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HHS Secretary Robert F. Kennedy Jr. Eases Restrictions on Six Peptides Against FDA Advice

HHS Secretary Robert F. Kennedy Jr. Eases Restrictions on Six Peptides Against FDA Advice

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has announced an interim enforcement discretion policy allowing broader use of six previously restricted peptides: BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. This decision was made against the advice of the Food & Drug Administration (FDA). The policy permits compounding pharmacies to prepare these peptides without HHS enforcement action, provided they adhere to specific regulations. These regulations include sourcing raw ingredients from FDA-registered manufacturers following good manufacturing practices, possessing a certificate of analysis for purity and lack of contaminants, ensuring each product contains only one peptide, and limiting peptides to specific forms (e.g., intranasal for Semax). The peptides will still require a prescription from a licensed physician and cannot be purchased over the counter. Secretary Kennedy has been a vocal advocate for peptide use, stating that this policy aims to discourage the use of research-use-...

FDA Issues Warning Letter to New York Tong Ren Tang Over Unapproved Drugs Marketed Online

FDA Issues Warning Letter to New York Tong Ren Tang Over Unapproved Drugs Marketed Online

Jing Cheong Asia Inc., operating as New York Tong Ren Tang, has received a warning letter from the FDA dated October 26, 2026. The FDA identified three unapproved new drugs being marketed through the company's e-commerce website: 'Ofloxacin Eye Drops,' 'Jingzhi Niuhuang Jiedu Pian,' and 'Gui Pi Wan.' The agency flagged the ophthalmic product, Ofloxacin Eye Drops, as the most significant public health concern due to its intended use for bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and post-operative ocular infections, which require sterility assurance and regulatory approval. The other two products, traditional Chinese medicines, made therapeutic claims for conditions like aplastic anemia, thrombocytopenic purpura, measles, and mumps. These claims classify the products as drugs under the Federal Food, Drug, and Cosmetic Act, requiring FDA approval that they lack. The violations were discovered during a website review in September 2026.

FDA Issues Final Guidance on Prescription Drug Use-Related Software, Clarifying Regulatory Approach for Mobile Apps

FDA Issues Final Guidance on Prescription Drug Use-Related Software, Clarifying Regulatory Approach for Mobile Apps

The U.S. Food and Drug Administration (FDA) released final guidance on October 20, 2026, titled "Regulatory Considerations for Prescription Drug Use-Related Software." This guidance outlines how the FDA intends to apply its drug labeling authorities to software, such as mobile applications, that drug sponsors distribute for use with their prescription drugs. Concurrently, the Obesity Action Coalition (OAC) published new research detailing patient preferences for prescription companion apps, emphasizing the importance of clear medication instructions, data privacy explanations, and patient control over shared health information. The OAC's findings indicate that 86% of surveyed patients would be influenced by FDA review when deciding to use an app, highlighting the significance of regulatory oversight in patient trust and adoption of digital health tools. The FDA's guidance clarifies when such software should be included in official drug information and when drug companies must submit app content to the agen...

Federal Agencies Collaborate on Consumer Protection, Addressing Deceptive Practices and Product Safety

Federal Agencies Collaborate on Consumer Protection, Addressing Deceptive Practices and Product Safety

Multiple federal agencies are actively involved in consumer protection, each with specific legal authority over different aspects of the market. The Federal Trade Commission (FTC) focuses on deceptive and unfair practices, including inadequately supported advertising claims. The Consumer Product Safety Commission (CPSC) addresses hazards in consumer products within its jurisdiction. The Food and Drug Administration (FDA) covers specific categories such as food, drugs, cosmetics, and medical devices. The Consumer Financial Protection Bureau (CFPB) handles financial products and services. These agencies' responsibilities and enforcement tools vary, and their authority is established by enabling statutes. Overlapping jurisdiction can occur, meaning several agencies might have authority over different aspects of a single underlying matter, requiring each to verify its specific powers before acting. For instance, a lead-paint toy case could involve both the CPSC for physical safety and the FTC for misleading ad...

