA’s webpage once developed.^[71]

Limited Disclosure of Cosmetic Registration & Listing Information

The Cosmetic Registration & Listing Draft Guidance notes that FDA will only publicly disclose cosmetic product facility registration and listing information to the extent permitted by law.^[72] Pursuant to Section 607(d), product listing numbers will not be made available for public disclosure.^[73] Additionally, pursuant to Section 607(e), brand names from facility registration submissions or facility registration numbers from product listing submissions will not be made available in response to requests made under the Freedom of Information Act, 5 U.S.C. § 552.^[74]

Conclusion

Both the Tattoo Ink Draft Guidance and the Cosmetic Registration & Listing Draft Guidance are important for members of the cosmetics industry. The draft guidances indicate that FDA is on its way to implementing MoCRA. Therefore, cosmetics industry stakeholders should take full advantage of the comment process for the draft guidances, as well as future public meetings and commenting opportunities, to ensure their valuable input is considered during FDA’s implementation efforts.

In addition, although the modern regulatory framework for cosmetic products is in its infancy, the Cosmetic Registration & Listing Draft Guidance demonstrates how the new cosmetic regulatory framework draws from existing regulatory concepts and requirements (like facility registration and product listing) that exist for drugs and devices. Thus, in addition to paying attention to what already exists for cosmetics (e.g., the VCRP), the cosmetics industry could also benefit from close review of regulatory frameworks for drugs and devices for more clues as to how FDA may implement MoCRA.

Finally, the Tattoo Ink Draft Guidance shows how MoCRA has not fixed all problems with respect to regulation of cosmetic products. The jurisdictional ambiguity related to distinguishing a drug or device from a cosmetic has been a long-standing issue for FDA, and the Tattoo Ink Draft Guidance further demonstrates that clearly distinguishing between cosmetics and drugs/devices remains challenging.

 

 

[1] See Consolidated Appropriations Act, 2023, Pub. L. No. 117-328, §§ 3501–3508 (2022).

[2] This Article was finalized in November 2023 and does not include FDA policy updates or announcements that have occurred since then.

[3] Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination (June 2023), https://www.fda.gov/media/169265/download [hereinafter Tattoo Ink Draft Guidance]; 88 Fed. Reg. 38,516–18 (June 13, 2023).

[4] 88 Fed. Reg. at 38,516.

[5] FDCA § 201(i), 21 U.S.C. § 321(i) (emphasis added).

[6] See Tattoo Ink Draft Guidance, supra note 3, at 3.

[7] FDCA § 301(a), 21 U.S.C. § 331(a).

[8] FDCA § 601(c), 21 U.S.C. § 361(c).

[9] Tattoo Ink Draft Guidance, supra note 3, at 7.

[10] Public Meeting: Good Manufacturing Practices for Cosmetic Products, June 1, 2023, https://www.fda.gov/cosmetics/cosmetics-news-events/public-meeting-good-manufacturing-practices-cosmetic-products-06012023; see also Docket No. FDA-2023-N-1466. 

[11] Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products at 3 (Aug. 2023), https://www.fda.gov/media/170732/download.

[12] “Intended use” may be inferred from a manufacturer’s promotional claims. Specifically, “FDA may consider, among other things, any written or oral claims or statements in any label, labeling, advertising, and/or promotion of a . . . product by or on behalf of a firm in determining whether a . . . product is intended to cure, mitigate, treat or prevent disease or affect the structure or function of the body.” Guidance for Industry and FDA Staff: Regulatory Considerations for Microneedling Products at 7 (Nov. 10, 2020), https://www.fda.gov/media/107708/download [hereinafter Microneedling Guidance].

[13] FDCA § 201(i), 21 U.S.C. § 321(i) (emphasis added).

[14] FDCA § 201(g)(1), 21 U.S.C. § 321(g)(1) (emphasis added).

[15] FDCA § 201(h)(1), 21 U.S.C. § 321(h)(1) (emphasis added).

[16] See also Compliance Program Guidance Manual § 7329.001, “Cosmetics Program; Import and Domestic,” https://www.fda.gov/media/78441/download.

[17] E.g., FDA, Cosmetic Labeling Guide (Oct. 1991) (“one may say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body”).

[18] Letter from Cosmetics Manufacturers to John M. Taylor, Associate Commissioner for Regulatory Affairs at 3–4 (Sept. 11, 1987) (describing FDA’s interpretation of the distinction).

[19] Id.

[20] Microneedling Guidance, supra note 12, at 7–8.

[21] Tattoo Ink Draft Guidance, supra note 3, at 5.

[22] Id. at 4.

[23] Microneedling Guidance, supra note 12, at 7.

[24] Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (Aug. 2023), https://www.fda.gov/media/170732/download [hereinafter Cosmetic Registration & Listing Draft Guidance].

[25] 88 Fed. Reg. 53,490–92 (Aug. 8, 2023), https://www.federalregister.gov/documents/2023/08/08/2023-16771/registration-and-listing-of-cosmetic-product-facilities-and-products-draft-guidance-for-industry. Although the comment period has closed, an interested party can submit comments at any time. See 21 C.F.R. § 10.115(g)(5). To ensure that FDA considers comments on a draft guidance before it begins work on the final version, it is best practice to submit comments before the comment period closes.

