Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Featured Stories
U.S. Energy Secretary and Saudi Arabia's Energy Minister Announce Deal on Civil Nuclear Cooperation
WASHINGTON, Nov. 19 -- The U.S. Department of Energy issued the following news release:
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U.S. Energy Secretary and Saudi Arabia's Energy Minister Announce Deal on Civil Nuclear Cooperation
U.S. Secretary of Energy Chris Wright and the Kingdom of Saudi Arabia's Minister of Energy Prince Abdulaziz bin Salman Al Saud today signed a Joint Declaration on the Completion of Negotiations on Civil Nuclear Cooperation.
Secretary Wright released the following statement and video:
"Today is a historic day for the United States and the Kingdom of Saudi Arabia. We've come together on a deal for civil
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WASHINGTON, Nov. 19 -- The U.S. Department of Energy issued the following news release:
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U.S. Energy Secretary and Saudi Arabia's Energy Minister Announce Deal on Civil Nuclear Cooperation
U.S. Secretary of Energy Chris Wright and the Kingdom of Saudi Arabia's Minister of Energy Prince Abdulaziz bin Salman Al Saud today signed a Joint Declaration on the Completion of Negotiations on Civil Nuclear Cooperation.
Secretary Wright released the following statement and video:
"Today is a historic day for the United States and the Kingdom of Saudi Arabia. We've come together on a deal for civilnuclear cooperation. Together, with bilateral safeguard agreements, we want to grow our partnership, bring American nuclear technology to Saudi Arabia and keep a firm commitment to nonproliferation.
"All of this is made possible because of President Trump's vision of prosperity at home and peace abroad. This philosophy, this partnership, has transformed the Middle East into a region focused now on commerce, not conflict."
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Original text here: https://www.energy.gov/articles/us-energy-secretary-and-saudi-arabias-energy-minister-announce-deal-civil-nuclear
SEC Obtains Final Judgment Against South Texas Trader for Fraudulent "Free-Riding" Scheme
WASHINGTON, Nov. 19 -- The Securities and Exchange Commission issued the following litigation release (No. 4:25-CV-03122; S.D. Tex. filed July 3, 2025) involving Cyrus P. Naderi:
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On October 7, 2025, the Securities and Exchange Commission obtained a final judgment against Cyrus P. Naderi of The Woodlands, Texas, for charges related to conducting a fraudulent "free-riding" scheme through which he attempted to profit by purchasing and selling stocks without having sufficient funds to pay for the trading.
According to the SEC's complaint, filed in the U.S. District Court for the Southern District
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WASHINGTON, Nov. 19 -- The Securities and Exchange Commission issued the following litigation release (No. 4:25-CV-03122; S.D. Tex. filed July 3, 2025) involving Cyrus P. Naderi:
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On October 7, 2025, the Securities and Exchange Commission obtained a final judgment against Cyrus P. Naderi of The Woodlands, Texas, for charges related to conducting a fraudulent "free-riding" scheme through which he attempted to profit by purchasing and selling stocks without having sufficient funds to pay for the trading.
According to the SEC's complaint, filed in the U.S. District Court for the Southern Districtof Texas, from April 2021 through March 2024, Naderi initiated at least $565,000 of unfunded deposits into brokerage accounts he controlled at four different broker-dealers. The SEC alleges that the brokerage deposits were drawn against bank accounts that Naderi knew lacked sufficient funds to cover the deposits. The SEC further alleges that the broker-dealers, unaware that the deposits were unfunded, extended instant deposit credit, allowing Naderi to conduct trades in the accounts. Ultimately, as alleged, the deposits were reversed when the broker-dealers rejected them for insufficient funds, or when Naderi placed a stop-payment order on the transfer from his bank accounts. According to the complaint, before the reversals and stop-payment order, Naderi executed several hundred trades, buying and selling securities valued at more than $22.4 million, and causing three of the broker-dealers to incur an aggregate loss of at least $65,770. According to the complaint, after the fraudulent deposit at the fourth broker-dealer was reversed, Naderi's trades were cancelled, preventing him from transferring out illicit trading profits.
