Supplement Regulations

In the United States, nutritional supplements are dietary supplements, and as such, they full under FDA regulations that require the label: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” The FDA does allow dietary supplements three types of claims: Health claims, nutrient content claims and structure/function claims (CLICK HERE).

Unlike pharmaceutical drugs, the FDA’s does not approve dietary supplements before they are marketed to consumers. Instead, the burden of proof rests with the FDA to remove or restrict a dietary supplement from the market. The FDA’s review process is normally triggered by repeated complaints of adverse health outcomes or reported deaths linked to a supplement.

The FDA requires that supplements be manufactured following “good manufacturing practices.” Some supplements claim they are manufactured to “pharmaceutical manufacturing standards” or may claim that they have a “seal of approval” from an independent organization (CLICK HERE). Some supplement lines are only available from licensed health care professionals. As the quality of supplements can vary  greatly, consumers should obtain supplements from a reliable source and research each supplement line.

Some regulatory concern has been expressed about providers selling supplements. Part of this concern is based on state laws that prevent providers from taking “financial advantage” of patients. More specifically, ethical issues have been identified when providers sell supplements though multi-level marketing (MLM) companies while enrolling patients as “down line” distributors, which raises a potential conflict of interest in the provider promoting supplements not only for patient use, but also for patient promotion. Providers should check their state regulations regarding selling supplements prior to entering into any vendor agreements or selling supplements.