Repeat offender gets $3.7 million FTC fine over disease claims

By Hank Schultz

- Last updated on GMT

Related tags Weight loss Food and drug administration Dietary supplement

Repeat offender gets $3.7 million FTC fine over disease claims
A dietary supplement company that has received a previous warning letter from the Food and Drug Administration has agreed to a $3.7 million fine to settle a case brought by the Federal Trade Commission and the State of Maine for making over the top disease claims.

The company, Health Research Laboratories LLC, and its owner, Kramer Duhon, were charged with marketing two dietary supplements for a wide range of health conditions without proper scientific backing​.  In addition to the disease claims, the company is alleged to have violated provisions of the Telemarketing and Electronic Fund Transfer Acts, in that consumers found it difficult to stop recurring debits from their accounts once they had signed up for deliveries of products, fraudulent ‘risk free’ trial periods as well as other violations.

Duhon and his company were charged with marketing two of its health products, BioTherapex, a dietary supplement that purportedly targets the liver to address a host of ailments, and NeuroPlus, a brain supplement, using a variety of false and unsupported claims.

Primarily through direct mail marketing campaigns targeting consumers across the United States and Canada, FTC said the defendants advertised that BioTherapex, which they sold for $39.95 per bottle, could treat arthritis, relieve joint and back pain, and cause significant weight loss. The defendants advertised that NeuroPlus, which they sold for $39.99 per bottle, could protect the brain against Alzheimer’s disease and dementia, reverse memory loss, and improve memory and cognitive performance. The complaint alleges that these health and efficacy claims are false or unsubstantiated.  The complaint also alleges that the company was advertising a large scale clinical trial that was never actually conducted.

Gut check gotcha

The company and Duhon have agreed to an injunction that prevents them from making any of the so-called ‘gut check’ weight loss claims that FTC has said in the past are always false with respect to dietary supplements or topical products  Those are:

  • Causes weight loss of two pounds or more a week for a month or more without dieting or exercise;
  • Causes substantial weight loss no matter what or how much the consumer eats;
  • Causes permanent weight loss;
  • Blocks the absorption of fat or calories to enable consumers to lose substantial weight;
  • Safely enables consumers to lose more than three pounds per week for more than four weeks;
  • Causes substantial weight loss for all users; or
  • Causes substantial weight loss by wearing a product on the body or rubbing it into the skin.

As for the other claims, the injunction prevents Duhon and the company from making these without competent and reliable scientific evidence in the form of human clinical testing.

To settle the case, Duhon and his company have agreed to pay $800,000, of which $450,000 is stated to be already in an escrow account.  If Duhon fails to pay the $350,000 balance within seven days of entry of the order, the entire $3.7 million becomes immediately due.  The suspension of the balance of the judgement is provisional on the truthfulness of Duhon’s financial disclosures.

Past warning letter

This is not Duhon’s first go round with federal regulatory enforcement action connected to dietary supplements that he has marketed. In 2014, ​the company received a warning letter from FDA that listed 36 separate impermissible claims on a variety of products, one of which was also labeled as BioTherapex.  Among the claims Duhon was making on products at that time were a testimonial that a product had cleared the blockage of a customer’s arteries, the products could combat the onset of Parkinsons Disease, Alzheimers Disease and Huntingtons Disease,​ and a product would dramatically decrease risk of heart attack.

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