On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested. FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021, which also failed to detect asbestos in any of the 50 cosmetic samples tested for those years. Read the full Alert on Duane Morris’ website.
U.S. House Reps Reintroduce Federal Bill Banning Intentionally Added PFAS in Cosmetics
On November 30, 23, U.S. Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA) and Annie Kuster (D-NH) reintroduced H.R. 6519–the “No PFAS in Cosmetics Act“–which would require the Food and Drug Administration (FDA) to ban use of “intentionally added per- and polyfluoroalkyl substances” (PFAS) in cosmetics.
According to the Environmental Protection Agency, PFAS are a group of long
lasting manufactured chemicals that have been widely used in industry and consumer products since the 1940s because of their useful properties. There are thousands of different PFAS, some of which have been more widely used and studied than others.
The “No PFAS in Cosmetics Act,” which was previously introduced in Congress in June 2021, and referred to the House Committee on Energy and Commerce on November 30, 2023, would amend the Food, Drug, and Cosmetic Act (FDCA) to require FDA to prohibit intentionally added PFAS in cosmetics within 270 days of the bill’s enactment.
Notably, the bill does not define PFAS beyond “intentionally added” perfluoroalkyl and polyfluoroalkyl substances. Nor does the bill differentiate which chemicals in the PFAS group–for example, Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS), two of the most widely used and studied chemicals in the PFAS group–should be banned.
Last year’s Modernization of Cosmetics Regulation Act (MOCRA) requires FDA to publish a report within three years (i.e., by end of year 2025) assessing the use of PFAS in cosmetics and their safety, signaling the possibility of further legislation or regulation, if warranted. Senate appropriators also have directed FDA “to develop a plan outlining research needed to inform regulatory decision-making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics.”
The proposed bill reflects the growing number of state legislatures that have enacted or are considering legislation banning the intentional use of PFAS in cosmetics, as well as other consumer products such as children’s products, menstrual products, cleaning ingredients, dental floss, and textiles. For example:
- In 2021, Maine became the first state to require manufacturers of products with intentionally added PFAS to report to the Maine Department of Environmental Protection (DEP) documenting the purpose and amount of each PFAS compound used. The law aims to phase out the use of PFAS in cosmetics, among other new consumer products, by 2030.
- Starting on January 1, 2025, California and Maryland will prohibit the manufacturing, sale, or delivery of cosmetic products containing certain intentionally added PFAS in cosmetics, including PFOA and PFOS, unless they contain technically unavoidable trace quantities of the substances stemming from impurities of natural or synthetic ingredients.
- Starting January 1, 2025, Minnesota and Colorado will prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.
- Beginning January 1, 2025, Washington State will prohibit the manufacturing, knowing sale, or distribution of cosmetic products containing PFAS, defined as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”
- Oregon’s Toxic Free Cosmetics Act, which bans the sale or distribution of cosmetics that contain intentionally added PFAS (among other chemicals) is scheduled to take effect on January 1, 2027.
New York, which last year banned the use of intentionally added PFAS in apparel, effective January 1, 2025, is considering several bills that would prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.
FDA Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products under MoCRA
On December 14, 2023, FDA published updated instructions for reporting serious adverse events for cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enforceable starting December 29, 2023.
FDA recommends that industry “responsible persons” as defined by MoCRA report serious adverse event reports for cosmetic products by using the current MedWatch Form 3500A , which is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF).
FDA has updated the form’s instructions to make it easier for the responsible person to complete the form , and requests that the completed form (along with any information to support the report) be submitted to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:
FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA strongly encourages electronic submission of serious adverse event reports to facilitate efficiency and timeliness of data submission and management for the agency.
FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics, and will provide more information on the launch date for this process in the coming months.
As a reminder, MoCRA requires that a “responsible person” must report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, and include a copy of the label on or within the retail packaging of such cosmetic product.
If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, the responsible person must submit this new information to FDA within 15 business days.
