While the FDA certainly regulates the dietary supplement market and provides detailed guidelines for manufacturers to produce safe products, there are checks and balances that prevent the FDA from overstepping their bounds.
Organizations such as the Council for Responsible Nutrition (CRN) call on the FDA to modernize dietary supplement regulations when the science and market command necessary shifts. At times, the FDA is navigating uncharted territory—such as determining regulations to guide the safe use of hemp-derived CBD in the dietary supplement market (an issue CRN has been quite vocal about over the past few years).
Other times, a product that has been on the market for years is later established as a valuable supplement to individuals with certain health needs, such as marine omega-3s EPA and DHA. In these cases, the FDA reviews extensive amounts of published clinical science and substantiation for claims that certain dietary ingredients have clinical evidence to help with specific health conditions.
For example, in 2019 the FDA announced a new qualified health claim that EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease) when the product meets certain criteria (i.e, provides at least 800 mg of EPA and DHA per serving and includes the claim in its entirety as it related to the brand’s specific product). Products with these omega-3 dietary ingredients can make this specific claim about blood pressure, hypertension, and CHD—as long as they include the exact language approved by the FDA.
For mindbodygreen, since we meet the FDA criteria for this special claim, we’re happy to share that language as it relates to our high-potency omega-3 product: “Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of omega-3 potency+ provides 1.5 grams of EPA and DHA.”
With enough clinical evidence, the FDA allows products containing specific dietary ingredients to make substantiated health claims beyond the confines of DSHEA. But even then, the exact wording on labels and in marketing materials is strictly defined and regulated (for brands staying in the “FDA lanes”). Beware of irresponsible claims on dietary supplements. They are a red flag for the supplement brand’s quality and trustworthiness overall.