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Treasury Disrupts Sinaloa Cartel Narco-Terrorist Fentanyl Trafficking Operations
WASHINGTON, May 21 -- The U.S. Department of the Treasury issued the following news release on May 20, 2026:* * *
Treasury Disrupts Sinaloa Cartel Narco-Terrorist Fentanyl Trafficking Operations
Today, the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) sanctioned more than a dozen individuals and entities, comprising two distinct networks, linked to the terrorist Sinaloa Cartel and its fentanyl trafficking activities.
Armando de Jesus Ojeda Aviles (Ojeda Aviles) leads a network involved in laundering the proceeds of fentanyl and other narcotics trafficking activities ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of the Treasury issued the following news release on May 20, 2026: * * * Treasury Disrupts Sinaloa Cartel Narco-Terrorist Fentanyl Trafficking Operations Today, the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) sanctioned more than a dozen individuals and entities, comprising two distinct networks, linked to the terrorist Sinaloa Cartel and its fentanyl trafficking activities. Armando de Jesus Ojeda Aviles (Ojeda Aviles) leads a network involved in laundering the proceeds of fentanyl and other narcotics trafficking activitieson behalf of the Sinaloa Cartel. Jesus Gonzalez Penuelas (Gonzalez Penuelas), a fugitive from justice, heads a longstanding organization involved in trafficking illicit drugs into the United States and laundering funds for the Sinaloa Cartel. The violent Sinaloa Cartel is a U.S.-designated Foreign Terrorist Organization (FTO) responsible for a significant portion of the illicit fentanyl trafficked into the United States that kills tens of thousands of Americans each year.
"As President Trump has made clear, this Administration will not allow narco-terrorists to flood our borders with poison," said Secretary of the Treasury Scott Bessent. "Treasury will continue to target terrorist cartels and their fentanyl trafficking networks to protect our communities and Keep America Safe."
Today's action reflects the culmination of a coordinated Homeland Security Task Force (HSTF)-led investigation involving the Drug Enforcement Administration (DEA). OFAC works in close coordination with the HSTFs, which target the proliferation of illicit drugs and the networks, enablers, and financial mechanisms that support their production and distribution. These sanctions were further coordinated with the Government of Mexico's financial intelligence unit, the Unidad de Inteligencia Financiera.
OFAC sanctioned the persons in this action pursuant to Executive Order (E.O.) 14059, which targets the proliferation of illicit drugs and their means of production, and pursuant to E.O. 13224, as amended, which targets terrorists and their supporters.
BLOODLINE OF A CARTEL: LOS CHAPITOS AND FENTANYL FLOWS
The terrorist Sinaloa Cartel is one of the oldest and most powerful cartels in Mexico and represents a major threat to the United States. The Sinaloa Cartel was identified by the United States as a significant foreign narcotics trafficker on April 15, 2009 pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act). On December 15, 2021, OFAC also designated the Sinaloa Cartel pursuant to E.O. 14059. The Sinaloa Cartel has trafficked fentanyl, methamphetamine, cocaine, and other illicit drugs into the United States and engaged in widespread violence. On February 20, 2025, the U.S. Department of State designated the Sinaloa Cartel as an FTO and a Specially Designated Global Terrorist.
Collectively referred to as Los Chapitos, the four sons of incarcerated Sinaloa Cartel leader Joaquin "El Chapo" Guzman Loera --Archivaldo Ivan Guzman Salazar (Ivan), Jesus Alfredo Guzman Salazar (Alfredo), Ovidio Guzman Lopez (Ovidio), and Joaquin Guzman Lopez (Joaquin)--consolidated control over, and assumed leadership of, the Sinaloa Cartel following their father's capture, extradition, and conviction in the United States on drug trafficking charges.
Although Ovidio and Joaquin are now in U.S. custody, Ivan and Alfredo remain at large and lead the Los Chapitos faction of the Sinaloa Cartel. This faction's dominance over fentanyl trafficking is largely the result of its capacity to procure precursor chemicals, while also controlling production via its secret laboratories in the Mexican state of Sinaloa. Since September 2024, turf wars between Los Chapitos and its rivals have engulfed Sinaloa, resulting in the deaths of over 600 people. Ivan and Alfredo were previously designated on May 8, 2012 and June 7, 2012 pursuant to the Kingpin Act, in 2021 pursuant to E.O. 14059, and in June 2025 pursuant to E.O. 13224, as amended. On June 9, 2025, OFAC designated Los Chapitos pursuant to counterterrorism and counternarcotics authorities.
