North Dakota residents warned about companies promoting unapproved stem cell injections through restaurant sales presentations
Bismarck, North Dakota – North Dakota Attorney General Drew H. Wrigley has issued an urgent warning to residents about companies promoting unapproved stem cell treatments and human tissue injections during sales presentations held at local restaurants.
According to the Attorney General’s Office, some businesses are using these events to advertise expensive medical treatments while making claims about their effectiveness that have not been supported by reliable scientific evidence.
The companies reportedly tell potential customers that their products can reduce pain or help treat serious medical conditions, including Parkinson’s disease, diabetes, multiple sclerosis, Alzheimer’s disease, autism, dementia and various orthopedic problems.
Wrigley warned that these claims are false or misleading and could expose consumers to serious health complications and significant financial losses.
The advisory also raises concerns about companies targeting older adults and individuals who may be searching for relief from ongoing pain or difficult medical conditions.
Unapproved treatments can pose serious health risks
The Attorney General’s Office explained that stem cell treatments and similar human tissue products must meet strict federal requirements before they can legally be marketed for the medical purposes being advertised.
Under state and federal law, companies cannot lawfully sell treatments that require approval from the U.S. Food and Drug Administration (FDA) without completing the necessary clinical testing and receiving that approval.
However, some businesses attempt to reassure potential customers by claiming that their products come from FDA-registered facilities or that their operations follow FDA guidelines.
State officials emphasized that these statements do not establish that the treatments themselves have received FDA approval.
They also do not guarantee that the products are being manufactured, handled or marketed in accordance with federal safety requirements.
The FDA has previously taken enforcement action against businesses selling unapproved stem cell products and warned about the potential dangers to patients.
The Federal Trade Commission has also determined that similar sales presentations involving misleading stem cell treatment claims violated federal consumer protection laws and harmed consumers.
According to the advisory, serious medical problems have been reported following injections of unapproved stem cell products.
These complications include life-threatening infections, ongoing pain and other harmful health effects.
Officials are therefore encouraging residents to approach advertisements promising relief from multiple unrelated medical conditions with caution.
Company accused of misleading consumers through free dinner presentations
One business specifically identified in the advisory is Freedom Regenerative LLC.
According to the Attorney General’s Office, the company has sent promotional mailers to North Dakota residents inviting them to attend free dinner events.
During these gatherings, company representatives reportedly present information about stem cell treatments and other products while making misleading claims about their ability to reduce pain or provide other medical benefits.
The Attorney General’s Office alleges that the presentations exaggerate the effectiveness of the treatments being offered.
The company is also accused of conducting business in North Dakota without obtaining the transient merchant license required under state law.
Officials said the treatments marketed by Freedom Regenerative LLC cost between $9,000 and $29,000.
Such prices could create substantial financial burdens for consumers, particularly those who purchase the products believing they will receive medical benefits that have not been proven.
Wrigley stressed that companies making unsupported medical promises could face consequences for violating consumer protection requirements.
“There is a cause for alarm, because these unproven products or therapies pose a significant risk to an individual’s health and financial well-being,” said Wrigley. “Businesses that make unsubstantiated claims and violate the law will be held accountable, particularly when they target older adults and take advantage of a person’s pain or illness for their own gain,” adds Wrigley.
The warning highlights the importance of checking medical claims before agreeing to costly treatments, especially when those treatments are promoted outside traditional healthcare settings.
Residents encouraged to consult doctors and report misleading claims
Wrigley is urging North Dakota residents to speak with their primary care physicians before purchasing alternative medical treatments advertised on the internet or promoted through local sales events.
A medical professional can help patients better understand the available evidence, possible risks and whether a proposed treatment is appropriate for their condition.
The Attorney General’s Office also wants consumers to know that they can report businesses they believe have provided false or inaccurate information about stem cell treatments.
Individuals who have questions or believe they purchased a treatment based on misleading promises can submit a complaint to the Attorney General’s Consumer Protection and Antitrust Division.
Complaints can be filed through the official website at www.attorneygeneral.nd.gov.
Residents can also contact the division by calling 701-328-3404.
The advisory serves as a reminder that medical treatments promoted through free meals, mailed invitations or sales presentations should not automatically be considered safe or effective.
North Dakota officials are encouraging consumers to verify medical claims, seek advice from qualified healthcare professionals and remain cautious about expensive products advertised as solutions for serious health conditions.