MoCRA defines the “responsible person” as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
Additionally, MoCRA expands the definition of “serious adverse event” ” to include infections or “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other
than as intended, under conditions of use that are customary or usual.”
Products will not be considered “injurious” if they cause minor or transient reactions to certain users.
This expanded definition still includes previously identified adverse events such as death; a life-threatening experience; in-patient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or medical or surgical intervention to prevent any of these outcomes.
New GAO Report Recommends FDA “Strengthen Efforts” to Implement MoCRA
On December 11, 2023, the United States Government Accountability Office (GAO) issued a report calling for FDA to strengthen its efforts to implement the Modernization of Cosmetics Regulation Act (MoCRA), and institute reforms necessary to exercise its new authorities under MoCRA.
The GAO’s report, entitled
“COSMETIC SAFETY: Better
Planning Would Enhance FDA Efforts to Implement New Law,” issues seven recommendations to the Office of the Chief Scientist to implement FDA’s new cosmetic oversight responsibilities:
- Develop an implementation plan for MoCRA — including a timeline with interim steps and interim deadlines — for completing all MoCRA requirements within the statutorily prescribed deadlines.
- Report on key milestones for all MoCRA requirements.
- Develop processes to collect needed data and evidence to measure FDA’s MoCRA implementation efforts against requirements identified in MoCRA.
- Assess the effects of implementing all MoCRA provisions on the current and future workforce.
- Develop a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements.
- Develop a plan to strengthen diversity, equity, inclusion (DEI) and accessibility when recruiting and hiring additional staff to implement MoCRA.
- Adopt effective recruitment and hiring practices for MoCRA implementation, such as customized strategies to recruit highly specialized and hard-to-fill positions.
As previously reported on this blog and elsewhere, MoCRA represents the most significant statutory change to FDA’s ability to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938. MoCRA significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.
The GAO’s report acknowledges that although FDA has taken important steps in implementing MoCRA, “FDA has not fully addressed leading practices that help ensure the success of agency reforms–in this case, the organizational changes necessary to implement the law.”
The GAO report acknowledges that FDA has undertaken significant organizational changes. In February 2023, FDA proposed moving the Office of Cosmetics and Colors out of its Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist to better align the expertise of the agency’s cosmetics subject matter experts with those of the Chief Scientist, who is focused on research, science, and innovation.
However, the GAO noted that FDA has not developed an implementation plan for MoCRA, including interim steps or deadlines; not implemented processes for measuring the results of its efforts against MoCRA’s requirements; and has not developed a strategic workforce to ensure that FDA has the necessary personnel with the requisite skills and competences to exercise its new authorities,
FDA was provided an opportunity to review and comment on the GAO’s report, and generally agreed with its findings and recommendations.
According to FDA’s Chief Scientist, FDA had not developed an implementation plan because FDA had been focused on meeting near-term MoCRA deadlines, such as additional requirements for adequate safety substantiation and adverse event reporting, which take effect December 29, 2023.
Additionally, FDA acknowledged that timely progress in implementing MoCRA and addressing GAO’s recommendations “hinges upon a significant increase in funding.”
Although MoCRA authorized FDA funding levels to increase sharply between 2023 to 2027, with authorized funding levels growing from $14.2 million in FY 2023 to $41.9 million in FY 2025 through 2027, no funding has been specifically set aside for MoCRA implementation. Accordingly, the FY 2024 President’s Budget request includes $5 million for MoCRA implementation, and in particular, hiring new staff. FDA also anticipates requesting funding for additional staff in subsequent fiscal years in order to fully implement MoCRA.
The GAO’s report comes shortly after FDA announced last month that it intended to delay enforcement of MoCRA’s requirements for cosmetic product facility registration and product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024.
This delay is intended to provide the personal care products industry additional time to comply with these requirements, and comes in response to industry concerns about the need for additional time to gather information required for facility registration and product listing.
FDA has advised that it will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and encourages companies to meet that deadline if they are able to do so.
FDA Publishes Updated SPL Implementation Guide with Validation Procedures
Yesterday FDA published an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, including updates to cosmetics product facility registrations and product listings that are now included within the SPL framework.
