| From: Pogeu Mahone | 7/12/2022 5:25:21 PM | | | | | | WARNING LETTER
Lianhuaqingwencaps.comMARCS-CMS 608667 — JULY 06, 2020
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Product:Drugs
Recipient:Lianhuaqingwencaps.com304 Tarrigart DriveMoore, SC 29369United States
support@lianhuaqingwencaps.com
Issuing Office:Center for Drug Evaluation and Research | CDERUnited States
Federal Trade Commission
WARNING LETTER
Date: July 6, 2020
RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address lianhuaqingwencaps.com on June 15, 2020, and July 1, 2020, respectively. The FDA has observed that your website offers a traditional Chinese medicine (TCM) product for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. [2] In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. [3] Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Some examples of the claims on your website that establish the intended use of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include:
A graphic with the image of your product Lianhua Qingwen Capsules under the header “CAPS AGAINST COVID-19 . . .” [from your website lianhuaqingwencaps.com]“LIANHUA QINGWEN CAPS TREATS MILD FEVER COUGH AND FATIGUE IN C-VIRUS PNEUMONIA . . .” [from your website lianhuaqingwencaps.com]“Lianhua Qingwen 24 capsules . . . has also been identified as having potential antiviral activity against coronaviruses such as SARS-CoV-2.” [from your website lianhuaqingwencaps.com]“Traditional Chinese Medicine Lianhua Qingwen Plays an Important Role in Fighting Against COVID-19. . . It has been listed in the ‘Diagnosis and Treatment Plan for COVID-19 Infection’ (Trial Version 4/5/6/7) of the China Health and Health Commission and recommended drugs in the diagnosis and treatment plans of COVID-19 of the Health and Health Commission of 20 provinces. . .” [from your website lianhuaqingwencaps.com]Research Provides Scientific Evidence for Lianhua Qingwen . . . The antiviral effect of Lianhua Qingwen has been confirmed by a large number of scientific researches. . . Professor Yang Zifeng . . . said ‘[L]ianhua Qingwen capsule (granule) showed significant cytopathic effect of inhibiting COVID-19 virus. It is known for all that the COVID-19 virus is not only a virus, but also causes a series of over-expression of inflammation. Therefore, people have also observed that Lianhua Qingwen capsule (granule) inhibits the over-expression of human common coronavirus (HcV-229E), novel coronavirus (COVID-19) infected cells and induced inflammatory factors such as TNF-a, IL-6, CCL2/MCP-1 and CXCL-10/IP-10. This is consistent with clinical inflammatory factors. ’[sic]This just proves that Lianhua Qingwen has the multi-target effect of inhibiting novel coronavirus and resisting inflammation.” [from your website lianhuaqingwencaps.com]“Lianhua Qingwen is widely used in epidemic prevention and control, helping the global epidemic prevention and control.” [from your website lianhuaqingwencaps.com]“Tags: 19 . . . covid . . . inhibitor” [from your website lianhuagingwencaps.com]You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at fda.gov. Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. 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 are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.
In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the specific actions you have taken to address the FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088  .
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Sincerely,
/S/
Serena Viswanathan
Acting Associate Director
Division of Advertising Practices
Federal Trade Commission
[1] As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
[2] Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at phe.gov. The declaration was renewed for another 90 days on April 21, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. April 21, 2020. (Accessible at phe.gov.
[3] President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at whitehouse.gov.
Content current as of:07/07/2020
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| From: Pogeu Mahone | 7/21/2022 11:37:32 AM | | | | | | The virus kicking ass, I certainly would like to see Paxlovid
rebound,The FDA needs a wake up call.
-----------------------------------------------
President Joe Biden tests positive for COVID-19
By
Steven Nelson
July 21, 2022 10:27am
MORE ON:CORONAVIRUS
Chinese authorities apologize for ‘violent’ COVID-19 break-ins
Hochul pressed on renewing donor-friendly COVID state of emergency edict
Jan. 6 panel chair has COVID, primetime hearing to go ahead
Hey, Team Biden: Enough with the COVID emergency declarations!
President Biden on Thursday tested positive for COVID-19 — one day after giving a gaffe-filled speech that spurred health concerns and about four days after returning from meetings in Saudi Arabia with killer Crown Prince Mohammad bin Salman.
Biden, 79, is the oldest-ever American president and his advanced age puts him at elevated risk of serious illness or death, though he has received four shots of Pfizer’s coronavirus vaccine, reducing the risk.
“This morning, President Biden tested positive for COVID-19,” press secretary Karine Jean-Pierre said in an emailed press release.
”He is fully vaccinated and twice boosted and experiencing very mild symptoms. He has begun taking Paxlovid,” she said.
“Consistent with CDC guidelines, he will isolate at the White House and will continue to carry out all of his duties fully during that time. He has been in contact with members of the White House staff by phone this morning, and will participate in his planned meetings at the White House this morning via phone and Zoom from the residence.”
Biden managed to evade the virus for more than 2 1/2 years of the COVID-19 pandemic, including by campaigning for president largely from his home in Wilmington, Del.
President Biden has tested positive for COVID.Getty ImagesThe president will isolate at the White House and conduct meetings via Zoom.APThe president is “fully vaccinated and twice boosted and experiencing very mild symptoms,” White House press secretary Karine Jean-Pierre said.Getty ImagesThis year, Biden has regularly hosted mask-free interactions with guests at the White House and shaken hands with people at events across the nation and world.
