Dietary Supplement Health and Education Act
A dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients:
- a vitamin
- a mineral
- an herb or other botanical (excluding tobacco)
- an amino acid
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or
- a concentrate, metabolite, constituent, extract, or combination of any of the above
Furthermore, it must be:
- intended for ingestion in pill, capsule, tablet, powder or liquid form
- not represented for use as a conventional food or as the sole item of a meal or diet
- labeled as a "dietary supplement"
The Dietary Supplement Health and Education Act (DSHEA) was signed by President Clinton on October 25, 1994. Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. The FDA does not approve dietary supplements based on their safety and efficacy; the FDA can take action only after a dietary supplement has been proven harmful. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements. The FDA claims that their rationale for a lack of regulation is a "freedom to choose" by the consumer, but there are economic benefits as well. The FDA chooses not to regulate dietary supplements because clinical trials are lengthy and costly. They tend to believe that the supplement is beneficial until problems arise.
Some interesting facts about dietary supplements include:
- It has been estimated that 40% of the US population uses dietary supplements often and that almost twice as many have used at least 1 of the estimated 29,000 dietary supplements on the market.
- Although most consumers of alternative therapies also take prescription medications, one survey found that 72% of respondents who used alternative therapies did not report that use to their health care providers. Despite their widespread use, health care providers often fail to ask patients about their use of these substances when asked about their current use of medications.
- In 1993, dietary supplement out-of-pocket expenditures were at $4.1 billion (up slightly from 1992's $3.9 billion expenditure); but after DSHEA was implemented, 1994 expenditures on dietary supplements nearly doubled to $8.1 billion.
- Finding reliable and unbiased information on herbal remedies continues to be a challenge, yet out-of-pocket expenditures on dietary supplements exceeded $22 billion in 2007 (accurate numbers for more recent years have not yet been made available).
- Pharmacy Times, A Review of Federal Legislation Affecting Pharmacy Practice, Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
- Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000
- Food and Drug Administration, Legislation, http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
- Food and Drug Administration, History, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm#Pharmacy Technician #Practice and Procedures, Gail G. Orum Alexander and James J. Mizner, Jr., McGraw Hill, 2011