Yesterday’s release updates the SPL Implementation Guide published by FDA on October 13, 2023, which included facility registrations and product listings within the SPL framework, and described the soon-to-be-released Cosmetics Direct electronic submission portal function as an SPL authoring tool intended to feature user friendly data entry forms, perform initial validations, create and save SPL submissions, and submit the SPL forms to FDA for internal processing.
Noteworthy changes to the required technical conformance criteria include:
-
- Clarification of initial versus updated cosmetic product coding;
- Clarification of coding requirements for human OTC drugs that are also cosmetic products;
- Clarification between “leave-on” versus “rinse-off” product coding, unless the document type is a Cosmetic Facility Registration;
- Clarification of cosmetic product category and cosmetic product facility codes;
- Reclassification of “feminine deodorants” as “other personal cleanliness products”;
- Clarification of market status coding as to discontinued or soon-to-be discontinued cosmetic products; and
- Replacement of “Registrant” information with “Authorized Agent” information.
FDA has not yet announced when it expects the Cosmetics Direct portal to go live, but anticipates it being available for companies to register facilities and list products sometime before year end.
FDA Issues Update On Ongoing Cosmetic Product Facility Registration and Product Listing Under MoCRA
Today, FDA announced that it is effectively pushing back its anticipated October launch date for electronically submitting cosmetic product facility registration and product listing information required by the Modernization of Cosmetics Regulation Act (MoCRA).
MoCRA requires any facility that manufactures or processes cosmetic products intended for sale in the United States—irrespective of whether the facility is located in the United States—to register with FDA, and further requires manufacturers, packers, and distributors of cosmetics intended for sale in the United States to submit to FDA lists of products and ingredient information. The statutory deadline for facility registration and product listing is December 29, 2023.
FDA has previously stated that it expected its newly developed draft electronic submission portal–Cosmetics Direct–to begin accepting submissions in October 2023, in advance of the year-end deadline.
Today, however, FDA advised that it will provide more information on the launch date for electronic submission and paper submission forms “in the coming weeks.”
FDA advised that “[i]ndustry can continue to prepare for registration and listing by reviewing the documents FDA has provided and being proactive in collecting the information required to complete their facility registrations and product listings.”
FDA’s announcement comes after its issuance of draft guidance in August 2023, which, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.
FDA also solicited comments on Cosmetics Direct in its draft form, as well as the proposed paper forms (Forms FDA 5066 and 5067). The comment period is now closed, and FDA is in the process of obtaining approval from the Office of Management and Budget (OMB) in the Executive Office of the President, under the Paperwork Reduction Act for the proposed collection of registration and listing information, as well as concluding beta-testing of Cosmetics Direct.
In October 2023, FDA also announced publication of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, which can be used to develop SPL authoring tools and generating SPL-formatted submissions for cosmetic product facility registrations and product listings.
FDA will continue to provide updates on its MoCRA rollout, and until then, stay tuned for additional MoCRA updates.
New York Federal Court Dismisses Putative Class Action Suit Alleging Deceptive Marketing Of PFAS-Containing Mascaras
On September 30, 2023, the US District Court for the Southern District of New York dismissed a putative class action in which plaintiffs claimed they would not have purchased or paid a premium price for certain waterproof mascaras had they known of the presence of per- and polyfluoroalkyl substances (“PFAS”).
In a 22-page opinion, the court held that plaintiffs failed to sufficiently allege that the mascaras they individually purchased actually contained PFAS, or that there was a material risk that they did; thus, plaintiffs could not establish an actual injury.
The court dismissed plaintiffs’ claims under Sections 349-50 of New York’s General Business Law, as well as a host of other state consumer protection laws, and common law claims for unjust enrichment, breach of express and implied warrant, and fraudulent concealment.
