The US FDA alleged that both Utah-based companies have violated the federal Food, Drug and Cosmetic Act (FDCA) by distributing and manufacturing these dietary supplements
The US Department of Justice said that the US District Court for the District of Utah has restricted Evig and Premium Productions from producing and distributing adulterated and misbranded dietary supplements until further notice.
The complaint was filed in October in the federal court by the US Food and Drug Administration (FDA) against Evig and its CEO, David Lex Howard and Premium Productions and its manager Ryan Petersen.
FDA alleged that both Utah-based companies have violated the federal Food, Drug and Cosmetic Act (FDCA) by distributing and manufacturing these dietary supplements.
As per the complaint, these dietary supplements are commercialised across the US under the brand name Balance of Nature.
According to the lawsuit filed against Evig and Howard, the defendants stated that their dietary supplements might prevent, cure, or treat several diseases and health conditions.
The complaint stated that the supplements were neither approved by the American health regulator nor exempted from approval, making them unapproved new drugs and misbranded as per the requirements of the FDCA.
Additionally, FDA inspections revealed that the defendants had no system in place to handle customer concerns despite receiving adverse reaction reports not listed on the label.
According to the separate lawsuit filed against Premium Productions and Petersen, the defendants’ operations violated the FDCA by failing to create sufficient quality controls, proper operating procedures, and current good manufacturing practices (CGMP).
In August 2019, the FDA sent warning letters to both firms stating that their actions were in violation of the FDCA.
The government claims that after receiving those letters, the defendants did not take the necessary action to comply, the Justice Department said.
Justice Department Civil Division head principal deputy assistant attorney general Brian Boynton said: “Dietary supplement makers also must abide by federal health and safety requirements.
“The department will continue to work closely with FDA to stop the distribution of unapproved, adulterated and misbranded dietary supplements.”
The two consent decrees of permanent injunction against both firms prohibit them from distributing or manufacturing products until they comply with CGMP and labelling regulations.