Is the supplement industry actually unregulated?

No — this is a common misconception that Phil Vigeant, CEO of PlantFusion and a four-decade natural products industry veteran, directly addressed in a Qredible Live broadcast. 'A lot of people say it's an unregulated industry, which is fundamentally false,' Vigeant stated. 'The FDA by definition regulates anything we put in our body.' Supplements occupy a regulatory middle ground: more regulated than food, less regulated than prescription drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established the foundational framework — prohibiting disease claims without FDA authorization, creating the structure-function claim framework, and establishing labeling requirements. Federal agencies including the FDA and FTC actively prosecute companies making prohibited disease claims or engaging in false advertising.

Why was supplement adverse event reporting legislation created, and what does it require?

Adverse event reporting legislation was passed following the ephedra safety crisis around 2000, when deaths occurred — particularly among individuals with pre-existing heart conditions taking high doses of the stimulant ingredient. A critical finding from the crisis was that supplement companies were not systematically tracking or reporting consumer complaints, preventing regulators from identifying the pattern of harm. Phil Vigeant, who served on the committee that developed the legislation, described it: 'One of the things they found with that ingredient was that the companies that were selling it were not recording the complaints that were coming in on it, which is a dangerous thing.' The resulting legislation now requires supplement companies to submit adverse event reports to the FDA whenever a consumer reports a health issue associated with their product — transforming complaint tracking from an optional practice into a legal obligation.

Why are reports about heavy metals in supplements often misleading?

A significant source of misleading supplement heavy metals reporting is the use of California's Proposition 65 lead standard — 0.5 micrograms of lead per serving — as the benchmark for evaluating supplement safety without providing the context that this threshold is lower than the naturally occurring lead levels found in common healthy foods. As Phil Vigeant explained: 'It sets a standard for lead that's 0.5 micrograms of lead per serving, which is actually much less than what you get in a cup of spinach.' Even organic vegetables from healthy soil can contain heavy metals above the Prop 65 threshold, meaning that applying this standard to supplements without context implies safety concerns that would logically apply equally to everyday vegetables — and aren't. Vigeant's conclusion: 'If an outlet is using the California standard, it's just fundamentally misleading.' Consumers evaluating supplement safety reports should ask which heavy metals standard is being applied and whether it is being applied consistently to comparable food products.

How are major marketplaces like Amazon changing supplement compliance requirements?

Phil Vigeant confirmed during the Qredible Live broadcast that major marketplace platforms are significantly escalating their documentation, quality, and compliance requirements for supplement brands. 'Even major marketplaces like Amazon are escalating their requirements around documentation, quality, and compliance for any of these supplements,' he noted. This trend extends beyond Amazon to payment processors, distributors, and retailers, who increasingly require verification of product claims and testing documentation before partnering with supplement brands. For established companies like PlantFusion that helped write many of these industry standards, compliance with escalating requirements comes naturally — they already maintain the documentation these platforms require. For brands that relied on the historically lower documentation bar, the rising requirements represent a significant operational challenge that automated compliance infrastructure like Qredible's Q-Trust is specifically designed to address.

Supplement Industry Regulation: Expert Guide to Safety Standards

Q: What does DSHEA allow and prohibit supplement companies from claiming?

DSHEA, the Dietary Supplement Health and Education Act of 1994, prohibits supplement companies from making disease claims — statements that a product diagnoses, treats, cures, or prevents specific diseases — without prior FDA authorization through the drug approval process. Companies making prohibited disease claims can be prosecuted by the FTC or FDA. DSHEA permits structure-function claims, which describe how a supplement may support normal body functions without promising to treat or cure diseases — for example, 'may help support blood glucose levels' rather than 'cures diabetes.' As Vigeant explained, the DSHEA framework was developed proactively by the industry itself: 'We said, Hey, we have to be proactive about setting some standards for the industry.' The legislation was designed to create appropriate standards for products that are regulated more strictly than food but less strictly than prescription drugs, reflecting their different risk profile.

Supplement Industry Regulation: What Consumers Need to Know About Safety Standards

Category: Consumer Learning Center Videos

Author: The Qredible Team

Date: December 26, 2025

You've probably heard the claim before: the supplement industry is unregulated. It's a line that appears in countless news articles and consumer reports, often accompanied by alarming stories about contaminated products or misleading labels. But is it actually true?

During a recent Qredible Live broadcast, Phil Vigeant, CEO of PlantFusion and a four-decade veteran of the natural products industry, shared valuable insights on how supplement industry regulation actually works. This discussion highlighted the frameworks already in place, the role industry leaders have played in establishing standards, and why consumers remain confused despite these protections.

