Federal Authorities Seize Dietary Supplements from Suburban Chicago Company Due to Allegedly Poor Manufacturing Practices

CHICAGO — At the request of the U.S. Food and Drug Administration, U.S. Marshals have seized more than 300,000 containers of dietary supplements, including tablets, capsules and teas, from a suburban Chicago company.

The containers were held by Life Rising Corp., a Willowbrook-based manufacturer and distributor of dietary supplement products bearing the brand names Life Rising, Holicare, and HopeStream, among others.  The goods were seized Friday at Life Rising’s facilities in the 7800 block of South Quincy Street in the southwest suburb.  The seized goods consisted of more than 500 products, valued at approximately $3.5 million.

The products were seized after the U.S. Attorney’s Office in Chicago filed a civil forfeiture complaint on behalf of the FDA.  The U.S. District Court for the Northern District of Illinois determined there was probable cause that Life Rising prepared, packed and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (cGMP) requirements.

The complaint and seizures were announced by John R. Lausch, Jr., United States Attorney for the Northern District of Illinois; Melinda K. Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs; and Jason R. Wojdylo, Acting Chief Deputy U.S. Marshal for the Northern District of Illinois.  The government is represented by Assistant U.S. Attorney Ernest Y. Ling.

“When dietary supplement manufacturers deviate from proper manufacturing requirements, they put the public health at risk,” said U.S. Attorney Lausch.  “The U.S. Attorney’s Office will continue to work closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health.”

“This seizure underscores the agency’s commitment to taking aggressive action when manufacturers distribute adulterated dietary supplements that have the potential to put consumers at risk,” said Associate FDA Commissioner Plaisier.  “The FDA has a variety of enforcement tools at its disposal, and when products don’t comply with FDA regulations, we will not hesitate to take appropriate action.”

“Were it not for civil asset forfeiture, these products would remain in commerce and a danger to the community,” said Acting Chief Deputy U.S. Marshal Wojdylo.  “Civil forfeiture ensures that no individual or company profits from misconduct, especially when that profit comes from putting the citizens of our communities at risk.”

According to the civil complaint, the FDA earlier this year conducted an inspection of Life Rising’s facility and observed, among other things, significant and continuing deviations from the dietary supplement manufacturing regulations, many of which were similar or identical to violations noted during a prior FDA inspection of Life Rising in 2016 and in a warning letter the FDA issued to Life Rising in 2017.  The FDA inspection found that the company failed to establish product specifications for the identity, purity, strength, and composition of each finished batch of dietary supplement.  The company also lacked written procedures for pest control, and for maintaining, cleaning, and sanitizing equipment that came in contact with the dietary supplements, according to the FDA.

The FDA last month issued an Administrative Detention Order to prevent the products from reaching consumers until they could be seized.  The FDA also issued a safety alert for three Life Rising products (Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing tablets) because those products may be contaminated with lead.  These products were recalled by Life Rising on May 2, 2019, shortly before the FDA’s safety alert.

The FDA discourages consumers from purchasing or using dietary supplement products bearing brand names Life Rising, Holicare, or HopeStream.  Health care professionals and consumers should report to the FDA any adverse events related to Life Rising’s products by completing and submitting the report online at www.fda.gov/medwatch/report.htm, or by downloading the form, completing it, and faxing it to 1-800-FDA-0178.

The public is reminded that a complaint contains only allegations and is not evidence of liability.  The government has the burden of proving the civil case by a preponderance of the evidence.