The president’s diagnosis comes just over four days after he returned from Saudi Arabia, where he sought to repair relations with bin Salman in exchange for greater oil production to lower high US gas prices. He had previously sought to sideline the prince over his role in the murder of Washington Post journalist Jamal Khashoggi.
Since March 2020, COVID-19 has killed more than 1 million US residents. But the current strains have proven to be fatal largely among those who are unvaccinated.
President Donald Trump caught COVID-19 in October 2020 and was hospitalized for three nights at the Walter Reed National Military Medical Center in Maryland.
The virus swirled around Biden repeatedly this year without him catching it.
In April, a large number of prominent DC Democrats tested positive for the virus, including Vice President Kamala Harris, Attorney General Merrick Garland, Commerce Secretary Gina Raimondo and Harris’ communications director Jamal Simmons.
House Speaker Nancy Pelosi (D-Calif.) tested positive April 7 after attending two White House events with Biden. Biden kissed Pelosi on the cheek at one event and she stood behind his shoulder one day later at a bill-signing ceremony.
Biden was scheduled to make a trip Thursday to Pennsylvania to discuss his approach to crime before attending a fundraiser in Philadelphia.
“Consistent with White House protocol for positive COVID cases, which goes above and beyond CDC guidance, he will continue to work in isolation until he tests negative. Once he tests negative, he will return to in-person work,” Jean-Pierre said in her statement.
“Out of an abundance of transparency, the White House will provide a daily update on the president’s status as he continues to carry out the full duties of the office while in isolation.”
FILED UNDER CORONAVIRUS JOE BIDEN 7/21/22
READ NEXT
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| To: Yorikke who wrote (16149) | 7/22/2022 8:48:39 AM | | From: Pogeu Mahone | | | | Massachusetts reports 30 new monkeypox cases, another one-week high as WHO considers declaring global emergency
The state has reported a total of 79 monkeypox cases
This 2003 electron microscope image made available by the Centers for Disease Control and Prevention shows mature, oval-shaped monkeypox virions, left, and spherical immature virions, right, obtained from a sample of human skin associated with the 2003 prairie dog outbreak. On Wednesday, May 18, 2022, Portuguese health authorities confirmed five cases of monkeypox in young men, marking an unusual outbreak in Europe of a disease typically limited to Africa. (Cynthia S. Goldsmith, Russell Regner/CDC via AP)
By RICK SOBEY | rick.sobey@bostonherald.com | Boston Herald
PUBLISHED: July 21, 2022 at 5:42 p.m. | UPDATED: July 21, 2022 at 6:22 p.m.
State health officials reported 30 new monkeypox cases on Thursday, yet another one-week virus high as the World Health Organization considers declaring monkeypox a global emergency.
The 30 new monkeypox cases in the Bay State is up from 18 cases during the previous week. The 30 new cases were diagnosed in men within the past week, according to the Massachusetts Department of Public Health.
It brings the total number of monkeypox cases in the state to 79 since the state’s first case was announced in mid-May. That first case was also the country’s first confirmed case.
There have been 2,323 reported cases of monkeypox virus in U.S. residents this year, according to the Centers for Disease Control and Prevention. That’s a significant jump of 1,270 cases since last week.
No deaths have been reported related to this global outbreak, and patients generally recover fully in 2 to 4 weeks.
Gay and bisexual men and other men who have sex with men make up a large proportion of the cases.
“However, the risk is not limited to the LGBTQ+ community, and anyone who has been in close contact with someone who has monkeypox is at risk,” DPH said.
World Health Organization officials met on Thursday to consider if it should declare monkeypox a “Public Health Emergency of International Concern.”
“I remain concerned about the number of cases, in an increasing number of countries, that have been reported to WHO,” WHO Director-General Tedros Adhanom Ghebreyesus said at the meeting.
“It’s pleasing to note an apparent declining trend in some countries, but others are still seeing an increase, and six countries reported their first cases last week,” he later added.
Transmission occurs through direct contact with body fluids and monkeypox sores, by touching items that have been contaminated with fluids or sores (clothing, bedding, etc.), or less commonly, through respiratory droplets following prolonged face-to-face contact.
In many of the recent cases, the locations of the rash lesions suggest transmission during sexual contact.
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Monkeypox outbreak: US boosting its vaccination strategy, handing out 296,000 vax doses in coming weeksDPH received its initial allocation of 2,004 doses of the monkeypox vaccine on July 5.
The number of health care providers and locations offering vaccination across the state has now expanded to 11, and nearly 3,000 vaccine doses have been administered.
DPH said, “Due to extremely limited national availability of vaccine, the JYNNEOS vaccine in Massachusetts remains severely limited at this time.”
Tags: CDC Centers for Disease Control and Prevention Department of Public Health DPH Massachusetts monkeypox vaccination vaccine WHO World Health Organization
Rick Sobey
Rick Sobey is a multimedia, general assignment reporter -- covering breaking news, politics and more across the region. He was most recently a reporter at The Lowell Sun. Rick is a Massachusetts native and graduated from Boston University. While not reporting, he enjoys long-distance running.
rick.sobey@bostonherald.com
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