What safeguards are in place to protect supplement consumers, and are they enough?

Story at a glance

• Because supplements (i.e. vitamins and minerals) are regulated as food by the FDA, they do not need to undergo efficacy and safety testing prior to market entrance.

• This classification, determined by the 1994 Dietary Supplement Health and Education Act, has prompted increased calls for regulation, as the number of supplements brought to market has skyrocketed since the act’s passage.

• In part two of this series, Changing America explores current safeguards in place to protect consumers and proposed legislation aimed at increasing ingredient transparency.

Read part one of this 2-part series, which looks into causes behind the recent supplement craze and the myriad risks these products can pose to consumers.

If you’ve ever spent time scrolling through Instagram or YouTube, chances are you’ve likely come across some form of advertising or sponsored content for nutritional supplements.

Researchers from Northwestern University estimate that in 2021, the industry spent around $900 million on marketing alone. 

And although federal law prohibits supplements from being marketed to treat, cure, diagnose or prevent a disease or condition, many products are targeted to individuals looking to “boost” their wellness or “enhance” their well–being.

One area where this practice is rampant is the market for hair, skin, and nails supplements.

Influencers and sponsored content  

Because the 1994 Dietary Supplement Health and Education Act (DSHEA) does not require safety warnings on supplement labels — as they are classified as “food” not “drugs” — some influencers and consumers may be in the dark when it comes to dangerous adverse effects.

“You’ll have influencers promoting these [products] but they don’t talk necessarily about what the ingredients [are] and they rarely talk about the risks,” explained Rajani Katta, a voluntary clinical faculty member at the Baylor College of Medicine and the McGovern Medical School, University of Texas, Houston.

As a dermatologist, one of Katta’s main interests is understanding the intersection between diet and dermatology, she explained in an interview with Changing America. However, after realizing the public was more interested in supplements’ effects on the skin rather than diet’s, Katta began studying the health risks and efficacy of these products.

Instead of focusing on dosing, ingredients, or efficacy of so-called beauty supplements, Katta’s research shows influencers tend to focus more on the fact that the products they’re promoting are all-natural.

“A lot of patients who I’ve spoken to believe that because supplements are ‘all natural,’ that therefore they are not going to cause harm,” Katta said. But regardless of where a product originates it can still cause harm, she explained, noting poison ivy is also “all-natural.”

For example, the botanical saw palmetto can be used in supplements for hair loss but can also decrease levels of a particular testosterone, Katta said. In pregnant women, this can be of particular concern as it may cause abnormalities in male fetus genitalia, but supplement labels are not required to contain that information. “Certainly at a minimum, I think [manufacturers] really need to enhance their labeling laws for products that might cause birth defects,” she said.

“Beyond that, patients do need to realize that supplements are produced in a factory. And so when you have a product that contains 5,000 percent of the recommended daily allowance of a certain vitamin, that’s not found in nature. That’s produced in a factory,” Katta added.

Another market witnessing a boost in online promotion is the customizable, prescription vitamin service. These companies allow users to take online health quizzes to determine which combination of pills or gummies would be right for them, or offer specific formulations tailored to address stress relief and even anxiety.

However, say an individual was concerned about hair loss and was looking to take one of these individualized supplements, there are myriad different causes for hair loss, Katta said, and a quick online health quiz may not discern which is the root cause.

“It’s an excellent marketing strategy. It makes absolutely no sense from a consumer perspective,” said Pieter Cohen, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance, when asked about the personalized services.

In essence “this is just a way of positioning your product, charging more to consumers to give them something they don’t need,” Cohen told Changing America. “It’s a great deal for the manufacturer because you have the same inexpensive vitamins, minerals that you’re selling, but now you can sell them for more because you’re claiming that you’ve got a mix that’s just right for this individual person.”

Numerous studies have shown that for the average healthy person, taking multivitamins does not preserve health or make healthy people healthier, while experts stress the best way to receive all necessary minerals and nutrients is through a well-balanced diet.

Room for reform 

Concerns regarding the supplement industry are compounded by the fact its governing regulation is nearly 30 years old and thus was not created with online marketing in mind. And although the DSHEA has been updated in the years since its passage, some argue the law is insufficient to address the estimated 80,000 supplements on the market in 2022.

These problems have not gone unnoticed by lawmakers.

In April, U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022, which would require manufacturers to provide the FDA with names of their products, a list of ingredients, electronic copies of the labels, and a list of the health claims made about their products, Durbin explained in a contributor piece for The Hil.

“FDA would then be tasked with making this information available to the public, in an easily searchable online database,” Durbin wrote.

On its face, the bill seems to be a step forward in that at least the FDA could keep an adequate list of what products were being sold by which individual companies, said C. Michael White, department head and distinguished professor of pharmacy practice at the University of Connecticut School of Pharmacy, in an interview with Changing America.

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If individuals began reporting adverse reactions to a certain supplement that’s manufactured by a particular company, the FDA “would have a much easier time trying to figure out what other products it is that those companies are selling,” White said.

Then, if the FDA “wanted to invest some of their very limited testing dollars into testing some of the other products from that same company, that may be a more efficient use of their funds,” he continued.