The "Unregulated Industry" Myth

One of Vigeant's most emphatic points addressed a common misconception that frustrates many industry professionals.

"A lot of people say it's an unregulated industry, which is fundamentally false," Vigeant stated. "The FDA by definition regulates anything we put in our body. So it is a regulated industry. It is not as regulated as pharmaceuticals, and that's appropriate because it's not as dangerous as pharmaceuticals."

This distinction matters. Supplements occupy a middle ground. More regulated than food, less regulated than prescription drugs. According to Vigeant, this balance is intentional and appropriate given the nature of the products involved.

How DSHEA Changed the Industry

The foundation of modern supplement industry regulation traces back to 1993, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Vigeant was personally involved in this effort.

"That was a proactive bill that the industry got together on," he explained. "We said, 'Hey, we have to be proactive about setting some standards for the industry.'"

DSHEA established critical boundaries for what supplement companies can and cannot claim. "We can't say that this bottle of supplements cures diabetes because that's a disease claim. We're not allowed to say that. That's flat out against the law," Vigeant said. "Companies that do those types of things are prosecuted by the FTC or the FDA."

The legislation also created the framework for structure-function claims. Statements that describe how a supplement may support bodily functions without promising to treat or cure diseases. As Vigeant put it: "This may not cure diabetes, but it might help support blood glucose levels, but you still should see a doctor."

Adverse Event Reporting: A Response to Real Problems

When specific ingredients have caused harm, the industry has responded with additional safeguards. Vigeant pointed to ephedra, a stimulant popular around 2000, as a turning point.

"There were a number of deaths from people taking too much of ephedra," he recalled. "For people that had pre-existing heart issues, it wasn't good for them to take a lot of it."

The problem wasn't just the ingredient itself. It was that companies weren't tracking complaints. "One of the things they found with that ingredient was that the companies that were selling it were not recording the complaints that were coming in on it, which is a dangerous thing," Vigeant explained.

In response, he served on a committee that worked to pass adverse event reporting legislation through Congress. "Now today, if somebody calls up and says, 'Hey, I had this issue with your plant protein,' we are regulated by law to submit that to the FDA as an adverse event report," he said.

The Problem with Sensationalized Reporting

While legitimate concerns exist, Vigeant expressed frustration with media coverage that misleads consumers, particularly regarding heavy metals in supplements.

He cited a recent Consumer Reports piece as an example. "Candidly, it was incredibly misleading," he said. "The theme of it was you really might want to cut down ingesting protein because of heavy metals. And that's a little bit like saying you might not want to work out that much or exercise that much because you could break your ankle."

Much of the confusion stems from California's Proposition 65 standards, which Vigeant argued creates unrealistic benchmarks. "It sets a standard for lead that's 0.5 micrograms of lead per serving, which is actually much less than what you get in a cup of spinach," he explained.

"If you followed that threshold that they used, you wouldn't eat very little vegetables because even organic vegetables from the healthiest soil in the world could have heavy metals above that Prop 65 level," Vigeant added. "If an outlet is using the California standard, it's just fundamentally misleading."

Growing Accountability Across the Supply Chain

Beyond government oversight, market forces are increasingly demanding higher standards. Vigeant confirmed that major platforms are tightening requirements.

"Even major marketplaces like Amazon are escalating their requirements around documentation, quality, and compliance for any of these supplements," he noted.

This extends to payment processors, distributors, and retailers who now require verification of claims and product testing before partnering with brands. For established companies like PlantFusion that helped write many of these standards, compliance comes naturally. For others, the bar is rising.

Why Confusion Persists

Despite existing regulations, Vigeant acknowledged that consumers remain overwhelmed. "I don't envy the consumer in this category," he said. "It's one of the categories that has the most conflicting bits of information."

The confusion comes from multiple directions—pop media making sweeping claims, doctors who lack nutritional training, and bad actors who make promises legitimate companies cannot.

"I think it's the loud minority that gets all the bad press in any industry," Vigeant observed. "There are a number of other brands besides us that are trying to do the right thing and get the right products in people's hands. I think that's more of the majority of the industry than the minority."

Find Brands You Can Trust

Supplement industry regulation provides a foundation, but informed consumers still need to do their homework. Look for brands that can speak to their sourcing, maintain transparent testing practices, and have track records of compliance.

As Vigeant summarized: "Most people I work with in the industry are very genuine and authentic about what we're trying to deliver. We really are trying to create solutions and answers for consumers."

The industry isn't unregulated, but it does require consumers to seek out the companies committed to exceeding the minimum standards.

Watch the full Qredible Live episode with Phil Vigeant here.