Without admitting or denying the allegations in the SEC's complaint, Naderi consented to the entry of a final judgment, permanently enjoining him from violations of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder. The final judgment also imposes conduct based injunctions and orders Naderi to pay a $40,000 civil penalty.
The investigation was conducted by Jeff Cohen, of the SEC's Fort Worth Regional Office, under the supervision of Derek Kleinmann, with the assistance of Alex Lefferts of the SEC's Office of Investigative and Market Analytics. The litigation was led by Matthew Gulde under the supervision of Keefe Bernstein.
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Resources
* Final Judgment (https://www.sec.gov/files/litigation/litreleases/2025/judg26418.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26418
SEC Charges Six Investment Advisers With Making Misrepresentations in Forms Filed With the Agency
WASHINGTON, Nov. 19 -- The Securities and Exchange Commission issued the following litigation release (No. 25cv09507, 25cv09505, 25cv03649, 25cv03650, 25cv03651, 25cv03645; S.D.N.Y. filed Nov. 13, 2025, D. Colo. filed Nov. 13, 2025):
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Bluesky Eagle Capital Management Ltd., Supreme Power Capital Management Ltd., AI Financial Education Foundation Ltd., AI Investment Education Foundation Ltd., Invesco Alpha Inc., Adamant Stone Limited
The Securities and Exchange Commission today announced charges against purported investment advisers Bluesky Eagle Capital Management Ltd. ("Bluesky Eagle"),
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WASHINGTON, Nov. 19 -- The Securities and Exchange Commission issued the following litigation release (No. 25cv09507, 25cv09505, 25cv03649, 25cv03650, 25cv03651, 25cv03645; S.D.N.Y. filed Nov. 13, 2025, D. Colo. filed Nov. 13, 2025):
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Bluesky Eagle Capital Management Ltd., Supreme Power Capital Management Ltd., AI Financial Education Foundation Ltd., AI Investment Education Foundation Ltd., Invesco Alpha Inc., Adamant Stone Limited
The Securities and Exchange Commission today announced charges against purported investment advisers Bluesky Eagle Capital Management Ltd. ("Bluesky Eagle"),Supreme Power Capital Management Ltd. ("Supreme Power"), AI Financial Education Foundation Ltd. ("AI Financial"), AI Investment Education Foundation Ltd. ("AI Investment"), Invesco Alpha Inc. ("Invesco Alpha"), and Adamant Stone Limited ("Adamant Stone"), for making material misrepresentations and unsubstantiated statements in forms filed with the SEC regarding their organizations, office locations, assets under management, and clients.
The SEC's complaints, filed separately in the United States District Courts for the Southern District of New York (against Bluesky Eagle and Supreme Power) and the District of Colorado (against AI Financial, AI Investment, Invesco Alpha, and Adamant Stone), allege that the entities made misrepresentations in their Forms ADV filed with the SEC. Form ADV is used by investment advisers to register with both the SEC and state securities authorities. It requires the adviser to report information about its business, ownership, and other information. According to the SEC's complaints, in their ADV filings made on various dates in 2023 and 2024, Bluesky Eagle, Supreme Power, AI Financial, and Adamant Stone each claimed to manage $10 million in assets in the United States, Invesco Alpha claimed to manage $5 million in assets, and AI Investment claimed to manage $1 million; and they each claimed to advise a private fund and that a separate registered investment adviser reported information about those private funds on its own Form ADV. In addition, according to the complaints, Bluesky Eagle and Supreme Power claimed that they are public companies operating out of office space in New York City. The complaints allege that AI Financial, AI Investment, Invesco Alpha, and Adamant Stone claimed that they operate out of office space in Denver, Colorado. Contrary to these representations, the complaints allege that the current business residents of the New York and Colorado office spaces have no knowledge of the entity or its purported management personnel claiming to operate there, and the other adviser has not reported information about the purported private funds. The complaints also allege that Bluesky Eagle and Supreme Power claimed to be public companies, but that a search of the Commission's public company database yields no information on Bluesky Eagle or Supreme Power.
