Story at a glance
- In the United States, all supplements — defined as minerals, vitamins, probiotics and other ingredients — fall under the 1994 Dietary Supplement Health and Education Act.
- These products are thus regulated as “food” by the Food and Drug Administration, meaning manufacturers do not have to prove their efficacy or safety prior to market introduction.
- This lack of oversight has resulted in a burgeoning industry capitalizing off of loose federal regulation, newfound consumer zeal and the ease of online advertising.
This year, a jury in one high-profile case against Alex Jones brought by parents of Sandy Hook Elementary school students found Jones liable for $50 million worth of damages after he claimed the shooting was a hoax.
Jones made a good chunk of his immense fortune by selling dietary supplements on his show, InfoWars.
Another celebrity, actress Gwyneth Paltrow, has also tapped into this market, and continues to make headlines for her controversial wellness brand Goop, which offers “vitamins and supplements designed by doctors.”
Furthermore, a stream of celebrities and social media influencers hawk similar products to their millions of followers online, often promoting the substances as all-natural wellness boosters and beauty enhancers.
All told, supplements seem to be having a bit of a heyday, and this boom was compounded by the COVID-19 pandemic.
The dearth of safe and effective treatments for COVID-19 during the first few months of the crisis led to a scramble for immunity-boosting products among health-conscious consumers, even though these likely do not prevent illness.
Simultaneous heightened distrust in the medical establishment alongside the proliferation of online misinformation contributed to the rise of pseudoscience, as individuals sought to take their health into their own hands in the face of a then-unknown virus.
This perfect storm has culminated in huge surges in supplement use and sales in the United States and around the world.
But despite 77 percent of U.S. adults reporting they take at least one supplement, numerous studies have detailed significant problems with the industry, especially when it comes to products’ safety, efficacy, marketing and lack of regulation.
What are supplements and what risks do they pose?
Per the 1994 Dietary Supplement Health and Education Act (DSHEA), “supplements” is an umbrella term covering vitamins, minerals, probiotics, botanical herbal extracts and other ingredients. Unlike medicines, these substances are regulated under the “food” category of the Food and Drug Administration (FDA), meaning they receive substantially less scrutiny, oversight and testing.
There’s no doubt certain regulated vitamins and minerals are necessary for those who may be unable to easily absorb nutrients due to injuries or disease. For these patients, prescribed supplements at regulated doses can be hugely beneficial. But evidence that supplements actually help already healthy people maintain or improve their health is scarce, experts say.
Although normal doses of regulated vitamins might not benefit the average healthy person, they also don’t pose high risks.
Problems arise when it comes to proprietary blends — or a combination of mixed ingredients that are not disclosed on labels — and extremely high concentrations of certain vitamins or minerals not naturally found but manufactured into products.
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These supplements can contain unapproved or toxic dangerous substances, but because of DSHEA, manufacturers are not required to disclose their presence on packaging.
“It’s a completely different situation once you start purchasing supplements that have multiple different ingredients in them,” explained Pieter Cohen, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance, in an interview with Changing America.
Mixtures of undisclosed substances, along with inclusion of active pharmaceutical ingredients, unapproved drugs, heavy metals, and bacterial or mold contamination can all lead to adverse health effects in unsuspecting consumers.
These effects are borne out in the data. High doses of vitamin A can cause birth defects, while supplements containing vitamins B6 or B12, iodine and whey have been linked with acne.
Several skin, hair and nail supplements are associated with an increased risk of cancer and diabetes, while patients who do not notify their doctors they take supplements risk harmful drug-supplement interactions or receiving inaccurate laboratory test results.
If an individual is allergic to seafood but wishes to take a collagen supplement, there is no requirement the supplement’s label disclose the source of the collagen, which could be seafood.
In the past, numerous deaths have been linked with supplement consumption.
Although the FDA can’t vet any of these products before they’re sold to humans, they can respond to reports of those that cause injury and work to take them off the market, Cohen explained.
Systems like the Health Fraud Product Database can aid in this effort, but the thousands of products for sale in the United States can complicate efforts.
In the past, the FDA has issued warnings on certain supplements, particularly for a range of products promoting sexual enhancement.
Phosphodiesterase 5 (PDE5) inhibitors are the active ingredients in erectile dysfunction (ED) treatments including Viagra and Cialis — drugs that have been approved by the FDA for ED. But when consumed incorrectly, they can pose significant dangers.
“Let’s say your doctor told you that you couldn’t have Viagra or Cialis because you were taking a nitrate for your coronary artery disease, your heart failure,” explained C. Michael White, department head and distinguished professor of pharmacy practice at the University of Connecticut School of Pharmacy, in a hypothetical situation.
“So you’re looking for a natural alternative to those drugs because you can have severe drops in blood pressure if you take the two together through this drug interaction. Then you come across this product and it looks like it’s all natural and [the label] doesn’t tell you that it has those PDE5 inhibitors in them.”
In this scenario, the patient unknowingly puts himself at risk for a severe blood pressure drop, White explained to Changing America in an interview. Or, if an individual is already taking an ED drug but is looking for a natural enhancer and takes one of these supplements, he can unknowingly overdose himself.
“Major study after study has shown that if you analyze the contents of the supplements, they’re very often not what’s listed on the label,” said Cohen.
Even though this is technically illegal and products are supposed to be accurately labeled, “the fact is, that’s just not happening. A lot of the time the things that are listed on the label are not there. And other times there are things that are potentially dangerous that are in the bottle, but not listed on the label.”
Advertising and Marketing
Unlike FDA-approved treatments, supplements cannot be marketed in a way that leads consumers to believe they cure, prevent or treat disease. But under DSHEA, it is legal to advertise supplements as if they have benefits on the human body, “even if there’s zero evidence from human clinical studies that demonstrate that they work,” Cohen said.
This loophole explains the plethora of supplements sold that claim to “enhance”, “promote,” or “boost” a bodily function or process. “You could even have situations where there are human trials that show that this supplement does not work, but you can still continue to sell it as if it does,” Cohen added.
Although manufacturers can and do acquiesce to FDA demands that products found to be harmful must be removed from the market, the manufacturers can also immediately replace the withdrawn product with another adulterated alternative.
“Right now, it’s not that you are guilty until proven innocent, you’re innocent until proven guilty,” White said.
“A lot of the companies that are manufacturing these products, they’re manufacturing them, they’re selling them, outside of the country. So even if you need to, it’s very easy to fold your company and then create a brand new company that happens to be at the same exact location.”
In addition to misleading labeling on bottles and packaging, these supplements and vitamins have found a strong foothold in the online advertising world.
Touching on the rise in supplement sales seen throughout COVID-19, Cohen explained how within the months preceding availability of an effective outpatient treatment, it was really tempting for consumers to trust marketing claims that products could boost your immune system, especially when distributed online.
“[DSHEA] was passed in 1994, at a time when internet and social media didn’t exist and internet sales was a small fraction, if any, of any sales whatsoever of supplements,” he said. “So the way these products have been promoted and sold has completely been revolutionized over the 27 years or so since the law was passed.”
Part 2 of this series dives deeper into the online advertising of supplements and explores different solutions to address risks from consumer and regulatory standpoints.