The Regulator

139: that is how many federal food recipes FDA just opened to salt substitutes, in a final rule published October 13 that lets makers cut sodium without losing the product’s legal name. The Food and Drug Administration (FDA) amended 80 “standards of identity,” the rules that spell out what bread, cheese, canned vegetables and similar foods must contain, and 59 more inherit the change by cross-reference. Until now, many of those recipes named salt (sodium chloride) as a required or optional ingredient, so a maker that swapped it out risked selling a food that no longer met its standard. The rule defines a salt substitute as any safe and suitable ingredient that does salt’s job, and FDA names potassium chloride, yeast extracts, monosodium glutamate (MSG) and amino acids as possible examples. It is voluntary and FDA estimates no required costs, but reformulating and relabeling is on the maker, and the rule adds no new labeling requirement and declines to require a high-potassium warning. Oysters and two breaded-shrimp standards were left alone. It takes effect December 14, 2026, and objections to the dairy changes are due November 12. Confidence: High. Source: Federal Register, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods.

FDA finalized its answers on what biosimilar makers must tell the agency when they change how a product is made. The final guidance, announced in the October 13 Federal Register, finalizes a July 23, 2024 draft and covers biosimilars (near-copies of biologic drugs) and the higher-tier “interchangeable” versions that pharmacists can swap in. FDA previously gave no recommendations for interchangeable products, citing limited experience, and now says the same principles apply to both. It also aligns more closely with an international manufacturing-change standard known as ICH Q5E and clarifies how a maker can reuse comparison data from its original application. The guidance is non-binding. The excerpt available to us does not state whether clinical studies are needed after a change, so read the full document before assuming a lighter burden. Confidence: High on scope and the draft-to-final history; Low on the practical burden until the full text is parsed. Source: Federal Register, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.

Medicare Open Enrollment opens Thursday, October 15, with about 71% of Medicare Advantage drug-plan members in plans rated 4 stars or higher for 2027, up from about 67%. The Centers for Medicare & Medicaid Services (CMS) posted the 2027 Star Ratings October 8. Of 508 rated Medicare Advantage contracts with drug coverage, 188 (about 37%) earned 4 or more stars, and the enrollment-weighted average slipped to 3.99 from 4.01. Stand-alone Part D drug plans improved sharply, with 22% of members in 4-star-plus plans versus about 2% a year ago. The ratings set 2028 quality bonus payments, which CMS does not price in the fact sheet, and CMS raised the weight of the physical and mental health improvement measures from one to three. Open Enrollment runs through December 7. Confidence: High. Source: CMS, 2027 Medicare Advantage and Part D Star Ratings fact sheet.

Two federal comment windows are open: autism research suggestions close October 23, and a HRSA Healthy Start data collection closes November 12. The Interagency Autism Coordinating Committee (IACC), staffed by the National Institute of Mental Health, is asking for suggested research articles for its statutory 2025-2026 Summary of Advances, with voluntary responses accepted through October 23. Separately, the Health Resources and Services Administration (HRSA) sent its Healthy Start Evaluation and Quality Improvement information collection to the Office of Management and Budget, and comments are due November 12. Neither carries a dollar figure in the notice. Confidence: High on the dates. Sources: Federal Register, 2025-2026 IACC Summary of Advances, Federal Register, Healthy Start Evaluation and Quality Improvement information collection.