Teh One Who Knocks
03-08-2022, 01:26 PM
Beth Mole - Ars Technica
https://i.imgur.com/cZUHomXl.jpg
The Department of Justice, the Food and Drug Administration, and the Federal Trade Commission together filed a civil lawsuit against a New York man for falsely and repeatedly claiming that a $60 16-ounce bottle of herbal tea can prevent and cure COVID-19.
The agencies accused Andrew Martin Sinclair, who solely owns and operates B4B Earth Tea LLC, of selling snake oil and preying on vulnerable patients during a pandemic that has, to date, claimed the lives of more than 6 million people worldwide.
According to the lawsuit filed Thursday in the Eastern District Court of New York, Sinclair was warned multiple times by the federal agencies that his health claims for "Earth Tea" were illegal. Yet the Brooklyn resident, who goes by “Busta Sinclair,” continued to claim online and on social media that his herbal tea—said to be made of unnamed vegetables, aloe vera, honey, and bottled spring water—"works within minutes" to cure COVID-19 and can get someone "out of quarantine within 24 hours."
Dubious trial
To support his health claims, Sinclair posted on B4B's website individual pages from what he claims are the results of a 15-person clinical trial carried out in India. The pages are made to resemble the official results of a trial, but the report doesn't make clear what the trial was actually measuring, and it also doesn't include any actual results or data analysis. The efficacy conclusion section simply provides this incomprehensible explanation:
The data from 15 patients who received the Investigational drug [the tea] and completed the study were considered to perform the statistical analysis by using the latest version of SAS system software. In the analysis, patients showed a significant reduction in clinical cure and micro biologically cure analysis on Day 02 of evaluation visit. Moreover, significant reduction in the RT-PCR report noted on Day-02. Hence, we can conclude that drug is showing very good results on Day-02 of evaluation visit.
In the overall conclusion, the report states that the results "clearly demonstrate the efficacy... in the significant reduction of COVID-19." It goes on to also note that the 15 people "were extremely satisfied with the drug" and "were also not extremely worried about any side effects."
The FDA, FTC, and DOJ were not convinced. "The unpublished results of this study, even if accurately presented in the report on Defendants' website, do not comprise competent and reliable scientific evidence of any benefit of Earth Tea relating to COVID-19," the suit alleges. "Among other reasons, there was no control group to establish that Earth Tea performed any better than a placebo."
As such, the FDA and FTC sent Sinclair a letter in February 2021 warning him that he was unlawfully marketing his tea. In response, Sinclair removed efficacy claims against COVID-19 from his website—at least temporarily. According to the lawsuit, Sinclair was back at it by April. In September, FTC staff reached out to Sinclair again warning him to stop but were ignored.
Fighting words
In the lawsuit filed Thursday, the federal agencies are seeking civil penalties and a permanent injunction barring Sinclair from selling Earth Tea or similar products, as well as monetary relief and legal fees. The lawsuit noted that Sinclair is believed to "have earned a substantial amount of money from sales of its Earth Tea product during the pandemic, indicating that Defendants' unsubstantiated claims of efficacy against COVID-19 have led to consumers buying the product."
The agencies had harsh words for Sinclair. In a statement, US Attorney for the Eastern District of New York Breon Peace lamented that there are "too many people who are taking advantage of this crisis by pushing alleged treatment products that are nothing more than snake oil. We will not tolerate attempts to make a dishonest dollar while putting our communities at risk during a pandemic.”
The director of the FTC's Bureau of Consumer Protection, Samuel Levine, said the suit highlights the agency's "commitment to using every tool available to stop and deter those who would treat the pandemic as opportunity to peddle bogus treatments." And the FDA's Associate Commissioner for Regulatory Affairs Judy McMeekin worried that claims like Sinclair's can delay patients from seeking proper medical care. "Preying on patients' vulnerabilities during the COVID-19 pandemic is unacceptable."
In a series of media posts and a statement on his website, Sinclair has defended his tea and health claims. "We are been [sic] sued by the government because Our Natural Immune Booster helps our body naturally," a banner on the company's website claims. "Its[sic] available in the USA until a decision is made against us." On Monday, Sinclair posted a Twitter thread suggesting the tea could also treat HIV.
