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What Regulations exist for Dietary Supplements?



When you incorporate a new dietary supplement into your daily routine, you probably don’t think about the many steps it took before reaching you. Supplements undergo a lot of clinical research in order to be deemed safe for consumers, and they must comply with specific regulations before they can be sold. Some of the most important regulations are set out for manufacturers and consumer brands by the FDA, and importantly, these regulations differ from the ones set out for “conventional” foods.


Adulteration and Misbranding

The FDA requires supplement manufacturers or distributors to evaluate the safety of their product before it is even allowed to be marketed to consumers. Further, the labeling of supplements is the responsibility of these brands, and it must comply with FDA requirements for food, drug, and cosmetic safety.


Dietary supplements must be accurately branded and cannot be marketed as curing or preventing any health conditions.


Ingredient Disclosure

In addition to requiring supplements to be clearly labeled as “dietary supplements” or some equivalent such as “iron supplements,” the FDA requires all supplements to be labeled with a Supplement Facts panel which states the active dietary ingredients in the product.


Additionally, it is required for dietary supplements to state any additional ingredients, such as fillers, flavorings, or preservatives, in an “Other ingredients” panel.


What isn’t regulated?

While supplements are highly regulated by the FDA, several areas are the sole responsibility of the manufacturer and are not standardized across the board. For instance, there is not a generally agreed upon serving size for supplements to comply with, nor is there a limit to the concentration of a dietary ingredient allowed to be in a serving.


However, the FDA mandates that manufacturers of dietary supplements must meet other safety and labeling standards, and must be produced in line with up-to-date good manufacturing guidelines.


Supplement Regulations FAQ

What are the regulations for supplements?

Dietary supplement manufacturing, labeling, and distribution are all regulated. Supplement ingredients are regulated by the FDA.

Do supplements need to be FDA approved?

No, FDA approval is reserved for drugs, as they require approval before marketing. However, FDA regulations still apply to supplements.

How are vitamins and supplements regulated?

Organizations such as the FDA require vitamin and supplement companies to have evidence that their product is safe before they can be marketed to consumers.


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