BREAKING THE BLOCKCHAIN: SINALOA CARTEL-LINKED CRYPTO LAUNDERING NETWORK
Operating from Sinaloa, Mexico, Armando de Jesus Ojeda Aviles (Ojeda Aviles) is the head of a network involved in laundering the illicit proceeds of the Sinaloa Cartel's drug trafficking activities, including from illicit fentanyl sales. He is affiliated with Los Chapitos. Specifically, Ojeda Aviles has coordinated the collection of bulk quantities of cash in the United States--the proceeds of fentanyl and other illicit drug sales. He then facilitates the conversion of this bulk cash into cryptocurrency for ultimate transfer to the Sinaloa Cartel in Mexico.
Ojeda Aviles took over as the primary launderer for Los Chapitos after the murder of Mario Alberto Jimenez Castro, whom OFAC designated on September 26, 2023, citing Jimenez Castro's use of digital currency and wire transfers, among other methods, to transfer proceeds from illicit fentanyl sales in the United States to Sinaloa Cartel leaders in Mexico. In addition to laundering drug proceeds, Ojeda Aviles is also directly involved in overseeing shipments of narcotics into the United States, including illicit fentanyl, cocaine, and methamphetamine. Ojeda Aviles's network is composed of Mexico-based drug suppliers, as well as U.S.-based couriers who conduct money pickups.
A close associate of Ojeda Aviles, Jesus Alonso Aispuro Felix (Aispuro Felix) is the chief money broker for this drug trafficking and money laundering network. He is responsible for brokering bulk transfers of drug proceeds through digital currency addresses.
Rodrigo Alarcon Palomares (Alarcon Palomares) is also an associate of Ojeda Aviles and has facilitated money pickups in the United States on behalf of the network. In addition, in April 2024, a federal grand jury in the U.S. District Court for the District of Colorado returned an indictment against Alarcon Palomares for three counts of laundering drug proceeds through cryptocurrency. Alarcon Palomares has also been involved in narcotics sales in the United States. In October 2023, Alarcon Palomares was found in possession of weapons and ammunition and detained in Mexico.
Businessman Alfredo Orozco Romero serves as a security advisor to Ojeda Aviles and acts as a debt collector for money owed on cocaine shipments. Alfredo Orozco Romero controls a Mexican security company, Grupo Especial Mamba Negra, S. de R.L. De C.V., and a Mexican restaurant based in Chihuahua, Mexico, Gorditas Chiwas, through his family members, Amalia Margarita Romero Moreno and Liliana Orozco Romero, who act as his trusted front persons.
OFAC designated Ojeda Aviles and Aispuro Felix pursuant to E.O. 14059 for having provided, or attempted to provide, financial, material, or technological support for, or goods or services in support of, the Sinaloa Cartel. They are also being designated pursuant to E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, the Sinaloa Cartel. OFAC designated Alarcon Palomares pursuant to E.O. 14059 for having engaged in, or attempted to engage in, activities or transactions that have materially contributed to, or pose a significant risk of materially contributing to, the international proliferation of illicit drugs or their means of production. OFAC designated Alfredo Orozco Romero for having provided, or attempted to provide, financial, material, or technological support for, or goods or services in support of, Ojeda Aviles. He is also being designated pursuant to E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, Ojeda Aviles. Finally, OFAC designated Grupo Especial Mamba Negra, S. de R.L. De C.V., Gorditas Chiwas, Amalia Margarita Romero Moreno, and Liliana Orozco Romero pursuant to E.O. 14059 and E.O. 13224, as amended, for being owned, controlled, or directed by, or having acted or purported to act for or on behalf of, directly or indirectly, Alfredo Orozco Romero.
EXPOSING A TRUSTED SINALOA CARTEL MONEY LAUNDERING NETWORK
Jesus Gonzalez Penuelas (Gonzalez Penuelas) has been responsible for the production and distribution of methamphetamine and heroin to the United States since 2007 and is also a major distributor of cocaine and fentanyl. Gonzalez Penuelas was indicted out of the U.S. District Court for the Southern District of California in 2017 and the U.S. District Court for the District of Colorado in 2018 on international drug trafficking charges. In January 2024, DEA offered a reward of $5 million for information leading to the arrest and/or conviction of Gonzalez Penuelas. Shortly after, the U.S. Department of State offered a similar reward. As a cell leader of the Sinaloa Cartel, Gonzalez Penuelas operates primarily in Sinaloa, Mexico with U.S.-based distribution cells in California, Texas, Colorado, Washington, Utah, and Nevada. Treasury previously sanctioned Gonzalez Penuelas pursuant to the Kingpin Act on May 12, 2021.