Additionally, the complaints allege that Bluesky Eagle, Supreme Power, AI Financial, AI Investment, Invesco Alpha, and Adamant Stone each failed to respond to requests by the Commission to provide records to substantiate the information on their Forms ADV, including the amount of assets under management in the United States.
The SEC's complaints charge Bluesky Eagle, Supreme Power, AI Financial, AI Investment, Invesco Alpha, and Adamant Stone with violations of Sections 204(a) and 207 of the Investment Advisers Act of 1940. The complaints seek injunctive relief and civil penalties.
The SEC's investigation is ongoing and is being conducted by Mark Albers, Alexandra Lavin, Xinyue Angela Lin, David London, Sarah McAteer, Samantha McGregor, Ryan Murphy, Dahlia Rin, and Michele Perillo, of the SEC's Boston Regional Office. The SEC thanks the Financial Industry Regulatory Authority (FINRA) for its assistance in this matter.
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Resources
* SEC Complaint - Adamant Stone Limited (https://www.sec.gov/files/litigation/complaints/2025/comp26416-adamant-stone-limited.pdf)
* SEC Complaint - AI Financial Education Foundation Ltd. (https://www.sec.gov/files/litigation/complaints/2025/comp26416-ai-financial-education-foundation-ltd.pdf)
* SEC Complaint - AI Investment Education Foundation Ltd. (https://www.sec.gov/files/litigation/complaints/2025/comp26416-ai-investment-education-foundation-ltd.pdf)
* SEC Complaint - Bluesky Eagle Capital Management Ltd. (https://www.sec.gov/files/litigation/complaints/2025/comp26416-bluesky-eagle-capital-management-ltd.pdf)
* SEC Complaint - Supreme Power Capital Management Ltd. (https://www.sec.gov/files/litigation/complaints/2025/comp26416-supreme-power-capital-management-ltd.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26416
FDA Issues Warning Letter to Sinsin Pharmaceutical
WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Sinsin Pharmaceutical Co. Ltd. from the Center for Drug Evaluation and Research:
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Recipient: Hyun Kwang Dan, Senior Managing Director, Sinsin Pharmaceutical Co., Ltd., 9 Sojeongsandandong-Ro, Sojeong-myeon Sejong 30002, South Korea, hktan@sinsin.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
RE: 718720
Hyun-Kwang Dan:
This letter is to advise you that on April 15, 2025, the U.S. Food and Drug Administration
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WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Sinsin Pharmaceutical Co. Ltd. from the Center for Drug Evaluation and Research:
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Recipient: Hyun Kwang Dan, Senior Managing Director, Sinsin Pharmaceutical Co., Ltd., 9 Sojeongsandandong-Ro, Sojeong-myeon Sejong 30002, South Korea, hktan@sinsin.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
RE: 718720
Hyun-Kwang Dan:
This letter is to advise you that on April 15, 2025, the U.S. Food and Drug Administration(FDA) reviewed your product labeling, including your website at www.sinsinpas.us/, which directs consumers to your Amazon storefront where your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS drug products are available for purchase in the United States without a prescription. We also reviewed your social media on Facebook and Instagram at https://www.facebook.com/search/top?q=sinsinpas_us and https://www.instagram.com/sinsinpas_us, which also direct consumers to your Amazon storefront.
SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
Unapproved New Drug and Misbranded Drug Violations
SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Examples from the SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:
SINSINPAS AREX INSTANT PAIN RELIEF
"Drug Facts . . . Purpose: Topical Analgesic . . . Uses For temporary relief of minor aches and pains of muscles and joints associated with: * Arthritis * Simple Backache * Strains * Bruises * Sprains," "- Joint Pain - Muscle pain - Sprains - Backache" [from the product label]
SINSINPAS Pain Relieving Liquid MULPAS
"Drug Facts . . . Purpose: Topical Analgesic . . . Uses For temporary relief of minor aches and pains associated with: * arthritis * simple backache * sprains * strains * bruises" ; "Muscle Pain Arthritis Strains Insect Bites" [from the product label]
Unapproved New Drug Violations
Based on the above labeling evidence SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a "new drug" within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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 FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application --commonly referred to as "over-the-counter (OTC) monograph drugs"--may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here External Analgesic Drug Products for Over-the-Counter Human Use (hereafter M017)./1 However, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS do not conform to the conditions specified in M017 for the reasons described below.
