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NOAA Research Offers Roadmap to Improve West Nile Forecasting and Prevention
SILVER SPRING, Maryland, May 13 (TNSjou) -- The National Oceanic and Atmospheric Administration issued the following news:* * *
NOAA research offers roadmap to improve West Nile forecasting and prevention
A new technique based on weather data is the first to successfully predict caseloads
*
A new technique for forecasting West Nile virus based on NOAA weather data is the first of its kind to successfully predict caseloads of the most common and deadliest mosquito-borne disease in the nation.
Since the first cases were detected in New York in 1999, West Nile Virus has caused over 30,000 ... Show Full Article SILVER SPRING, Maryland, May 13 (TNSjou) -- The National Oceanic and Atmospheric Administration issued the following news: * * * NOAA research offers roadmap to improve West Nile forecasting and prevention A new technique based on weather data is the first to successfully predict caseloads * A new technique for forecasting West Nile virus based on NOAA weather data is the first of its kind to successfully predict caseloads of the most common and deadliest mosquito-borne disease in the nation. Since the first cases were detected in New York in 1999, West Nile Virus has caused over 30,000cases of severe illness and nearly 3,000 deaths in the U.S. There is still no human vaccine or effective treatment for the disease. A method for developing skilled predictions of where seasonal outbreaks could occur had not been identified until now.
A NOAA-led research team including scientists from the University of Minnesota and the Centers for Disease Control and Prevention (CDC) Division of Vector-Borne Diseases have taken a first step on a path to predicting West Nile virus incidence using a method based on historical weather conditions. The technique provides a foundation for supporting proactive public health actions, such as more effective public awareness and control of the Culex mosquitos that spread West Nile, and informing health care providers about likely increases in West Nile disease caseloads.
"West Nile has emerged as a major public health concern across much of the United States," said lead author Ryan Harp, who was a postdoctoral researcher affiliated with NOAA's Global Systems Laboratory and the CDC when he began working on the problem. "Improving our ability to predict the prevalence of West Nile infection will allow for more targeted and effective surveillance, public outreach, and mosquito control."
Harp, now with the University of Minnesota, led a research team that includes scientists with CIRES, NOAA's Cooperative Institute for Research in Environmental Science at the University of Colorado. Their study was published in the journal GeoHealth (https://agupubs.onlinelibrary.wiley.com/doi/10.1029/2025GH001657).
One bite could change your life
While most people who are bitten by mosquitos infected with the West Nile virus will show no symptoms, about one in 150 will develop a severe, neuroinvasive form of the disease that can cause inflammation of the brain, spinal cord, and nervous system. Symptoms include severe headache, high fever, stiff neck, confusion, tremors, and muscle weakness. Ten percent of neuroinvasive disease cases are fatal. Many who survive have enduring disabilities.
In the U.S., West Nile virus is carried by Culex mosquitoes and amplified predominantly by songbirds. Mosquitoes acquire the virus by feeding on infected birds, and go on to transmit it to other birds, humans, and animals. Mosquito populations respond to environmental conditions, but the relationship with weather variables is complex. For example, precipitation can lead to more areas for Culex mosquitoes to breed, but if rains are too heavy, existing breeding grounds can be washed out.
The scientists started by examining CDC data of West Nile Neuroinvasive Disease caseloads from 2005 to 2022. While West Nile Virus is widespread--46 states reported cases in 2025--the number of cases per county is still relatively small. To overcome challenges caused by small statistical samples in some parts of the country, researchers aggregated data into 11 regions. Then they evaluated six variables related to temperature and moisture, looking for statistical correlations to identify climatological factors most relevant for virus transmission. They found moisture and temperature to be the most important variables driving variation in West Nile cases.
A path to actionable forecasts
This new method established with historical data is a key step toward an effective nationwide forecast. Researchers will refine the method and link it to NOAA weather models with the goal of providing actionable forecasts for public health agencies, said co-author Stan Benjamin, a retired NOAA GSL Senior Scientist who now works for CIRES.
