What is the U.S. Dietary Supplements, Health and Education Act?:

It’s Not Just a Good Idea. It’s the Law.

The Dietary Supplements, Health and Education Act (DSHEA), signed into law by President Clinton in 1994, created a new Federal regulatory framework for the safety and labeling of dietary supplements. Under DSHEA all companies engaged in the manufacturing and distribution of dietary supplements must provide proper assurances that the product is safe, and that all claims made about the product are substantiated by adequate evidence to assure that the claims are not false or misleading. The administration of DSHEA falls under the authority of the U.S. Food and Drug Administration (FDA), but all enforcement product claims and false advertising falls under the authority of the U.S. Federal Trade Commission (FTC). The manufacturer of dietary supplements is responsible for ensuring the validity of all health, structure/function and nutrient content claims made for its products, with FDA and FTC intervening only when false claims have been identified.

The most common claims for dietary supplements relate to health and nutrition. Qualified health claims, especially for nutraceutical medical foods, must be supported by a sufficient body of evidence that provides documentation of the health benefits. A qualified health claim by definition must embody two essential components: (1) a substance, such as, a food or food ingredient, and (2) a health related condition, such as, blood glucose imbalance or high cholesterol level. A product statement lacking either of these components does not meet the regulatory definition of a qualified health claim. Nutrition claims require documentation of the nutrient content, and most nutrient claims regulations apply only to those nutrients or dietary substances that have an established daily intake value.

Nutraceutical functional food supplements making specific health claims require a significantly higher level of scientific documentation of the health claims made, either for the product or the ingredients in the product. For example, in the Diabatrol® formulation the bioactive natural whole grain derivatives have been documented in clinical trials to support the health claims made for lowering and stabilizing blood sugar levels among individuals exhibiting the type 2 diabetic condition. In addition, the bioactive nutritional embodiments in the Diabatrol formulation are documented in the nutritional labeling as required under DSHEA. Any additional nutritional and/or nutraceutical benefits promoted for the product are at the discretion of the manufacturer, but they are still regulated by the FDA and FTC relative to the documentation and validity of the claims made.  Added claims like those made for Diabatrol®, including hypoallergenic, gluten free, low glycemic and trans-fat free, are all subject to FDA and FTC regulatory oversight.

In summary, the Dietary Supplements, Health and Education Act was enacted to help protect U.S. Consumers from false health and nutritional labeling claims. No product sold as a dietary supplement can make false or misleading health claims without the expectation of punitive action by the FDA or FTC. Even scientifically documented nutraceutical medical foods, like pharmaceutical drugs, cannot claim to cure a disease like diabetes; they can only claim to help mitigate and manage health related conditions that may lead to more serious health complications.