MacFarguhar et
al have written an excellent article in the Feb.
8, 2010 edition of the Archives of Internal
Medicine entitled “Acute Selenium Toxicity
Associated with a Dietary Supplement.” They
report that in 2008 a chiropractor in Florida
noted common symptoms of gastrointestinal
illness and hair loss among several of his
patients. In response to these symptoms these
patients had doubled the dose of a dietary
supplement they have purchased at the
chiropractic office. Due to excellent
surveillance work performed by the local health
department and the Food and Drug Administration
the dietary supplement was identified as the
common exposure among all affected persons.
The product
causing the selenium toxicity was a blend of 16
vitamins, 12 elements with labeled
concentrations, 58 trace elements, 18 amino
acids and 3 essential fatty acids, Coenzyme Q10
and antioxidants, all suspended in an ionic
colloidal liquid. While the product labeling
indicated that it contained 200ug of selenium
per fluid ounce, the testing performed by the
FDA determined that the actual concentration of
selenium was 40,800 ug per fluid ounce, or more
than 200 times the labeled concentration.
Furthermore, the chromium concentration was 17
times the labeled concentration.
Of great
concern is that there is no proven antidote nor
curative treatment for selenosis due to an
overdose of selenium. Treatment consists of
stopping the exposure and providing supportive
care for symptoms.
At present,
dietary supplements such as vitamins, minerals
and herbal products are not subject to premarket
review or approval for safety, efficacy or Good
Manufacturing Practices. Under the Federal Food,
Drug and Cosmetic Act the manufacturer of a
finished dietary supplement is responsible for
ensuring the safety and the quality of the final
product, which includes all ingredients received
from suppliers. That responsibility includes
testing of received ingredients, including
premixed ingredients and the final product.
Had the
manufacturer been held to standards used in the
pharmaceutical industry this outbreak may have
been prevented.
In total more
than 200 individuals developed acute selenium
toxicity.
The expansion
of the dietary supplement industry has exceeded
our ability to monitor and regulate. In 1994
there were 4000 different dietary supplements on
our shelves, and today that number exceeds
75,000. Over the last 15 years the industry has
grown from $4 billion to $ 25 billion in sales.
DAI encourages the Food and Drug Administration Center for
Food Safety and Nutrition to allocate more of their
resources for the monitoring of dietary
supplements, and ensure quality control in raw
materials, purification and honest labeling and
packaging.
You may be
asking yourself “what the heck are these guys at
writing about when they are a company which
manufactures and distributes adsorbents”. You
may be correct in asking this question, but then
you would be missing the point.
DAI is in the
business of providing products and solutions for
the separation and purification of materials
critical in the manufacture of drugs and
nutritional supplements. We provide specialized
activated aluminas used to remove pyrogens and
other harmful materials which are untoward
consequences of manufacturing as well as
providing superior silica and alumina adsorbents
essential in the purification of marine and
plant alkaloids which are critical for drug
production.
We seek to have
the most secure nutraceutical and pharmaceutical
supplies available globally, and if we take our
eye off the “8-ball” we will allow processing
issues to occur, which if unchecked may lead to
untoward harm.
The Food and
Drug Administration was established to assure
the safety of the food and drug supply in this
country, and its jurisdiction and controls need
to be strengthened to assure that no harm is
allowed to occur. We make products to assure the
safety of the food and drug supply. We are
concerned scientists, and safety and health
remain our paramount priorities.
Gary Witman, MD
THINK ALUMINA -- THINK DYNAMIC
