BOSTON – The United States Attorney’s Office filed a complaint for a permanent injunction today to stop Daniel R. Marold from distributing a product the government contends to be an unapproved new drug and an adulterated food under the Federal Food, Drug, and Cosmetic Act (FDCA).
The United States contends that Marold sells Chill6, a multi-flavored beverage powder, to consumers across the country through a website that claims that the product cures, treats, mitigates and prevents anxiety, insomnia, stress, alcoholism and post-traumatic stress disorder, among other conditions. The complaint, filed in partnership with the U.S. 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 FDA sent him a warning letter in July 2021.
The United States’ complaint seeks to permanently enjoin Marold from selling Chill6 in its current form to any consumer and requires him to comply with federal food safety regulations before selling any other food products.
“The FDA is responsible for making sure drugs meet the necessary safety guidelines for human consumption. We allege that Chill6 does not, and even after being warned, Mr. Marold continued distributing this unapproved substance,” said United States Attorney Rachael S Rollins. “Be it by criminal offense or civil violation, we are committed to ending the distribution of unregulated and adulterated supplements.”
“Those who distribute drugs, dietary supplements, or foods must comply with federal law designed to ensure these products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with FDA to stop the distribution of unapproved new drugs and adulterated food products.”
“The FDA’s primary responsibility is to protect U.S. 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 keep pursuing individuals and firms that distribute products that put the public at risk and violate federal law.”
U.S. Attorney Rollins, AAG Boynton and Associate Commissioner McMeekin made the announcement today. The matter is being handled by Assistant U.S. 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 must prove by a preponderance of the evidence.