FDA Issues Final Guidance on Prescription Drug Use-Related Software Labeling

FDA Issues Final Guidance on Prescription Drug Use-Related Software Labeling

On October 20, 2026, the U.S. Food and Drug Administration (FDA) released its final guidance titled 'Regulatory Considerations for Prescription Drug Use-Related Software.' This guidance, which finalizes a draft from September 2023, outlines how the FDA will apply its drug labeling authorities to software, such as mobile applications, that drug sponsors distribute for use with their prescription drugs. It also covers Center for Drug Evaluation and Research (CDER)-led or Center for Biologics Evaluation and Research (CBER)-led combination products. The guidance clarifies when software output is considered FDA-required or promotional labeling, when software should be described in a drug’s prescribing information (PI), and what information sponsors must submit to the FDA. This includes software disseminated by or on behalf of a drug sponsor that produces 'end-user output' related to the drug products. The FDA considers this end-user output, which is any content presented to a patient, caregiver, or healthcare p...

FDA and HHS Submit Interim Policy for Compounding Peptides Amid Increased Enforcement

FDA and HHS Submit Interim Policy for Compounding Peptides Amid Increased Enforcement

The U.S. Department of Health and Human Services (HHS) and the FDA submitted an 'Interim Access Policy for Compounding Using Certain Peptides' to the Office of Management and Budget for regulatory review on October 14, 2026. This move comes as the FDA has intensified enforcement actions against research-use-only peptide sellers and high-volume compounders since August 2026. While senior HHS leadership has publicly supported broader access to peptides, the FDA has not yet added any peptide to its 503A Bulks List, which would allow pharmacies to compound them. The advisory committee's July 2026 recommendations to add six peptides to this list are advisory only, and formal rulemaking has not begun. Any near-term access is likely to come through temporary FDA enforcement discretion, which would not constitute product approval and could be withdrawn.

Energy Drinks and Stimulant Supplements Linked to Acute Cardiovascular Events in Young Consumers

Energy Drinks and Stimulant Supplements Linked to Acute Cardiovascular Events in Young Consumers

New study results presented at the American Heart Association (AHA) Scientific Sessions 2026 in Chicago indicate a disproportionate reporting of acute cardiovascular events associated with caffeine- and stimulant-containing energy drinks and dietary supplements. Investigators reviewed data from the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition Adverse Event Reporting System. The analysis compared cardiovascular event reports for products containing caffeine, methylxanthines (like guarana and green tea extracts), sympathomimetics (such as yohimbine and ephedra), and popular caffeinated brands (including Celsius, Red Bull, Monster, and Rockstar) against other orally consumed products. The study found that 8 out of 10 cardiovascular outcomes achieved statistical signal thresholds, with the strongest signal for cardiac arrest, followed by myocardial infarction, ventricular arrhythmia, and palpitations. These findings suggest a significant link between these products and...

Whole Foods Market Recalls Ashwagandha Supplement Due to Salmonella Risk

Whole Foods Market Recalls Ashwagandha Supplement Due to Salmonella Risk

Vitality Works Inc. has initiated a recall of 120-count bottles of 365 Whole Foods Market Ashwagandha in its Standardized and Full Spectrum Blend formulation. The recall, announced by the Food and Drug Administration (FDA) on October 30, is due to concerns about possible salmonella contamination. The affected product, lot number 2025-26227, has an expiration date of October 13, 2028. Sales of these capsules occurred between November 24, 2025, and October 20, 2026. The supplement was sold nationwide through Amazon and in Whole Foods Market stores across 30 states and Washington, D.C. Routine testing of a retail-purchased unit revealed the potential contamination, though Vitality Works has not reported any illnesses related to the recall.

