While 7-Keto has been growing steadily since its launch in 1998 – Humanetics has struck licensing deals with more than 100 firms that now use it in dietary supplements – sales have “caught fire” since it featured in a ‘belly blasting’ segment on Dr Oz, said NutraBridge president Scott Steil.
There are still snake oil merchants out there
Steil, who promotes 7-Keto on behalf of Humanetics, said Dr Oz had introduced 7-Keto to a new wave of consumers as well as reminding those already familiar with it that it is one of the few weight management ingredients supported by strong human clinical data in a market that has been plagued by its fair share of snake oil merchants.
He added: “There are still snake oil merchants out there. But we’ve seen a few of them hit pretty badly recently and people are beginning to realize that if you want to play in this market, you’ve got to do it right.
“I’d say the weight management category is probably the most dynamic it’s been for four or five years, but what’s interesting is that it’s not the latest and greatest thing that’s driving it at the moment, but more established products.
“We’ve seen the FDA and the FTC crack down on companies making unsubstantiated claims as well as several class action lawsuits. But I think Dr Oz has also helped raise awareness about legitimate weight loss ingredients. He talks a lot about weight management and he doesn’t recommend products that are in what I’d call the borderline or the greyzone.”
NDI guidance and weight loss ingredients
Similarly, the current debate over the NDI draft guidance was focusing minds on which ingredients have gone through the necessary regulatory approvals to be used in dietary supplements, said Steil.
He added: “There are probably more than 40 ingredients that fall into the weight loss category and many of them that should have gone through the NDI (new dietary ingredient) notification process, have not done so.”
Humanetics submitted two NDI notifications for 7-Keto in 1997 and 2002 received no objections from the FDA.
However, speaking at a public hearing about the NDI process in November 2004, its chief medical and scientific officer Dr John Zenk said he and others in the room could all think of several ingredients that “would be considered new dietary ingredients for which no pre-market notification has been filed”.
What is 7-Keto?
A metabolite of DHEA that is found naturally in the body and “declines dramatically as we age”, says Steil, “7-Keto increases the activity of fat-burning enzymes and increases metabolism without the use of stimulants.
“By the time you reach 40, you’ve lost 50% of your normal 7-Keto levels and by 60 you’ve lost 70-75%, so you can benefit from taking 7-Keto from around your 30s onwards,” he claimed.
“But we also know that anyone that goes on a calorie-restricted diet will also benefit as your body responds to calorie restriction by slowing down your metabolism. Taking 7-Keto effectively eliminates this effect so your diet can be totally effective.”
Humanetics has filed a suite of patents around 7-Keto since the early 1990s in areas including immune modulation and weight management, and has also invested a significant sum in human clinical data to support its claimed effects, said Steil.
“We’ve got 11 human clinical studies looking at 7-Keto alone or in combination with other ingredients. They have repeatedly shown that people on diet and exercise programs taking 7-Keto lose three times more weight than those on the same program taking a placebo.”
Beyond weight management?
Right now, Humanetics has its “hands full with weight management”, said Steil. However, it is also exploring some other indications for 7-Keto.
“When it comes to weight loss, we have proved its efficacy again and again, but looking at the mechanism of action beyond its effect on fat burning enzymes could open up some new areas of opportunity. How does it affect neurotransmitters in the brain, for example?”