RFK Jr., The FDA, And Supplement Regulations

0:07Let's take a walk down the supplement aisle. It's an aisle full of products that promise a healthier, better you. One pill offers stronger hair and nails, while another says it will improve your memory, which will help when you have to remember to take all these pills. And if you add on just one more, you could finally have all the energy back of your teen years. But how true are these claims? Currently, the Food and Drug Administration does not approve dietary supplements or their labeling before they hit those market aisles. That means supplements can legally reach the public without the FDA even being aware.

0:38Around 75 % of Americans take a supplement, including Health Secretary Robert F. Kennedy Jr. He once said he took so many vitamins he couldn't remember them all. But RFK Jr., who champions supplements and other alternative medicines, is pushing the FDA for stronger regulations. What could that mean for the supplement industry? And why are so many Americans turning to health alternatives today? I'm Jen White. You're listening to the 1A Podcast. We tackle those questions and more today with our panel right after this. Stay with us.

1:12Let's get right into it with our guests. Dr. Peter Lurie is the president of the Center for Science and the Public Interest. That's a consumer advocacy group. He was also a commissioner for public health strategy and analysis at the FDA. Peter, thanks for joining us. Thank you for having me. Also with us is Daniel Fabricant. He's the CEO of the Natural Products Association. That's a trade association representing the natural products industry. He also previously served as the Director of Dietary Supplement Programs at the FDA. Daniel, welcome to the program. Pleasure to be here. And we're hearing from many of you who use supplements and health alternatives in your daily routine.

1:48Hi, I'm Tim Schreiber and I live in Aurora, Illinois. The only supplement I've really been taking is I work out quite a bit. And taking creatine has really helped me get some gains, have a lot better endurance about things. and I read some articles about it saying helping your concentration and some mental things, and I'm taking a master's class right now, and it seems to be working out pretty well. I am a firm believer in using alternative medication or supplements, so I take several every day, including FAM-E and turmeric and omega-3 fatty acid and omega-7 fatty acid, and I am a big believer in acupuncture.

2:33Daniel, let's first talk about what we mean when we say supplement. It can be a pretty big umbrella. How do you define it? Well, there's clearly a definition in law, and that's how we define it. I think that's the important thing. There's a lot of, and I was somewhat encouraged by your intro, there's always the news story that the industry is unregulated. That's not the case. Both Peter and I worked at the FDA together and did quite a bit of regulating in the space. but there's still some nuances I think that folks don't always understand. At the same time, you know, I hear you talk about it as an alternative.

3:06I don't know if that's the case anymore. 70 % of the country doesn't sound very alternative to me. That sounds pretty mainstream. And so I'm curious to hear your perspective on this as well, Peter. Well, it's true that there is some regulation by FDA. That's certainly true. But the fact is, it's extremely weak. Yes, it's true that the companies that are part of Dan's association need to register with the FDA, but they don't have to list the products that they are selling. Moreover, the companies can bring new products to market without even notifying the FDA, merely by certifying them as safe themselves.

3:43So yes, there's regulation, but really it's pretty weak. And it's done by a group that Dan used to run that is very small in number, completely under-resourced, and therefore doesn't really stand a chance against the$65 billion industry. I'm going to correct one thing Peter said. You actually do have to notify a new dietary ingredient to the agency. Anything past 1994, October 15, 1994, you have to provide safety and identity information to the agency, to which they can object to. So, So again, I think that these things are important to get the details correct, and that makes it a better, really better marketplace for all Americans.

4:22Well, we did reach out to the FDA and the Department of Health and Human Services. HHS Press Secretary Emily Hilliard wrote, quote, FDA's new dietary ingredient notification process was designed for the pre-market review and evaluation of new ingredients and dietary supplements. FDA takes the pre-market notification requirement seriously and appreciates responsible industry members that follow the appropriate procedures prior to bringing their products to market. But Peter, what I'm hearing is that you take some exception to the claim that there's enough regulation happening. No, certainly not.

