The FDA does have powers that can be useful in regulating supplements. The FDA
requires that manufacturers must follow good manufacturing practices (GMP) to
ensure the identity, purity, strength, and composition of their products. They can
monitor information on the product’s label and package insert and, at least in theory,
make sure that information about the supplement’s content is accurate and that any
claims made for the product are truthful and not misleading. The FDA can require
a recall of unsafe products. Between 2007 and 2016, the FDA ordered recalls
of 776 supplements because they contained unapproved, unlabeled drug ingredients
that are potentially dangerous. Although the FDA has the mandate to oversee
the labeling and manufacture of supplements, it just does not have the funds or
workforce to keep up with and appropriately monitor all 90,000 supplements on the

Independent testing has found that the strength of supplements may vary markedly
and that the contents may not even be what is described on the label. The contents
may be different, diluted, or even be missing entirely. Four out of 5 herbal supplements
tested by the New York State Attorney General’s office in 2015 did not
contain the herbs listed on the labels.40 A commentary on a 2018 survey of unapproved
drugs in supplements noted, “…between 2007 and 2016 the FDA identified
746 brands of supplements adulterated with pharmaceutical agents. The adulterants
included prescription medications such as sildenafil and fluoxetine, withdrawn
medications including sibutramine and phenolphthalein, and unapproved drugs,
including dapoxetine and designer steroids. Twenty percent of the adulterated supplements contained two or more undeclared drugs…Most supplements adulterated with drugs were marketed as weight loss, sexual enhancement, or sports supplements…”

A few supplements have obtained an independent evaluation and come with a written
guarantee that the product is made under the FDA’s good manufacturing practices
(GMP) conditions, as well as a Certificate of Analysis (COA) that assures that the
label accurately describes what the customer is buying. Consumers can also gain assurance
from labeling that shows that the product has been “U.S.P. Verified.” This
proves the supplement has been inspected and approved under the United States
Pharmacopeial Convention. Unfortunately, fewer than 1% of supplements on the
market have been U.S.P. Verified.

Paul A. Offit, and Sarah Erush of the Children’s Hospital of Philadelphia, reached
out to supplement manufacturers for verification of GMP. They found that about
90% of the companies never responded, and of the remainder, many manufacturers
refused to provide either a statement of GMP or a COA; “in other words, they refused
to guarantee that their products were what they said they were. Others lied;
they said they met GMP standards, but a call to the FDA revealed they had been
fined for violations multiple times.” The FDA estimates that approximately 50,000
adverse reactions to dietary supplements occur every year, but few dietary supplement
consumers are aware of this risk.

Offit and Erush concluded, “…until the day comes when medical studies prove
that these supplements have legitimate benefits, and until the FDA has the political
backing and resources to regulate them like drugs, individuals should simply steer
clear. For too long, too many people have believed that dietary supplements can
only help and never hurt. Increasingly, it’s clear that this belief is a false one.”

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