"We believe such a future capability would be the first active use of NOAA forecast data to predict a vector-borne disease in the United States," said Benjamin.
"We know that vector-borne diseases are intrinsically linked to climate," said Northeastern University scientist Michael Johansson, who was with CDC when the research was ongoing. "This method identifies critical relationships between weather conditions and disease prevalence that reflect varied ecologies across the country and provide the foundation to build more predictive West Nile models in the years to come."
* * *
Original text here: https://research.noaa.gov/noaa-research-offers-roadmap-to-improve-west-nile-forecasting-and-prevention/
FDA Center for Veterinary Medicine Issues Warning Letter to Fish Aid
WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to The Fish Aid from its Center for Veterinary Medicine:* * *
Recipient: The Fish Aid, 1309 Coffeen Avenue, Sheridan, WY 82801, United States, thefishaid@gmail.com
Issuing Office: Center for Veterinary Medicine, United States
WARNING LETTER
Re: 726862
This letter concerns your firm's distribution of animal drug products for use in aquarium fish and birds.
In March 2026, the United States Food and Drug Administration (FDA) reviewed your website (https://thefishaid.com/) ... Show Full Article WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to The Fish Aid from its Center for Veterinary Medicine: * * * Recipient: The Fish Aid, 1309 Coffeen Avenue, Sheridan, WY 82801, United States, thefishaid@gmail.com Issuing Office: Center for Veterinary Medicine, United States WARNING LETTER Re: 726862 This letter concerns your firm's distribution of animal drug products for use in aquarium fish and birds. In March 2026, the United States Food and Drug Administration (FDA) reviewed your website (https://thefishaid.com/)where you take orders for the following products: Amoxicillin Clavulanate, Amoxicillin, Azithromycin, Cephalexin, Ciprofloxacin, Clindamycin Hydrochloride, Doxycycline, Metronidazole, Minocycline, Penicillin, Sulfamethoxazole/Trimethoprim. These are sold under various brand names (e.g. Aqua Soma Labs, Fish Care Lab, Aqua, Fishbiotic, Midland Vet Services (MVS), Fish Aid, Kraft Drug).
The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. Sec. 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. Sec. 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. Sec. 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
Unapproved New Animal Drugs
Examples of claims observed on your website (https://thefishaid.com/) that establish the intended use of these products as drugs include, but may not be limited to, the following:
Aquarium Fish
* Aqua Amoxicillin Clavulanate, 875 mg/125 mg tablets. According to your website, it is "... a semisynthetic antibiotic. For treatment against many gram-positive and gram-negative microorganisms."
* Fix Mox 250, Amoxicillin, 250 mg capsules and Fix Mox 500, Amoxicillin, 500 mg capsules. According to the label of the product on your website, each is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Zithro 250, Azithromycin, 250 mg capsules. According to the label of the product on your website, it is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections"
* Fix Flex 250, Cephalexin, 250 mg capsules and Fix Flex 500, Cephalexin, 500 mg capsules. According to the label of the product on your website, each is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Flox 500, Ciprofloxacin, 500 mg capsules. According to the label of the product on your website, it is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Cin 150, Clindamycin Hydrochloride, 150 mg capsules. According to the label of the product on your website, it is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Doxy 100, Doxycycline, 100 mg tablets. According to the label of the product on your website, it is an "Antibacterial Fish Medication" for the "Treatment of Common Bacterial Infections."
* Aqua Minocycline, 100 mg capsules. According to your website, it is "... a broad-spectrum antibiotic that controls gram-positive and some gram-negative bacteria in fish."
* Fix Zole 250, Metronidazole, 250 mg tablets; Fix Zole 500, Metronidazole, 500 mg tablets. According to the label of the product on your website, each product is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Pen 500, Penicillin, 500 mg tablets. According to the label of the product on your website, this is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
* Fix Sulfa 960, Sulfamethoxazole/Trimethoprim, 960 mg tablets. According to the label of the product on your website, this is an "Antibacterial Fish Medication" for "Treatment of Common Bacterial Infections."
