A patient asks a nurse how to know whether dietary supplements are safe. The nurse will tell this patient that:
a. any standards addressing safety merely regulate labeling and manufacturing processes.
b. manufacturers must provide the FDA with efficacy claims prior to marketing their supplements.
c. the DSHEA requires labeling that prohi-bits claims of treatment of specific dis-eases or conditions.
d. the FDA must approve dietary supple-ments prior to marketing them in the United States.
A
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This special category exempts them from the scrutiny applied to foods and drugs. A set of standards issued by the FDA in 2007 is designed to ensure that supplements are devoid of adulterants, contaminants, and impurities and that labels reflect the contents—these standards do not ensure safety and efficacy. Efficacy claims must be provided but are not re-quired to prove these claims; a claim to efficacy does not guarantee safety. Regulations prohibit-ing disease-specific claims do not ensure safety. The FDA does not approve dietary supplements prior to marketing.
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