Castulo Bojorquez Chaparro (Bojorquez Chaparro), a close associate of Gonzalez Penuelas, has been involved in the production and distribution of illicit drugs to the United States on behalf of Gonzalez Penuelas. Fredi Ismael Garcia Sandoval (Garcia Sandoval) and Bojorquez Chaparro utilize businesses in Mexico to launder narcotics proceeds on behalf of Gonzalez Penuelas.
Luis Arnulfo Moreno Zamora (Moreno Zamora) and Baltazar Saenz Aguilar (Saenz Aguilar) oversee the laundering of drug proceeds and are also responsible for the movement of bulk cash from the United States to Mexico on behalf of Gonzalez Penuelas.
Noe de Jesus Castro Rocha (Castro Rocha) is a long-time drug trafficking associate of Gonzalez Penuelas, responsible for trafficking cocaine and heroin to the United States on his behalf.
OFAC designated Gonzalez Penuelas pursuant to E.O. 14059, and pursuant to E.O. 13224, as amended, for being owned, controlled, or directed by, or having acted or purported to act for or on behalf of, directly or indirectly, the Sinaloa Cartel. OFAC designated Bojorquez Chaparro, Garcia Sandoval, Moreno Zamora, Saenz Aguilar, and Castro Rocha pursuant to E.O. 14059, and pursuant to E.O. 13224, as amended, for being owned, controlled, or directed by, or having acted or purported to act for or on behalf of, directly or indirectly, Gonzalez Penuelas.
SANCTIONS IMPLICATIONS
As a result of today's action, all property and interests in property of the designated or blocked persons described above that are in the United States or in the possession or control of U.S. persons are blocked and must be reported to OFAC. In addition, any entities that are owned, directly or indirectly, individually or in the aggregate, 50 percent or more by one or more blocked persons are also blocked. Unless authorized by a general or specific license issued by OFAC, or exempt, OFAC's regulations generally prohibit all transactions by U.S. persons or within (or transiting) the United States that involve any property or interests in property of blocked persons.
Violations of U.S. sanctions may result in the imposition of civil or criminal penalties on U.S. and foreign persons. OFAC may impose civil penalties for sanctions violations on a strict liability basis. OFAC's Economic Sanctions Enforcement Guidelines provide more information regarding OFAC's enforcement of U.S. economic sanctions. In addition, financial institutions and other persons may risk exposure to sanctions for engaging in certain transactions or activities involving designated or otherwise blocked persons. The prohibitions include the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any designated or blocked person, or the receipt of any contribution or provision of funds, goods, or services from any such person. Non-U.S. persons are also prohibited from causing or conspiring to cause U.S. persons to wittingly or unwittingly violate U.S. sanctions, as well as engaging in conduct that evades U.S. sanctions. Individuals located in the United States or abroad who provide information about sanctions violations to the Financial Crimes Enforcement Network's (FinCEN) whistleblower incentive program may be eligible for awards if the information they provide leads to a successful enforcement action that results in monetary penalties exceeding $1,000,000.
Furthermore, engaging in certain transactions involving the persons designated pursuant to E.O. 13224, as amended, may risk the imposition of secondary sanctions on participating foreign financial institutions. OFAC can prohibit or impose strict conditions on opening or maintaining, in the United States, a correspondent account or a payable-through account of a foreign financial institution that knowingly conducts or facilitates any significant transaction on behalf of a person who is designated pursuant to the relevant authority.
The power and integrity of OFAC sanctions derive not only from OFAC's ability to designate and add persons to the Specially Designated Nationals and Blocked Persons List (SDN List), but also from its willingness to remove persons from the SDN List consistent with the law. The ultimate goal of sanctions is not to punish, but to bring about a positive change in behavior. For information concerning the process for seeking removal from an OFAC list, including the SDN List, or to submit a request, please refer to OFAC's guidance on Filing a Petition for Removal from an OFAC List.
Click here for more information on the persons designated today (https://ofac.treasury.gov/recent-actions/20260520).
