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HEALTHY BASE INITIATIVE

Beware: tainted dietary supplements are harmful

(from the U.S. Food and Drug Administration website)

Some products marketed as dietary supplements are tainted with the same ac- synthetic steroids, FDA has issued warning letters and conducted seizures and
tive ingredients as FDA-approved drugs, analogs of the active ingredients in FDA- criminal prosecutions.
approved drugs, or other compounds, such as novel synthetic steroids, that do not
qualify as dietary ingredients. The FDA has found that products that are marketed These products can be found on the internet (major distributors and online mar-
as dietary supplements and that contain hidden or deceptively labeled ingredients ketplaces), and in retail stores, like gas stations, salons, spas, grocery stores, and
are often promoted for weight loss, sexual enhancement, and body building. even popular dietary supplement stores.

The FDA laboratory tests have revealed alarming varieties and amounts of unde- Consumers should be very careful with products with the following characteristics:
clared active ingredients in products marketed as dietary supplements. Examples of - Product Categories – Weight loss, bodybuilding, sexual enhancement
active ingredients found in these products include: - Labeling claims like
- “Alternative to [approved drug product]” or “legal alternative to [anabolic steroid]”
- Erectile Dysfunction drugs (e.g. sildenafil, tadalafil, vardenafil) - Sexual enhancement or weight loss products claiming immediate effects
- Anabolic Steroids (e.g. madol, androstenedione, turinabol) - Directions and warnings that resemble FDA-approved drug products “May
- Weight loss drugs that have never been approved or have been removed from cause positive result in performance enhancing drug test”
the market for safety reasons (e.g. sibutramine, cetilistat, rimonabant, fenfluramine) - Labels primarily in a foreign language
- Cancer causing agents (e.g. phenolphthalein) - Products marketed through email spam
- Anticonvulsants (e.g. phenytoin) If you suspect that a product is tainted, the FDA advises you to stop taking the
- Cholesterol drugs (e.g. lovastatin) product and consult a healthcare professional. They also ask consumers to report
- Blood pressure drugs (e.g. propranolol) suspected tainted products marketed as dietary supplements to the FDA by sending
- Controlled substances (e.g. sibutramine and anabolic steroids) an email to TaintedProducts@fda.hhs.gov and/or using the anonymous reporting
The FDA is focusing on these illegal tainted supplements because the ingredi- form “Report Suspected Criminal Activity” located at: http://www.fda.gov/oci1.
ents in these products can pose considerable dangers to consumers who may take If you have been injured by any of these tainted products, the FDA asks you to
these products without knowing that the ingredients are present, that the ingredients report your injury to their MedWatch Adverse Event Reporting program online, by
may be associated with death or serious injury, or that they may interact in danger- regular mail, or by fax.
ous ways with other products consumers may be taking. The FDA has received
numerous reports of serious adverse events associated with consumer use of these
tainted products including strokes, acute liver injury, kidney failure, pulmonary em-
bolisms (artery blockage in the lung), and death. Make no mistake, these products
can kill you.
They have found nearly 300 products marketed as dietary supplements that
contain drugs, analogs of drugs, or anabolic steroids over the past several years,
and suspect that only a small fraction of the tainted supplements on the market
have been uncovered. Unfortunately, it is not possible for the FDA to test and
identify all tainted products. This is why it is so important for consumers to ex-
ercise extreme caution with these types of products and to read FDA tips for
identifying tainted products.
Where FDA investigations have discovered products marketed as dietary supple-
ments that contain the same active ingredients as in FDA-approved drug products,
analogs of such drug ingredients, or other compounds of concern, such as novel

FDA clears new traumatic brain injury assessment device

by Ms. Crystal Maynard and Afghanistan,” said Lt. Col. Chess- The Ahead 200 uses commercial smartphone technology to analyze a patient’s
Army Medicine ley Atchison, program manager for the brain activity for signs of a traumatic brain injury within 24 hours of the injury.
Technology Enabled Capability Demon-
FORT SAM HOUSTON, Texas -- A stration: Brain in Combat portfolio of the wounded warfighters quickly,” Atchison for those injured in the line of duty, and
new handheld medical device for analyzing CCCRP. “There is a great need for a tool said. “Our goal is to not only save lives, tools like the Ahead 200 help us reach
brain injuries has been cleared by the U.S. like this in theater. A normal [electroen- but to ensure the best possible outcome that goal.”
Food and DrugAdministration, or FDA. In cephalogram] machine is a big piece of
May 2015, the Ahead 200 was cleared by machinery and can’t be used in the field.”
the FDA to help clinicians assess mildly-
presenting head trauma patients. The device works by measuring the
brain’s electrical activity via a disposable
The device, which was developed by headset that is placed on the forehead.
the U.S. Army Medical Research and Once recorded, the Ahead 200 uses algo-
Materiel Command’s Combat Casualty rithms, which quantify and characterize
Care Research Program, or CCRP, and activity associated with traumatic brain
the BrainScope Company, Inc., uses injuries. Used in conjunction with other
commercial smartphone technology tools, the Ahead 200 medical device will
to analyze a patient’s brain activity for help assist clinicians in the real-time
signs of a traumatic brain injury within screening and care of warfighters with
24 hours of the injury. head injuries.

“Traumatic brain injuries have been “The size and ease of use of the
one of the signature injuries in Iraq Ahead 200 allows medics to triage