FDA Regulatory News and Trends - January 9, 2024

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.

Temporary order to place certain synthetic cannabinoids in schedule I.

• On December 13, 2023, the Drug Enforcement Administration (DEA) issued a final rule which temporarily places six synthetic cannabinoids and their derivatives in schedule I. The temporary order was effective immediately and will remain in effect for two years from the date of the final rule, with a possible extension of one year, pending completion of the regular (permanent) scheduling process.
  
  
• As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions apply to schedule I controlled substances on persons who handle (ie, manufacture, distribute, reverse distribute, import, export, engage in research of, conduct instructional activities or chemical analysis with, or possess) or propose to handle these six specified controlled substances.
  
  

FDA finalizes guidance on registration and listing of cosmetic product facilities and products.

• FDA has issued its final guidance, entitled, “Registration and Listing of Cosmetic Product Facilities and Products.”
  
  
• The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law in December 2022 as part of the Consolidated Appropriations Act, 2023. Among other provisions, MoCRA established requirements for cosmetic product facility registration and product listing by adding section 607 to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 364c).
   
• Generally, this final version provides updated information regarding FDA’s recently developed Cosmetics Direct system – launched on December 18, 2023 – and alternative Forms 5066 and 5067, plus clarification for US agents of foreign facilities and for obtaining FDA Establishment Identifier numbers. The document also notes the Agency’s compliance policy published in November 2023, which explains that FDA does not intend to enforce the cosmetic product facility registration and listing requirements under FD&C Act Section 607 until July 1, 2024.
  
  
• The newly added Appendix B additionally sets out frequently asked questions and answers. Most of the questions relate to exceptions to the registration and listing requirements, which entities must register/list, and what qualifies as a “responsible person” with respect to these requirements. The appendix was distributed for comment purposes only, and the comment period will end on January 18, 2024.
  
  

FDA issues draft guidance on the Advanced Manufacturing Technologies Designation Program.

• On December 12, 2023, FDA released its draft guidance, entitled, “Advanced Manufacturing Technologies Designation Program.”
  
  
• The draft guidance includes the eligibility criteria for advanced manufacturing technologies (AMT) designation, the submission and assessment process for requests, the benefits of receiving an AMT designation, and a Q&A section covering additional details regarding program utilization. Comments are due by February 12, 2024.
  
  
• In 2022, one of the directives provided in the Food and Drug Omnibus Reform Act (FDORA) included the establishment of an AMT Designation Pilot Program for reviewing certain manufacturing advanced methods and expediting development and review of applications using the designated technology.
  
  
• According to FDA, AMTs, which encompass innovative pharmaceutical manufacturing technology and approaches, can improve the reliability and robustness of the manufacturing process and supply chain, while also increasing timely access to quality small molecule drugs or biological products. As such, FDA encourages the early adoption of AMTs that may benefit patients by improving manufacturing and supply dependability and optimizing development time of medicines. 
  
  

Updates to FDA interim policy on compounding using bulk drug substances.

• In December 2023, FDA updated two draft guidance documents concerning the use of bulk drug substances for pharmaceutical compounding – one guidance relating to compounding pharmacies and another relating to outsourcing facilities.
  
  
• In recent years, FDA has taken an interim approach to the issue of bulk substances in compounding, allowing compounding of certain ingredients under a policy of enforcement discretion (namely those placed on Category 1 lists of nominated bulk substances pending evaluation by FDA). The recent draft guidance updates indicate that FDA will gradually transition away from its interim policy.
  
  
• Significantly, the guidances set out FDA’s intention to freeze its lists of nominated bulk substances. However, this change will not be immediate and will not impact the current nominated substances lists for compounding pharmacies or outsourcing facilities.
  
  
• Once the revised guidances are finalized, FDA will no longer categorize nominations received for inclusion on the bulk drug substances lists prior to evaluating them, meaning no new substances will qualify for enforcement discretion from that point onwards. This may result in an uptick of nominations to the bulk lists in the near term, before the guidances become final.
  