The Council for Responsible Nutrition (CRN), a trade association representing the supplements industry, strongly supports the act, CRN CEO Steve Mister told Changing America, underscoring the importance of ingredient transparency for consumers.

As the law is currently written, we believe the kind of accountability it gives to the FDA is very important for the future of the industry, Mister said. CRN has also been spearheading the effort to advance mandatory product listing. Should this practice be enshrined into law with the passage of the Listing Act, “FDA can actually see what the marketplace looks like and find those offending products more easily,” Mister added.

However, the law has been met with some criticism from those who say it does not go far enough.

The law does not give the FDA any additional regulatory powers or allow it to read a label prior to listing supplements on the market, Cohen stated. “Rather, it would create the impression of reform while leaving the current lax regulatory framework largely untouched,” he wrote in a July 2022 perspective article in The New England Journal of Medicine. The piece was co-written by Jerry Avorn and Aaron S. Kesselheim.

Furthermore, the bill’s “requirements could distract the FDA’s Office of Dietary Supplements, which has fewer than three dozen employees, from enforcing the authority it has under DSHEA to inspect supplement facilities, issue import alerts, and recall hazardous supplements,” authors said.

Currently, the Listing Act is rolled into the FDA user fee authorization bill that is passed every 5 years to maintain the FDA’s revenue stream. Because this bill has to pass, there’s a good chance the Listing Act will soon become law, but whether or not the content will change following negotiations remains to be seen.

The current authorization bill is set to expire on September 30th.

“I don’t think [the Listing Act] would do anything to protect consumers from dangerous supplements or ensure that advertising is accurate,” Cohen told Changing America.

The FDA is funded in large part by user fees, but these fees cannot be used to regulate supplements under the FDA’s structure, meaning it already has limited resources to allocate to supplement oversight.

One thing critics and supporters of the Listing Act agree on is that the FDA needs more resources to better regulate the industry, while any significant reform has to come from congressional action.

“FDA can always be more proactive in its enforcement,” Mister said, adding, “we do think they need to be much more aggressive in prosecuting the bad actors.”

However, “In terms of whether the current law [DSHEA] gives [FDA] the right amount of authority, I think the existing authority is appropriate because supplements are not drugs. They are not allowed to make drug-like claims…and they shouldn’t be regulated in the same way that drugs are.”

Current practice 

Given extensive supplement contamination documented in previous research, “at some point you need to move away from naturally assuming that everything is fantastic until you prove otherwise, into a system where you want somebody to be able to show you,” the products aren’t contaminated before consumption, White said.

In the absence of significant FDA reform several groups like the NSF and US Pharmacopeia (USP) carry out independent analyses of supplements on the market and provide seals to those whose labels accurately reflect contents.

Just because these products are approved, the seals do not guarantee active ingredients will actually do what labels claim, “but at least you know that it doesn’t have any of these extraneous issues that could be risky to your health,” White explained.

Certain retailers have latched onto these practices and CVS was at the forefront of the movement with its Tested To Be Trusted program. All supplements sold at the chain have been tested by third parties and are guaranteed to be free from harmful levels of heavy metals, pesticides, microbiological components, and other contaminants.

CRN member companies also abide by federal regulatory standards and additional voluntary programs “to make sure that consumers are getting high quality safe products,” Mister said. The organization is working to give FDA more authority to carry out remote inspections and record examinations, along with allowing third parties to conduct audits of supplement companies.

When it comes to advertising, the FDA is responsible for oversight of claims made on labels and packaging, but the Federal Trade Commision (FTC) oversees online and print advertising, including sponsored content and product promotions from social media influencers.

Mister said CRN constantly reminds its members about FTC online advertising requirements and hosts webinars and conference sessions each year to do so.

But the combined responsibility of supplement regulation can get complicated. Going forward, the FTC would definitely “need to be part of the solution to get consumers accurate information about what they’re putting into their body,” Cohen said.

One more safeguard in place to ensure supplement companies abide by federal regulations is the threat of private litigation. Class action lawsuits alleging consumers have been misled by marketing or that labels are inaccurate serve as a major deterrent for the industry to not step out of line, Mister said. “That’s another, I think, very important piece of what keeps the industry honest.”

However, not all supplements on the market are CRN members, and the numerous independent protections in place means a large responsibility is put on consumers to vet products before purchase.

“For a lot of things that are on the market, there’s very little science to show that it actually helps,” Katta said. This awareness, along with researching store policies and assessing product labels for certification seals, can all help consumers make more informed decisions.

For Cohen, being skeptical is key. “Claims on the bottle do not have to be supported by scientific evidence in humans,” he said. “You have to really try to ignore any health claims on supplement bottles. And that’s hard to do.”

Overall, it’s important to remember the reasons why consumers may seek out supplements, White noted. Rising health care costs and lack of insurance coverage have prompted some to take their health into their own hands, and in a sense, the market represents some pitfalls of the United States health system.

Consumers are “looking for the ability to be able to do something that would promote their own health. And so there’s a value in giving people access to some things that may allow for that to happen,” White explained.

But without being able to guarantee products are devoid of heavy metals, microbial contamination, and other prescription drugs, and that they actually contain the active ingredient listed on the label and others at safe doses, is ultimately “doing the consumer a disservice.”

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