Your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are formulated with active ingredients that are not permitted for OTC external analgesic drug products under M017.12. Specifically, according to your product's labeling, your SINSINPAS AREX INSTANT PAIN RELIEF product is formulated with the active ingredients zinc oxide and mentha oil. However, zinc oxide and mentha oil are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product.
In addition, your SINSINPAS Pain Relieving Liquid MULPAS is formulated with the active ingredients chlorpheniramine maleate and thymol. However, chlorpheniramine maleate and thymol are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product. Furthermore, FDA has also determined that OTC external analgesic and anesthetic drug products with the active ingredient thymol are not generally recognized as safe and effective (GRASE) under a final determination issued under 21 CFR par 330./2
Thus, your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE./3 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Additionally, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list 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 result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 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 15 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 "718720" 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, U.S. Food and Drug Administration
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Footnotes:
1/ M017 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000033, available at FDA's website OTC Monographs@FDA https://dps.fda.gov/omuf.
2/ Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses. See Order ID OTC000007, available at FDA's website OTC Monographs@FDA, https://dps.fda.gov/omuf.
3/ FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sinsin-pharmaceutical-co-ltd-718720-11122025
FDA Issues Warning Letter to Lowkeydis.com
WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to lowkeydis.com from the Center for Tobacco Products:
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Recipient: lowkeydis.com, United States, directconnect222@gmail.com, store+56747458733@t.shopifyemail.com, hello.cake.info@gmail.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://lowkeydis.com and determined that electronic nicotine
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WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to lowkeydis.com from the Center for Tobacco Products:
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Recipient: lowkeydis.com, United States, directconnect222@gmail.com, store+56747458733@t.shopifyemail.com, hello.cake.info@gmail.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://lowkeydis.com and determined that electronic nicotinedelivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA's jurisdiction to products "containing nicotine from any source," not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of "tobacco product" under section 201(rr) of the FD&C Act (21 U.S.C. Sec. 321(rr)) to include products containing nicotine from any source. Tobacco products, including ENDS products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States ENDS products that lack a marketing authorization order, including: Fog Off 50,000 Puff - Grape Slush and Fog Off 50,000 Puff - Blue Razz Ice.
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec.387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2502372, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ John E. Verbeten, Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Contact Privacy Inc. Customer 0163043946
lowkeydis.com@contactprivacy.com
Tucows, Inc.
domainabuse@tucows.com
Shopify, Inc.
abuse@shopify.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lowkeydiscom-719647-11142025
FDA Issues Warning Letter to 123Herbals
WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to 123Herbals from the Center for Drug Evaluation and Research:
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Recipient: Anthony Trinh, 123Herbals, 7214 Berne St, Rosemead, CA 91770, United States, hello@123herbals.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
RE: 719198
Anthony Trinh:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.123herbals.com from July 2025 to
... Show Full Article
WASHINGTON, Nov. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to 123Herbals from the Center for Drug Evaluation and Research:
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Recipient: Anthony Trinh, 123Herbals, 7214 Berne St, Rosemead, CA 91770, United States, hello@123herbals.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
RE: 719198
Anthony Trinh:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.123herbals.com from July 2025 toNovember 2025. The FDA has observed that your website offers various products including, "SILINTAN," "Ganoderma Huo Luo Dan," "Hong Kong Vail Bon Tong," "SAM NHUNG BO THAN," "TDCARE," and "Vall Boon Antacid" for sale in the United States. In addition, FDA has obtained a sample of your "SILINTAN" product. 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). Furthermore, your "SILINTAN" product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
FDA confirmed through laboratory analysis that a sample of your "SILINTAN" product contains the undeclared active pharmaceutical ingredient meloxicam. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Unapproved New Drugs
Based on a review of your website, your "SILINTAN," "Ganoderma Huo Luo Dan," "Hong Kong Vail Bon Tong," "SAM NHUNG BO THAN," "TDCARE," and "Vall Boon Antacid" 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 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:
SILINTAN
On the webpage https://123herbals.com/collections/frontpage/products/silantin-gout-joint-arthritis-supplements?variant=48198515425580:
* "SILINTAN 100% natural herbal to relief gout, joint, arthritis body aches [sic]."
