The recent warning letter was sent to a firm known as The Truth Company, which lists Nathanael Mohr as the CEO. The company lists as its address a warehouse in Boulder, CO, though Mohr’s LinkedIn page lists his residence in Florida.
The company markets supplements under a two brand names: UMZU and Kinobody. The firm markets products including those based on betaine, amino acids, collagen, vitamins, minerals and various botanical extracts and ingredients. The lineup includes a number of branded ingredients. The indications include blood sugar management, pain management, for a wide variety of non compliant disease claims.
The company was cited for a wide variety of allegedly non compliant disease claims in a warning letter dated Oct. 14, 2022. The letter was made public shortly before Thanksgiving. IN all, FDA cited more than 30 noncompliant claims in the letter.
Claims found on a variety of web pages
FDA found the claims on a variety of webpage that the company associated with the marketing of the products. Those included a blog page for turmeric, in which FDA cited the following claims:
- “This spice is known to relieve blood clots…fight inflammation and even reduce depression.”
- “Turmeric, or curcumin more specifically, is effective for treating . . . arthritis.”
Another page deals with blood sugar management. Some claims FDA cited there include:
- “GlucoHelp, also known as Banaba leaf [described as an ingredient in your Sensolin product], has been used in natural medicines to treat diabetes for centuries.”
- “SENSOLIN . . . proven to help users lower their blood sugar and A1C . . .”
Another page addressing circulatory issues included the following statements:
- “Increasing your nitric oxide levels can benefit almost every aspect of your circulatory health from your blood pressure, symptoms of erectile dysfunction, and symptoms of varicose veins.”
In addition to the claims made by teh company directly, the waring letter cited a noncompliant testimonial that read:
- “I am an MD and there is no product on the conventional over the counter market that approaches the combination of safety and effectiveness of zuRelief for my own joint and muscle aches.”
Recent warning letter activity has included a focus on categories of violations, including the use of ingredients that are on FDA’s Ingredient Advisory List or that are judged to be new ingredients that lack an NDI filing. But the Truth Company letter shows FDA has not lowered its vigilance on the bread and butter disease claims front.