Notably, the court rejected plaintiffs’ attempts to establish actual injury by relying on a 2021 study conducted by researchers at the University of Notre Dame, which screened 231 cosmetic products, including lip products, eye products, foundations, face products, mascaras, concealers, and eyebrow products, for their total fluorine levels to identify the possible presence of PFAS, as well as specially commissioned third party analysis of the waterproof mascaras purchased by plaintiffs.
The court concluded that the mascaras purchased by plaintiffs weren’t analyzed in the Notre Dame Study; moreover, the court identified “glaring shortcomings” with plaintiff’s’ third party analysis, noting that the study “does not allege, for instance, how many products were tested … whether all those tested products revealed the presence of PFAS, and if not, what percentage of the products had PFAS.”
Although plaintiffs are seeking to amend their complaint to revive their claims, the takeaway here is, following the U.S. Supreme Court’s decision in TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2207 (2021), absent an actual injury, plaintiffs will not have standing to pursue class action claims.
It’s important to note that hovering in the background of cosmetics-related PFAS litigation is the recent Modernization of Cosmetics Regulation Act (“MoCRA”), which overhauled federal regulation of cosmetics in the United States. Among its many new rulemaking requirements, MoCRA requires FDA to publish a report no later than 2025 assessing the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics and safety risks associated with such use. It remains to be seen what effect FDA’s report will have on putative PFAS class actions in the beauty and wellness space, and what, if any, defenses cosmetics companies can assert based on FDA’s analysis.
The case is Zaida Hicks, et al. v. L’Oréal USA Inc., No. 22-1989, (S.D.N.Y. Sept. 30, 2023).
MoCRA Requires Federal Regulatory Overhaul
On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.
To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,
Introducing Cosmetics Direct – FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA
Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act).
Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register Notice, announcing the new system.
What’s New
Cosmetics Direct includes the required registration and listing submission information in a standard electronic format to help users organize their registration and listing submissions to include the information needed for FDA. Cosmetics Direct also is intended to give users access to prior Cosmetic Direct registrations and listing submissions.
Cosmetics Direct can be accessed through the Welcome to FDA Direct webpage, which will provide short background information about Cosmetics Direct. New users will need to create an account.
Users who intend to submit information about cosmetics and drugs may create a functional joint account with Cosmetics Direct and CDER Direct, FDA’s portal for drug submissions, which is intended to streamline the submission process.
Notable system features include:
- Users will be able to create initial submissions using blank forms, or importing an FDA-accepted SPL stored in a valid XML zip file. SPL (Structured Product Labeling) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Importing an existing Facility Registration or Cosmetic Product Listing SPL will be beneficial for bulk submission.
- By selecting a country outside the U.S. as a facility location, users will be prompted to identify U.S. Agent contact information.
- Users will be prompted to sign a confirmation statement, attesting to the veracity of the information submitted, as well as additional contact information for any authorized agents submitting the information.
- Users will be promoted to save and validate any new submissions, be able to view the status of registrations and listings, and be notified if system detects any errors through a Validation Failure message. The system will provide a list of errors that require fixing before resubmitting.
- Users may also upload and submit existing Facility Registration or Cosmetic Product Listing SPL, and have the option to clone successfully submitted SPLs as starting points.
- Users will be able to view the status and details of all submissions on the Cosmetics Direct homepage.
FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency; however, those who wish to submit paper forms still have the option to do so via FDA Forms 5066 and 5067.
As of March 2023, FDA discontinued use of Forms FDA 2511, 2512, and 2512a, previously used for voluntary registration activities, and stopped accepting new submissions to the Voluntary Cosmetic Registration Program (VCRP).
Takeaways
FDA’s announcement of Cosmetics Direct comes on the heels of its recent draft guidance for facility registration and product listing, clarifying, among other things, who must register and list, when, and what must be submitted.
FDA has stated that it expects its new portal to begin accepting submissions sometime in October 2023, in advance of the December 29, 2023 statutory deadline for facility registration and product listing.
FDA Issues Long-Awaited Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA
MoCRA’s long-awaited rollout continues as today FDA released draft guidance to assist persons submitting cosmetic product facility registrations and product listings under newly-added Section 607 of the federal Food, Drug, and Cosmetic Act (FD&C Act).
