The market of dietary supplements is ever-growing worldwide thanks to the Covid-19 pandemic as global sales were valued at $140.3 billion in 2020 and is expected to grow to $151.9 billion in 2021.
However, US federal law does not require that dietary supplements be proven safe before they are marketed which is raising concern for public health, reports Wall Street Journal.
According to the FDA, some products have had to be recalled for contamination by microbes, pesticides or heavy metals; quantity of material that does not match the label's specifications; or does not contain the ingredients that the product was claimed to contain.
Supplements include vitamins, minerals, amino acids, enzymes, organ tissue, glands, metabolites and botanicals such as herbs. They can be purchased as pills, powders, or liquids—but They are administered as food, not as drugs.
By law, supplements can only contain approved dietary ingredients. But some contain far more, or far less, ingredients than the label promised, and some contain unknown drugs or rejected substances.
Health Managing Director of NSF International, a non-profit organization that reviews dietary supplements, David Trosin said, "We are talking about extreme cases where bad players are taking advantage and gaming the system so that they can make as much money as possible and before they are caught. to get out."
Undeclared content is often a problem in products promoting weight loss, bodybuilding, pain relief, sleep aid or sexual enhancement, which, according to the FDA, may include approved drugs that have been falsely depicted as dietary supplements.
United States Pharmacopeial Convention (USP) Director (Customer Engagement) Edward P Wiszumiala said approved drugs cannot be marketed as dietary supplements.
"If it was used as a drug before dietary supplements, it cannot be used in that framework," he added.
To assist consumers, the NSF and USP, among other groups, ensure that it complies with industry standards and the company's mandate to ensure that what is in bottles is on the label.
However, "NSF" or "USP Verified" programs are voluntary, and only a fraction of all supplements are screened.
About 5% to 7% of those found on the shelves of bricks-and-mortar stores have been verified by the USP, Wiszumiyala said.
According to Trosin, about 10% of products made by companies that request review by the NSF fail to achieve certification.
"This may be because we found contaminants in the product or it may be that it fails the specified level of ingredients," Mr Trosin said.
Even without certification, manufacturers and distributors of dietary supplements are prohibited from marketing adulterated or misbranded products.
In December, the FDA found almost 50 Weight Loss and Men's Sexual Enhancement Products that contained undeclared medications, including those that were listed as bestsellers.
In 2017, researchers at the University of Guelph in Ontario examined 31 commonly used melatonin supplements for insomnia and found melatonin content ranged from 83% less than promised and 478% more. The results were published in the peer-reviewed Journal of Clinical Sleep Medicine.
The health consequences of using mislabeled or adulterated supplements can be serious.
In October 2020, a federal court in Texas sentenced two dietary-supplement executives to prison and ordered the two companies to pay a combined $10.7 million in developing, manufacturing or marketing their products that was linked to liver damage.
The FDA's database of tainted products marketed as dietary supplements has about 1,000 entries, but the agency warns that the list only includes a fraction of potentially dangerous supplements sold online and in stores.