How are dietary supplements regulated?

The FDA says about 4,000 dietary supplement products existed in the mid-1990s. Today that number has ballooned to more than 95,000.

How are dietary supplements regulated?
Scripps News

Capsules, pills, powders, tinctures — all promising a healthier you. The FDA says about 4,000 dietary supplement products existed in the mid-1990s. Today that number has ballooned to more than 95,000. It’s a nearly $40 billion industry. 

More than 80% of Americans have taken a dietary supplement at some point, according to the Pew Research Center. 

Companies claim their products can shrink your waist, clear your skin or help your bones. But, the FDA doesn’t look at supplements the same way as medication — making it murky for the rest of us.

Nearly 30 years ago, Congress passed the Dietary Supplements Health and Education Act known as DSHEA.  

Dr. Pieter Cohen, an assistant professor with Harvard Medical School and general internist at Cambridge Health Alliance, explains DSHEA was designed so consumers could openly access dietary supplements without government involvement. 

"Basically, the law allows supplements companies to make claims that the supplement will help improve your health, even if there's no evidence that they actually work," Cohen said. 

Cohen says this meant companies can suggest their supplement can do something without backing it up.  

"The law said that if you make what's called a structure function claim, you can basically say anything you want to. As long as you avoid claiming that the supplement will treat or cure a disease," Cohen said. 

Take diabetics, who may turn to a supplement to help bring down their blood sugar. 

"So you go to the store and while the supplements are not permitted to say 'this will treat diabetes,' that would be illegal. What the supplement bottle can say is 'this supplement maintains healthy sugar levels' or 'this maintains normal sugar levels' when there's no evidence that it actually works," Cohen said. 

Current laws do require a supplement manufacturer to oversee the quality and safety of its products. But the FDA does not test products or approve their claims before they go out on the shelf. 

Regulators can only come in after if there’s widespread evidence they cause harm or are misleading customers about their ingredients.  

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"We've already seen that in the past, products that come on the store shelves and then within a few months, there are multiple people whose liver is inflamed, some people requiring liver transplants or even dying," Cohen said. 

He’s talking about "Oxy-Elite Pro." You may remember the supplement from about a decade ago. Its maker, USP Labs, claimed it helped people burn fat quickly. 

The FDA recalled the product in 2013 after it was linked to an outbreak of liver illnesses — including one death. It wasn’t the only harmful supplement. 

A 2018 analysis showed between 2007 and 2016, nearly 800 dietary supplements were sold with unapproved pharmaceutical ingredients. 

Tests over the past 30 years have turned up lead in protein powders and calcium supplements, and arsenic and other heavy metals in fish oils. 

In 2019, the FDA warned 17 companies who were selling dozens of unapproved or misbranded drugs, falsely claiming to be supplements that prevented, treated or cured Alzheimer’s disease and other serious health conditions.  

Lindsay Dahl is the chief impact officer with vitamin and supplement brand Ritual. She says the company is trying to be transparent their on ingredients and the supply chain to get it.  

"Every single Ritual product consumers can see all the ingredients, all of the manufacturer for those ingredients where they are or final place of manufacturing is in addition to what tests every single product has gone through," Dahl said. 

And since the FDA doesn’t test Ritual’s products for safety and efficacy, Dahl says they pay United States Pharmacopeia, an independent science nonprofit, to test instead. 

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One of the best things people can look for when they're shopping the supplements aisle is the USP logo. It's the most rigorous certification in the industry.  

"It's one of the kind of best things that consumers can know that what's in the product is actually matching what's on the label," Dahl said.

The company is also advocating for policy change. In March, Ritual laid out a roadmap of points the company wants Congress to address.  

"We're asking for the FDA to set health protective limits for things like heavy metals," Dahl said. "We're also asking for clear definitions of terms like clinically studied and ingredient traceability become the norm. Those are pretty standard. And I think most American consumers assume a lot of that. That's already happening and it's not."

For years the FDA has called on Congress to modernize the 30-year old DSHEA law. In its fiscal budget request to the Biden administration for 2024, the agency asked for the power to require all dietary supplements to list with the FDA. 

And the FDA wants to clarify its authority "over products marketed as dietary supplements.

Dr. Cohen tells Scripps News he doesn’t expect regulation to tighten any time soon. In the meantime he says taking supplemental vitamins and minerals can be crucial to a healthy lifestyle, if you’re not already getting them through your diet.  

Experts and the FDA recommend talking to your doctor about any potential risks or side effects before reaching for another bottle of supplements.