Background
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA, update content within 60 days of any changes, and renew their registration every two years.
As of March 27, 2023, FDA ended its voluntary cosmetics registration program (VCRP), and advised that information submitted to VCRP would not be transferred over to any new system.
Section 607(c) of the FD&C Act further requires that for each cosmetic product, the responsible person must submit to FDA annually “a cosmetic product listing,” including ingredients.
MoCRA defines a “responsible person” as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act (FPLA).
Key takeaways from Today’s FDA Draft Guidance:
Small Business Exemption: Small businesses, as defined by Section 612 of the FD&C Act (average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1 million, adjusted for inflation, and who do not manufacture or process certain cosmetic products described in Section 612(b)), are not required to register facilities and list cosmetic product(s).
Electronic Submission Portal: FDA’s new electronic submission portal is expected to be available in October 2023, with FDA strongly encouraging electronic submissions. FDA is developing a paper form as an alternative submission tool.
Definitions: The Draft Guidance defines “contract manufacturer,” “cosmetic products,” “facility,” “manufacturing or processing,” “operator,” “owner,” “responsible person,” and “small business.”
Who Makes the Submissions: Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility and submit a cosmetic product listing unless:
-
- it is exempt as a “small business”; or
- the cosmetic product is also a drug or device subject to the requirements of Chapter V of the FD&C Act.
What Information to Include (Registration):
-
- the name of the owner and/or operator of the facility;
- the facility’s name, physical address, email address, and telephone number;
- with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact
information (email); - the facility registration number, if any, previously assigned;
- all brand names under which cosmetic products manufactured or processed in the facility are sold;
- the product category or categories (listed in Appendix A of the Draft Guidance) and responsible person for each cosmetic product manufactured or processed at the facility; and
- type of submission (initial, amended, biennial renewal, or abbreviated renewal)
FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. The e owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.
FDA also requests that the following additional optional information be submitted:
• parent company name (if applicable);
• facility DUNS Number; and
• additional contact information for individuals associated with the registration.
What Information to Include (Product Listing):
-
- the facility registration number of each facility where the cosmetic product is manufactured or processed;
- the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
- the applicable cosmetic category or categories for the cosmetic product (listed in Appendix A of the Draft Guidance)
- a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
- the product listing number, if any previously assigned; and type of submission (initial, update to content (annual), abbreviated renewal)
FDA also requests that the following additional optional information be submitted:
-
- parent company name (if applicable);
- type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
- image of the label;
- product webpage link;
- whether the cosmetic product is for professional use only;
- Responsible person DUNS Number (Dun & Bradstreet number) for address listed on product label;
- Unique Ingredient Identifiers (UNIIs); and
- additional contact information for individuals associated with the listing.
Multiple Listings: Under Section 607(c)4()B), a single listing for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents
Attestation: FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.
How/When to Submit: Stakeholders should plan to register and list in advance of the December 29, 2023 statutory deadline.
Fees: There is no fee to submit a registration or product listing to FDA under section 607 of the FD&C Act.
Public Disclosure: Under section 607 of the FD&C Act, FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552).
All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, FDA’s disclosure regulations under 21 CFR Part 20, and other applicable federal law.
Drugs AND Cosmetics?: Cosmetic products that are also drugs under Chapter V of the FD&C Act are not subject to listing requirements. Likewise, a facility that manufactures or processes cosmetic products that are also drugs is not subject to registration requirement unless it also manufactures or processes cosmetic products that are not also drugs.
Enforceability: As a reminder, FDA’s guidance documents do not establish legally enforceable responsibilities, but are intended to describe FDA’s current thinking and should be viewed as recommendations.
Conclusion
Today’s Draft Guidance provides much-needed clarity regarding MoCRA’s requirements and upcoming registration and listing deadlines. However, we expect further guidance in the upcoming months as to MoCRA’s additional December 2023 deadlines, and feedback with FDA regarding any flexibility in meeting these deadlines.