The injunction, which was issued by a federal court judge in Tennessee, prohibits two companies named Basic Reset and Biogenyx, which operate out of the same location, from engaging in the business activities unless and until they comply with federal law and other requirements listed in a consent decree.
"Americans expect and deserve products that meet appropriate standards for quality. To ensure safe use by consumers, it's important that companies who sell products adhere to standards set forth by the FD&C Act, including product labeling and quality," said Acting FDA Commissioner Ned Sharpless, MD "Despite previous warnings, Basic Reset and Biogenyx placed consumers at risk by distributing certain products in violation of current good manufacturing practice (CGMP) requirements and products which failed to adequately meet labeling standards.”
Case started in 2012
FDA said it began inspecting the companies’ Hendersonville, TN, operations in 2012, inspections which continued into 2017. The companies sell a variety of liquid mineral supplements meant to be added to water, including a supplement that claims to have 25,000 species of probiotics even though no species are listed on the label. The company also markets weight loss supplements in capsule form, a coffee product with added ingredients such as reishi mushroom powder, and a pendant which claims to block harmful electromagnetic radiation. The company sells to consumers directly and also advertises a multi-level marketing scheme.
FDA sent a warning letter to the companies in 2016 in which the agency detailed a slew of illegal disease claims including claims relating arthritis, osteoporosis, heart disease, diabetes and psoriasis. Since the 2016 warning letter was issued, the company has also started selling CBD products.
FDA also said its investigators found numerous violations of the CGMP requirements for dietary supplements, including failing to establish specifications to ensure that the products they receive for labeling are adequately identified and consistent with the purchase order. Because the defendants failed to follow CGMP regulations, FDA deemed their dietary supplements to be adulterated.
Labeling, adverse event deficiencies
Several of the defendants' dietary supplements are also missing information on their labels required by law, rendering those products misbranded. In addition, the warning letter noted that the companies had no system for collecting adverse event reports. The warning letter said that company officials had received complaints of headaches, diarrhea and off taste connected to its products, but none of those complaints were documented.
The agency said subsequent inspections of the manufacturing facility showed that the observations in the warning letter had not been adequately addressed.