Birds
* Fix Zithro 250, Azithromycin, 250 mg capsules. According to the label of the product on your website, this is an "Antibacterial Bird Medication" for "Treatment of Common Bacterial Infections."
These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. Sec. 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. Sec. 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug's labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met.
To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species ("index listing") under section 512, 571, or 572 of the FD&C Act [21 U.S.C. Sec. 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed.
Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. Sec.Sec. 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
The FDA is particularly concerned about the marketing of these unapproved animal drugs because they contain antimicrobials considered medically important to human health./1 The growing threat of antimicrobial resistance, especially to drugs that are medically important in human medicine, has prompted FDA to promote judicious use of these drugs in animals. A key part of this effort is ensuring that these medically important antimicrobials are used only under the supervision of a licensed veterinarian. Over-the-counter use of these drugs without veterinary oversight contributes to the development of antimicrobial resistance, posing risks to both human and animal health.
Misbranded New Animal Drugs
Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. Sec. 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of all of your unapproved/unindexed products.
We have the following comments:
1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at:
* https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and
* https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications
The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species.
2. Information on establishment registration and drug listing is available on the FDA website at:
* https://www.fda.gov/industry/fda-basics-industry/registration-and-listing
Within fifteen (15) business days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) business days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov.
Sincerely,
/S/ Dillard Woody, Acting Director, Division of Drug Compliance, Office of Surveillance and Compliance, Center for Veterinary Medicine
* * *
Footnote:
1/ CVM is in the process of updating the list of medically important drug classes of antimicrobials. The list currently under consideration is available in the revised draft GFI #152, at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fish-aid-726862-04032026
FDA Center for Veterinary Medicine Issues Warning Letter to DK Hardware Supply
WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to DK Hardware Supply from its Center for Veterinary Medicine:* * *
Recipient: Edward Fishman, Vice President, DK Hardware Supply, 1835 E. Hallandale Beach Blvd. PMB #264, Hallandale Beach, FL 33009, United States, sales@dkhardware.com, cs@dkhardware.com
Issuing Office: Center for Veterinary Medicine, United States
WARNING LETTER
Re: 726865
Dear Edward Fishman:
This letter concerns your firm's distribution of animal drug products for use in aquarium fish.
In ... Show Full Article WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to DK Hardware Supply from its Center for Veterinary Medicine: * * * Recipient: Edward Fishman, Vice President, DK Hardware Supply, 1835 E. Hallandale Beach Blvd. PMB #264, Hallandale Beach, FL 33009, United States, sales@dkhardware.com, cs@dkhardware.com Issuing Office: Center for Veterinary Medicine, United States WARNING LETTER Re: 726865 Dear Edward Fishman: This letter concerns your firm's distribution of animal drug products for use in aquarium fish. InMarch 2026, the United States Food and Drug Administration (FDA) reviewed your website (https://www.dkhardware.com) where you take orders for the following products sold under various brands: Amoxicillin, Cephalexin, Ciprofloxacin, Doxycycline, Metronidazole, Penicillin, Sulfamethoxazole/Trimethoprim.
