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THE FACTS OF DIETARY SUPPLEMENTS PART 2
What information is required on a dietary supplement label?
FDA requires that certain information appear on the dietary supplement label:
General information
Name of product (including the word “supplement” or a statement that the product is a supplement)
Net quantity of contents
Name and place of business of manufacturer, packer, or distributor
Directions for use
Supplement Facts panel
Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established
If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name standardized in the reference Herbs of Commerce, 2nd Edition (2000 edition) and the name of the plant part used
If the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight
Other ingredients
Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend
The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product.
A label for a fictitious botanical product is available at http://vm.cfsan.fda.gov/~acrobat/fdsuppla.pdf.
Does a label indicate the quality of a dietary supplement product?
It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.
FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.
Are dietary supplements standardized?
Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.
Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements. Because of this, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality.
General Safety Advisory
The information in this article does not replace medical advice.
Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition, take any medications, are pregnant or nursing, or are planning to have an operation.
Before treating a child with an herb or a botanical, consult with a doctor or other health care provider.
Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous.
If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.
Disclaimer
Reasonable care has been taken in preparing this document and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.
STAY STRONG~~!!!
IPL
FDA requires that certain information appear on the dietary supplement label:
General information
Name of product (including the word “supplement” or a statement that the product is a supplement)
Net quantity of contents
Name and place of business of manufacturer, packer, or distributor
Directions for use
Supplement Facts panel
Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established
If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name standardized in the reference Herbs of Commerce, 2nd Edition (2000 edition) and the name of the plant part used
If the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight
Other ingredients
Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend
The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product.
A label for a fictitious botanical product is available at http://vm.cfsan.fda.gov/~acrobat/fdsuppla.pdf.
Does a label indicate the quality of a dietary supplement product?
It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.
FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.
Are dietary supplements standardized?
Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.
Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements. Because of this, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality.
General Safety Advisory
The information in this article does not replace medical advice.
Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition, take any medications, are pregnant or nursing, or are planning to have an operation.
Before treating a child with an herb or a botanical, consult with a doctor or other health care provider.
Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous.
If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.
Disclaimer
Reasonable care has been taken in preparing this document and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.
STAY STRONG~~!!!
IPL