Featured Stories
USGS Links Wyoming Water-Quality Changes to Watershed Conditions
WASHINGTON, Oct. 7 (TNSLrpt) -- The U.S. Geological Survey finds that watershed conditions shaped water-quality responses to energy development in 'Streamflow, Water Quality, and Energy Development Characteristics and Water-Quality Trends for Selected Sites in the Green River and Muddy Creek Drainage Basins, Southwestern Wyoming, Water Years 2006-16,' Scientific Investigations Report 2026-5059. Authors Steven K. Sando, Cheryl A. Eddy-Miller, Roy Sando, Sara L. Caldwell Eldridge, Seth E. Younger and Haylie Brown identified stronger responses to land disturbance in downstream Muddy Creek than at
... Show Full Article
WASHINGTON, Oct. 7 (TNSLrpt) -- The U.S. Geological Survey finds that watershed conditions shaped water-quality responses to energy development in 'Streamflow, Water Quality, and Energy Development Characteristics and Water-Quality Trends for Selected Sites in the Green River and Muddy Creek Drainage Basins, Southwestern Wyoming, Water Years 2006-16,' Scientific Investigations Report 2026-5059. Authors Steven K. Sando, Cheryl A. Eddy-Miller, Roy Sando, Sara L. Caldwell Eldridge, Seth E. Younger and Haylie Brown identified stronger responses to land disturbance in downstream Muddy Creek than atthe Green River basin sites.
Published in 2026 and prepared with the Bureau of Land Management, the 52-page report examines four monitoring sites: the New Fork River near Big Piney, Green River near Green River, Muddy Creek above Olson Draw near Dad, and Muddy Creek below Young Draw near Baggs. Researchers analyzed records within water years 2006-16, although sampling periods varied by site. They combined streamflow measurements, monthly water samples, watershed mapping and oil-and-gas well records to evaluate changes while accounting for seasonal and year-to-year flow variability. The work forms part of the Wyoming Landscape Conservation Initiative, which assesses natural resources alongside development.
The New Fork River site showed no statistically detectable water-quality trends during its analysis period, despite upstream well density increasing from 0.37 to 2.66 wells per square mile between the start of water year 2006 and the end of 2016. At the Green River site, magnesium and alkalinity increased, but the researchers characterized the basin as relatively insensitive to development. Mountain snowmelt supplies much of the water at both sites and may dilute effects associated with development in lower-elevation areas. Operations at Fontenelle Dam complicated interpretation of the Green River results.
Downstream Muddy Creek near Baggs showed upward trends in dissolved solids, chloride, sulfate, sodium, calcium, magnesium, barium and suspended sediment, among other indicators, during water years 2007-16. Selenium declined. Well density upstream increased from 0.78 to 1.36 wells per square mile across the broader study period. Additional modeling suggested that water-quality trends were related to changes in energy development. By contrast, the upstream Muddy Creek site near Dad had little development growth and mixed trends, including declines in several dissolved constituents. The authors caution that shorter records at three sites limit conclusions.
The report explains that construction of roads, pipelines and well pads can expose naturally salt-rich soils and geological materials, allowing precipitation to carry salts into streams. Muddy Creek's lower runoff efficiency gives water more opportunity to interact with those materials than in the mountain-fed basins. At Baggs, mean annual runoff represented about 1.5 percent of long-term average precipitation, compared with 35 percent at the New Fork River site. The researchers also note that the four-site sample was too small for a statistical evaluation of the relationship between runoff efficiency and water chemistry.
The authors conclude that geology, water movement and land disturbance must be considered together when evaluating development risks. They identify possible similar concerns from road and facility construction for wind and solar projects that began after the study's data collection ended, but do not report measured effects from those projects. Further monitoring could help distinguish development-related changes from natural variability and guide management of sensitive watersheds.