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Original text here: https://home.treasury.gov/news/press-releases/sb0503
Justice Dept.: Canadian Steel Companies and Owner to Pay $19M to Settle False Claims Act Allegations Relating to Evaded Customs Duties
WASHINGTON, May 21 -- The U.S. Department of Justice issued the following news release:* * *
Canadian Steel Companies and Owner to Pay $19M to Settle False Claims Act Allegations Relating to Evaded Customs Duties
Two Canada-based steel companies, Farjess Inc. and Royal Canadian Steel Inc., along with their part-owner and president, Feroz Jessani, have agreed to pay $19 million to resolve allegations that they violated the False Claims Act by knowingly and improperly failing to pay duties owed on flat-rolled steel that was manufactured in Europe and Asia.
"Import duties serve an important role ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of Justice issued the following news release: * * * Canadian Steel Companies and Owner to Pay $19M to Settle False Claims Act Allegations Relating to Evaded Customs Duties Two Canada-based steel companies, Farjess Inc. and Royal Canadian Steel Inc., along with their part-owner and president, Feroz Jessani, have agreed to pay $19 million to resolve allegations that they violated the False Claims Act by knowingly and improperly failing to pay duties owed on flat-rolled steel that was manufactured in Europe and Asia. "Import duties serve an important rolein protecting our national interests generally and the American steel industry in particular," said Assistant Attorney General Brett A. Shumate of the Justice Department's Civil Division. "The Department of Justice will zealously pursue anyone who fraudulently evades the duties owed on steel products imported into this country."
"Our border is the frontline of American industry. Approximately half of all U.S.-Canada land trade flows through our district." said U.S. Attorney Jerome F. Gorgon Jr. for the Eastern District of Michigan. "And we will continue to protect our businesses from foreign fraudsters,"
"This settlement underscores the United States' strong commitment to enforcing trade laws and maintaining the integrity of our supply chains. U.S. Customs and Border Protection is proud to have supported the Department of Justice in this cross-border investigation, ensuring that all duties owed to the government are collected and that fair competition is preserved," said Acting Director Jonathan Restivo of Center of Excellence and Expertise (CEE), Base Metals. "This case sends a clear message that CBP, in partnership with our federal counterparts, will continue to uphold the rule of law and protect the interests of American businesses and consumers."
"Since 1789, the United States has imposed tariffs and collected customs duties on imports to fund government operations, provide public services and protect American industry," said Acting Special Agent in Charge Jared Murphey of Homeland Security Investigations' Detroit field office. "This record-setting settlement underscores HSI's commitment to protecting American manufacturers and consumers from unfair trade practices and ensuring the integrity of our nation's economic policies."
To enter goods into the United States, an importer must declare, among other things, the country of origin of the goods, the value of the goods, whether the goods are subject to duties, and the amount of duties owed. U.S. Customs and Border Protection (CBP) collects applicable duties.
The settlement resolves allegations that, from May 2019 through January 2025, Farjess Inc., Royal Canadian Steel Inc., and Feroz Jessani avoided duties owed to the United States by knowingly misrepresenting to CBP that the country of origin of certain flat-rolled steel was Canada or the United States, when in fact they knew the true country of origin was China, Indonesia, Italy, Turkey, or Vietnam.
The settlement resolves a civil lawsuit filed by Shamsh Dhala, a broker who worked with Farjess Inc., under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and to share in a portion of the government's recovery. The lawsuit was filed in the Eastern District of Michigan and is captioned United States ex rel. Dhala v. Royal Canadian Steel Inc. et al., No. 2:23-cv-12097 (E.D. Mich.). As part of today's resolution, Mr. Dhala will receive approximately $3,610,000 of the settlement proceeds.
This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration's war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division's FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division's FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.
The Civil Division coordinated this action through the Department of Justice's Trade Fraud Task Force, a cross-agency law enforcement effort. The Task Force was created to leverage all of the Department's tools and authorities to prevent trade fraud that deprives the government of vital revenue, threatens critical domestic industries, undermines consumer confidence, and weakens national security. The Task Force is designed to pursue enforcement actions against parties who seek to evade tariffs and other duties, as well as smugglers who seek to import prohibited goods into the American economy. The Justice Department encourages whistleblowers to alert the government to credible allegations of fraud, including utilizing the qui tam provisions of the False Claims Act or through the Department's Corporate Whistleblower Program at CorporateWhistleblower@usdoj.gov using the form available here (https://www.justice.gov/media/1362356/dl?inline=&utm_medium=email&utm_source=govdelivery).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department's Civil Division, Commercial Litigation Branch, Fraud Section, and the U.S. Attorney's Office for the Eastern District of Michigan, with assistance from U.S. Customs and Border Protection's Office of the Associate Chief Counsel, Homeland Security Investigations, and the Justice Department's Office of Foreign Litigation.