[26] Constituent Update: FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (Mar. 27, 2023), https://www.fda.gov/food/cfsan-constituent-updates/fda-has-stopped-accepting-submissions-voluntary-cosmetic-registration-program-vcrp.

[27] See Cosmetic Registration & Listing Draft Guidance, supra note 24, at 4.

[28] See id. at 4–6.

[29] FDCA § 604(2), 21 U.S.C. § 364(2); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 5.

[30] FDCA § 604(3), 21 U.S.C. § 364(3); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 5.

[31] FDCA § 604(4), 21 U.S.C. § 364(4); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[32] FDCA § 612(b), 21 U.S.C. § 364h(b); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[33] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 4–6.

[34] Id. at 6.

[35] FDCA § 604(3)(B)(viii), 21 U.S.C. § 364(3)(B)(viii); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 5.

[36] FDCA § 604(3)(C), 21 U.S.C. § 364(3)(C); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[37] FDCA § 604(3)(B), 21 U.S.C. § 364(3)(B); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[38] FDCA § 607(a)(3), 21 U.S.C. § 364c(a)(3); Cosmetic Registration & Product Listing Draft Guidance, supra note 24, at 7.

[39] Id.

[40] See also Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[41] Id.

[42] FDCA § 612(b), 21 U.S.C. § 364h(b); see also Cosmetic Registration & Listing Draft Guidance, supra note 24, at 6.

[43] See Cosmetic Registration & Listing Draft Guidance, supra note 24, at 8, fn 3.

[44] FEI Search Portal, https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login.

[45] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 8.

[46] See id. at 12–15.

[47] FDCA § 607(c)(4)(A), 21 U.S.C. § 364c(c)(4)(A); Cosmetic Registration & Listing Draft Guidance, supra note 24, at 8–9.

[48] Id.

[49] Id.

[50] See Guidance for Industry and FDA Staff: Medical Device Classification Codes (Apr. 11, 2013), https://www.fda.gov/media/82781/download [hereinafter Medical Device Classification Codes Guidance]; see also FDA Product Code Classification Database, https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database.

[51] Medical Device Classification Codes Guidance, supra note 50.

[52] Id.

[53] See Cosmetic Registration & Listing Draft Guidance, supra note 24, at 12, fn 6.

[54] See id. at 8–9.

[55] The Data Universal Numbering System (DUNS) number is a unique, site-specific identification number assigned to a facility’s physical location. The UNIIs are generated based on scientific identity characteristics in accordance with ISO 11238 and can be searched through FDA’s UNIIs search service, Global Substance Registration System (GSRS). See FDA’s GSRS, https://precision.fda.gov/uniisearch.

[56] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 10; see also FDCA § 607(a)(1)(A), 21 U.S.C. § 364c(a)(1)(A).

[57] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 11; see also FDCA § 607(c)(2)(B), 21 U.S.C. § 364c(c)(2)(B).

[58] Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Nov. 2023), https://www.fda.gov/media/173606/download; 88 Fed. Reg. 77,323–24 (Nov. 9, 2023).

[59] Cosmetic Registration & Listing Compliance Policy, supra note 24, at 4.

[60] See Cosmetic Registration & Listing Draft Guidance, supra note 24, at 10–11; see also FDCA § 607(a)(4) & (c)(5), 21 U.S.C. § 364c(a)(4) & (c)(5).

[61] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 10–11.

[62] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 10; see also FDCA § 607(a)(2), 21 U.S.C. § 364c(a)(2).

[63] See Cosmetic Registration & Listing Draft Guidance, supra note 24, at 11; see also FDCA § 613, 21 U.S.C. § 364i.

[64] FDCA § 613, 21 U.S.C. § 364; see also 21 U.S.C. §§ 351–360fff-8.

[65] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 11.

[66] Id.

[67] In September 2023, FDA requested comments on its newly developed draft electronic submission portal (Cosmetics Direct) along with paper forms (Forms FDA 5066 and 5067). See 88 Fed. Reg. 63,960–63 (Sept. 18, 2023), https://www.federalregister.gov/documents/2023/09/18/2023-20139/agency-information-collection-activities-submission-for-office-of-management-and-budget-review; see also Draft Cosmetics Direct: Electronic Submissions Portal Screenshots for Commenting (Sept. 2023), https://www.fda.gov/media/171557/download?attachment.

[68] See Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (Oct. 2023), https://www.fda.gov/media/84201/download?attachment; see also Cosmetics Constituent Update: FDA Issues Update on Cosmetic Product Facility Registration and Cosmetic Product Listing (Nov. 2023), https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-update-cosmetic-product-facility-registration-and-cosmetic-product-listing?utm_medium=email&utm_source=govdelivery.

[69] See 88 Fed. Reg. 63,961.

[70] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 4.

[71] Id. at 10.

[72] See id. at 9.

[73] Id.; see also FDCA § 607(d), 21 U.S.C. § 364c(d).

[74] Cosmetic Registration & Listing Draft Guidance, supra note 24, at 9; see also FDCA § 607(e), 21 U.S.C. § 364c(e).