The nutritional supplement industry is booming, but experts warn it poses risks – The Hill


The story at a glance

  • In the United States, all supplements – defined as minerals, vitamins, probiotics and other ingredients – fall under the Health and Education Supplement Act of 1994.

  • These products are therefore regulated as “foods” by the Food and Drug Administration, which means that manufacturers do not have to prove their effectiveness or safety before they are introduced to the market.

  • This lack of oversight has allowed a burgeoning industry to take advantage of loose federal regulation, new consumer zeal, 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 claiming the shooting was a prank.

Jones has made much of his immense fortune 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 “doctor-designed vitamins and supplements.”

Additionally, a stream of celebrities and social media influencers are selling similar products to their millions of online followers, often promoting the substances as all-natural wellness boosters and beauty enhancers.

All told, supplements seem to be experiencing a bit of their peak, and that boom has been made worse by the COVID-19 pandemic.

The dearth of safe and effective treatments for COVID-19 in the early months of the crisis led to a rush for immunity-boosting products among health-conscious consumers, even though these are unlikely to prevent sickness.

The simultaneous heightened distrust of the medical establishment and 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 resulted in huge increases in supplement usage and sales in the United States and around the world.

But despite 77% of American adults saying they take at least one supplement, numerous studies have detailed significant issues with the industry, particularly around product safety, efficacy, marketing and lack of regulation.

What are supplements and what are the risksdo they ask?

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), “supplements” is an umbrella term covering vitamins, minerals, probiotics, botanical herbal extracts and other ingredients. Unrelated to drugs, these substances are regulated under the Food and Drug Administration (FDA) “Food” category, which means they are subject to far less scrutiny, monitoring and testing.

There is no doubt that certain regulated vitamins and minerals are necessary for those who may be unable to absorb nutrients easily due to injury or illness. For these patients, prescribed supplements in regulated doses can be extremely beneficial. But evidence is sparse that supplements actually help already healthy people maintain or improve their health, experts say.

Although normal doses of regulated vitamins may not be beneficial for the average healthy person, they also do not pose high risks.

Problems arise when it comes to proprietary blends – or a combination of blended ingredients that are not disclosed on labels – and extremely high concentrations of certain vitamins or minerals that are not found naturally but are transformed into products.

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These supplements may contain unapproved hazardous or toxic substances, but due to DSHEA, manufacturers are not required to disclose their presence on the packages.

“It’s a completely different situation once you start buying supplements that have multiple different ingredients,” said Pieter Cohen, associate professor at Harvard Medical School and internist at the Cambridge Health Alliance, in an interview with Changing America. .

Mixtures of undisclosed substances, as well as the inclusion of active pharmaceutical ingredients, unapproved drugs, heavy metals, and bacterial or mold contamination can all have adverse health effects for unsuspecting consumers.

These effects are confirmed 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 to acne.

Several supplements for skin, hair and nails are associated with an increased risk of cancer and diabetes, while patients who do not tell their doctor that they are taking supplements risk harmful drug interactions or receive negative results. inaccurate lab tests.

If a person is allergic to seafood but wants to take a collagen supplement, the supplement’s label need not disclose the source of the collagen, which could be seafood.

In the past, many deaths have been linked to the use of supplements.

Although the FDA cannot screen 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 such as the Health Fraud Product Database can help with this effort, but the thousands of products on sale in the United States can complicate the effort.

In the past, the FDA has issued warnings on certain supplements, particularly for a line of sexual enhancement products.

Phosphodiesterase 5 (PDE5) inhibitors are the active ingredients in erectile dysfunction (ED) treatments, including Viagra and Cialis, FDA-approved drugs 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 a nitrate for your coronary artery disease, your heart failure,” explained C. Michael White, department head and distinguished professor of practice. pharmaceuticals at the University. from the Connecticut School of Pharmacy in a hypothetical situation.

“So you’re looking for a natural alternative to these drugs because you can have severe blood pressure drops if you take the two together through this drug interaction. Then you come across this product and it seems like it’s all natural and [the label] does not tell you that it contains these PDE5 inhibitors.

In this scenario, the patient is unknowingly exposing themselves to a severe drop in blood pressure, White told Changing America in an interview. Or, if a person is already taking erectile dysfunction medication but is looking for a natural stimulant and takes one of these supplements, they may be unknowingly overdosing themselves.

“Major study after study has shown that if you analyze the contents of supplements, very often they don’t match what’s on the label,” Cohen said.

Even though this is technically illegal and the products are supposed to be accurately labelled, “the fact is, it just doesn’t happen. Most of the time, the things that are on the label aren’t there. And other times there are potentially dangerous things 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 if they have benefits on the human body, “even if there’s no evidence from human clinical studies that show they work.” , Cohen said.

This loophole explains the plethora of supplements being sold that claim to “enhance”, “promote” or “boost” some bodily function or process. “You might even have situations where there are human trials that show this supplement doesn’t work, but you can still continue to sell it as if it does work,” Cohen added.

While manufacturers can accept and acquiesce to FDA requirements that products found to be harmful be removed from the market, manufacturers can also immediately replace the removed product with another adulterated alternative.

“Right now it’s not that you’re guilty until proven innocent, you’re innocent until proven guilty,” White said.

“A lot of companies that make these products, they make them, they sell them, outside of the country. So, even if you need to, it is very easy to merge your business and then create a whole new business that is in the exact same place. »

In addition to misleading labeling on bottles and packages, these supplements and vitamins have found a prominent place in the world of online advertising.

Referring to the surge in supplement sales seen throughout COVID-19, Cohen explained how, in the months before effective outpatient treatment became available, it was truly tempting for consumers to trust marketing claims that the products could boost your immune system, especially when distributed online.

“[DSHEA] was passed in 1994, at a time when the internet and social media did not exist and internet sales represented a small fraction, if any, of all supplement sales,” he said. “So the way these products have been promoted and sold has been completely revolutionized in the roughly 27 years since the law was passed.”

Part 2 of this series dives deeper into online supplement advertising and explores different solutions to address the risks from a consumer and regulatory perspective.


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