The Justice Department, together with the Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA), announced a civil enforcement action against B4B Earth Tea LLC, B4B Corp., and Andrew Martin Sinclair for alleged violations of the COVID-19 Consumer Protection Act, the FTC Act, and the Federal Food, Drug, and Cosmetic Act (FDCA).
Article continues below
According to a complaint filed in the U.S. District Court for the Eastern District of New York, the defendants advertised that their herbal tea product, Earth Tea, could prevent or treat COVID-19, without competent or reliable scientific evidence to support those claims.
Further, the defendants allegedly made deceptive statements about a scientific study to bolster their unproven COVID-19 claims. The complaint also alleges Earth Tea is an unapproved new drug the defendants are selling in violation of the FDCA.
The complaint seeks civil penalties and other available equitable relief, as well as an injunction to stop the defendants from continuing their unlawful marketing and sales of Earth Tea.
“The Department of Justice will not tolerate individuals or companies seeking to profit from the COVID-19 public health emergency by unlawfully advertising unproven products,†said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice’s Civil Division.
“The department is committed to protecting consumers and enforcing the COVID-19 Consumer Protection Act and the FDCA against those who unlawfully market unproven COVID-19 treatments.â€
“COVID-19 has tragically claimed nearly one million lives in this country and close to six million lives worldwide,†stated U.S. Attorney Breon Peace for the Eastern District of New York. “Unfortunately, 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.â€
“Without any scientific evidence, the defendants claimed that drinking their herbal tea is more effective in preventing COVID-19 than approved vaccines, and cures anyone who has gotten ill within 24 hours,†said Director Samuel Levine of the FTC’s Bureau of Consumer Protection.
“In bringing this matter with our partners at the Department of Justice and the Food and Drug Administration, the Commission continues its commitment to using every tool available to stop and deter those who would treat the pandemic as opportunity to peddle bogus treatments.â€
“Products like this may delay patients from seeking proven treatments from their health care provider,†said Associate Commissioner Judy McMeekin, Pharm.D., for FDA Regulatory Affairs.
“Preying on patients’ vulnerabilities during the COVID-19 pandemic is unacceptable. The FDA will continue to actively monitor the U.S. market for any companies or individuals falsely marketing products with claims it prevents or treats COVID-19, and will take actions against those who violate the law and endanger patients.â€
The COVID-19 Consumer Protection Act, passed by Congress in December 2020, prohibits deceptive acts or practices associated with the treatment, cure, prevention, mitigation or diagnosis of COVID-19. Persons who violate the COVID-19 Consumer Protection Act may be subject to civil penalties, injunctive relief and other remedies available under the FTC Act.
The FDCA provides that a product is an unapproved new drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans but is not generally recognized as safe and effective for its intended uses and is not the subject of an FDA approval. Remedies for violation of the FDCA include injunctive relief. ■