FDA Steps Up Enforcement on Unapproved Dietary Supplement Claims

FDA regulations prohibit making drug claims for dietary supplement products even if such claims are supported by scientific evidence. A recent FDA enforcement action involving dietary supplement products promoted to address high cholesterol, hypertension, diabetes, depression and muscle pain claims show that the agency is prepared to take significant steps where manufacturers continue to make drug claims for dietary supplement products, particularly where the facility fails to meet cGMP requirements.

Dietary supplement manufacturer and distributor Michael Floren has consented to a permanent injunction that will see operations cease at his three companies, EonNutra LLC, CDSM LLC and HABW LLC, until they comply with federal regulations. Floren marketed products on many websites, including  www.sotosupplements.com,  www.deerantlermax.com,  www.warhorselabs.com,  www.primalragenutrition.com and www.dnnutrition.com. In addition, his products were sold in a retail location in Colorado Springs, Colorado. Through their investigation, which included four visits to Mr. Floren’s businesses since 2012, the FDA concluded that Mr. Floren and his businesses were marketing the products as drugs without the required FDA approval. Some of the products were marketed as remedies to high cholesterol, hypertension, diabetes, depression and muscle pain. Such claims are considered unapproved drug claims because they are intended to diagnose, cure, mitigate, treat, or prevent disease or illness. Despite repeated representations to address the FDA’s concerns, Mr. Floren failed to make the necessary corrections.

The FDA has also found that Mr. Floren’s businesses were manufacturing and distributing misbranded and adulterated dietary supplements, violating the FDA’s current Good Manufacturing Practice (CGMP) regulations for dietary supplements. Specifically, the FDA found that the businesses failed to “test or verify that components and finished products meet product specifications for identity, purity, strength or composition.” Further, the businesses failed to accurately list the number of servings per container, the serving size, and the ingredients in the dietary supplements on the label, resulting in misbranded products.

The FDA filed suit in federal court in Colorado seeking to shut down the business. The defendants consented to an injunction that prohibits Mr. Floren and his businesses from marketing misbranded or unapproved drugs and dietary supplements until it can be shown that they are in compliance with FDA regulations. In particular, Mr. Floren and his businesses are required to “recall their dietary supplements, hire labeling and good manufacturing practices experts and receive written permission from the FDA” prior to resuming operations.

TAKEAWAY: Manufacturers and distributors of dietary supplements need to give careful consideration to the product claims that could be considered “drug” claims. In addition, failure to comply with CGMP regulations will result in increased enforcement risk.

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