BOSTON – The United States Attorney’s Office today filed a complaint for a permanent injunction to stop Daniel R. Marold from distributing a product that the government claims is an unapproved new drug and an adulterated food under the Federal Food, Drug , and Cosmetic Act (FDCA) ).
The United States alleges that Marold is selling Chill6, a multi-flavored beverage powder, to consumers nationwide through a website that claims the product cures, treats, reduces and prevents anxiety, insomnia, stress, alcoholism and post-traumatic stress disorder , under other conditions. The complaint, which was filed in cooperation with the US Food and Drug Administration (FDA), also alleges that Chill6 contains Phenibut HCL, an unsafe food additive that is not approved for use in the United States. The government further alleges that Marold continued to distribute Chill6 even after the FDA sent him a warning letter in July 2021.
The US complaint seeks to permanently enjoin Marold from selling Chill6 in its current form to all consumers and requires it to comply with federal food safety regulations before selling any other food products.
“The FDA is responsible for ensuring that drugs meet the necessary safety guidelines for human consumption. We contend that Chill6 does not, and even after being warned, Mr. Marold continued to distribute this unapproved substance,” said United States Attorney Rachael S Rollins. “Whether through a criminal offense or civil violation, we are committed to ending the distribution of unregulated and adulterated supplements.”
“Those who distribute drugs, nutritional supplements or food must comply with federal law to ensure that these products are safe,” said Chief Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to stop the distribution of unapproved new drugs in adulterated food products.”
“The FDA’s primary responsibility is to protect US patients and consumers from unproven and dangerous products,” said Judith McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs in the FDA’s Office of Regulatory Affairs. “With our partners at the Department of Justice, we will continue to pursue individuals and companies that distribute products that endanger the public and violate federal law.”
US Attorney Rollins, AAG Boynton and Associate Commissioner McMeekin made the announcement today. The matter is being handled by Assistant US Attorney Steven Sharobem of Rollins’ Affirmative Civil Enforcement Unit and Trial Attorney Manu J. Sebastian of the Justice Department’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Leah A. Edelman of the FDA’s Office of the Chief counsel.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government would have to prove by a preponderance of the evidence.