Ganoderma Huo Luo Dan
On the webpage https://123herbals.com/collections/frontpage/products/ganoderma-huo-luo-dan-arthritis-stiff-joints-gout-hot-item:
* "Ganoderma Huo Luo Dan for relief of Rheumatism, Gout, Arthritis, Stiff Joints, Back Pains."
Hong Kong Vail Bon Tong
On the webpage https://123herbals.com/collections/frontpage/products/hong-kong-vail-bon-tong-cough-herbals-capsules:
* "Non Drowsy Treatment of acute or chronic bronchitis, Coughs due to colds, chronic coughs, sore throats, excessive sputum or phlegm."
SAM NHUNG BO THAN
On the webpage https://123herbals.com/collections/frontpage/products/kian-pee-wan-appetite-stimulant:
* "SAM NHUNG BO THAN herbal supports kidney tonic to nourish blood to improve physiological functions. Improve the symptoms of numb limbs, back pains, relief knee pain due to kidney failure. Relief of Urinary Tract Infection(UTI) symptoms. Support kidney health and limit urged to urinate at night."
TDCARE
On the webpage https://123herbals.com/collections/frontpage/products/korean-red-ginseng-made-in-korea-buy3-get1-more-free-plus-free-shipping:
* "TDCARE helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease."
Vall Boon Antacid
On the webpage https://123herbals.com/collections/frontpage/products/antacid-tablets-606:
* "VALL BOON ANTACID herbals For Use: Gastric pain, Dyspepsia, Bloating, Flatulence, Heartburn, Indigestion."
Your "SILINTAN," "Ganoderma Huo Luo Dan," "Hong Kong Vail Bon Tong," "SAM NHUNG BO THAN," "TDCARE," and "Vall Boon Antacid" 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, new drugs 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).
Misbranded Drug
Your "SILINTAN" product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article's labeling or advertising "is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations." The labeling for your "SILINTAN" product does not declare that the product contains meloxicam. As previously mentioned, this undeclared ingredient in your "SILINTAN" product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose this ingredient in the product labeling renders your "SILINTAN" product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
Your "SILINTAN" product is not the first product found by FDA to contain hidden ingredients. You previously sold the product "Vail-Bon Jie Yang Wan," which FDA laboratory testing identified as containing undeclared dexamethasone and chlorpheniramine.1 In addition, you market other products on your website that are intended for pain relief, similar to "SILINTAN." While the Agency has not sampled and tested these products from your inventory to date, this letter is to emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.
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 "719198" 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
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Footnote:
1/ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/123herbals-llc-123herbalscom-issues-voluntary-nationwide-recall-vail-bon-jie-yang-wan-capsules-due
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/123herbals-719198-11132025
Environment and Natural Resources Division: Hanover Foods Agrees to Pay $1.15M Penalty and Implement Actions to Address Clean Water Act Violations at Wastewater Treatment Facility
WASHINGTON, Nov. 19 -- The U.S. Department of Justice Environment and Natural Resources Division issued the following news release:
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Hanover Foods Agrees to Pay $1.15M Penalty and Implement Actions to Address Clean Water Act Violations at Wastewater Treatment Facility
The Justice Department and Environmental Protection Agency (EPA), working in conjunction with the Pennsylvania Department of Environmental Protection (PADEP), today announced a proposed consent decree with Hanover Foods Corporation. Under the proposed settlement, Hanover Foods would pay a $1.15 million civil penalty and take
... Show Full Article
WASHINGTON, Nov. 19 -- The U.S. Department of Justice Environment and Natural Resources Division issued the following news release:
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Hanover Foods Agrees to Pay $1.15M Penalty and Implement Actions to Address Clean Water Act Violations at Wastewater Treatment Facility
The Justice Department and Environmental Protection Agency (EPA), working in conjunction with the Pennsylvania Department of Environmental Protection (PADEP), today announced a proposed consent decree with Hanover Foods Corporation. Under the proposed settlement, Hanover Foods would pay a $1.15 million civil penalty and takea series of actions to address violations of the Clean Water Act at its wastewater treatment facility in Hanover, Pennsylvania.