4:57And yes, the responsible ones might go through this new dietary ingredient pathway that Dan has talked about. But the one we're worried about here is the GRAS pathway, which is the more common path to market these days. And as Dan well knows, the FDA can request substantiation of claims for products, but they don't even really know what's on the market. So they're in a very poor place to be able to ask anybody anything if they don't know what's there, and they don't have the resources to do it in any kind of a consistent way. This is a largely unregulated market. Yes, there's a little bit of regulation, but it's just not even remotely up to the task.

5:33Yeah, I'm going to continue to disagree with Peter. as being the former chief regulator of supplement space. There are people sitting in jail from those regulations. So I think there's a lot of folks that would beg to differ. I do think there's a willpower issue. I'm not so keen on the, every regulator can always ask for more resources. So let's put a pin in that for a second. I think the structure works. Now we're talking about self-grass, that's a different story. I don't think Peter or anyone knows how many companies self-grass or not self-grass. I think that's the issue that RFK is bringing up is like, okay, there should be some sort of, discussion there that that information is at least, you know, based on the current legal paradigm, that information is at least shared with the agency that someone did a self-grasks.

6:15So I think we need to include some definitions here. And I want to read a bit more from the FDA statement 21A, quote, dietary supplements are a category of foods. And in fact, it's common that many dietary supplements utilize food ingredients. We believe that stronger grass oversight will ultimately benefit the dietary supplement marketplace along with conventional foods by making both safer. Now, Health Secretary RFK Jr. wants the FDA to reconsider what's called the GRAS rule or generally recognized as safe. So quickly, Daniel, explain what that is and where it came from. Well, GRAS goes back to the 50s and the Delaney Amendment, so you can put anything carcinogenic in food.

6:55And so what has happened over time is folks have done their own science on ingredient, convene their own panel of experts within the same framework FDA would, and given it a green light to go to market. FDA has allowed that process. FDA actually, I believe, was sued by Peter's organization back in 2018. I think that was disposed of in 2021 to where FDA said, yeah, we can still enforce. So therefore, this is perfectly legal, perfectly fine. Now, with all that said, I think the policy stance right now from FDA is a logical one. I think there's some challenges with the regulations and with the laws.

7:28And so that's where I think this is going to get challenging. I don't know of another food system. And similarly, dietary supplements, you know, Peter wants to rail on us, but we do provide those notices. I think every other country, you put something new in the food supply, you do notice the agencies. Many supplements may be manufactured in the U.S., but their ingredients are sourced globally. So, how does where these ingredients come from affect how they are regulated? It certainly can. And I think that goes into, for like the NDI notification, if there's a manufacturing change. NDI? New dietary ingredient.

7:59Thank you. There's a manufacturing change. Let's say someone makes it here from, they extract it from a plant, but let's say overseas they're using a bacterial transformation to make it. You have to then notify the agency of that change. So there are those features in the regulations that do cover some of that. Peter, how well do you think GRAS stands up in terms of a regulation that helps consumers know what's actually in the supplement they're taking and make sure that it's safe? Frankly, terribly. You know, it has the origins that Dan describes and that's as far as, well, as far, it's good as far as it goes.

8:34But the fact is, it's a gigantic loophole and you can't have a situation whereby the companies are determining for themselves that something is generally recognized as safe. I mean, then the only generals are the companies themselves. So we can't really have a situation like that. And you can't have an agency that can't even define the marketplace that it's regulating. You can't have an agency that's under-resourced and expect that things will work out well. So the result is these companies are making a series of claims. FDA can ask them for substantiation of those claims. They really do. And that's why we see what we see.

9:07A bunch of things that are out on television, print, and so on, in which there's really no reason to trust much of it. It certainly doesn't come even remotely up to the standards of what we expect in drugs. And that's one of the things that's so contradictory about RFK is that he claims, and I'm not sure that I necessarily believe this, but at least with respect to vaccines, they expect very high standards for anybody to make a claim or to even get on the market. But suddenly, when it comes to these other products, which have trivial evidence for them, if any, he's all open arms. I mean, just can't understand it.

