The Regulator

The Food and Drug Administration (FDA) finalized a rule October 9 that lets food makers swap salt substitutes into 139 standardized foods, including breads and cheeses, without changing the food’s legal name or recipe standard. The rule amends 80 “standards of identity” directly and makes 59 more that cross-reference them eligible, and it names no specific substitute; potassium chloride, herbs, yeast extracts and monosodium glutamate are among the examples FDA has cited. It imposes no mandate and no penalty, so the cost falls only on manufacturers who choose to reformulate and relabel. Existing labeling rules still apply: the substitute must be named in the ingredient list, and potassium must appear on the Nutrition Facts label when it reaches 2 percent or more of the daily value per serving. FDA declined to require a high-potassium (hyperkalemia) warning. The rule takes effect December 14, and objections or hearing requests on the dairy standards are due November 12. Confidence: High on the rule’s scope and dates; the Federal Register publishes the final text October 13. Sources: Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, Federal Register. Supplemental: Food Safety Magazine.

FDA finalized its question-and-answer guidance on manufacturing changes made after approval to biosimilars and interchangeable biosimilars, which the Federal Register lists for publication October 13. The document finalizes a July 2024 draft (docket FDA-2024-D-2581) and extends FDA’s earlier biosimilar-only guidance to interchangeable products, the versions pharmacists may substitute without calling the prescriber. Makers of biosimilars, copies of complex biologic drugs, use this kind of guidance to decide which plant or process changes need new FDA review before shipping. This run reviewed the Federal Register summary, not the full guidance text, so the specific changes from draft to final are not confirmed here. Confidence: High that the final guidance exists; Low on content changes. Sources: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers, Federal Register.

Health plans have until early March 2027 to start filing price data by provider network, not by plan, after the Centers for Medicare and Medicaid Services (CMS) and the Labor and Treasury departments finalized Transparency in Coverage rules. The Federal Register published the rule October 6, effective December 7. Plans must update in-network and out-of-network price files quarterly instead of monthly, five months after publication, and add a taxonomy file and a utilization file 11 months after. Out-of-network reporting drops its threshold from 20 claims to 11, and plans must give personalized cost-sharing estimates by phone. A Prescription Drug File schema starts development in November, with plans publishing in it from December 2027. CMS estimates net savings to plans and insurers of about $174.5 million a year beginning in the second year. Confidence: High. Sources: Transparency in Coverage final rule, Federal Register, Transparency in Coverage Final Rules fact sheet, CMS, CMS press release.

FDA published draft guidance October 9 saying it does not intend to enforce some food traceability recordkeeping requirements for certain retail food establishments and restaurants. The guidance concerns the additional traceability records the agency requires for foods on its high-risk list, and FDA says current understanding of risk supports the lighter enforcement posture for those sellers. Grocers and restaurant operators have the most to gain, because lot-level record systems are a recurring compliance cost; a companion public meeting on lot-level traceability challenges was noticed the same day. Comments on the draft are due November 23. This run reviewed the Federal Register abstract, not the full guidance, so which retail categories qualify is not confirmed here. Confidence: Medium. Sources: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants, Federal Register, Challenges and Solutions in Lot-Level Food Traceability; Public Meeting, Federal Register.

FDA opened a public request for information October 5 on how to design early-stage human trials of ibogaine, a psychedelic compound being studied for opioid use disorder and post-traumatic stress disorder (PTSD). The agency asks for data on dose escalation, care setting, cardiac and neurologic monitoring, eligibility, stopping rules and independent safety oversight, and says starting doses should not exceed 10 milligrams per kilogram. The request follows an April 2026 executive order on serious mental illness and FDA’s July final guidance on psychedelic drug trials. Developers, academic sites and addiction-treatment investors get an early read on what FDA will accept in an investigational application. Comments are due November 20 under docket FDA-2026-N-10429. Confidence: High. Sources: FDA seeks public input to support ibogaine research, FDA.

A Brooklyn owner of a social adult day care business pleaded guilty October 2 to a roughly $65 million New York Medicaid fraud, admitting he billed for day care and home health services that were never provided. The U.S. Department of Justice prosecuted the case; the HHS Office of Inspector General (OIG) listing does not name the defendant or give a sentencing date. Social adult day care, a Medicaid-funded program meant to serve seniors and people with disabilities, has been a repeat target in New York, and a plea of this size signals how much of the program’s billing prosecutors consider fictitious in the worst cases. Confidence: Medium. The OIG listing is brief, and this run did not review the underlying Justice Department release. Sources: Social Adult Day Care Owner Pleads Guilty to $65M Medicaid Fraud, HHS Office of Inspector General.