history at a glance
- In the United States, all supplements, defined as minerals, vitamins, probiotics, and other ingredients, are governed by the Dietary Supplement Health and Education Act of 1994.
- Therefore, these products are regulated as “foods” by the Food and Drug Administration, which means that manufacturers do not have to prove their efficacy or safety before they are placed on the market.
- This lack of oversight has resulted in a booming industry that takes advantage of lax federal regulation, new consumer enthusiasm, and the ease of online advertising.
This year, a jury in a high-profile case against Alex Jones brought by parents of Sandy Hook Elementary School students found Jones liable for $50 million in damages after he claimed the shooting was a hoax.
Jones did a good deal of his immense fortune selling dietary supplements on his show, InfoWars.
Another celebrity, actress Gwyneth Paltrow, has also taken advantage of this market and continues to make headlines for her controversial Goop wellness brandthat offers “doctor designed vitamins and supplements.”
Also, a stream of celebrities and social media influencers falcon similar products to their millions of online followers, often promoting the substances as all-natural wellness enhancers and beauty enhancers.
All in all, 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 months of the crisis led to a scramble for immunity-boosting products among health-conscious consumers, despite the fact that these probably won’t prevent the disease.
Simultaneous increase in mistrust in the medical establishment along with the proliferation of misinformation online contributed to the rise of pseudoscienceas people were looking to take their health into their own hands in the face of a then unknown virus.
This perfect storm has culminated in huge waves of use of supplements Y sales in the united states and around the world
But even though 77 percent of American adults report taking at least one supplement, numerous studies have detailed significant problems with the industry, especially when it comes to product safety, efficacy, marketing and lack of regulation.
What are supplements and what risk?What do they pose?
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), “supplements” is an umbrella term that encompasses vitamins, minerals, probiotics, herbal botanical extracts, and other ingredients. Unlike drugs, these substances are regulated under the Food and Drug Administration (FDA) category of “food,” which means they receive much less scrutiny, oversight, and testing.
There is no question that certain regulated vitamins and minerals are necessary for those who cannot easily absorb nutrients due to injury or illness. For these patients, supplements prescribed in regulated doses may be enormously beneficial. But the evidence that supplements actually help people who are already healthy maintain or improve their health is scant, experts say.
While normal dosages of regulated vitamins may not benefit the average healthy person, they also do not 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 that are not found naturally but are manufactured into products.
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These supplements may contain toxic or unapproved hazardous substances, but due to DSHEA, manufacturers are not required to disclose their presence on the packaging.
“It’s a completely different situation once you start buying supplements that contain multiple different ingredients,” explained Pieter Cohen, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance, in an interview with Changing America.
Undisclosed substance mixtures, along with the inclusion of active pharmaceutical ingredients, unapproved drugs, heavy metals, and bacterial or mold contamination, can lead to adverse health effects in unsuspecting consumers.
These effects are confirmed in the data. High doses of vitamin A can cause birth defectswhile supplements containing vitamins B6 or B12, iodine, and whey have been acne related.
Various supplements for skin, hair and nails are associated with an increased risk of cancer and diabeteswhile patients who do not notify their doctors that they take supplements are at risk of being harmful drug-supplement interactions or receiving inaccurate laboratory test results.
If a person is allergic to shellfish but wishes to take a collagen supplement, the supplement label does not need to reveal the source of the collagen, which could be shellfish.
In the past, numerous deaths have been linked with consumption supplement.
Although the FDA cannot test any of these products before they are sold to humans, it can respond to reports of those causing injury and work to remove them from the market, Cohen explained.
systems like the Health Fraud Product Database can help 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 about certain supplements, particularly a range of products that promote 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 take Viagra or Cialis because you were taking nitrate for your coronary artery disease, your heart failure,” explained C. Michael White, department chair and distinguished professor of practice pharmacy at the University. from the 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 seems that it is completely natural and [the label] it doesn’t tell you it contains those PDE5 inhibitors.”
In this scenario, the patient is unknowingly putting themselves at risk for a severe drop in blood pressure, White explained to Changing America in an interview. Or, if a person is already taking an erectile dysfunction medication but is looking for a natural enhancer and takes one of these supplements, he may overdose without knowing it.
“Study after study has shown that if you look at the contents of supplements, very often they are not what they appear on the label,” Cohen said.
Although this is technically illegal and the products are supposed to be accurately labelled, “the fact is that is simply not happening. Many times 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 on the label.”
Advertising and marketing
Unlike FDA-approved treatments, supplements cannot be marketed in a way that leads consumers to believe that they cure, prevent, or treat disease. But under DSHEA, it’s legal to advertise supplements as having benefits to the human body, “even if there’s no evidence from human clinical studies that they work,” Cohen said.
This lacuna accounts for the plethora of supplements sold that claim to “improve,” “promote,” or “boost” a bodily function or process. “There could even be situations where there is human testing that shows this supplement doesn’t work, but you can still continue to sell it as if it does,” Cohen added.
Although manufacturers can and do accept the FDA’s demands that products deemed harmful be removed from the market, manufacturers can also immediately replace the recalled product with another adulterated alternative.
“Right now, it’s not that you’re guilty until proven guilty, you’re innocent until proven guilty,” White said.
“Many of the companies that manufacture these products, manufacture them, sell them, outside the country. So even if you need to, it’s very easy to close your business and then create a new business that’s in the exact same location.”
In addition to misleading labeling on bottles and packaging, these supplements and vitamins have found a strong foothold in the world of online advertising.
Referring to the surge in supplement sales seen during COVID-19, Cohen explained how in the months before effective outpatient treatment became available, it was really tempting for consumers to trust marketing claims that products could stimulate your immune system, especially when distributed online.
“[DSHEA] it was passed in 1994, at a time when the internet and social media were non-existent and internet sales were a small fraction, if any, of any supplement sales,” he said. “So the way these products have been promoted and sold has been completely revolutionized in the 27 or so years since the law was passed.”
Part 2 of this series delves into online supplement advertising and explores different solutions to address risks from a consumer and regulatory standpoint.
