Dietary Supplement Companies Must Make Label Claims with Care

Dietary Supplements Companies Must Make Label Claims with Care

Denis Storey
January 7, 2021

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Health Claims Substantiation for Risk-Free Supplements Innovation Webinar

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While the pandemic ravaged industries worldwide, consumers flocked to dietary supplements, looking to improve their well-being and shore up their immune systems during an unprecedented health crisis.


More than 43% of dietary supplement users that the Council for Responsible Nutrition (CRN) surveyed admitted to changing their supplement routines since March 2020. Among them, 91% of consumers report increasing their supplement intake, which includes taking new supplements (46%), taking the same supplements more often (25%), or increasing doses (22%), according to the CRN’s research.


“As consumers continue to confront the devastating public health effects of COVID-19, Americans are focused more than ever on their overall health and well-being,” CRN Senior Vice President of Communications Brian Wommack said in a press release announcing the survey findings. “As evidenced in the survey, dietary supplements continue to play a critical role in the lives of most Americans, and even more so in light of the ongoing health crisis. More than three-quarters of Americans report taking dietary supplements and the overwhelming majority of supplement users, 83%, believe these products play an important role in helping to support health and wellness during COVID-19.”


Success Brings Scrutiny

As the popularity of dietary supplements soared in 2020, so did the scrutiny from health experts and regulators alike.


In November, for example, the American Medical Association (AMA) called for increased regulation of dietary supplements, including an update to the Dietary Supplement Health and Education Act of 1994 (DSHEA).


“Patients and physicians expect the dietary supplements they purchase and recommend to be safe, quality products that are accurately labeled with their contents. As the dietary supplements industry continues to grow with little oversight, many more people will use supplements without having a clear understanding of what’s contained in these products—potentially putting their health at risk,” AMA Immediate-past Board Chair Dr. Jesse M. Ehrenfeld explained.


Since 1994, the AMA pointed out, manufacturers rolled out at least 75,000 new dietary supplement products, yet the Food and Drug Administration (FDA) collected adequate safety data for less than 250 new ingredients.


CRN, one of the leading dietary supplement trade groups, echoed the AMA’s position.


“Like CRN, the AMA’s new policy statement calls for increased enforcement of the current law, the removal of unsafe products from the market, and truthful labeling of products,” CRN President and CEO Steve Mister said in a release. “The AMA statement shares CRN’s strong support for establishing a mandatory product listing for supplements, improving label literacy to help consumers better understand the products they take, and for open-minded, better-informed dialogues between healthcare practitioners and their patients about supplement usage.


Focus on Label Claims

A considerable part of that increased scrutiny has focused on label claims. While the FDA doesn’t regulate supplements the same way it does drugs, the agency is charged with confirming that companies adhere to Current Good Manufacturing Practices (CGMPs), which help dietary supplements meet required specifications for strength, identity, purity, and composition.


Additionally, federal law prohibits dietary supplements companies from claiming products can treat or cure disease. Any health claims these companies make must be supported by strong scientific evidence demonstrating a link between a specific condition and the supplement. Supplement manufacturers can only say that a particular product or ingredient can “reduce the risk of a condition.”


Even if companies abide by the regulations and shun dubious supplement claims, researching, substantiating, and documenting health-related claims requires a lot of time and resources. Not only are multiple federal regulatory agencies watching, but state agencies and consumers are, too. The stakes have never been higher, so companies must get it right. But when manufacturers leave other departments – such as R&D, legal, and marketing – out of the loop, it puts the entire organization at risk.


TraceGains hosted CRN to discuss how dietary supplements and natural products manufacturers can better manage health claims substantiation, accelerate new product development, and connect teams through a networked platform. Watch the on-demand webinar, “Health Claims Substantiation for Risk-Free Supplements Innovation" here.