Dietary Supplements Fact

In addition to regulating label claims, FDA regulates dietary supplements facts in different ways. Supplement ingredients purchased in the United States before October 15, 1994, usually are not required to be reviewed by FDA for their safety before they may be marketed because they are presumed harmless based on their good reputation for use by humans. For a brand new dietary ingredient (one not sold as a dietary supplement before 1994) the producer must notify FDA of their intent to advertise a dietary supplement containing the new dietary ingredient and showcase how it determined that reasonable evidence exists for safe human utilisation of the product. FDA either can refuse to allow new ingredients into or remove existing ingredients in the marketplace for safety reasons.

Unlike drug products, there are no provisions inside law for FDA to "approve" dietary supplements for safety or effectiveness before they achieve the consumer. Once a dietary supplement is marketed, FDA needs to prove the product is unsafe in order to restrict its use or take it out of the market. In comparison, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.

The label of a dietary supplement technique is required to will and not misleading. In the event the label does not meet this requirement, FDA may take away the product in the marketplace or take other appropriate actions.

What info is required with a dietary supplement label?

FDA makes it necessary that certain information be visible on the dietary supplement label (see sample product labels):

General information

Name of product (such as word "supplement" or a statement that this product is a supplement)

Net amount of contents

Name and office of manufacturer, packer, or distributor

Directions for use

Supplement Facts panel

Meal, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established

In the event the dietary ingredient is really a botanical, the scientific name with the plant or even the common or usual name standardized in the reference Herbs of Commerce, 2nd Edition (2000 edition) and the name of the plant part used

When the dietary ingredient is often a proprietary blend (i.e., a blend exclusive to the maker), the total weight in the blend and the components of the merge order of predominance by weight

Other ingredients

Nondietary ingredients including fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend

The label from the supplement may contain a cautionary statement however the lack of a cautionary statement doesn't imply that no side effects are from the product.

Does a label indicate the standard of a dietary supplement product?

It is hard to determine the quality of the dietary supplement product by reviewing the label. The amount of qc depends on the manufacturer, the supplier, and others in the production process.

In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a collection of requirements and expectations by which dietary supplements has to be manufactured, prepared, and stored to make certain quality. Functions and features expected to ensure that the identity, purity, strength, and composition of the Nutritional Facts. For example, the GMPs make an effort to prevent the inclusion with the wrong ingredients, adding too much or weak hands of a dietary ingredient, the potential for contamination (by pesticides, volatile organic compounds such as lead, bacteria, etc.), and the improper packaging and labeling of the product.