A bill entitled the “Dietary Supplement Safety Act of 2003” has been introduced into the Senate by Sen. Richard Durbin (Ill.). This bill, according to the American Association for Health Freedom (AAHF), a lobby group, “would allow no more consumer protection than current law provides.”

The bill would amend the Federal Food, Drug and Cosmetic Act to require that manufacturers of dietary supplements submit to the Food and Drug Administration reports on adverse experiences with dietary supplements.

Currently, food supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DHEA), which:

• Defines dietary supplements and dietary ingredients;

• Establishes a framework for assuring safety;

• Outlines guidelines for literature displayed where supplements are sold;’

• Provides for use of claims and nutritional support statements;

• Requires ingredient and nutrition labeling; and

• Grants the FDA the authority to establish good manufacturing practice regulations.

The proposed bill defines “a serious adverse experiences” as “an adverse dietary supplement experience that:

• Results in: death; a life-threatening condition; inpatient hospitalization or prolongation of hospitalization; a persistent or significant disability or incapacity; or a congenital anomaly, birth defect or other effect regarding pregnancy, including premature labor or low birth weight; or

• Requires medical or surgical intervention to prevent one of the outcomes described above.

The bill was introduced into the Senate in March and was twice read and referred to the committee on Health, Education, Labor and Pensions. Co-sponsors of the bill include Sen. Hillary Rodham Clinton (NY), Sen. Dianne Feinstein (Calif.), and Sen. Charles Schumer (NY).

The AAHF (formerly the American Preventive Medical Association) is opposed to this bill, stating, “Despite its name, the ‘Dietary Supplement Safety Act of 2003’ would allow no more consumer protection than current law provides. It will, however, grant the Food and Drug Administration more authority … The FDA currently has all the necessary enforcement power to protect the public from unsafe or illegal dietary supplements.”

The AAHF is a lobby organization for healthcare practitioners who use nutritional and other complementary therapies in-patient care.

To read the bill and check its status, search for S722 on Thomas (http://thomas.loc.gov/), the legislative database of the Library of Congress.

Sources: S 722, Dietary Supplement Safety Act of 2003; U.S. Food and Drug Administration; American Association for Health Freedom (www.apma.net).