A federal court on Monday entered a consent decree of permanent injunction against an Iowa-based manufacturer and distributor of dietary supplements.
Under the consent decree, Iowa Select Herbs LLC and its owners, Gordon L. Freeman and Lois A. Dotterweich, cannot resume operations until they recall their products, hire labeling and cGMP (current Good Manufacturing Practice) experts and receive written permission from FDA, according to an agency news release.
Iowa Select Herbs and its owners marketed their products via the company’s website, through online marketplace websites, such as eBay, Amazon and buy.com, and through a retail location in Cedar Rapids, Iowa.
The U.S. Justice Department filed a complaint against Iowa Select Herbs for unlawfully manufacturing and distributing adulterated and misbranded supplements and drugs.
During an August 2014 inspection, FDA found the company had violated cGMPs for supplements—rendering them adulterated under federal law—and was making claims that its products could treat such medical conditions as cancer, heart disease and herpes, according to the news release. Eight months later, based on the inspection and a review of the company’s website, FDA issued a warning letter to Iowa Select Herbs.
A subsequent inspection last summer revealed “significant violations," the government’s lawsuit alleged. Although FDA had issued a Form 483 that cited 13 observations or alleged violations of FDA regulations, the Justice Department claimed the company still had not responded to the agency as of the date of the complaint.
In a phone interview last month with Natural Products INSIDER, Freeman said an FDA investigator never told him that he needed to send the FDA evidence of compliance with the regulations.
“It is unfortunate the matter escalated to this point," said Marc Sanchez, a lawyer representing Iowa Select Herbs, in an emailed statement. “It was not the result of obstinance or a refusal to comply with the Warning Letter or facility inspection, but borne from confusion on the regulatory requirements and communication obligations and channels with the FDA.
“The dietary supplement industry continues to experience growing pains as facilities grapple with making claims and complying with Part 111 (GMP requirements)," added Sanchez, who specializes in FDA regulations. “The low barriers to pre-market entry coupled with a dietary supplement definition lagging behind the market concept of supplements creates a ripe environment for confusion and regulatory violations."