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 its bounds.
Organizations such as the Council for Responsible Nutrition (CRN) call on the FDA to modernize dietary supplement regulations when science and the market command the necessary changes. Sometimes the FDA navigates 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 vocal about over the past few years). .
Other times, a product that has been on the market for years later establishes itself as a valuable supplement for people with certain health needs, such as marine omega-3 EPA and DHA. In these cases, the FDA reviews large amounts of published clinical science and substantiation of claims that certain food ingredients have clinical evidence to help specific health conditions.
For example, in 2019 the FDA announced a new qualified health claim that EPA and DHA combined can lower blood pressure and reduce the risk of hypertension, a risk factor for coronary heart disease when the product meets certain criteria (i.e. minus 800mg of EPA and DHA per serving and includes the claim in its entirety as it relates to the specific brand product). Products containing these omega-3 dietary ingredients can make this specific claim regarding blood pressure, hypertension, and coronary artery disease, as long as they include the exact FDA-approved language.
For mindbodygreen, since we meet the FDA criteria for this special claim, we are happy to share this language regarding our high potency omega-3 product: “Combined consumption of EPA and DHA may reduce blood pressure and reduce the risk of hypertension, a risk factor for coronary artery disease. However, the FDA concluded that the evidence is inconsistent and inconclusive. One serving of Omega-3+ Power provides 1.5 grams of EPA and DHA.
With sufficient clinical evidence, the FDA permits products containing specific dietary ingredients to make substantiated health claims beyond the limits of the DSHEA. But even then, the exact wording on labels and in marketing materials is strictly defined and regulated (for brands remaining in “FDA lanes”). Beware of irresponsible claims on dietary supplements. They are a red flag for the overall quality and reliability of the supplement brand.