-- Moira Sirois, Targeted News Service
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View full text here: https://pubs.usgs.gov/sir/2026/5059/sir20265059.pdf
[Category: USGS]
Trump's Transportation Department Moves to Modernize Outdated Vehicle Lighting Standards, Make America's Roads Safer
WASHINGTON, Oct. 7 -- The U.S. Department of Transportation National Highway Traffic Safety Administration issued the following news release:
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Trump's Transportation Department Moves to Modernize Outdated Vehicle Lighting Standards, Make America's Roads Safer
New regulations will examine headlight glare, enhance performance, and upgrade testing procedures
October 6, 2026 Washington, DC
The U.S. Department of Transportation's National Highway Traffic Safety Administration (NHTSA) today announced it is modernizing its outdated vehicle lighting standards to make America's roads safer for
... Show Full Article
WASHINGTON, Oct. 7 -- The U.S. Department of Transportation National Highway Traffic Safety Administration issued the following news release:
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Trump's Transportation Department Moves to Modernize Outdated Vehicle Lighting Standards, Make America's Roads Safer
New regulations will examine headlight glare, enhance performance, and upgrade testing procedures
October 6, 2026 Washington, DC
The U.S. Department of Transportation's National Highway Traffic Safety Administration (NHTSA) today announced it is modernizing its outdated vehicle lighting standards to make America's roads safer forall drivers. The long-overdue update to Federal Motor Vehicle Safety Standard No. 108 demonstrates the Trump Administration's commitment to bolstering driver safety, slashing red tape, and embracing new technologies.
To accelerate the rulemaking process, NHTSA will consult industry stakeholders, safety advocates, and technical experts to tackle key safety and engineering challenges, including:
* Addressing Headlight Glare: Examining the role that modern headlighting technology has on glare for other road users and making appropriate changes.
* Modernizing Lighting Technology: Improving rules for LEDs, dusk sensors, automatic high beams, and replaceable light sources.
* Improving Performance: Evaluating how headlamp height and aim affect driver visibility.
* Updating Testing & Materials: Streamlining test procedures for plastic optics and replaceable lenses.
* Aligning Global Standards: Harmonizing U.S. vehicle lighting regulations with international safety standards.
"Today's standards do not allow automakers to deploy the latest safety-improving lighting technologies, so we are bringing key experts and stakeholders together to modernize our standards and address potential causes of glare," said NHTSA Administrator Jonathan Morrison. "This collaborative approach will allow us to update outdated regulations, foster innovation, and keep everyone on our roads safer."
For the first time in more than 25 years, NHTSA is using negotiated rulemaking to update its vehicle lighting standards. U.S. Transportation Secretary Sean P. Duffy will appoint up to 18 stakeholders across vehicle lighting manufacturers, motor vehicle equipment associations, safety organizations, research institutions, and engineering associations.
Additional Information:
NHTSA is soliciting public comments on the scope, committee membership balance, as well as formal nominations for membership. All comments and membership applications must be received by Nov. 9, 2026.
Applications and comments can be submitted at www.regulations.gov (Docket No. NHTSA-2026-1981).
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Original text here: https://www.nhtsa.gov/press-releases/modernize-outdated-vehicle-lighting-standards
SSA Missed Opportunities to Inform Disabled Beneficiaries of Their Potential Eligibility for Higher Retirement Benefits
WOODLAWN, Maryland, Oct. 7 (TNSbrep) -- The Social Security Administration Office of the Inspector General issued the following news release:
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SSA Missed Opportunities to Inform Disabled Beneficiaries of Their Potential Eligibility for Higher Retirement Benefits
October 06, 2026
The Social Security Administration's (SSA) Office of the Inspector General (OIG) released an audit report, Follow-up on Disabled Beneficiaries Who Are Eligible for Higher Retirement Insurance Benefits. The audit examined whether SSA properly notified certain disabled beneficiaries--specifically those whose disability
... Show Full Article
WOODLAWN, Maryland, Oct. 7 (TNSbrep) -- The Social Security Administration Office of the Inspector General issued the following news release:
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SSA Missed Opportunities to Inform Disabled Beneficiaries of Their Potential Eligibility for Higher Retirement Benefits
October 06, 2026
The Social Security Administration's (SSA) Office of the Inspector General (OIG) released an audit report, Follow-up on Disabled Beneficiaries Who Are Eligible for Higher Retirement Insurance Benefits. The audit examined whether SSA properly notified certain disabled beneficiaries--specifically those whose disabilitybenefits the Social Security Act requires SSA to reduce because they also received workers' compensation or public disability benefits--about their potential eligibility for higher retirement benefits.
