Dietary Supplement Age Restrictions: Concerns for Consumers, Retailers, and Public Health

Steve Mister, president and CEO of the Council for Responsible Nutrition discusses the proposed state legislation to restrict access to dietary supplements marketed for weight loss or muscle building to those 18 and older in an interview with Pharmacy Times®. Mister argues that these ambiguous laws would limit consumer access to a wide range of safe supplements, despite a lack of evidence linking supplements to eating disorders. Retailers, especially pharmacies, would face significant operational challenges and potential liability from implementing these restrictions. Overall, Mister emphasizes that these laws violate consumer rights and are an ineffective solution to the complex issue of eating disorders among young people.

Pharmacy Times

What negative impacts would age restrictions on dietary supplements have on consumers?

Steve Mister

So, what we're seeing is a number of states now are introducing legislation that would put age restrictions 18 years or older on any dietary supplement that is marketed, promoted or otherwise held out in some way to be for what the bills say are weight loss or muscle building. The problem is that this legislation and the bills are all very similar in about 10 different states now. They are very ambiguous as to what would be included in that. And so, you know, a whole range of dietary supplements that might be making label claims around metabolism or even preventing muscle support, preventing muscle atrophy, many of those products then would be age restricted. The real crux of the problem is that when you try to age restrict these dietary supplements to a limited number of people, what ends up happening is that they are of limited access to everybody. In order to implement these kinds of restrictions, stores are going to make those products less accessible to everyone.

Pharmacy Times

What is the safety profile for dietary supplements, and what are the FDA's challenges in regulating the supplements?

Steve Mister

That's what's so interesting about this, is that the legislation that we're looking at is ostensibly being done because the proponents of the legislation say that dietary supplements that are out there being promoted for weight management and the sports nutrition products are somehow contributing to eating disorders among young people. We've done our own research, we've looked at the data ourselves, done our own literature reviews, there is absolutely no scientific data that would support that these products cause or exacerbate eating disorders among young people. So, we start with a premise that's fiction in the first place, but this is the narrative that's being promoted to try to advance the legislation. In reality, these products are incredibly safe. They have one of the best safety margins of any consumer products out there. When you look at the number of Americans that use dietary supplements, about three out of four Americans use these products — and then look at the very narrow number of adverse event reports that come into FDA. It demonstrates that there is a wide margin of safety for these products. So, we're taking things that are very safe, that consumers want and are using, and then, if these bills were to advance, we would be limiting access to them and restricting them by age. These are not just the traditional things we think about in terms of weight loss. These would include things like probiotics, fiber products, protein powders. In many cases, even vitamins — vitamin B12, vitamin D, things that might make a claim on the label, for improving metabolism at the cellular level, or boosting energy levels. Those could be interpreted as contributing to weight management. And we have seen already, some of these products would be restricted.

I should add that one of these bills did get through last year and has already been enacted in New York. So, New York is already putting age restrictions on these products, and CRN is actively in litigation with the state of New York to try to overturn this law because it violates the First Amendment rights of consumers to be able to get truthful information about these products.

Pharmacy Times

What harm could age restrictions cause on local retailers, like pharmacies?

Steve Mister

I think retailers, local pharmacies, other stores that have pharmacies in them, could see real a burden from these restrictions. Some of the laws will require, not only an age restriction, but will physically require removing the products from self-service access. Imagine trying to take large sections of your dietary supplement aisle and putting them behind the counter. Just that the physical requirements of that would be difficult or putting them in a locked case. Imagine having them behind glass doors and every time somebody wants to buy a vitamin or a probiotic, they have to get a clerk to come over and unlock the case in order to get access to it. Unfortunately, that's sort of the best case scenario, because the worst case scenario is that many of these retailers look at this and say, I don't really want the lost sales that are going to come with taking these products away, but I also don't want the liability if somebody come comes in and buys the product and it's a sting operation, and they're 17 years old. Some retailers are opting to just remove the products from the store entirely, which means the retailers lose sales, and it means consumers have even less access to be able to get to these products where they want to purchase. Think about things like pseudoephedrine, which is an over-the-counter medicine, which is already a behind the counter product. Imagine taking a big section of your supplement aisle and treating them the same way that we treat pseudoephedrine. I think pharmacists would find it very time consuming. That's why some stores may just say we're going to have to take the lost sales, rather than the potential liability.

Pharmacy Times

What are the adverse effects of taking supplements, and what is the leading cause of the proposed age restriction?

Steve Mister

Dietary supplements have been required since 2008 to report all serious adverse events to FDA. So, supplement manufacturers, even if they disagree with a consumer's complaint, are required by law to report these things so we're able to track them. The number of adverse events that come into FDA are very, very small compared to the number of products that people are taking. When you look at things like the number of food recalls that go on really on a weekly basis, and you look at pharmaceutical recalls and things like that, our products are really, as I said, probably the safest of the health care products that are out there. We have so many people who use these products successfully and with health benefits every day, and actually very few adverse events.

The restrictions that we're seeing, as I said, are motivated by some public health folks who just sort of intuitively believe that these products cause eating disorders among young people. No question, eating disorders and body dysmorphia among young people is increasing. It is a problem, but it is a complex problem that is caused by a number of issues, including social media usage and peer pressure and just the constant bombardment of images and expectations that young people have around their bodies. There is no evidence that dietary supplements are the cause of any of that. But unfortunately, they're an easy scapegoat. We see these bills that are trying to target us, and really, I think the unfortunate thing is, in states like New York that have already passed this law, we are not seeing any decrease in eating disorders as a result. If these other states pass it as well, five years from now, we are not likely to see any impact from the results of these on eating disorders, but it just makes an easy target to blame for the problem and legislators feel like that they're doing something good.

Pharmacy Times

Is there anything you would like to add?

Steve Mister

For your pharmacist I would like to really flag for them that these bills are a restriction on their First Amendment rights, because the criteria for how these supplements are included in the age restrictions is based on what the retailer says about the product, as well as what's actually on the label of the product. One of the criteria for restricting these products is if a store puts these products in a certain area that sort of suggests that they might be contributing to muscle building or contributing to weight management. That should be alarming to pharmacists that the way that your present products in your store that are perfectly legal under federal law could somehow trigger an age restriction in one of these states that passes these bills. I think pharmacists really need to watch these bills. If you're in a state that is considering the legislation, pharmacists should be actively opposing it, because it will have an impact on their bottom line.