Golden Valley Electric Association Advises Members on Medical Device Preparedness for Power Outages

Golden Valley Electric Association Advises Members on Medical Device Preparedness for Power Outages

The Golden Valley Electric Association (GVEA) is urging its members, particularly those who rely on electrically powered medical devices, to develop emergency preparedness plans for power outages. GVEA acknowledges that power interruptions can pose significant challenges for these households. While the utility's Energy Emergency Alert (EEA) program aims to provide advance notice of potential controlled outages, such notifications cannot be guaranteed for all power interruptions, especially those caused by unexpected events like weather or equipment failures. GVEA emphasizes that it cannot selectively exclude individual households from controlled outages based on medical equipment needs. The U.S. Food and Drug Administration (FDA) provides guidance for individuals using medical devices during emergencies, recommending understanding device backup power options, planning for alternative power sources like generators, checking for water before reconnecting equipment, and verifying device settings after power r...

HHS Secretary Robert F. Kennedy Jr. Issues Interim Policy on Compounding Six Peptides

HHS Secretary Robert F. Kennedy Jr. Issues Interim Policy on Compounding Six Peptides

On October 28, 2026, the U.S. Department of Health and Human Services (HHS) published an interim Enforcement Discretion Policy regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Signed by HHS Secretary Robert F. Kennedy Jr., this policy outlines conditions under which HHS will not take enforcement action against state-licensed pharmacies, federal facilities, and licensed physicians who compound drug products using six specific peptide bulk drug substances. This interim measure is in effect while the official list of bulk drug substances for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) is being developed through rulemaking. The policy aims to discourage the use of 'research use only' peptides from foreign manufacturers, offering a more controlled alternative for U.S. patients. Notably, this policy was issued by the HHS Office of the Secretary, rather than the FDA, despite FDA scientific reviewers having previously recommended against listing these pep...

Gilead and Kite Announce New Data on Cancer and Autoimmune Disease Treatments at ASH 2026

Gilead and Kite Announce New Data on Cancer and Autoimmune Disease Treatments at ASH 2026

Gilead Sciences, Inc. and its company Kite have announced that they will present 23 new data presentations, including seven oral presentations, at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, scheduled from December 12–15, 2026. These presentations will highlight significant advancements across Gilead and Kite’s pipeline and portfolio, focusing on treatments for blood cancers and autoimmune disorders. Key data includes 18-month minimum follow-up results for anitocabtagene autoleucel (anito-cel) in relapsed or refractory multiple myeloma (RRMM) from the pivotal Phase 2 iMMagine-1 study. This data forms the basis of a Biologics License Application (BLA) currently under review by the U.S. Food and Drug Administration (FDA), with a target decision date of December 23, 2026. Additionally, five-year follow-up data for Yescarta® (axicabtagene ciloleucel) in first-line high-risk large B-cell lymphoma (LBCL) will be presented, along with early clinical results for KITE-753 in B-cell ...

FDA Approves New Oral Pellet Formulation for Hereditary Angioedema Treatment

FDA Approves New Oral Pellet Formulation for Hereditary Angioedema Treatment

The U.S. Food and Drug Administration (FDA) has approved a new oral pellet formulation of Orladeyo (berotralstat) for adults and adolescents aged 12 and older who suffer from hereditary angioedema (HAE). HAE is a rare genetic disorder characterized by sudden, unpredictable episodes of swelling in various parts of the body, including the skin, gut, and potentially life-threatening swelling in the airway. Orladeyo functions as a once-daily prophylactic oral therapy, working to block plasma kallikrein, which is responsible for the swelling in HAE. The original capsule formulation of Orladeyo received FDA approval in 2020. The new pellet formulation was initially approved for children aged 2 to 11 last December and is now extended to adolescents and adults, particularly benefiting those who experience difficulty swallowing capsules or prefer this alternative administration method. This development represents a strategic move in pharmaceutical lifecycle management, aiming to enhance patient convenience and adhe...