DSHEA (1994), HIPAA (1996) & FDAMA (1997)

What does the Dietary Supplement Health and Education Act (DSHEA) (1994) make dietary supplements be categorized as?

Dietary supplements such as vitamins and herbal supplements are considered food

What does the Dietary Supplement Health and Education Act (DSHEA) (1994) do for dietary supplements?

Dietary supplements do not have to be approved or authorized for investigation as a new drug by the FDA

What does the Food and Drug Administration Modernization Act (FDAMA) (1997) do?

Eliminates certain labeling requirements

What is an example of the Food and Drug Administration Modernization Act (FDAMA) (1997)?

The statement: “Caution: Federal law prohibits dispensing without a prescription” may be stated as “Rx only”

What does the Health Insurance Portability and Accountability Act (HIPPA) (1996) limit?

Limits the use and disclosure of protected health information (PHI) to the “minimum necessary”

What does the Health Insurance Portability and Accountability Act (HIPPA) (1996) allow for patients?

Provides an option for the patient to obtain a copy of their health record and request corrections

What does Health Insurance Portability and Accountability Act (HIPPA) account for when private information is leaked?

If protected health information (PHI) is exposed to unauthorized parties, the affected individuals must be notified