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Editorial
Dietary supplements: improving education is not enough
Worldwide demand for dietary supplements sky- health-care provider. The benefits of involving a
rocketed at the beginning of the COVID-19 pandemic; health-care professional in the decision to take dietary
some countries reported sales increases of more than supplements are immense and must be encouraged oung/
50% in March, 2020, compared with the same period because of the less obvious risks and harms associated. ates Y
the previous year, and the market continues to grow. Some dietary supplements can aggravate IBD—eg, if Sherry YScience Photo Library
Concerns about vaccine safety and hopes of boosting they contain lactose or artificial colours. Oral iron has For more on global sales
immune function against COVID-19 propelled people known gastrointestinal side-effects such as nausea increases see Pharma Nutrition
to turn to dietary supplements, despite insufficient data to and diarrhoea; it can also mask signs of serious 2021; 18: 100282
For more on COVID-19’s effects
support recommendations for this purpose. In response gastrointestinal disease such as dark stools. Interactions on uptake of supplements see
to concerns about public health and safety, the US Food with other prescribed medications can be dangerous, https://ods.od.nih.gov/
factsheets/COVID19-
and Drug Administration (FDA) launched Supplement causing major drug–drug interactions. In addition, some HealthProfessional/
Your Knowledge on June 2, 2022, an education initiative people, such as those with liver disease, can have life- For the FDA Supplement Your
aimed at helping people make informed decisions about threatening complications from seemingly innocuous Knowledge initiative see
https://www.fda.gov/food/
taking dietary supplements. The initiative explains the supplements such as vitamin A or green tea extract. information-consumers-using-
laws around the industry, highlighting the risks associated Dietary supplements are not allowed to be marketed dietary-supplements/
supplement-your-knowledge
with dietary supplements and the importance of involving in the USA as a treatment, prevention, or cure for any For more on new dietary
health-care professionals. disease, but illegal marketing is a huge problem that ingredients notifications
received by the FDA see https://
Regulations for dietary supplements vary worldwide the FDA has not adequately addressed. Fraudulent www.fda.gov/media/127746/
but are perhaps most controversial and stimulate the health claims target the most vulnerable and can delay download
greatest debate in the USA. In 1994, when the dietary people receiving appropriate treatment. Thousands of For more on drug–drug
interactions and liver disease
supplement industry was worth an estimated US$4 billion products have been found to be incorrectly labelled— see https://britishlivertrust.org.
and encompassed approximately 4000 products, the even containing hidden toxic ingredients. Weight uk/information-and-support/
living-with-a-liver-condition/
US Congress passed the Dietary Supplement Health and loss supplements in particular receive a lot of illegal diet-and-liver-disease/
Education Act (DSHEA). Under DSHEA, the FDA is not marketing, with hundreds of products found to contain complementary-and-alternative-
medicines-cam/
authorised to approve dietary supplements for safety and dangerous agents such as sibutramine or dinitrophenol, For more on incorrect labelling
effectiveness before marketing and instead relies on post- which can result in serious health complications or of products see N Engl J Med
2022; published online May 18.
market surveillance to remove unsafe and illegal products. death. In a previous Editorial we discussed liver injury https://www.doi.org/10.1056/
The US market is now worth an estimated $55 billion, related to dietary supplements; by one US analysis, the NEJMp2205675
with as many as 80 000 products; as a result, the FDA proportion of drug-induced acute liver failure caused by For more on weight loss
supplements containing
has struggled to keep up. Manufacturers are required these agents increased from 2·9% to 24·1% in 25 years. dangerous ingredients see
to submit a pre-market notification to the FDA before We welcome the new FDA education initiative, but https://www.fda.gov/drugs/
medication-health-fraud/
introducing new dietary ingredients, yet loopholes in it is only a small step towards improving the safety of tainted-weight-loss-products
the law mean that many new ingredients are introduced dietary supplements for consumers. Increasing awareness For our previous Editorial see
Editorial Lancet Gastroenterol
without any safety evaluation, thus failing to protect of the importance of joint decision making between Hepatol 2018; 3: 343
consumers against harmful products. In 2019, the FDA consumer and health-care professionals is an essential For more on numbers of liver
estimated that more than 4600 notifications for new step, but shifting the focus of accountability for safety injury related to dietary
supplements in the US see
dietary ingredients should have been submitted since should not be the aim. Trust in US public health bodies Liver Transpl 2022; 28: 169–79
DSHEA’s enactment; however, at the time of reporting, is low, with one 2021 poll reporting almost a quarter of For more on mistrust of the FDA
see https://cdn1.sph.harvard.
they had only received just over 1100. Americans having little or no trust in the FDA; therefore, edu/wp-content/uploads/
Although there is poor evidence of a benefit for whether the initiative will have the desired effect is sites/94/2021/05/RWJF-Harvard-
dietary supplements for most people with a healthy, questionable. Illegal marketing of dietary supplements Report_FINAL-051321.pdf
balanced diet, they are crucial for people with dietary is unacceptable, and major legislative change is required
deficiencies or at-risk populations. For example, people to restore public trust and ensure products only contain
with inflammatory bowel disease (IBD) or pancreatic approved, safe ingredients before they ever reach the
dysfunction might be prescribed vitamins by their market. ■ The Lancet Gastroenterology & Hepatology
www.thelancet.com/gastrohep Vol 7 August 2022 689
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