The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. Sec. 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. Sec. 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. Sec. 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
Unapproved New Animal Drugs
Examples of claims observed on your website (https://www.dkhardware.com) that establish the intended use of these products as drugs include, but may not be limited to, the following:
Aquarium Fish
* Fin Mox (Amoxicillin), 250 mg and 500 mg capsules, according to images of the product labels on your website:
o "Antibiotics"
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
* Aqua Soma Labs Fix Mox 250 (Amoxicillin), 250 mg capsules, according to an image of the product label on your website:
o "Antibacterial fish medication"
o "For Treatment of Common Bacterial Infections"
* Aqua Soma Labs Fix Flex 250 (Cephalexin), 250 mg and 500 mg capsules, according to images of the product labels on your website:
o "Antibacterial Fish Medication"
o "For Treatment of Common Bacterial Infections"
* Fin Flex (Cephalexin), 250 mg and 500 mg capsules, according to images of the product labels on your website:
o "Antibiotics"
o "For Control of Common Bacterial Infections in Fish"
* Fish Ceph (Cephalexin), 500 mg capsules, according to an image of the product label on your website:
o "Antibacterial Fish Medication"
* Fin Flox (Ciprofloxacin), 500 mg tablets, according to an image of the product label on your website:
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
* Fin Dox (Doxycycline), 100 mg capsules, according to an image of the product label on your website:
o "Antibiotics"
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
* Fin Zole (Metronidazole), 250 mg tablets, according to an image of the product label on your website:
o "Antibiotics"
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
* Fin Pen (Penicillin), 250 mg and 500 mg tablets, according to images of the product labels on your website:
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
* Aqua-Pen (Penicillin), 250 mg tablets, according to an image of the product label on your website:
o "Controls common bacterial infections in FISH"
* Fin Sulfa (Sulfamethoxazole/Trimethoprim), 960 mg tablets, according to an image of the product label on your website:
o "Antibiotics"
o "FOR CONTROL OF COMMON BACTERIAL INFECTIONS IN FISH"
These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. Sec. 321(v)] because they are for use in nonfood-producing fish, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. Sec. 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug's labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met.
To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species ("index listing") under section 512, 571, or 572 of the FD&C Act [21 U.S.C. Sec. 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed.
Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. Sec.Sec. 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
The FDA is particularly concerned about the marketing of these unapproved animal drugs because they contain antimicrobials considered medically important to human health.1 The growing threat of antimicrobial resistance, especially to drugs that are medically important in human medicine, has prompted FDA to promote judicious use of these drugs in animals. A key part of this effort is ensuring that these medically important antimicrobials are used only under the supervision of a licensed veterinarian. Over-the-counter use of these drugs without veterinary oversight contributes to the development of antimicrobial resistance, posing risks to both human and animal health.
Misbranded New Animal Drugs
Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. Sec. 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of all of your unapproved/unindexed products.
We have the following comments:
1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at:
* https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and
* https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications
The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species.
2. Information on establishment registration and drug listing is available on the FDA website at:
* https://www.fda.gov/industry/fda-basics-industry/registration-and-listing
Within fifteen (15) business days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) business days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov.
Sincerely,
/S/ Dillard Woody, Acting Director, Division of Drug Compliance, Office of Surveillance and Compliance, Center for Veterinary Medicine
* * *
Footnote:
1/ CVM is in the process of updating the list of medically important drug classes of antimicrobials. The list currently under consideration is available in the revised draft GFI #152, at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dk-hardware-supply-726865-04032026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Naveh Pharma/Bigdam
WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Naveh Pharma LTD./Bigdam Inc. from its Center for Drug Evaluation and Research:* * *
Recipient: Tal Bornstein, CEO, Roei Farhi, CEO, Naveh Pharma LTD/Bigdam Inc., 19, Yad Kharutsim St., Netanya, Sharon area, Israel, Tal@navehpharma.com, info@navehpharma.com, roei@navehpharma.com, hello@u-better.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Bigdam Inc, 1441 Woodmont Ln NW, Atlanta GA 30318, United States
RE: ... Show Full Article WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Naveh Pharma LTD./Bigdam Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Tal Bornstein, CEO, Roei Farhi, CEO, Naveh Pharma LTD/Bigdam Inc., 19, Yad Kharutsim St., Netanya, Sharon area, Israel, Tal@navehpharma.com, info@navehpharma.com, roei@navehpharma.com, hello@u-better.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Bigdam Inc, 1441 Woodmont Ln NW, Atlanta GA 30318, United States RE:724669
Dear Tal Bornstein and Roei Farhi:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites https://www.navehpharma.com/ and https://u-better.com/, and your Amazon storefront/1 in March 2026. The FDA has observed that you offer your products, "RSV Hypertonic Saline 3%" and "Hypertonic Saline 7%" for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
In addition, FDA reviewed the records you submitted in response to our initial April 28, 2025, request for records and other information, and subsequent correspondence, pursuant to section 704(a)(4) of the FD&C Act for your facility, Naveh Pharma (1966) LTD, FEI 3027300316, at 19 Yad Kharutsim, Netanya, Sharon Area, Israel.