This issue was first identified in a 2015 OIG audit, which found that SSA needed to improve its controls to ensure it informed disabled beneficiaries of their eligibility for higher retirement benefits and documented reasons when beneficiaries chose not to file. SSA agreed to take corrective action and later automated portions of its process to notify beneficiaries. However, this follow-up audit found that notification and documentation deficiencies persisted.
Based on the results of sample, OIG estimated SSA:
* did not notify 8,726 beneficiaries of their option to file for higher retirement benefits; and
* notified 3,659 beneficiaries but did not appropriately document their decisions not to file or reasons they did not file.
OIG estimated these beneficiaries could have been entitled to about $84 million in additional benefits; however, statutory restrictions prevent SSA employees from taking actions to issue the payments.
Auditors also determined SSA may be able to pay an estimated $41 million to an additional 4,785 beneficiaries who previously filed for retirement benefits but were not paid the correct, higher amount.
The report concludes that, while SSA has taken steps in recent years to automate its notification processes, gaps remain-- particularly in documenting decisions, ensuring correct payments when beneficiaries elect the higher benefit, and following up with non responders.
"Ensuring disabled beneficiaries are fully informed of their filing options--and accurately paid when they elect higher retirement benefits--is essential to delivering the customer service the public deserves," said Michelle L. Anderson, Assistant Inspector General for Audit as First Assistant. "These disabled beneficiaries depend on SSA to provide timely information that supports sound retirement decisions. Our findings show there is still work to be done to strengthen these processes and help safeguard beneficiaries' financial well-being."
The OIG made four recommendations aimed at improving notification, documentation, and payment accuracy, SSA agreed to implement all recommendations. These include correcting beneficiary records, refining processes to identify and address similar cases, improving controls over employee actions, and clarifying policy guidance--particularly related to how SSA follows up with beneficiaries who do not respond.
Read the full report here (https://oig.ssa.gov/~assets/audits/full/012320.pdf).
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Original text here: https://oig.ssa.gov/news-releases/2026-10-06-ssa-missed-opportunities-to-inform-disabled-beneficiaries-of-their-potential-eligibility-for-higher-retirement-benefits/
Report Finds SSA Can Improve Accuracy of Child's Insurance Benefit Disability Determinations
WOODLAWN, Maryland, Oct. 7 (TNSbrep) -- The Social Security Administration Office of the Inspector General issued the following news release:
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Report Finds SSA Can Improve Accuracy of Child's Insurance Benefit Disability Determinations
October 06, 2026
The Social Security Administration (SSA) did not consistently follow required policy when denying and later approving certain child's insurance benefit claims, according to a new report issued by the Office of the Inspector General (OIG). The audit examined whether SSA correctly denied initial claims for child's insurance benefits after
... Show Full Article
WOODLAWN, Maryland, Oct. 7 (TNSbrep) -- The Social Security Administration Office of the Inspector General issued the following news release:
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Report Finds SSA Can Improve Accuracy of Child's Insurance Benefit Disability Determinations
October 06, 2026
The Social Security Administration (SSA) did not consistently follow required policy when denying and later approving certain child's insurance benefit claims, according to a new report issued by the Office of the Inspector General (OIG). The audit examined whether SSA correctly denied initial claims for child's insurance benefits afterfinding the claimants were not disabled and whether it properly paid benefits when those claims were later approved.
OIG reviewed a statistically valid sample of 100 claims from a population of 5,237 child's insurance benefit claims filed between January 2023 and November 2025. All sampled claims had been initially denied after SSA determined the claimants were not disabled but were later approved.
The audit found that SSA correctly denied--and subsequently approved and paid--49 of the 100 reviewed claims. However, for the remaining 51 claims, SSA employees did not correctly deny the claims, process required documentation, and/or compute payments after approval.
Based on the sample, OIG estimated:
* SSA employees incorrectly denied an estimated 600 claims by not following policy.
* In an estimated 450 claims, SSA employees did not document required steps before denying claims for missing forms or evidence.
* After claims were later approved, SSA employees did not correctly determine entitlement dates or compute payments for an estimated 1,100 claimants, resulting in underpayments of approximately $1.2 million.
The review also found instances in which employees should have adopted prior disability determinations instead of forwarding claims for new determinations, contributing to significant delays for some applicants.