9:42The way to get through this is through science. Well, I want to pause there because we have to take a quick break. But coming up, an integrative medicine doctor weighs in. Back in just a moment.

9:57Let's get back into it by adding another voice to the conversation. Dr. Melinda Ring is director of the Osher Center for Integrative Health at Northwestern University. Dr. Ring, welcome to the program. Thanks for having me. So first, what do you think about the level of regulation that exists for supplements right now? Well, I'd agree. There's definitely room for improvement. It is regulated somewhere in between food and prescription medications and over-the-counter medications. So that claim that there's no regulation of dietary supplements is inaccurate. However, there's definitely room for further improvements in oversight of dietary supplements.

10:37We got this email from Barb in Michigan who says, Yes, I do take supplements. I rely primarily on the recommendations of the Micronutrient Information Center at Oregon State University. Their website has information on doses of vitamins, minerals, and some other supplements, plus information on dietary sources and their benefits. I can't say that the supplements are responsible, but I'm more active and am having more fun at 84 than I ever expected when I was 24. Dr. Ring, when you talk to your patients, how are they thinking about the role of supplements in their diet? Is it mostly to help fill in a gap in nutrients, or are they hoping it can act more medicinally?

11:16First of all, that source that your listener mentioned is a very reputable and great source, and there are other ones out there like consumerlab.com, et cetera, that are great sources. I would say from my patients, what I'm hearing is a both. So as an integrative medicine physician, we're always going to start with lifestyle. So it's diet first and diet, lifestyle, exercise, stress management. But the reality is that most people are not getting the nutrients they need from their diet, either because of poor choices, because the nutritional quality of our food has changed over time, because of medications they're taking that impacts their absorption of nutrients.

12:01So many people do benefit from some of those micronutrient supplements like vitamin D, omega-3s, magnesium, because they're not getting it in their diet. Then there's another sector of patients who are trying to use dietary supplements in a more therapeutic way. For example, they might used curcumin from turmeric for inflammation or probiotics and peppermint for gut issues. So the way that I address it with patients is, for one, assess what they really need. We don't want people having that huge paper bag full of supplements, but identifying as closely as possible what is the right approach for them and that they are using the right quality of supplements so that we minimize risk of harm.

12:48Well, let's go back to our voicemail. Here's the message we got from you. This is Evan from Orlando. I take a few supplements, including L-methylfolate for depression and a large dose vitamin C-zinc combination when traveling in order to prevent getting a cold or a flu. And I've had pretty good results with both of them, but I am frustrated by the lack of regulation in the supplement industry. I have a degree in science and I try to stick to evidence-based medicine. So in the meantime, I do try and always purchase supplements that have a USP, United States Pharmacopeia approval, in order to make sure that at least what I'm getting is the chemical that is promised.

13:38Evan, thanks for that message. So Peter, Evan mentioned looking for a USP certification seal. What is that? so that's a you know an independent organization um with with some affiliation with industry that it does do a good job i think of trying to certify what's actually in a product and you mentioned two consumer labs which does some testing so these are these are valuable resources but the truth is they're absolutely necessary and the reason that they're necessary is because so many supplement manufacturers do such a shoddy job of actually making their products. I mean, almost every time that somebody goes out and does a study to find out whether the active ingredient, so-called, is actually in a dietary supplement or to figure out if some contaminant like a heavy metal or bacterium is there that oughtn't to be, they find that stuff or they find that there's either no medication at all in it, there's some contaminant with an active drug, there's too much, there's too little.

14:38I mean, some of them are fine, but the rates of poor production are extraordinary and nothing that would vaguely be tolerated in a pharmaceutical. We've got this question from Jason who says, how are we supposed to trust an industry that self-regulates in the wake of issues with Boeing and its own self-regulation? Why shouldn't there be direct government involvement? Daniel, I'll come to you on that. There is direct government involvement. The notion that there's not is crazy. And I think that folks talk about regulation. It's a great topic to talk about the water cooler, but really understanding what that means.