  

CDRH proposes update to guidance on use of real-world evidence for medical devices.

• On December 18, 2023, CDRH released a draft update to its 2017 real-world evidence (RWE) guidance, entitled, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The update was congressionally mandated as part of Medical Device User Fee Amendment V (MDUFA V) funding negotiations.
  
  
• RWE is defined in the guidance as clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of real-world data (RWD). RWD is defined as data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources (eg, health records, insurance claims).
  
  
• The update is a significant step forward for CDRH's efforts to support the use of RWE. It provides additional granularity on factors the center will consider when assessing the relevance of RWE to help answer regulatory questions and the ability to rely on it for regulatory decision-making (ie, relevance and reliability).
  
  
• Device manufacturers who could leverage RWE and other industry stakeholders that could be sources of RWD (eg, hospitals, insurers) should review the draft update to this guidance and submit comments to Docket # FDA-2023-D-4395.
  
  

Proposed updates to menu labeling supplemental guidance.

• On December 13, 2023, FDA released proposed updates to its existing menu labeling supplemental guidance to respond to frequently asked stakeholder questions regarding implementation of the federal menu labeling requirements (codified at 21 C.F.R. 101.11).
  
  
• Newly added Questions and Answers 5.8 and 7.5 address the voluntary declaration of nutrition information for menus on third-party platforms to help consumers make informed and healthful decisions when ordering their meals online and the voluntary declaration of added sugars as part of the additional written nutrition information under 21 CFR 101.11(b)(2)(ii)(A), respectively.
  
  
• The federal menu labeling requirements apply to food sold in covered establishments, including restaurants or retail food establishments part of a chain with 20 or more locations doing business under the same name and offering substantially the same menu items, as well as restaurants or retail food establishments that voluntarily register with FDA to be covered by these requirements.
  
  
• Comments on the draft guidance should be submitted by February 12, 2024. 

Advancements toward unified Human Foods Program and Office of Regulatory Affairs model.

• On December 13, 2023, FDA provided an update on its efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model, sharing additional details about the proposed structure, status of activities, and timeline for next steps. 
  
  
• The reorganization package both modifies how the Agency’s foods and field work is conducted and impacts a number of additional FDA offices outside of these areas of responsibility. Proposed changes include: 
  
  
  • Making FDA’s HFP and Product Centers solely responsible for receipt, triage, and closing consumer and whistleblower complaints (rather than splitting this role between Centers and Field Offices), refining the processing of complaints and improving the consistency of compliance decisions
    
    
  • Renaming ORA as the Office of Inspections and Investigations (OII) and strengthening its role as the frontline of FDA’s field-based inspection, investigation, and import operations
    
    
  • Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to centralize coordination of cross-agency medical issues
    
    
  • Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) into a new office, enhancing support for regulatory science and preparedness research efforts, and
    
    
  • Creating an Office of Enterprise Transformation to ensure more strategic and efficient use of FDA resources.   
    
    
• The proposed reorganization package is now under review at the US Department of Health and Human Services, which begins the formal external review process. The reorganization plan must clear additional steps, including review by the Office of Management and Budget and providing Congress with a 30-day notification period, prior to implementation. 
  
  

Finalized guidance on direct-to-consumer promotional labeling and advertisements.

• On December 11, 2023, FDA issued a revised final guidance, titled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” This is the first revision since the guidance was first finalized in June 2023. 
  
  
• On page 1, the updated guidance replaced “over-the-counter” animal drugs with “nonprescription” animal drugs to include nonprescription veterinary feed directive (VED). 
  
  

Revised draft guidance on clinical pharmacology considerations for peptide drug products.

• On December 13, 2023, FDA issued a revised draft guidance, titled, “Clinical Pharmacology Considerations for Peptide Drug Products.” The draft guidance was first issued in September 2023.
  
  
• The revised draft guidance updated the reference guidance for bioanalytical approach, from the May 2018 version to the November 2022 version of the ICH M10 Bioanalytical Method Validation and Study Sample Analysis guidance.