Dietary Supplement Drug Definition

The first issue arises from the definition of a dietary supplement in dshea.

Dietary supplement drug definition. Under the dietary supplement health and education act dshea the fda treats supplements like food and the dshea defines supplements as products taken orally for supplementing the diet supplements. A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains a dietary ingredient. If a dietary supplement meets the definition of a drug it is. Dietary supplements come in many forms.

The general rule is drugs are considered unsafe until they re proven safe. After enumerating vitamins minerals botanicals and amino acids the law adds a dietary supplement may also be a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Products intended for use as a nasal spray. The dietary supplement health and education act defines dietary supplements as a category of food.

John s wort and goldenseal are known to cause clinically important drug interactions and should be avoided by most patients receiving any pharmacologic therapy. Adults report concurrently taking a prescription medication with a dietary supplement. Dietary ingredients include vitamins minerals amino acids and herbs or botanicals as well as other substances that can be used to supplement the diet. The manufacturing of prescription pharmaceutical products is regulated by the us food and drug administration fda which mandates standards for consistency and quality assurance.

Conventional foods including meal replacements medical foods preservatives or pharmaceutical drugs. Nearly 25 of u s. The dietary ingredients in these. Under dshea dietary supplements are deemed to be food except for purposes of the drug definition per dshea dietary supplements are consumed orally and are mainly defined by what they are not.

21 cfr 312 3 b dietary supplement. Some supplements such as st. For the purposes of this definition an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Although they may seem to contain similar ingredients there may be important differences between the prescription and dietary supplement preparations.

Fda regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products.