Many dietary supplements and drugs claim to provide some type of health benefit. Walk into any Walgreens and you will see an entire aisle devoted to supplements. Or look at any of the ads you are bombarded with when you visit your favorite websites. But how do we really know that these supplements and drugs provide any benefit to those wanting to maximize a healthy lifestyle?
Judge Edward J. McManus of the U.S. District Court for the Northern District of Iowa addressed this question in approving a consent decree on August 17, 2015, permanently enjoining Iowa Select Herbs (“Iowa Select”) from marketing misbranded and adulterated drugs and dietary supplements. Iowa Select is a company claiming “to provide the best product in the world at the lowest possible purchase price on the market.” The company manufactures and distributes a number of dietary supplements, including products such as Cold BeGone, Papaya Leaf Extract, Echinacea Angustifolia Extract, Elderberry Extract, Feverfew Extract, and others. The products were marketed on eBay, Amazon, buy.com, and at retail locations.
The U.S. Department of Justice filed a civil complaint on July 10, 2015 alleging that Iowa Select’s “dietary supplements are manufactured under conditions that are inadequate to ensure the safety of its products.” The complaint stemmed from a U.S. Food and Drug Administration (“FDA”) inspection in August 2014, in which the FDA found that Iowa Select manufactured and distributed misbranded and unapproved drugs. Without obtaining the requisite approval from the FDA, Iowa Select marketed the products, claiming that they could cure everything from cancer to malaria to heart disease. The inspection also revealed that Iowa Select violated the FDA’s Current Good Manufacturing Practice (“CGMP”) regulations, including the failure “to test dietary ingredient components.” Iowa Select’s failure to comply with CGMP regulations resulted in the products being deemed adulterated.
The consent decree sets forth the following:
- Iowa Select and its owners cannot market “misbranded or unapproved new drugs and adulterated or misbranded dietary supplements.”
- Iowa Select and its owners must recall the drugs/dietary supplements, hire labeling/CGMP experts, and obtain prior written consent from the FDA before resuming operations.
Judge McManus’s order is a step in the right direction for providing transparency to consumers focused on improving their health. Hopefully, Iowa Select will now think twice before claiming its products are the panacea for all diseases and ailments.
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