The matter was handled by Trial Attorney James Nealon and Assistant U.S. Attorney John Postulka for the Eastern District of Michigan.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
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Original text here: https://www.justice.gov/opa/pr/canadian-steel-companies-and-owner-pay-19m-settle-false-claims-act-allegations-relating
FDA Center for Tobacco Products Issues Warning Letter to Vapetrinity.com
WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to vapetrinity.com from its Center for Tobacco Products:* * *
Recipient: vapetrinity.com, United States, muninrym2@outlook.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://www.vapetrinity.com and determined that a dissolvable tobacco product listed there is offered for sale or distribution ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to vapetrinity.com from its Center for Tobacco Products: * * * Recipient: vapetrinity.com, United States, muninrym2@outlook.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://www.vapetrinity.com and determined that a dissolvable tobacco product listed there is offered for sale or distributionto 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)), this product is a tobacco product because it is made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including dissolvable tobacco 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.
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 Product Without Required Marketing Authorization is Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States a dissolvable tobacco product that lacks a marketing authorization order: Lost Mary Airplane Mode Strawberry Nicotine Film - 2mg/Strip - 20pk.
The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, it is 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 this product was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Additional Considerations
Children are at particular risk for ingesting oral tobacco products like dissolvable tobacco products with labeling, advertising, and/or design features that cause the product to imitate a food and/or edible products, particularly products that are typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to nicotine in a dissolvable product, even in relatively small amounts, could result in acute toxicity.
FDA finds this unauthorized product particularly concerning because the product labeling, advertising, and/or design for Lost Mary Airplane Mode Strawberry Nicotine Film product (see Exhibit A) may be attractive to children and youth by imitating the look of breath strips with a candy-like flavor (see Exhibit B).
Exposure to oral tobacco products containing 2-3 mg of nicotine or more per product unit likely presents a serious risk of severe acute toxicity, including seizures and potentially life-threatening outcomes, in children under 6 years old.
Further, the unauthorized product's labeling, advertising, and/or design may be attractive to youth because the labeling, advertising, and/or design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the product is a tobacco product or be confused with an everyday object and accidently ingested by young children. Any labeling, advertising, and/or design features that could entice youth to initiate or maintain use of tobacco products are of concern to FDA. Sales of such unauthorized tobacco products are prohibited, and FDA is concerned that your actions could encourage unlawful sales and maintain or increase youth use.
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, RW2602413, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
MAT BAO CORPORATION
abuse@matbao.com
* * *
Cloudflare, Inc.
abuse@cloudflare.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vapetrinitycom-730109-05192026
FDA Center for Tobacco Products Issues Warning Letter to Smoker Business
WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Smoker Business from its Center for Tobacco Products:* * *
Recipient: Smoker Business, 1700 W 23rd Street, Lawrence, KS 66046, United States, smoker1700@gmail.com, waleed.alsamet@gmail.com, 402smoker@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://smoker.business and determined ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Smoker Business from its Center for Tobacco Products: * * * Recipient: Smoker Business, 1700 W 23rd Street, Lawrence, KS 66046, United States, smoker1700@gmail.com, waleed.alsamet@gmail.com, 402smoker@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://smoker.business and determinedthat dissolvable tobacco 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 dissolvable tobacco 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.
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 dissolvable tobacco products that lack a marketing authorization order, including: Hyde Nic Strips - Cool Mint 2mg.
The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, it is 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 this product was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Additional Considerations
Children are at particular risk for ingesting oral tobacco products like dissolvable tobacco products with labeling, advertising, and/or design features that cause the product to imitate a food and/or edible products, particularly products that are typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to nicotine in a dissolvable product, even in relatively small amounts, could result in acute toxicity.
FDA finds this unauthorized product particularly concerning because the product labeling, advertising, and/or design for Hyde Nic Strips product (see Exhibit A) may be attractive to children and youth by imitating breath strips (see Exhibit B).
Exposure to oral tobacco products containing 2-3 mg of nicotine or more per product unit likely presents a serious risk of severe acute toxicity, including seizures and potentially life-threatening outcomes, in children under 6 years old.
