In March 2017, the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, requiring the businesses to immediately cease operations until they comply with federal laws.
The products were made available on numerous websites and via a retails location in Colorado.
“Companies that market their products with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs, in a recent press release issued by the U.S. Food and Drug Administration. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”
The FDA inspected the businesses numerous time since 2012. Despite assurances the deficiencies would be remedied, subsequent FDA inspections revealed that they had not been.
The FDA also determined that the dietary supplement products were misbranded and unapproved new drugs because they were being marketed with drug claims despite not being approved for any use.
According to the FDA, some of the claims the dietary supplement products were marketed with included the treatment of high cholesterol, hypertension, diabetes, depression and muscle pain.
During the inspections, FDA investigators also found the businesses were manufacturing and distributing misbranded and adulterated dietary supplements.
Numerous violations of the FDA’s current Good Manufacturing Practice (cGMP) regulations for dietary supplements were found, including failure to establish specifications for dietary supplement components and failure to test or verify that components and finished products meet product specifications for identity, purity, strength or composition.
The FDA stated that because the businesses failed to follow cGMP regulations, their dietary supplements were adulterated under the Federal Food, Drug, and Cosmetic Act.
According to the FDA, some of the supplements were also misbranded because the business failed to properly list on the products’ label the number of servings per container and the correct serving size per container. Additionally, the FDA believed that they failed to list each ingredient contained in the dietary supplements and identify the specific part of the plant each botanical dietary ingredient was derived from.
The consent decree prohibits the marketing of misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Additional requirements include product recall, the retention of labeling and good manufacturing practices experts, and written permission from the FDA to resume operations.
If you are a manufacturer or distributor of dietary supplements, contact an advertising compliance lawyer to evaluate whether product claims could be considered “drug” claims, as well as how to mitigate enforcement risk exposure by complying with CGMP regulations.
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HINCH NEWMAN LLP. ADVERTISING MATERIAL. These materials are provided for informational purposes only and are not to be considered legal advice, nor do they create a lawyer-client relationship. No person should act or rely on any information in this article without seeking the advice of an attorney. Information on previous case results does not guarantee a similar future result.