We Need to Better Regulate Nutraceuticals

We Need to Better Regulate Nutraceuticals

Nutraceuticals are a class of products such as pills, powders, bars and tinctures with ingredients derived from plant and animal food products. Their manufacturers claim that, among other things, these supplements can fight cancers or heart disease, boost gut health or improve general wellness. Pharmacy aisles and Internet ads are chockablock with these products, which are something between vitamins and processed foods (many, but not all, nutraceuticals contain vitamins). Market research estimates they were worth around $400 billion globally in 2021.

But some items in this market could pose a threat to human health and safety, and Congress should empower the Food and Drug Administration to start treating these products (as well as vitamins and mineral supplements) more like drugs. Right now no federal agency fully oversees the clinical testing and chemical verification of nutraceuticals in the U.S., and these products are often plagued by quality and safety problems. Nutraceutical makers can perform their own testing for safety and purity, but those tests, as well as any purported health benefits, are not required to be independently verified or submitted to the FDA. Studies have found that active compounds in these products can be in different chemical forms or different quantities than what is stated on the label, so dosing can be inconsistent. Some products contain pharmaceutical compounds not allowed in dietary supplements or other ingredients not listed on the packaging. Both the Federal Trade Commission and the FDA can intervene in the event of false claims but only after the product has hit the shelves and people have spent money on it.

In contrast, the FDA regulates all prescription and over-the-counter drugs on the U.S. market. FDA approval is typically a years-long process and involves many phases of research and testing from basic efficacy (the drug does what its developers say it does) to human safety (trials involving thousands of people to measure side effects and adverse reactions). The agency also inspects plants where prescription drugs are manufactured, and it can issue drug recalls if there are problems. Beyond postmarket regulation, nutraceuticals do not have these guardrails.

It is understandable people would think these products are safe and effective. After all, many sit in pharmacies next to over-the-counter drugs. Nutraceutical companies certainly benefit from this confusion. And consumers might not closely read nutraceuticals’ labels, which are required to declare that claims about the items have not been evaluated by the FDA and that they should not take the place of approved medical treatments. People might choose these products over medical interventions for serious illnesses or take one that interacts with their current medications.

A study by the Centers for Disease Control and Prevention estimated that about 23,000 emergency department visits and more than 2,000 hospitalizations every year are attributed to adverse effects of dietary supplements. Several past studies of prenatal vitamins have found them contaminated with heavy metals such as lead. In 2019 prenatal vitamin manufacturer Rainbow Light paid $1.75 million to settle a California case for falsely advertising its supplement as free of metals when an independent laboratory investigation found the pills contained lead, arsenic and cadmium. Regulators often have no way of identifying the harmful compounds in these products because many do not contain what the ingredient list says or even declare all their ingredients.

What can be done? A 2022 bill called the Dietary Supplement Listing Act would require supplement makers to register their product with the FDA and list all its ingredients, along with an explanation of how the nutrients in the supplement relate to its health claims. But the bill doesn’t give the FDA a mechanism to confirm such products’ ingredients, nor can it stop companies from exaggerating claims about their effects. The agency wouldn’t be able to prevent the sale of questionable supplements or inspect manufacturing facilities. Rather than protecting the consumer, some experts say, the bill could falsely bolster the credibility of supplements under the seal of new FDA oversight.

Ideally, Congress could strengthen the bill, explicitly including nutraceuticals and requiring manufacturers to conduct third-party testing for safety and efficacy and report their findings to the FDA. The FDA should be empowered to verify nutraceutical products by chemically confirming their ingredients, enforcing recalls and product bans, and maintaining a publicly searchable database of all supplement and nutraceutical health products with their associated ingredients and efficacy studies. Without drastic legislation, the consumer must evaluate potentially hyped claims alone.

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