Further, the unauthorized product's labeling, advertising, and/or design may be attractive to youth because the labeling, advertising, and/or design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the product is a tobacco product or be confused with an everyday object and accidently ingested by young children. Any labeling, advertising, and/or design features that could entice youth to initiate or maintain use of tobacco products are of concern to FDA. Sales of such unauthorized tobacco products are prohibited, and FDA is concerned that your actions could encourage unlawful sales and maintain or increase youth use.
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, RW2602414, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Smoker
923 Galvin Road South
Bellevue, NE 68005
* * *
Smoker Inc
Smoker, LLC
Attn: Waleed Samet
15847 Rosewood St Apt 06
Omaha, NE 68136
* * *
Smoker Inc
Attn: Damien P. Foster
11516 Nicholaus Street, Suite 302
Omaha, NE 68154
* * *
Contact Privacy Inc. Customer 0166501639
smoker.business@contactprivacy.com
* * *
Shopify, Inc.
abuse@shopify.com
* * *
Tucows Domains, Inc.
domainabuse@tucows.com
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smoker-business-730104-05192026
FDA Center for Tobacco Products Issues Warning Letter to Npouches.com
WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to npouches.com from its Center for Tobacco Products:* * *
Recipient: npouches.com, United States, privacy@npouches.com, info@npouches.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://npouches.com and determined that dissolvable tobacco products listed there are offered for sale or distribution ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to npouches.com from its Center for Tobacco Products: * * * Recipient: npouches.com, United States, privacy@npouches.com, info@npouches.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://npouches.com and determined that dissolvable tobacco products listed there are offered for sale or distributionto 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 dissolvable tobacco 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.
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 dissolvable tobacco products that lack a marketing authorization order, including: Hyde Nic Strips - Cool Mint 2mg.
The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, it is 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 this product was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Additional Considerations
Children are at particular risk for ingesting oral tobacco products like dissolvable tobacco products with labeling, advertising, and/or design features that cause the product to imitate a food and/or edible products, particularly products that are typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to nicotine in a dissolvable product, even in relatively small amounts, could result in acute toxicity.
FDA finds this unauthorized product particularly concerning because the product labeling, advertising, and/or design for the Hyde Nic Strips product (see Exhibit A) may be attractive to children and youth by imitating breath strips (see Exhibit B).
Exposure to oral tobacco products containing 2-3 mg of nicotine or more per product unit likely presents a serious risk of severe acute toxicity, including seizures and potentially life-threatening outcomes, in children under 6 years old.
Further, the unauthorized product's labeling, advertising, and/or design may be attractive to youth because the labeling, advertising, and/or design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the product is a tobacco product or be confused with an everyday object and accidently ingested by young children. Any labeling, advertising, and/or design features that could entice youth to initiate or maintain use of tobacco products are of concern to FDA. Sales of such unauthorized tobacco products are prohibited, and FDA is concerned that your actions could encourage unlawful sales and maintain or increase youth use.
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, or 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 http://www.fda.gov.
Please note your reference number, RW2602421, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
* * *
Shopify, Inc
abuse@shopify.com
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/npouchescom-730125-05192026
FDA Center for Tobacco Products Issues Warning Letter to Gethyppe.com
WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to gethyppe.com from its Center for Tobacco Products:* * *
Recipient: gethyppe.com, 1301 South Shamrock Ave., Monrovia, CA 91016, United States, info@gethyppe.com, info@21pouches.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://gethyppe.com and determined that dissolvable tobacco products ... Show Full Article WASHINGTON, May 21 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to gethyppe.com from its Center for Tobacco Products: * * * Recipient: gethyppe.com, 1301 South Shamrock Ave., Monrovia, CA 91016, United States, info@gethyppe.com, info@21pouches.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://gethyppe.com and determined that dissolvable tobacco productslisted 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 dissolvable tobacco 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.
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 dissolvable tobacco products that lack a marketing authorization order, including: Hyppe Nicotine Lozenges - Toffee 6mg, Hyppe Nicotine Lozenges - Magic Love 6mg, Hyppe Nicotine Lozenges - Mighty Mint 6mg, and Hyppe Nicotine Lozenges - Blue Razz 6mg.
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)).
Additional Considerations
Children are at particular risk for ingesting oral tobacco products like dissolvable tobacco products with labeling, advertising, and/or design features that cause the product to imitate a food and/or edible products, particularly products that are typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to nicotine in a dissolvable product, even in relatively small amounts, could result in acute toxicity.
