Jeffrey Bland, PhD (video dated Nov 18–19, 2015) comments on the November 17 Department of Justice collaborative meeting addressing 'egregious abusers' in the dietary supplement market. He reviews the 1990s push (citizen groups, Senator Hatch, industry quality-assurance efforts) that led to the Dietary Supplement Health and Education Act (DSHEA) and industry self-policing via voluntary quality alliances. Bland contrasts responsible manufacturers (who follow CGMPs and DSHEA structure-function claim rules) with offenders who add synthetic pharmacologic agents (examples: DMAA, steroids, sildenafil mimics) to products labeled as supplements. He highlights evidence of harm (low-dose DMAA studies, interactions with caffeine/alcohol, hepatotoxicity, liver transplant cases) and raises the policy question of how regulators and industry should respond without unduly restricting legitimate supplement access.
Chapters
November 18, 2015 Boy, do we have a whirlwind swirling right now. In response to the November 17th Department of Justice Collaborative meeting on the Dietary Supplement egregious abusers and the recent evidence that individuals who are being exposed to certain unbranded products may be at risk and in fact suggestions of even death. What is this all about? And we've had a number of very remarkable bits of feedback from our video blog yesterday from all of you about whether in fact this is a good or not so good intervention by the doj. In order to understand that, I think we have to look back slightly in history to appreciate what's going on. So as I recall for you yesterday in our blog, in 1993 there was this extraordinary movement in Congress activated by a consumer group, Citizens for Health, and many others to allow freedom of choice in the area of nutritional supplements that ultimately gave rise to the passage of the EPIC Dietary Supplement and Health Education act, dshea, which has become the law of the land now for the past 20 plus years. Prior to that being passed, there were some concerns about dietary supplement quality and safety. And therefore I and Lorna Israelsin, who is the founder and executive director of the United Natural Products association from Utah at that point in early 90s, put together what we call the Natural Products Quality Assurance alliance, which is a voluntary group made up of CEOs of member companies in the dietary supplement natural foods area, to establish an internal document that became our document that was ultimately submitted into the Congressional Record through Senator Hatch of Utah that defined kind of internal policing as to what the quality assurance would be within the industry. Kind of a self policing activity both in terms of good manufacturing practice standards and in terms of claims and safety related to products. And that was a tremendous step forward. I felt for the industry, something I was very proud of being involved with and ultimately led as a part of the body of work that resulted in the passage of the DSHEA. Now let's go forward, roll forward 21 years into 2015 for most manufacturers of dietary supplements. They took this very seriously and have worked along with the FDA in the implementation of good manufacturing practices or CGMPs for the manufacture of products and maintain the caveats of claims allowed the structure function claims that are allowed under DSHEA for the sale of dietary supplements. But there are always those that are egregious offenders and take advantage. And that's been the problem that we've seen emerging with companies that really are putting unbranded products, even pharmaceutical drugs, or unproven safe and effective chemically derived Materials under the aegis of coming from natural products. And a good example of that, of course, was the case history that was described yesterday in the DOJ report, which is this USP lab kind of abuse, putting a compound in their products, which has been used quite a bit for enhancement of function, physical function. You probably know this as dimethylamylamine, dimethylaminelamine, dmaa. And if you ask, where does this come from? Well, it's been suggested that it comes from natural products because you can find it in a few plants like Shinzenza chinensis and you can also find it in geranium stems. But it's at such a low dose that it really is almost physiologically inconsequential. In order to get a higher dose then products have been tainted or doped with synthetic dimethyl amyl amine, dmaa. Now you get into the pharmacology. It's no longer the botanical, it's a pharmacology of a drug like effect. There have been studies done, one of which was done at a reputable institution, demonstrating that low dose 25 milligram doses of DMAA probably doesn't raise blood pressure significantly, it doesn't raise heart rate significantly, it probably is sub therapeutic. But when you start administering DMAA along at higher doses with other things like caffeine or alcohol, now you get into potentially significant problems which have been accounted for being at least a contribution to hepatotoxicity, liver toxicity, ultimately leading to liver transplants in some cases. So now you get an abuse level. So when is a drug a drug and when is a nutritional supplement? A nutritional supplement? And that's a question that you might say is debatable, but it's really not debatable when you start putting pharmacological doses of a synthetic single ingredient that comes out of a complex plant matrix that becomes really something very different than that which you get in the plant itself. So here we are, we're at a very interesting point where we're seeing an abuse. We're seeing steroids that are being added to sexual enhancement products. We're seeing and bodybuilding products. We're seeing various kinds of metabolic activators that are synthetic being added to weight loss products. We're seeing sildenafil mimics or generics that are being added to sexual enhancement products and all labeled as nutritional supplements. Now, come on, come on. This is really an abuse of what was intended to provide open opportunity for the consumer to be able to buy quality nutritional supplements. Fortunately, the industry itself generally is producing very high quality products that are safe and effective for nutritional needs. But these examples have to be responded to. Now, the question is, are we going to over respond? Are we going to start to make this whole field into a new form of pharmaceutical medicine, requiring licensure and prescriptions and all the things that are associated with drug approval process? And my answer to that is, how is the industry going to respond? And how are consumers going to respond to a responsible industry? Are we going to then protect those that are doing a good job and not throw the baby out with the bathwater? Or is it going to require an overreaction to really bring back into balance these egregious cases of abuse that are causing people jeopardy in the quality of their life and maybe even their life itself? It's a very important question that awaits further explication, but certainly the stage is set.