15:09The most important thing, and FDA was created to inspect and test. FDA has the right to go into every dietary supplement facility at any time they want to. Above and beyond the Fourth Amendment rights, you have your program's First Amendment, so we'll stay on that theme. But how often does that happen? Quite a bit. They did last year over 500 inspections, so 500 firms got inspected. Now, they're coming back from COVID levels, post-COVID levels, but certainly they have the capability. They also have the capability to do four-cause inspections. If they get information, information like we've given them, we have manufacturers who test products, also Amazon, give that to the agency and say, hey, go test them or go see them.

15:47A lot of times FDA doesn't act on that information. So, again, I can appreciate the dialogue, but I think it's basic law enforcement, right? And when you say the FDA doesn't follow up on those inspections, why? Is it a lack of resources? Is it staffing? Is it lack of interest? It's sometimes lack of interest. I mean, flat out. And that's the problem. It's a willpower issue. I think if you look, having been there, having pulled at the levers, there's a lot that can be done. Like I said, there are people still sitting in jail from things that we did while I was at the agency. So with all the conversation, that's ultimately the telltale is if there are, and if Peter knows of firms that there are problems with, turn those over to FDA and have them go swing an ax at somebody.

16:25Peter, when it comes to regulatory oversight, what kind of regulations would you like to see put in place? Yeah, so I think a good place to start would be to look at this grass loophole and to shut it down, frankly, except in the rarest of instances. So that would be a good place to start. I think another good place to start would be for the companies to be required to list their products, all of them, not simply register with the FDA that they are a manufacturer, but list the particular things that they're making. That would be a good start. I'd like to see FDA have more personnel so that it could actually look at the information that we'd also like to see made available that would substantiate their claims.

17:12But that would require a lot of appropriations. And it's hard to imagine that when we have a government shutdown over government spending. But those are the kinds of things I'd like to see. And I think they'd make a difference. Daniel, do you think those are reasonable regulations? I mean, I think the grass issue is something that needs to be discussed further. I think the other issues are somewhat mischaracterized. And I think by and large, the plane landing safe doesn't make the news. The reason that the industry has grown from where it was in 1994 when the implementing laws came into now is because people are deriving a benefit.

17:45But also, there's a trust there. People have been using the product safe. We didn't step over any bodies on the way in from people having vitamin injuries. So I think that some of this needs to be put in the proper context. Well, Dr. Ring, I want to come to you as someone who sees patients. The idea that more Americans are turning to supplements, what do you think is at the root of that? Well, I think there's many factors at play here. There is some concerns about the adverse effects from pharmaceutical drugs. So, you know, sort of agreeing with the previous speaker, generally when we look at dietary supplements, the number of adverse events is significantly low.

18:34So when we think about ER visits, for example, with pharmaceuticals, we'll have 100 ,000 hospitalizations annually due to adverse effects from pharmaceuticals. The rate of that for dietary supplements is significantly lower, even if we say that they're underreported. So I'm not saying that dietary supplements are all safe. Certainly precautions need to be made. But again, compared to pharmaceuticals, I think patients are looking for safer alternatives to it. But what about the efficacy question, Dr. Ring? So there's safety and then there's efficacy. Right. So a growing number of supplements really do have strong clinical evidence behind them that are backed by large randomized controlled trials and meta-analyses that involve thousands of participants.

19:27So, you know, these are rigorous placebo-controlled trials. They're published in peer-reviewed journals. They're not just anecdotal reports. Things like, again, omega-3s, like curcumin, like peppermint, creatine was mentioned by one of your viewers. So, you know, the idea, again, that there's no evidence is inaccurate. There is growing scientific evidence behind these. And I'm seeing my conventional biomedical colleagues, my gastroenterologists, cardiologists starting to include these because, again, the evidence is growing and is significant. We heard from Nancy who emails, my number one alternative health measure is a healthy diet, appropriate exercise, and enough sleep all my life.

