Are Dietary Supplements Different From Foods & Drugs?
The U. S. Food and Drug Administration regulate dietary supplements as foods; however, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.

What Claims Can Manufacturers Make For Dietary Supplements and Drugs?
The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

A dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure / function claim.
1-Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
2-Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product.
3-A structure / function claim is a statement describing how a product may affect the organs or systems of the body and it cannot mention any specific disease. Structure / function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market. Product labels containing such claim must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

How Does FDA Regulate Dietary Supplements?
In addition to regulating claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994 are not required to be reviewed by the FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans.

For new ingredients, one not sold as a dietary supplement before 1994, the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.

Manufacturers do not have to provide FDA with evidence that dietary supplements are effective or safe, however, they are not permitted to market unsafe or ineffective products. Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market. In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that is both safe and effective.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions. 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.

What Information Is Required On a Dietary Supplement Label?
FDA requires that certain information appear on the dietary supplement label:
1)-General Information:
1-Name of product including the word “supplement” or a statement that the product is a supplement.
2)-Net quantity of contents,
3)-Name and place of business of manufacturer, packer, or distributor.
4)-Directions for use
2)-Supplement Facts Panel:
1-Servings size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (% DV), if established.
2-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.
3-If the dietary ingredient is a propriety blend (i.e. a blend exclusive t o the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight.
3)-Other Ingredients:
Non-dietary 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.

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 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.

In the United States, dietary supplements are not required to be standardized. 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.

What Does USP Verified Mean?
The U.S. Pharmacopoeia (USP) launched the Dietary Supplement Verification Program (DSVP) in 2001 to help dietary supplement manufacturers assure consumers that their products meet stringent standards and contain the ingredients declared on the label. The DSVP helps to inform and safeguard the growing number of consumers who use dietary supplements. USP is an independent, non-governmental organization, which provides standards recognized by federal law for prescription drugs and dietary supplements

As an independent, non-governmental organization, USP is uniquely positioned to provide standards for prescription drugs and dietary supplements that are recognized under federal law. Under DSVP, USP evaluates and verifies supplements according to stringent standards for product purity, accuracy of ingredient labeling, and proper manufacturing practices.
Recognized worldwide, USP has more than 180 years of scientific expertise in establishing state-of-the-art standards for pharmaceuticals and other health care products, including dietary supplements.

If a product submitted to DSVP meets USP's rigorous standards for purity, accuracy of ingredient labeling, and manufacturing practices, it will be awarded the DSVP certification mark. The DSVP mark helps assure consumers, health care professionals, and supplement retailers that a product:
Contains the ingredients stated on the label in the declared amount and strength.
Meets specified standards for product purity by meeting requirements for known contaminants.
Has been manufactured properly by complying with USP and proposed FDA standards for good manufacturing practices (GMPs).
Will disintegrate or dissolve effectively to release nutrients into your body.

USP evaluates dietary supplements submitted to the program based on:
Extensive laboratory testing.
Comprehensive review of quality control and manufacturing documentation.
Evaluation of manufacturer compliance with USP and proposed FDA standards for GMP.

Once a dietary supplement is granted the DSVP certification mark, USP will periodically conduct random off-the-shelf tests on verified products to ensure they continue to meet DSVP's strict standards. USP also will continue to conduct audits of manufacturer sites for GMP compliance on a three-year basis. During the intervening years, manufacturers will be required to conduct annual self-audits and report the results to USP for review.

Since 1820, USP has established standards for more than 3,400 prescription and over-the-counter medicines, which pharmaceutical manufacturers are required to meet by federal regulation. USP brings nearly two centuries of experience to the Dietary Supplement Verification Program. In fact, USP's dietary supplement standards-setting dates back to the organization's beginning when all drugs were made from natural products.

USP also has developed monograph standards for more than 900 nutritional and dietary supplement products. These standards are compiled in the USP-NF and are recognized as the nation's official compendia for pharmaceuticals and dietary supplements.
USP is recognized worldwide as an authoritative source of standards for pharmaceuticals, dietary supplements, and other health care products.

USP has verified 730 dietary supplements as of October 1, 2004. For further information, on verified dietary supplements, go to:

http://www.uspverified.org/participants/products_cons.html