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Some popular weight loss and workout supplements contain a chemical called BMPEA that includes an ingredient nearly identical to amphetamine, according to a new study. Dr. Pieter Cohen of Harvard Medical School and Daniel Fabricant of the Natural Products Association join Hari Sreenivasan to discuss the safety and regulation of dietary supplements.
A study out this week is calling new attention to the health risks of some dietary supplements, and whether the industry and the U.S. Food and Drug Administration are doing enough to protect consumers.
It found that some popular weight loss and workout supplements contains a chemical called BMPEA that includes an ingredient nearly identical to amphetamine.
And again to Hari, who has the latest on this from our New York studios.
Researchers found the amphetamine-like stimulant in 11 of 21 products they tested, including in popular ones like JetFuel Superburn and JetFuel T-300 that are sold at stores nationwide.
Last year, Canadian health officials pulled some supplements with those chemicals from shelves over concerns of stroke risk and cardiovascular health. Today, the Vitamin Shoppe chain announced it would stop selling any products in the study that were believed to contain BMPEA.
The study is raising flags once again about the regulation and responsibility of a $30 billion-a-year industry.
Dr. Pieter Cohen of Harvard Medical School was the lead author of the study. And Daniel Fabricant is with the industry trade group the Natural Products Association. He also ran the FDA's Division of Dietary Supplements from 2011 to 2014.
Pieter, let me start with you. What did your study find?
DR. PIETER COHEN, Harvard Medical School:
Well, what we found was that yet another synthetic stimulant has appeared in supplements.
We have seen a plethora of things trying to replace ephedra since banned in 2004. And what we found was this new stimulant extremely similar to amphetamine.
So, Daniel Fabricant, when at the FDA, you actually did your own study. You discovered this synthetic drug. So, why is it still on the shelves and why wasn't it pulled then?
DANIEL FABRICANT, Natural Products Association:
Well, the study was initiated towards the end of my career at the end of 2013.
And the types of studies, in FDA's evidentiary burden, they have got to Fourth Amendment stuff. There has got to be due process. So it was a scientific study not necessarily done for regulatory purposes. But it was started during my time. And in all fairness, FDA should have continued the work, and have the authority to take a product like that off the market.
They don't have the authority now?
They do have the authority.
The FDA did send a response to the NewsHour. I just want to read I out.
"It is true that under current law the agency faces a high burden before we can take enforcement action on a dietary supplement. That said, we recognize that more can and should be done. We're committed to leveraging our limited resources to address the various concerns being raised."
So, Pieter, why should this be off the shelf? What's the danger inside it?
DR. PIETER COHEN:
Well, the danger is that this is a new synthetic stimulant that has never — its effects have never been studied in people.
All we know is that when it was invented in the 1930s, it was used in experiments in cats and dogs, and it increased the heart rate, it increased blood pressure of the cats and dogs. But what we don't know, what we have no idea is, what's going to happen when people actually take it?
So this is literally an experiment we're watching before our eyes, which is what happens when consumers take this brand-new drug.
So, Daniel, mark me as a naive consumer, perhaps, but when I go to the store and I get something off the shelf and I put it in my body, I just have an assumption that the FDA has said it's OK. Well, why shouldn't I believe that?
Well, you can believe that. FDA does have ample authority to regulate the space.
I think the difference with dietary supplements is, people look at a dietary supplement like a pill and they think that it's been approved by the FDA. But I think people would be shocked to know even some over-the-counter products like aspirin have not been approved by the FDA, but are still out there and used safely every day.
Over 180 million Americans use dietary supplements every day. And the plane landing safely rarely, if ever makes the news.
Pieter, is that the case here, that there is so much that the FDA already does correctly, that we're focusing on the exception vs. the rule, when there have not been cardiovascular risks or strokes that have presented themselves in hundreds of cases around the country by people taking these supplements?
Unfortunately, we don't have an effective system to detect risk from supplements. So, it's well-known that doctors often don't realize that their patients are being harmed. And when they do realize it, they often don't know to inform the FDA about the case.
