I Made the U.S. Dietary Supplement Law. I Think It Needs to Be Rewritten.

A loophole in the Dietary Supplement Act has led to thousands of hospitalizations

Dana G Smith
Jan 16 · 6 min read
Photo: Yulia Reznikov/Getty Images

OnOn December 25, 2019, Emily Goss underwent liver transplant surgery to replace her failing organ. The condition came on suddenly; in just three weeks, the 23-year-old went from being perfectly healthy to suffering from acute liver failure. The is a dietary supplement Goss had been taking for several months called , which the company Alani Nu claims can “support hormonal balance, weight management, complexion, and fertility.”

The case is the latest in a long series of serious illnesses and even deaths caused by potent over-the-counter supplements that can contain either prohibited or prescription drugs. Public health experts and even those who work in and around the supplement industry are now calling for the reform of the Dietary Supplement Health and Education Act (), which is supposed to regulate supplements through the U.S. Food and Drug Administration (FDA) but in reality offers little scrutiny.

Two unlikely allies in this mission are Scott Bass, a partner at the law firm Sidley Austin LLP, who helped draft and negotiate DSHEA in 1994 from the industry side, and Pieter Cohen, an associate professor of medicine at Harvard Medical School who’s by supplement companies for exposing shady (and potentially illegal) practices. Last month, they in the New England Journal of Medicine calling for a number of changes to the law to ensure better regulation of the dietary supplement industry and better protection for consumers.

Elemental spoke with the two experts to hear about what needs to change and why.


Elemental: What prompted you to write the article?

Pieter Cohen: I’ve been concerned for many years about the potent drugs and new ingredients that are being sold over the counter in supplements. There are tens of thousands of emergency department visits and thousands of hospitalizations every year due to adverse effects of supplements. That’s all unnecessary harm. So the question is, how can we prevent that? Supplements should be available, and they should be safe. So what’s gone wrong, and how do we fix it?

Scott Bass: For the last 20-something years, I’ve always felt that the basic structure of the law is very sound. That was my view until a couple of years ago when I began to realize that a combination of events was undermining one of the main purposes of this law. There are two main purposes of the law: One is to provide access to United States citizens to an increasing number of healthy products for health maintenance, and the second is to protect the public from unsafe products. And it was my feeling that the second part was being undermined, both by some in [the] industry and by the FDA. So the purpose of the article is to hopefully see some legislative change, what we call DSHEA 2.0.

Scott, what changed your mind? How did you come to discover that the act wasn’t protecting people the way that it should?

SB: The main issue is what I call “the loophole that swallowed the law.” And that relates largely to the “generally recognized as safe” process — which is absurd to me that the FDA permits this. You could take a new biological product, a substance nobody’s ever taken, add it to an energy bar or drink, and have three sympathetic food safety people say, “Oh yeah, that’s definitely generally recognized as safe.” And then after six months, the FDA would say, “Oh, well, that’s commonly found in food, so you don’t have to notify us of safety as a dietary supplement.” That’s just astounding to me.

PC: When it comes to new ingredients, there are three big problems. Number one is the law was written such that there are many loopholes [like Scott mentioned], giving companies the opportunity to avoid sending any information to the FDA about safety prior to starting to sell a new ingredient. There is also noncompliance with the law. There are many ingredients that are introduced that would not fit any of the loopholes that are written into the law, but companies are not compliant with the law and do not submit their information to the FDA. Finally, we have a serious enforcement problem. The FDA is simply not enforcing the law.

What was the original thinking behind the loophole? Has this changed since 1994 when the law was first enacted?

SB: It wasn’t really a loophole. The original thought when we were drafting the law was that you want the FDA to see every new ingredient. Not pre-market approval [a more rigorous and lengthy process drugs and medical devices must go through], but show us your safety records so we can at least know what’s going on. However, if something has been in the food supply forever — you take oranges and you take out the bioflavonoids — that’s not a new product. You don’t want to make the FDA review and industry put in every single ingredient that’s already been out there. Hence, “commonly found in food without chemical alteration.”

PC: [I think the law] has always been problematic, but the problems are exacerbated as the number of products out there has dramatically increased. The internet has completely supercharged the industry in that now people can purchase supplements from any store in America, any town in America. So that’s creating a lack of vetting. When supplements were initially sold in 1994, they would have been sold at local pharmacies, and there’s a vetting process that goes on by those pharmacies. Now that there are direct-to-consumer sales over the internet, that has gotten rid of that level of scrutiny.

So what do you propose instead? How do you think the law should be changed?

PC: The law should be rewritten; it needs to clearly define what a new ingredient is. Unless you extract a key ingredient from a plant that’s part of the food chain and you’re getting that ingredient in the exact same amount as is provided in the food, [you need to submit the ingredient to the FDA].

The other thing we’re talking about is a requirement to have every supplement product registered with the FDA, so that if the FDA read the label and saw that the manufacturer included an ingredient that is prohibited from being in a supplement, they would not register the product. It would also require that the products have a registration number from the FDA to be sold as a supplement at both brick-and-mortar stores and on the internet. The FDA would also need to start enforcing the law and move aggressively to remove the product and take it off the registry if it included a prohibited ingredient.

So those are the two basic things that we’re proposing here: all new ingredients require some evidence of safety, and the process of registering to function effectively as a public health tool.

Do you think these changes are feasible? Do you think that Congress would adopt them, and can you get the FDA on board?

SB: I’m very encouraged because, based on informal conversations, I think there are significant portions of [the] industry that support this, I think there are people at FDA who support this, and I believe that Congress would be willing. All legislation is a complex process — nothing goes in in one form and stays in that form — but I think there are enough people who say it’s time for DSHEA 2.0.

What are the next steps?

PC: The most important next step is for consumers to understand that there are real health risks involved with introducing new ingredients in supplements without any vetting. This is not a pro or con supplement discussion. Half of American adults use supplements every day, and we need to make sure that those supplements are safe.

These interviews have been lightly edited for clarity and length.

Elemental

Your life, sourced by science. A new Medium publication about health and wellness.

Dana G Smith

Written by

Senior Writer for Elemental @ Medium covering health, science, and the science of wellness | dsmith@medium.com

Elemental

Elemental

Your life, sourced by science. A new Medium publication about health and wellness.

Welcome to a place where words matter. On Medium, smart voices and original ideas take center stage - with no ads in sight. Watch
Follow all the topics you care about, and we’ll deliver the best stories for you to your homepage and inbox. Explore
Get unlimited access to the best stories on Medium — and support writers while you’re at it. Just $5/month. Upgrade