"Hanover Foods allegedly failed to properly treat industrial wastes at its wastewater treatment facility, jeopardizing human health and the environment," said Principal Deputy Assistant Attorney General Adam Gustafson of the Justice Department's Environment and Natural Resources Division (ENRD). "The Clean Water Act was enacted more than 50 years ago with the purpose of putting a stop to this type of water pollution. If accepted by the court, the consent decree will hold the company accountable and help ensure it continues to upgrade its facility and take other steps to prevent unlawful discharges of industrial waste."
"Ensuring that Hanover Foods takes the necessary steps to prevent the release of nutrients and other pollutants underscores the EPA's commitment to protecting our nation's waterways," said Acting Assistant Administrator Craig Pritzlaff of the EPA's Office of Enforcement and Compliance Assurance (OECA). "The measures outlined in the consent decree are essential for bringing Hanover's facility into compliance with the Clean Water Act. They are vital for safeguarding the Chesapeake Bay and ensuring that local water sources remain clean, thereby protecting the health and well-being of the communities that rely on them."
As alleged in a complaint filed with the proposed consent decree, Hanover Foods failed to comply with a state-issued National Pollutant Discharge Elimination System (NPDES) permit to operate its wastewater treatment plant in Hanover, Pennsylvania. NDPES permits are required if wastewater is being discharged into a water of the United States (WOTUS).
At this facility, Hanover Foods industrially processes foods, including beans and vegetables, for canning and fresh packing. Hanover Foods treats industrial waste associated with these operations before discharging wastewater into Oil Creek, which eventually flows into the Susquehanna River and then the Chesapeake Bay. Since 2016, Hanover Foods violated its NPDES permit on more than 600 occasions by exceeding its permit limits for pollutants including suspended solids, ammonia nitrogen, and phosphorus. In addition, environmental inspections identified numerous alleged violations of operations and maintenance requirements at Hanover Foods' facility.
Under the terms of the proposed consent decree, Hanover will install new equipment and take other measures to prevent violations of its permit limits for certain nutrients and for temperature. Excessive nutrients and high temperatures can be harmful to aquatic life, including fish, shellfish, and underwater grasses that support aquatic ecosystems.
In addition to upgrades made while this case was under investigation, Hanover Foods will upgrade its wastewater treatment system, closely monitor compliance with its discharge permit, report any violations, identify their root causes, and take corrective action to address them. The upgrades include installation of a permanent boiler to maintain proper temperatures in its treatment process, implementation of spare-parts programs to avoid equipment downtime, and improvements to Hanover's operations and maintenance program, including additional monitoring and tracking requirements.
More information on the settlement is available from the Hanover Foods CWA Settlement case summary page: www.epa.gov/enforcement/hanover-foods-corporation-cwa-settlement-summary.
EPA investigated the case and worked closely with the PADEP.
Attorneys with ENRD's Environmental Enforcement Section are handling the case.
The proposed consent decree was lodged in the U.S. District Court for the Middle District of Pennsylvania and is subject to a 30-day public comment period and final court approval. The consent decree and information on how to submit a public comment are available on the Justice Department's website: www.justice.gov/enrd/consent-decrees.
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Original text here: https://www.justice.gov/opa/pr/hanover-foods-agrees-pay-115m-penalty-and-implement-actions-address-clean-water-act