The OIG recommended SSA:
1. Correct entitlement dates or benefit payments for identified claimants, and
2. Address the underlying factors contributing to policy non-compliance in determining whether to adopt prior disability determinations.
SSA agreed to implement both recommendations.
"These findings highlight opportunities for the Agency to strengthen its processes and ensure claimants receive timely and accurate decisions," said Michelle L. Anderson, Assistant Inspector General for Audit as First Assistant. "When employees do not follow policies, claimants can face unnecessary delays and financial hardship. We appreciate SSA's agreement with our recommendations and look forward to its corrective actions to better serve the public."
Read the full report here (https://oig.ssa.gov/~assets/audits/full/052610.pdf).
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Original text here: https://oig.ssa.gov/news-releases/2026-10-06-report-finds-ssa-can-improve-accuracy-of-child%E2%80%99s-insurance-benefit-disability-determinations/
LLNL's Filippo Scotti Wins Dawson Award for Contributions Toward a Flipped Approach for Magnetic Fusion
LIVERMORE, California, Oct. 7 -- The U.S. Department of Energy Lawrence Livermore National Laboratory issued the following news:
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LLNL's Filippo Scotti wins Dawson award for contributions toward a flipped approach for magnetic fusion
The race to put fusion energy on the grid requires scientists and engineers to continue rapidly solving key challenges and optimizing solutions. The ultimate goal is the development of a device that operates continuously with high performance and stability.
A multi-institutional team from the U.S. Department of Energy's DIII-D National Fusion Facility, including
... Show Full Article
LIVERMORE, California, Oct. 7 -- The U.S. Department of Energy Lawrence Livermore National Laboratory issued the following news:
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LLNL's Filippo Scotti wins Dawson award for contributions toward a flipped approach for magnetic fusion
The race to put fusion energy on the grid requires scientists and engineers to continue rapidly solving key challenges and optimizing solutions. The ultimate goal is the development of a device that operates continuously with high performance and stability.
A multi-institutional team from the U.S. Department of Energy's DIII-D National Fusion Facility, includingFilippo Scotti from Lawrence Livermore National Laboratory (LLNL), recently won the John Dawson Award for Excellence in Plasma Physics Research from the American Physical Society for substantially advancing a "flipped" approach for fusion.
Scotti, an LLNL researcher based at DIII-D since 2014, was recognized "for advancing the negative triangularity tokamak concept, through dedicated experiments at high beta, toward readiness for a fusion pilot plant."
Development of negative triangularity approach at DIII-D
Tokamaks, donut-shaped devices that contain 100,000,000oC plasmas with magnetic fields to drive fusion reactions, are one of the leading designs for commercial fusion pilot plants. Most tokamaks operate in what is called positive triangularity, a D-shaped plasma with the curve facing the outer edge of the device.
Positive triangularity plasmas can have high confinement, an important feature for power generation; however, these plasmas have notable challenges that have yet to be solved for commercial power generation.
One solution is to move away from the positive triangularity shape altogether, instead operating the plasma in a reverse-D shape called negative triangularity (NT). Initial NT experiments at DIII-D showed high performance without the development of instabilities that cause large releases of particles and heat. These initial experiments motivated a dedicated campaign to fully explore NT.
Scotti leads experiments to handle heat exhaust
Beginning in 2022, the team exploited the flexibility of DIII-D as a research platform to embark on a dedicated NT campaign. Scotti worked with the General Atomics engineering team for DIII-D to replace existing components with specialized pieces designed for NT operation.
The dedicated NT campaign spent weeks exploring plasmas with strong NT shaping to validate this approach for tokamak operation. These plasmas consistently exhibited strong confinement and stability over a vast operational space.
Scotti conducted the first experiments evaluating divertor heat exhaust during NT operation in DIII-D. A tokamak's divertor is built to direct heat away from the core and into a separate chamber. Researchers want to achieve what they call "detached divertor conditions" -- where the plasma cools and loses energy before it hits the reactor wall. This would dramatically reduce the wear and tear on the tokamak's hardware.
Scotti's experiments achieved this detached state for the first time during NT operation.
"Future reactors will need to operate in detached divertor conditions, where impurity radiation and recombination processes contribute to reduce heat and particle fluxes impinging on plasma-facing components," he said. "Demonstrating the compatibility of high-performance NT plasma with detached divertor operation is critical to assessing the feasibility of NT scenarios for a future power plant."