Unapproved New Drugs
Based on a review of your websites, your "RSV Hypertonic Saline 3%" and "Hypertonic Saline 7%" products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your websites that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
RSV Hypertonic Saline 3%
From the "RSV Hypertonic Saline 3%" document/2 available on the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline/:
* "For treatment of Bronchiolitis (RSV - respiratory syncytial virus)"
* "In recent years quite a number of studies around the world, proved the effectiveness of treatment with Hypertonic saline inhalation in infants hospitalized suffering from acute bronchiolitis."
* "Hypertonic saline inhalation therapy resulted in clinical improvement and shortening the duration of hospitalization."
* "Hypertonic saline works by raising fluid lining in the airway walls, reducing the edema layer of the submucosa, improving Rheological properties of sputum and acceleration of the mucus clearance (MC)."
* "For respiratory use with inhalators in cases of bronchiolitis- RSV infections"
On the webpage https://u-better.com/products/saline-solution-3-for-daily-inhalation-25-vials:
* "This 3% saline solution is ideal for nebulizer therapy and nasal irrigation. It helps clear mucus and supports easier breathing."
* "Gentle On Airways And Clinically Sterile Saline (NaCl + water) That Helps Loosen Mucus and Hydrate Nasal & Respiratory Passages--For Clear, Comfortable Breathing."
* The product name: "RSV Hypertonic Saline"
Hypertonic Saline 7%
On the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline-7/:
* "Hypertonic saline creates an osmotic pressure that increases the volume of airway surface liquid, restore mucus clearance, and improve lung function."
* "Recent clinical studies in patients with cystic fibrosis, have shown that inhalation of hypertonic saline produced a sustained acceleration of mucus clearance and improved lung function. This treatment improves sputum viscosity and ease expectoration."
* "The advantages of treatment with 7% hypertonic saline in lung diseases are:
o Improving lung function
o Stimulate mucociliary clearance
o Improving quality of life
o Decreases hospital admissions. . .
o Effective treatment of moderately and severe lung diseases."
On the webpage https://u-better.com/products/saline-solution-7-for-respiratory-relief-25-vials
* "This 7% saline solution is a powerful option for respiratory support, ideal for clearing mucus and promoting easier breathing. Designed for inhalation and nasal irrigation, it's perfect for adults and seniors managing respiratory health."
Your "RSV Hypertonic Saline 3%" and "Hypertonic Saline 7%" products are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Drug CGMP Violations
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a))
The records and information you submitted stated that your firm does not have a quality unit (QU) to provide adequate quality oversight over the manufacture and release of finished drug products shipped to the United States.
Without an established quality unit, your facility lacks an effective quality system. See FDA's guidance document ICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download, and https://www.fda.gov/media/71023/download, respectively.
In response to this letter, provide the following:
* A comprehensive assessment and remediation plan to ensure you establish a QU that is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier 724669 in the subject line of the email.
Sincerely,
/S/ Tina Smith, M.S., Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration
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Footnotes:
1/ https://www.amazon.com/stores/page/32459A2E-623E-4FF5-A843-5E2A11377B9E?ingress=0&visitId=41227466-4ab1-4d27-bdf4-403b4beb212f
2/ https://www.navehpharma.com//wp-content/uploads/2016/09/rsv-flier_en-1.pdf
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naveh-pharma-ltdbigdam-inc-724669-05042026
FDA Center for Drug Evaluation & Research Issues Warning Letter to IDO Pharm
WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to IDO Pharm Co. Ltd. from its Center for Drug Evaluation and Research:* * *
Recipient: Mr. Young Joo Kim, Chief Executive Officer, IDO Pharm Co., Ltd., 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu Ansan-si Gyeonggi-do 15616, South Korea
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-74
Dear Mr. Kim:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO Pharm ... Show Full Article WASHINGTON, May 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to IDO Pharm Co. Ltd. from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Young Joo Kim, Chief Executive Officer, IDO Pharm Co., Ltd., 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu Ansan-si Gyeonggi-do 15616, South Korea Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-74 Dear Mr. Kim: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO PharmCo., Ltd., 3017021001, at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, from November 10 to 13, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your December 4, 2025, response to our Form FDA 483 in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
You manufacture multiple drug products labelled as (b)(4).