So basically there are hundreds, if not thousands of serious reactions to supplements throughout the United States every year that are not reported to the FDA. So, absolutely, we have no idea what's actually happening.
So, Daniel, what do we do the figure out that risk tolerance with supplements that people assume are like just drugs, but they are not?
Well, actually, Dr. Cohen is mistaken.
The adverse event reporting requirements for dietary supplements are identical to those for over-the-counter drugs and Rx drugs. Actually, when the law was written for dietary supplements, which my association worked on, it was — over-the-counter drugs were brought in at the same time. So the same notification systems doctors use to notify the FDA of problems with drugs is identical to that for dietary supplements.
So the risk-detection warning system is clearly there.
So, Daniel, I want to ask. You mentioned that you worked for this group that you're working for now. Then went to the FDA. Then you went back. Obviously, the case for the revolving door is that there are experts hopefully looking at and regulating the industry that they're from. Right?
But, in this kind of scenario, people are going to wonder, wait, are you too chummy and did you not make the rules hard enough on the industry that you represented and still do?
Well, the agency benefits from experts from academia and industry, which I was both.
And if you look at my track record at the FDA, we did more on dietary supplements in my three years there than they did the 16 years prior. Precedent cases, as well as if you look at the number of injunctions we took, which is shutting firms down, we actually led all of FDA in injunctions, my little division of only 25 people.
So I think that would be a hard case for anyone to make if they actually look at the facts.
But, right now, it looks like the New York attorney general's office is the one that is doing what the FDA couldn't do.
Well, in this case, I agree with Dr. Cohen. He was one of the first ones on the scene to point out the science in the attorney general's study was flawed. They used a technique that wasn't really appropriate for those particular commodities.
So, Pieter, sorry. Continue. I was just going to say, but what are other academics saying about this? Is this entire field being researched? Just — you focused on a specific set of drugs, but dietary supplements, you're saying, is a very broad category.
It's a very broad category.
And we're particularly concerned with a whole — whole — hundreds, or if not thousands of different supplements that are using something that's legal under the law called the structure function claim. This allows these supplements to be sold for — to improve your workouts, to help you lose weight, even if there's not a shred of data that they actually work in people.
So, like you have pointed out, they look like drugs. They're being sold as if they have effects in humans, but there's absolutely zero need for evidence to support those claims.
So, Daniel, do you agree with that?
And structure function claims have to be substantiated by law. And also FTC regulates structure function statements that are made on products as well if they're made in advertising. Firms have to have substantiation. They have to have science behind it. Those that don't, there are laws are being enforced that people can act. Products have to be truthful and not misleading and FDA does take action where those products harm human health.
But, Daniel, in this particular scenario, the products were labeled as if they were having some sort of supplement from a dry grass somewhere, so there was also a false labeling concern, trying to convince the people that are buying the product to say, hey, you are going to get the stimulant from this little grass, but it's not really — it's a totally synthetic supplement.
Right. And FDA has authority to take action, and they should.
And also I think all of our mothers and fathers taught us if something sounds too good to be true in the marketplace, it probably is, especially where weight loss is concerned and things like that. If dietary supplements are claiming to have a pharmacological effect, to act like drug, that's not what dietary supplements are authorized by law to do.
Pieter, so what should a consumer do when they're out there looking at the store shelves?
Right now, consumers really need to avoid anything that suggests it will have a positive effect on the body, because unless you have talked to your doctor and you need a supplement like iron or calcium for your health, there is no reason the supplement should have immediate effect on your body.
So if you're feeling better, if your workouts are better, if you're losing weight or any other claim, like your diabetes is better controlled, I would steer well away from those types of supplements, because they're more likely to be spiked with harmful ingredients.
But, Daniel Fabricant, I want you to just quickly respond to that.
Well, again, I think Dr. Cohen's never worked in public health.
I think the key issue there is structure function claims are important to convey messages to consumers that they're looking for. We know that things like calcium do build strong bones. You have to engage consumers on those sorts of issues, so I think that's important for the medical community to do.
All right, Daniel Fabricant, Pieter Cohen, thanks so much for your time.
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