That result motivated the design of a closed pumped NT divertor, a planned upgrade led by Scotti that will seal off the exhaust chamber and actively pump out waste gas.
Moving negative triangularity forward
Together, the DIII-D team showed simultaneous achievement of high performance in the plasma core with mitigated heat flux at the divertor, demonstrating that NT operation can achieve key features required for future fusion pilot plants.
"The U.S. Department of Energy's Fusion Science and Technology Roadmap calls for advancing confinement approaches that combine high performance, stability and effective power exhaust. DIII-D's negative triangularity research is making important progress on that challenge, while growing engagement with the private sector is helping move promising concepts toward commercial fusion," said Matthew Lanctot, Acting Director, Fusion Energy Research Division, DOE Office of Science.
The NT research performed at DIII-D has established momentum for the development of NT-based machines around the world. Through 2026, DIII-D team members continued to advance the NT approach, optimizing plasma shape and further understanding NT confinement and stability properties in dedicated experiments.
In the near future, DIII-D will be installing an NT-optimized divertor through a public-private partnership with Kyoto Fusioneering to advance this operational approach for commercialization.
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Original text here: https://www.llnl.gov/article/55096/llnls-filippo-scotti-wins-dawson-award-contributions-toward-flipped-approach-magnetic-fusion
FDA Center for Drug Evaluation & Research Issues Warning Letter to Terramed
WASHINGTON, Oct. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Terramed from its Center for Drug Evaluation and Research:
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Recipient: Krystsina Uradzimskaya, CEO, Terramed, 10731 Queen Ave, La Mesa, CA 91941, United States, support@terramed.info, info@puritycosmetics.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
9310 Towne Center Dr Unit 72
San Diego, California, 92121
WARNING LETTER
Reference Number: 735070
To Krystsina Uradzimskaya:
This warning letter advises you of
... Show Full Article
WASHINGTON, Oct. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Terramed from its Center for Drug Evaluation and Research:
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Recipient: Krystsina Uradzimskaya, CEO, Terramed, 10731 Queen Ave, La Mesa, CA 91941, United States, support@terramed.info, info@puritycosmetics.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
9310 Towne Center Dr Unit 72
San Diego, California, 92121
WARNING LETTER
Reference Number: 735070
To Krystsina Uradzimskaya:
This warning letter advises you ofsignificant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://terramed.info, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately any address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
As discussed below, the "Genital Herpes Intimate Wash," "HerpCare Ointment," "HerpCare Spray," and "HerpCare Genital Wart Remover Ointment" products on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.
FDA Review
Violations were identified and documented during a review of your website https://terramed.info/ in July 2026. Based on our review, "Genital Herpes Intimate Wash," "HerpCare Ointment," "HerpCare Spray," and "HerpCare Genital Wart Remover Ointment" 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).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "Genital Herpes Intimate Wash," "HerpCare Ointment," "HerpCare Spray," and "HerpCare Genital Wart Remover Ointment" 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 website, 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:
Genital Herpes Intimate Wash
On the webpage https://terramed.info/products/genital-herpes-intimate-wash:
* "This genital herpes intimate wash is designed to support soothing relief for itching, tingling, burning, and irritation associated with genital herpes symptoms. The gentle cleansing formula helps maintain intimate hygiene while supporting skin comfort for sensitive intimate areas. The wash is suitable for daily intimate care for both men and women experiencing discomfort associated with herpes outbreaks."
* "GENITAL HERPES INTIMATE WASH
o Formulated for Herpes Relief"
* Supports Genital Herpes Comfort."
HerpCare Ointment
On the webpage https://terramed.info/products/genital-herpes-treatment-fast-acting-ointment:
* "This genital herpes relief ointment is designed to support soothing comfort for genital sores, itching, tingling, burning, and irritation associated with herpes outbreaks. The soothing formula helps calm sensitive skin while supporting comfort and relief for intimate areas. Each tube provides targeted topical support for genital herpes symptoms."
