Two Duluth companies agree to stop selling products after FDA complaintsTwo Duluth companies have temporarily stopped selling amino acid supplements after the U.S. Food and Drug Administration accused them of making unfounded claims that the products could treat diseases.
By: Candace Renalls, Duluth News Tribune
Two Duluth companies have temporarily stopped selling amino acid supplements after the U.S. Food and Drug Administration accused them of making unfounded claims that the products could treat diseases.
The owners of West Duluth Distribution Co., doing business as CHK Nutrition and NeuroResearch Clinics Inc., this week agreed to halt distribution of the products until they changed their unfounded healing claims.
A consent decree was filed in U.S. District Court in Minnesota in response to the FDA’s complaint alleging the companies violated the Food, Drug and Cosmetic Act.
The complaint alleges that CHK Nutrition’s amino acid capsules and powder — which are its only products — are marketed with claims that they may cure or treat diseases. Without going though the extensive studies needed to make such claims, the FDA considered them unapproved new drugs.
In stopping their distribution, the FDA is helping to prevent health risks for consumers who might take these drugs or delay other critical treatments, said Dara A. Corrigan, an FDA regulatory affairs spokeswoman.
“Until these companies meet FDA requirements, they will no longer be able to process or distribute their products,” Corrigan said in a statement.
But Josiah Lamb, a Minneapolis attorney representing the companies, said no one has been hurt by the products. It was a misunderstanding as to what representations the companies could make about their products, he said.
“It’s about the representations made, not the safety or effectiveness of their product,” he said.
The products aren’t sold in stores to the general public. They’re sold to doctors and other medical providers through direct marketing and CHK’s website. The FDA took issue with a link on the CHK website to the NeuroResearch website where amino acid therapy is touted for treating depression, Alzheimer’s, Parkinson’s and other diseases.
CHK Nutrition is owned by Amy Gunthert-Hinz of Duluth, while NeuroResearch Clinics is owned by her father, Dr. Martin C. Hinz of Florida.
Together the two companies employ about 22 people, Lamb said.
Hinz has become known for his advocacy of the healing effects of amino acid dietary supplements. A general practitioner, Hinz lost his Minnesota medical license in 1996 when he became ill, Lamb said.
“His ability to practice was affected, so he voluntarily submitted to a suspended license while hospitalized,” Lamb said.
Hinz regained his medical license from the Minnesota Board of Medical Practice a year later with stipulations that continued until 2005 when they were removed, Lamb said.
Hinz and his daughter agreed to hire an expert to review the claims they make for their products and to ensure improper claims are removed.
“They expect to resolve this matter shortly and resume selling their product,” Lamb said.
During an inspection of CHK Nutrition and NeuroResearch Clinics in July 2010, the FDA found evidence of a coordinated effort to sell the product with claims of being effective treatments for some diseases.
In September 2010, they noted the objectionable link from the CHK Nutrition website to NeuroResearch Clinics’ website, where the claims of amino acid therapy were posted.
The two companies failed to stop the claims, despite FDA warnings. The FDA’s follow-up review of the website in February found an ongoing connection between the sale of CHK Nutrition’s products and claims they can treat diseases. That led to the FDA’s recent court action to stop them.