Inadequate (b)(4) System Validation
Your firm did not establish procedures describing the operation, cleaning, maintenance, or validation of your (b)(4) system, which is used to make a component of your drug products. Hoses were observed to contain stagnant (b)(4), and your (b)(4) tank contained visible particulate matter floating on the (b)(4) surface, including what appeared to be an insect.
In your response, you state that you conducted an immediate inspection of the insanitary conditions in your (b)(4) system, storage tanks, piping, and hoses, and took corrective actions including draining and drying the hose containing stagnant (b)(4). You state that you will establish a (b)(4) system procedure that includes cleaning frequency for tanks, draining and drying criteria for hoses, and controls to prevent stagnant (b)(4). You also state you will conduct personnel training.
Your response is inadequate because your firm continues to manufacture drug products using an unqualified (b)(4) system that has not been validated for its intended use. You also failed to address the lack of qualification and validation of your (b)(4) system.
Inadequate Process and Equipment Cleaning Validation
Your firm did not conduct process validation or equipment cleaning validation for your (b)(4) over-the-counter drug products.
In your response, you state that your firm plans to relocate your facility in April 2026 and that equipment qualification and validation activities which include manufacturing processes, method validation, and cleaning validation will be performed in parallel by July 2026. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact of manufacturing with unvalidated processes, nor did you provide an action plan to address any drug product quality or safety risk for batches already distributed to the U.S. market.
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.
Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.
See FDA's guidance document at www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices for general principles and approaches that FDA considers appropriate elements of process validation.
In response to this letter please provide:
* A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
* A timeline for performing appropriate process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.
* Process performance protocols and written procedures for qualification of equipment and facilities.
* A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
* A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system.
- A (b)(4) system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.
* Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.
* A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
* A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
* The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system.
* A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4), USP monograph specifications and appropriate microbial limits.
2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
You failed to appropriately establish and validate your gas chromatographic (GC) method for assay testing of (b)(4) in your finished drug products. Also, you failed to validate your GC method for determining (b)(4) and volatile impurities in your (b)(4) raw material. In addition, you failed to test your (b)(4) raw material for the presence of (b)(4) and volatile impurities.
In your response, you state that you will discontinue using the unvalidated methods and intend to establish and validate new GC testing methods. You also state your firm will implement (b)(4) testing for your (b)(4) raw material and conduct impurity testing for every lot of (b)(4) per your updated release requirements.
Your response is inadequate because you failed to conduct a risk assessment evaluating the impact of using unvalidated methods and did not address testing of finished product retains that may have been manufactured using untested or inadequately tested raw materials.
Analytical methods must be validated to demonstrate they are suitable for their intended use and equivalent or better than applicable United States Pharmacopeia compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility of your test methods is essential to ensuring that manufactured drug products meet established specifications for chemical and microbial attributes.
In your response to this letter please provide:
* A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.
o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.
o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
* A comprehensive independent assessment of your laboratory practices, procedures, and methods. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
3. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your quality unit (QU) did not adequately exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure:
* Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
* Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188).
* Performance of routine calibrations of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
Your firm's quality systems are inadequate. See FDA's guidance documents, as well as for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download and at https://www.fda.gov/media/71023/download respectively.
In response to this letter, provide a comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
* A determination of whether procedures used by your firm are robust and appropriate.
* Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
* A complete and final review of each batch and its related information before the QU disposition decision.
* Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 31, 2026.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at IDO Pharm Co., Ltd., located at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, 15616, Republic of Korea, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3017021001 and ATTN: Yvette Johnson.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ido-pharm-co-ltd-723449-05042026
FCC Office of Engineering and Technology and Media Bureau Announce Release of Version 2.3.1 of TVStudy
WASHINGTON, May 13 -- The Federal Communications Commission's Media Bureau issued the following public notice (Docket No. DA 26-468):* * *
The Office of Engineering and Technology and the Media Bureau announce the release of updated TVStudy software (Version 2.3.1)./1 The TVStudy Version 2.3.1 software installation package, the TVStudy 2.3.1 Installation and Upgrade Guide, and the post-auction template XML file are all available on the TVStudy website at http://www.fcc.gov/oet/tvstudy.
As with prior updates, a full list of changes from TVStudy Version 2.3 is included in the "Differences Between ... Show Full Article WASHINGTON, May 13 -- The Federal Communications Commission's Media Bureau issued the following public notice (Docket No. DA 26-468): * * * The Office of Engineering and Technology and the Media Bureau announce the release of updated TVStudy software (Version 2.3.1)./1 The TVStudy Version 2.3.1 software installation package, the TVStudy 2.3.1 Installation and Upgrade Guide, and the post-auction template XML file are all available on the TVStudy website at http://www.fcc.gov/oet/tvstudy. As with prior updates, a full list of changes from TVStudy Version 2.3 is included in the "Differences Between2.3.1 and 2.3.0" section of the Change Log in the TVStudy 2.3.1 Installation and Upgrade Guide.
In particular, TVStudy 2.3.1 corrects an issue that caused applications for new low power television stations to be considered incorrectly in TV Interference Check studies. TVStudy 2.3.1 also corrects a number of minor issues throughout the software, and adds a handful of minor features.
* * *
Footnote:
1/ See Office of Engineering and Technology Announces Release of Version 2.1 of TVStudy for Processing Construction Permit Applications Filed With the Media Bureau Implementing the Results of the Repacking Process, Public Notice, 32 FCC Rcd 998 (OET 2017) ("OET will continue to make improvements and other changes to TVStudy that are necessary and appropriate, and will inform the public via public notice when new versions of TVStudy are released. OET welcomes feedback on this software's features and functions.").
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Original text here: https://docs.fcc.gov/public/attachments/DA-26-468A1.pdf
BLS Midwest Region Issues Report on Consumer Price Index, Chicago-Naperville-Elgin April 2026
CHICAGO, Illinois, May 13 (TNSLrpt) -- Consumer Price Index, Chicago-Naperville-Elgin April 2026 - A report from U.S. Department of Labor Bureau of Labor Statistics Midwest Region - May 12, 2026* * *
Area prices were up 0.9 percent over the past month, up 3.1 percent from a year ago
*
The Consumer Price Index for All Urban Consumers (CPI-U) in the Chicago-Naperville-Elgin area advanced 0.9 percent in April, the U.S. Bureau of Labor Statistics (BLS) reported today. Assistant Commissioner for Regional Operations Michael Hirniak noted that the energy index rose 10.6 percent due to higher gasoline ... Show Full Article CHICAGO, Illinois, May 13 (TNSLrpt) -- Consumer Price Index, Chicago-Naperville-Elgin April 2026 - A report from U.S. Department of Labor Bureau of Labor Statistics Midwest Region - May 12, 2026 * * * Area prices were up 0.9 percent over the past month, up 3.1 percent from a year ago * The Consumer Price Index for All Urban Consumers (CPI-U) in the Chicago-Naperville-Elgin area advanced 0.9 percent in April, the U.S. Bureau of Labor Statistics (BLS) reported today. Assistant Commissioner for Regional Operations Michael Hirniak noted that the energy index rose 10.6 percent due to higher gasolineprices. The food index increased 0.2 percent. The index for all items less food and energy was up 0.3 percent in April. (Data in this report are not seasonally adjusted. Accordingly, month-to-month changes may reflect seasonal influences.)