But there are some signs that Sinclair is concerned about the federal suit. Over the weekend, Sinclair tweeted New York officials asking a favor that they "get a judge that believes in both Natural products and Man made products that will be the only way we will get a fair trial." On Monday, he also tweeted: "if anyone know a lawyer that handles FDA DOJ cases etc please you can forward the information."
https://i.imgur.com/cZUHomXl.jpg
The Department of Justice, the Food and Drug Administration, and the Federal Trade Commission together filed a civil lawsuit against a New York man for falsely and repeatedly claiming that a $60 16-ounce bottle of herbal tea can prevent and cure COVID-19.
The agencies accused Andrew Martin Sinclair, who solely owns and operates B4B Earth Tea LLC, of selling snake oil and preying on vulnerable patients during a pandemic that has, to date, claimed the lives of more than 6 million people worldwide.
According to the lawsuit filed Thursday in the Eastern District Court of New York, Sinclair was warned multiple times by the federal agencies that his health claims for "Earth Tea" were illegal. Yet the Brooklyn resident, who goes by “Busta Sinclair,” continued to claim online and on social media that his herbal tea—said to be made of unnamed vegetables, aloe vera, honey, and bottled spring water—"works within minutes" to cure COVID-19 and can get someone "out of quarantine within 24 hours."
Dubious trial
To support his health claims, Sinclair posted on B4B's website individual pages from what he claims are the results of a 15-person clinical trial carried out in India. The pages are made to resemble the official results of a trial, but the report doesn't make clear what the trial was actually measuring, and it also doesn't include any actual results or data analysis. The efficacy conclusion section simply provides this incomprehensible explanation:
The data from 15 patients who received the Investigational drug [the tea] and completed the study were considered to perform the statistical analysis by using the latest version of SAS system software. In the analysis, patients showed a significant reduction in clinical cure and micro biologically cure analysis on Day 02 of evaluation visit. Moreover, significant reduction in the RT-PCR report noted on Day-02. Hence, we can conclude that drug is showing very good results on Day-02 of evaluation visit.
In the overall conclusion, the report states that the results "clearly demonstrate the efficacy... in the significant reduction of COVID-19." It goes on to also note that the 15 people "were extremely satisfied with the drug" and "were also not extremely worried about any side effects."
The FDA, FTC, and DOJ were not convinced. "The unpublished results of this study, even if accurately presented in the report on Defendants' website, do not comprise competent and reliable scientific evidence of any benefit of Earth Tea relating to COVID-19," the suit alleges. "Among other reasons, there was no control group to establish that Earth Tea performed any better than a placebo."
As such, the FDA and FTC sent Sinclair a letter in February 2021 warning him that he was unlawfully marketing his tea. In response, Sinclair removed efficacy claims against COVID-19 from his website—at least temporarily. According to the lawsuit, Sinclair was back at it by April. In September, FTC staff reached out to Sinclair again warning him to stop but were ignored.
Fighting words
In the lawsuit filed Thursday, the federal agencies are seeking civil penalties and a permanent injunction barring Sinclair from selling Earth Tea or similar products, as well as monetary relief and legal fees. The lawsuit noted that Sinclair is believed to "have earned a substantial amount of money from sales of its Earth Tea product during the pandemic, indicating that Defendants' unsubstantiated claims of efficacy against COVID-19 have led to consumers buying the product."
The agencies had harsh words for Sinclair. In a statement, US Attorney for the Eastern District of New York Breon Peace lamented that there are "too many people who are taking advantage of this crisis by pushing alleged treatment products that are nothing more than snake oil. We will not tolerate attempts to make a dishonest dollar while putting our communities at risk during a pandemic.”
The director of the FTC's Bureau of Consumer Protection, Samuel Levine, said the suit highlights the agency's "commitment to using every tool available to stop and deter those who would treat the pandemic as opportunity to peddle bogus treatments." And the FDA's Associate Commissioner for Regulatory Affairs Judy McMeekin worried that claims like Sinclair's can delay patients from seeking proper medical care. "Preying on patients' vulnerabilities during the COVID-19 pandemic is unacceptable."
In a series of media posts and a statement on his website, Sinclair has defended his tea and health claims. "We are been [sic] sued by the government because Our Natural Immune Booster helps our body naturally," a banner on the company's website claims. "Its[sic] available in the USA until a decision is made against us." On Monday, Sinclair posted a Twitter thread suggesting the tea could also treat HIV.
But there are some signs that Sinclair is concerned about the federal suit. Over the weekend, Sinclair tweeted New York officials asking a favor that they "get a judge that believes in both Natural products and Man made products that will be the only way we will get a fair trial." On Monday, he also tweeted: "if anyone know a lawyer that handles FDA DOJ cases etc please you can forward the information."