Information On Oshea Working

Title: Information on Oshea Working

In 1999, the Office of Dietary Supplements, created by the DSHEA, successfully carried out a mandate in the DSHEA to launch a database for dietary supplement research. This exciting development, called the International Bibliographic Information on Dietary Supplements (IBIDS) database, is a database of published scientific literature from around the world. The IBIDS database is free of charge through the Office of Dietary Supplements home page at and is intended to assist both scientists and the lay public in finding credible scientific publications on dietary supplements.

Finally, to exemplify the meaning of consumer savvy, a person must understand the meaning of the most current nutritional and sports supplement jargon, or buzzwords, as well as some basic terminology.

What is the Difference Between a Supplement and a Drug?

What exactly is a dietary supplement, and how does it differ from a drug? Generally, a nutritional supplement provides a substance that is a component of a normal physiological or biochemical process. In contrast, a drug alters a physiological or biochemical process. Of course, more complex legal definitions have been established to distinguish between these two entities.

As previously mentioned, the NLEA expanded the traditional definition of "dietary supplement" to include not just essential nutrients, but also to encompass "herbs, or similar nutritional substances." The DSHEA further expanded the definition of dietary supplements to include nonessential nutrients to encompass substances such as garlic, ginseng, fish oils, enzymes, psyllium (a fiber laxative), glandulars (extracts from animal glands or tissues), and combinations of these.

The following is an abbreviated, nontechnical definition of "dietary supplement" provided by the Office of Dietary Supplements at the National Institutes of Health (NIB), an office itself established as stipulated by the DSHEA: "The Dietary Supplement Health and Education Act defines dietary supplements as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical; or a dietary substance to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above; and intended for the ingestion in the form of a [liquid,] capsule, powder, soft gel, or gelcap, and not represented as a conventional food or as a sole item of a meal or the diet.

According to the FD&C Act, a "drug" is legally defined as any article (excluding a device) "intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body."

An additional distinction between a dietary supplement and a drug is the FDA pre market evaluation process. Before it is marketed, a drug must undergo clinical studies to determine its effectiveness, possible interactions with other substances, safety, and appropriate dosage. Then the FDA must analyze the generated data and authorize the drug's use before marketing it. In contrast, the FDA does not test or authorize nutritional supplements.

Legalizing Health Claims

At first, the distinction between dietary supplement and drug may appear straightforward. According to the definition of drug, a dietary supplement cannot claim to diagnose, cure, mitigate (alleviate), treat, or prevent a specific disease. For example, a dietary supplement could not carry the claim reverses heart disease or cures cancer or treats high blood pressure. However, to the public, the line between a nutritional supplement and a medicine is some­times a thin one, depending on the claims made. Under the DSHEA and prior labeling legislature, there are three types of claims that can possibly be made by supplement manufacturers when justified: nutrient-content claims, disease claims, and nutrition support claims. No longer is a manufacturer required to obtai
FDA approval to make these three types of health claims, as long as the manufacturers follow some simple guidelines.

Nutrient-content claims tout the amount of nutrient contained in a supplement. For example, a supplement's label could claim the product to be high in calcium if it contained a minimum of 200 milligrams of calcium. Similarly, a supplement label could read "Excellent source of vitami
C" in a supplement having at least 12 milligrams of vitami
C

Disease-specific claims make an association between a substance and a disease or health-related condition. These claims are preauthorized by the FDA based on its thorough review of the scientific evidence. Alternatively, disease claims can be based on a consensus statement from certain scientific bodies, such as the National Academy of Sciences, describing a proven link between a nutrient or food and health. Only certain nutrients are preapproved for such claims. For example, a disease claim could make a link between calcium intake and decreased risk of osteoporosis if the supplement contains sufficient levels of calcium. To date, just a few disease-specific claims have been authorized, and only two of these associations allow for nutritional supplements in addition to food: calcium and osteoporosis, and folic acid and neural tube defects. Currently, wordy, modellabel statements are required for a product marketed with a disease-specific claim. Thus, many manufacturers may be deterred from making such claims given the limited space on supplement labels.

Nutrition support claims describe a link between a nutrient and its deficiency disease. For example, a vitami
C supplement's label could legally state that vitami
C prevents scurvy if the product contains sufficient levels. When nutrition support claims are made, the prevalence of the deficiency disease in the U.S. must appear on the label. Certain nutrition support claims, called structure­function claims, can refer to the supplement's effect on the structure or function of the human body. An example of a structure-function claim would be "adequate protein is necessary to build muscle." To use structure-function claims, manufacturers do not need FDA approval. Supplement manufacturers base these claims on their interpretation of the scientific literature. But, as with all label claims, structure-function claims must be truthful and not misleading. To detect a structure-function, simply look for the label disclaimer that reads "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Interestingly, even though the manufacturer must be able to substantiate its claim, it need not furnish it to either the FDA or the public. This scenario beckons the phrase "There is no truth, just data to be manipulated."