* "GENITAL HERPES SYMPTOMS
o Soothes and calms genital sores"
HerpCare Spray
On the webpage https://terramed.info/products/genital-herpes-spray:
* "This genital herpes relief spray is designed to support soothing comfort for genital sores, itching, burning, tingling, and irritation associated with herpes outbreaks. The convenient spray format allows targeted application to sensitive areas while helping calm irritated skin."
* "Fast-acting Genital Herpes Symptom Relief
o Soothes and calms genital sores."
HerpCare Genital Wart Remover Ointment
On the webpage https://terramed.info/products/genital-wart-remover-oitnment:
* "This genital wart remover ointment with salicylic acid is designed to support targeted treatment for genital warts, irritation, redness, itching, and discomfort. The formula helps soften and break down wart tissue while supporting gentle skin recovery. The ointment helps provide targeted wart treatment while supporting skin comfort for sensitive areas."
* "HerpCare Genital Wart Remover Ointment
o Targets Genital Warts"
* "Genital Wart Treatment Support
o Designed to support treatment for genital wart symptoms."
* "Supports Genital Wart Removal"
The above-referenced webpages for each product also provide the following:
* "Terramed Intimate Care
o HerpCare - Proprietary Genital Herpes Care Line
* HerpCare is a proprietary and exclusively developed product line, fully owned and commercially distributed by Terramed Just Think Comfort, specifically created to support individuals managing genital herpes (HSV-2)."
"Genital Herpes Intimate Wash," "HerpCare Ointment," "HerpCare Spray," and "HerpCare Genital Wart Remover Ointment" 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 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.1 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).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number "735070" in the subject line of the email.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
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Footnote:
1/ We recognize that the "HerpCare Ointment" and "HerpCare Spray" labeling describes the products as being "homeopathic."
First, we note that under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term "drug" includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a "homeopathic drug product" as "a drug product that is labeled as 'homeopathic,' and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS)." Your "HerpCare Ointment" and "HerpCare Spray" include the active ingredient, lemongrass, which is not listed in the HPUS. Thus, your "HerpCare Ointment" and "HerpCare Spray" products fall outside the scope of products addressed in this guidance.
Notwithstanding, even if your above listed products were considered "homeopathic drug products" under this guidance, these products would fall under the guidance's category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/terramed-735070-10012026
CDC Morbidity & Mortality Weekly Report: Environmental Investigation of a Campylobacteriosis Outbreak Among Wedding Attendees -- York County, Pennsylvania, 2025
ATLANTA, Georgia, Oct. 7 (TNSLrpt) -- The U.S. Department of Health and Human Services Centers for Disease Control and Prevention issued the following document as part of its Morbidity and Mortality Weekly Report (No. 37) on September 24, 2026, entitled "Environmental Investigation of a Campylobacteriosis Outbreak Among Wedding Attendees -- York County, Pennsylvania, 2025.":
Here are excerpts:
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Summary
What is already known about this topic?
Unregulated private springs are a known risk factor for gastrointestinal illness, including campylobacteriosis.
What is added by this report?
A
... Show Full Article
ATLANTA, Georgia, Oct. 7 (TNSLrpt) -- The U.S. Department of Health and Human Services Centers for Disease Control and Prevention issued the following document as part of its Morbidity and Mortality Weekly Report (No. 37) on September 24, 2026, entitled "Environmental Investigation of a Campylobacteriosis Outbreak Among Wedding Attendees -- York County, Pennsylvania, 2025.":
Here are excerpts:
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Summary
What is already known about this topic?
Unregulated private springs are a known risk factor for gastrointestinal illness, including campylobacteriosis.
What is added by this report?
ACampylobacter jejuni outbreak among wedding attendees in Pennsylvania was linked to consumption of untreated water from an on-site spring; environmental sampling detected Campylobacter DNA in the spring and a tap it supplied. The broken springhouse roof permitted entry of debris and animal feces, an ultraviolet water treatment light was nonfunctional, and evidence of animal activity was observed in and around the spring.
What are the implications for public health practice?
Routine inspection and maintenance of untreated private springs and clear signage indicating whether water is potable might reduce the risk for waterborne outbreaks. Pairing environmental testing with epidemiology helps confirm exposure routes and can guide mitigation efforts.
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View the full document at: https://www.cdc.gov/mmwr/volumes/75/wr/pdfs/mm7537a2-H.pdf