The Chicago-Naperville-Elgin area all items CPI-U advanced 3.1 percent for the 12 months ending in April. The energy index rose 14.2 percent and food prices increased 3.5 percent. The index for all items less food and energy increased 2.2 percent over the year.
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Chart 1. Over-the-year percent change in CPI-U, Chicago-Naperville-Elgin, IL-IN-WI, April 2023-April 2026
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Food
Food prices advanced 0.2 percent for the month of April. Prices for food at home (grocery store purchases) advanced 0.4 percent, with higher prices in four of the six major grocery store food groups. Prices for food away from home (restaurant, cafeteria, and vending purchases) were unchanged for the same period.
Food prices increased 3.5 percent over the year. Prices for food at home increased 2.2 percent as four of the six major grocery store food group indexes rose over the year. Grocery store index increases ranged from 5.8 percent for fruits and vegetables to 2.0 percent for nonalcoholic beverages and beverage materials. The index for other food at home declined 0.8 percent over the year. Prices for food away from home increased 5.8 percent.
Energy
The energy index rose 10.6 percent over the month. Gasoline prices increased 13.7 percent from March to April.
Energy prices rose 14.2 percent over the year. From April 2025 to April 2026 gasoline prices were up 26.8 percent.
All items less food and energy
The index for all items less food and energy increased 0.3 percent in April. Among the index's components, prices were higher for lodging away from home and public transportation. In contrast, prices were lower for education and communication (-0.5 percent) and household furnishings and operations (-0.6 percent).
The index for all items less food and energy increased 2.2 percent over the year. Components contributing to the increase included owners' equivalent rent of residences (+4.0 percent) and public transportation. In contrast, prices were lower for education and communication (-3.2 percent) and medical care (-1.4 percent).
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The May 2026 Consumer Price Index for the Chicago-Naperville-Elgin area is scheduled to be released on Wednesday, June 10, 2026.
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Rebasing of Selected Consumer Price Index Series
Effective with this release, several CPI series were rebased to December 2024 = 100. When new base years are introduced, BLS recalculates each index back to the beginning of that series to ensure continuity. A complete list of indexes that were rebased is available at www.bls.gov/cpi/additional-resources/rebased-series.htm.
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Technical Note
The Consumer Price Index (CPI) is a measure of the average change in prices over time in a fixed market basket of goods and services. The Consumer Price Index for Chicago is published monthly. The set of components and sub-aggregates published for regional and metropolitan indexes is more limited than at the U.S. city average level; these indexes are byproducts of the national CPI program. Each local index has a much smaller sample size than the national or regional indexes and is, therefore, subject to substantially more sampling and other measurement error. As a result, local-area indexes are more volatile than the national or regional indexes. In addition, local indexes are not adjusted for seasonal influences. NOTE: Area indexes do not measure differences in the level of prices between cities; they only measure the average change in prices for each area since the base period.
The Chicago-Naperville-Elgin, IL-IN-WI Core Based Statistical Area includes Cook, DeKalb, DuPage, Grundy, Kane, Kendall, Lake, McHenry, and Will Counties in Illinois; Jasper, Lake, Newton, and Porter Counties in Indiana; and Kenosha County in Wisconsin.
Refer to the national CPI news release technical note or the Handbook of Methods for more information.
If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
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Table 1. Chicago-Naperville-Elgin, IL-IN-WI, CPI-U by expenditure category for April 2026, not seasonally adjusted (1982-84=100 unless otherwise noted)
Table 2. Chicago-Naperville-Elgin, IL-IN-WI, CPI-U by special aggregate index for April 2026, not seasonally adjusted (1982-84=100 unless otherwise noted)
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View original text plus charts and tables here: https://www.bls.gov/regions/midwest/news-release/2026/consumerpriceindex_chicago_20260512.htm