FDA finds these unauthorized products particularly concerning because the product labeling, advertising, and/or design for Hyppe Nicotine Lozenges (see Exhibit A, for example) may be attractive to children by imitating cough drops and candy (see Exhibit B, for example).
Exposure to oral tobacco products containing 2-3 mg of nicotine or more per product unit likely presents a serious risk of severe acute toxicity, including seizures and potentially life-threatening outcomes, in children under 6 years old.
Further, the unauthorized product's labeling, advertising, and/or design may be attractive to youth because the labeling, advertising, and/or design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the product is a tobacco product or be confused with an everyday object and accidently ingested by young children. Any labeling, advertising, and/or design features that could entice youth to initiate or maintain use of tobacco products are of concern to FDA. Sales of such unauthorized tobacco products are prohibited, and FDA is concerned that your actions could encourage unlawful sales and maintain or increase youth use.
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, or 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 http://www.fda.gov.
Please note your reference number, RW2602416, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Performance Plus Marketing Inc.
116 N Heliotrope Ave
Monrovia, CA 91016-2410
* * *
Performance Plus Marketing Inc.
4121 34th Street B6
Orlando, FL 32811
* * *
United State Corporation Agents, Inc.
479 Riverside Ave.
Jacksonville, FL 32202
* * *
Northwest Register Agent Service
4030 Wake Forest Road STE 349
Raleigh, NC 27609
* * *
GoDaddy.com, LLC
abuse@godaddy.com
* * *
Shopify, Inc.
abuse@shopify.com
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gethyppecom-730121-05192026
FCC to Streamline Broadband Data Collection Processes
WASHINGTON, May 21 -- The Federal Communications Commission issued the following news release on May 20, 2026:* * *
FCC to Streamline Broadband Data Collection Processes
Action Will Also Ensure Accuracy of Data Depicted on the National Broadband Map
*
Location-specific broadband availability data is an important tool for consumers, communities, and policymakers. Today, the Federal Communications Commission adopted rules to streamline the processes supporting its Broadband Data Collection. These improvements will help federal agencies; state, local, and Tribal governments; and other interested ... Show Full Article WASHINGTON, May 21 -- The Federal Communications Commission issued the following news release on May 20, 2026: * * * FCC to Streamline Broadband Data Collection Processes Action Will Also Ensure Accuracy of Data Depicted on the National Broadband Map * Location-specific broadband availability data is an important tool for consumers, communities, and policymakers. Today, the Federal Communications Commission adopted rules to streamline the processes supporting its Broadband Data Collection. These improvements will help federal agencies; state, local, and Tribal governments; and other interestedstakeholders identify and target broadband investment to areas where it is needed most.
Today's actions aim to reduce unnecessary regulatory burdens and costs, while also improving the accuracy of the data collected and shown on the National Broadband Map. The Report and Order aligns reporting requirements for broadband availability and subscription data; streamlines the Fabric challenge process by eliminating the requirement that providers be notified of and allowed to respond to Fabric challenges during the Fabric development cycle; simplifies verification and audit processes; and makes certain administrative changes to the BDC rules to increase clarity.
To ensure the Broadband Data Collection keeps pace with the evolving technologies that are expanding access to high-speed internet services, the Further Notice of Proposed Rulemaking seeks comment on: approaches to simplify and streamline the coverage restoration process; eliminating requirements to submit "grandfathered" data; establishing voluntary best practices for data retention; mobile verification and audit process improvements; and other process improvements.
In March 2020, Congress passed the Broadband DATA Act, requiring a more granular, location-specific collection of broadband availability data. Congress also required the FCC to establish and overlay fixed broadband availability data on the Broadband Serviceable Location Fabric and to establish processes for verifying the accuracy of the provider-reported data, including through public challenge processes. To implement these requirements, the FCC created the Broadband Data Collection and launched the National Broadband Map.
Action by the Commission May 20, 2026 by Report and Order and Further Notice of Proposed Rulemaking (FCC 26-33). Chairman Carr, Commissioners Gomez and Trusty approving. Chairman Carr and Commissioner Trusty issuing separate statements.
WC Docket Nos. 11-10, 19-195; GN Docket No. 25-133
* * *
Original text here: https://docs.fcc.gov/public/attachments/DOC-421878A1.pdf