20:12I've taken calcium, magnesium, zinc supplements since menopause to keep my bones strong. That's worked. Also lately, one probiotic capsule each morning has improved my digestion. And Caroline emails, I am a lifelong dancer. I used to get a bloated stomach. I have been taking high-quality metagenic supplements for 35 years, and at 66, I'm still dancing and feel like I'm 35. Daniel, your organization is pushing for supplements to be available at a discount through federal programs like WIC or SNAP. So far, that legislation has not been successful, but why are you advocating for that change? Well, we're the most industrialized nation in the world, and there's a scary cohort of the resurgence of things like spina bifida, neural tube defects because of a lack of folate.

20:56This ties into the Tylenol discussion too. So I think consistent with Dr. Ring said, get your levels checked. So few MDs. MDs get only 16 hours of nutrition before they graduate. They have thousands of hours of pharmacology. So I think what the discussion really focuses on now is there's a shift. It's supposed to be integrative. It's supposed to be complementary and alternative. It's not supposed to be one or the other. I think that's part of the challenge. And when you say it ties into the Tylenol discussion, what do you Well, that was an issue with folate and folate metabolism and the challenges with folate metabolism that, you know, I think for some groups of the population are, you know, need to be looked at carefully.

21:32Peter, your thoughts about pushing for supplements to be available through federal programs like WIPC or SNAP? Yeah, it's just a flat out terrible idea. Yeah. The fact of the matter is that the great majority of the products on the market, there may be occasional ones, like Dr. Ring said, that do something, but the majority of them don't. And what the science has shown over time is not that there's more and more evidence of things that seem to work, but rather more and more evidence of things that don't. There are randomized trials, after-randomized trials, that debunk all of the best wishes of the supplement makers.

22:11Some of them turn out to make the diseases that they were supposed to prevent actually more common. So I think it would be terrible for these HSAs, as they're called, health savings accounts, to be covering this. They should be restricted to things that actually work. The reason that there are as few adverse effects from dietary supplements as there are is because the great majority of them do nothing at all. That's the good news. The good news is that they're so inactive that they're not even able to create an adverse effect. It's the occasional one. If you're in a drug, of course, you're going to be trading off real benefit against adverse effects.

22:50So comparing the number of adverse effects from dietary supplements to drugs is totally spurious. Well, let's pause here for another quick break. But still to come, we get to more of your questions and thoughts.

23:06We've had multiple listeners bring up liver damage. Katie emails, frankly, my liver doctor told me not to take any supplements. He said that he's had more liver failure over supplements than anything else. And Lizzie emails, I take several but worry about the effects on my liver and kidneys. I recently had blood work done and my doctor said to take fewer. I wish there was some way of knowing which were harder on those organs. Now, a 2024 study from the University of Michigan found that millions of Americans are consuming supplements that can cause liver damage. Those supplements include turmeric and ashwagandha.

23:39Dr. Ring, what are your biggest concerns when it comes to supplements causing harm? The number one concern that I have is adulteration. And we particularly see this in certain classes of supplements. supplements targeting weight management, sexual performance, athletic performance. Those three categories have the most number of adulterations with things like steroids, with amphetamines, et cetera. So those categories be very careful with. It is true that adverse effects, particularly with the liver, are of growing concern. And even things like curcumin, turmeric, which has great evidence for it, can be used dietarily, but also is used therapeutically to decrease inflammation, can help depression and other things.

24:33Now, supplement companies are making these hyper-absorbable extracts, and those forms have been associated with an increased risk of liver issues. So yes, definitely a concern. and this is why working with somebody who can guide you on what is the best thing for you is going to make the most sense and be the safest way to go. I want to back up a little bit and just talk about everything that falls under that supplement umbrella. And I'm especially curious to hear from you, Daniel, about whether you think that umbrella is a little too big right now. No, not at all. And I think it's interesting, and Dr.

25:14Ring said it best, the adverse event profile is really important. The adverse event reporting law for dietary supplements is identical to that of pharmaceuticals. And so I've used that tool to remove products from commerce. To give you an idea of how effective that tool is, I removed about$200 million worth of product with 40 adverse events on liver injury. And this is back in 2013. For injury-related to OxyContin, it took the agency over 100 ,000 adverse event reports. So I think it is important if there are adverse events with products, report those to the agency. They have the authority to take action.