Prescription drugs have labels, package inserts, advertising, and health claims that
must be approved by the FDA as scientifically sound, accurate, and balanced, with
risks as well as benefits described. But the advertising and information provided to
consumers about dietary supplements do not require premarket review or approval
by the FDA, and the result has been the frequent development and introduction of
unsafe products. “There’s a false perception that supplements fall under the
same regulatory umbrella as prescription drugs,” said Orly Avitzur, medical adviser
for Consumer Reports. Although the dietary supplement manufacturer is responsible
for ensuring that a dietary supplement is safe before it is marketed, there are
many examples of unsafe products being sold. The FDA is responsible for taking
action against any dietary supplement that turns out to be an unsafe product after it
reaches the market.
Supplements can be advertised and sold without scientific proof of their value to
health because, in 1994, the U.S. Congress responded to lobbying by the so-called
“health food” industry and passed the Dietary Supplement Health and Education
Act. It curtailed the mandate of the FDA to regulate dietary supplements. The
result was an explosion of supplement options hitting the market. Their number
increased from about 4,000 in 1994 to 90,000 in 2018, with annual sales of $46
billion. An article in JAMA noted that nearly two-thirds of adults over
age 70 use supplements and that spending on supplements approaches 10% of all
outlays for pharmaceuticals. The author suggested that given their potential for
harm, it is time to focus on the safety of supplements.
Dietary supplement labels may and often do carry unproven health-related claims,
for example, that a dietary supplement addresses a nutrient deficiency, supports or
improves health, is good for bodybuilding, causes weight loss, or is linked to a particular
body function, like strengthening the immune system or benefiting sexual,
brain or heart health. Although supplement makers can claim their products help
maintain the structure or function or health of the body, they cannot claim to cure
disease. Labels with these types of claims must include the words, “This statement
has not been evaluated by the Food and Drug Administration. This product is not
intended to diagnose, treat, cure, or prevent any disease.” On a typical supplement
label, this language is likely to be written in small print and difficult to find at an obscure
part of the label or referred to by an asterisk at the health-related claim.
This blog presents opinions and ideas and is intended to provide helpful general information. I am not engaged in rendering advice or services to the individual reader. The ideas, procedures and suggestions in that are presented are not in any way a substitute for the advice and care of the reader’s own physician or other medical professional based on the reader’s own individual conditions, symptoms or concerns. If the reader needs personal medical, health, dietary, exercise or other assistance or advice the reader should consult a physician and/or other qualified health professionals. The author specifically disclaims all responsibility for any injury, damage or loss that the reader may incur as a direct or indirect consequence of following any directions or suggestions given in this blog or participating in any programs described in this blog or in the book, The Building Blocks of Health––How to Optimize Your Health with a Lifestyle Checklist (available in print or downloaded at Amazon, Apple, Barnes and Noble and elsewhere). Copyright 2021 by J. Joseph Speidel
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