Unit 4 Supplement Assignment

1. N E W C O N C E R N S A B O U T T H E S A F E T Y &
Q U A L I T Y O F O U R D I E T A R Y S U P P L E M E N T S
Dietary Supplements, Vitamins,
& Herbs
Elizabeth Rao
Kaplan University

2. What Are Dietary Supplements, Vitamins, &
Herbs?
The FDA defines dietary supplements in part as products (other than tobacco)
taken by mouth that contain a "dietary ingredient." Dietary ingredients include:
 a vitamin
 a mineral
 an herb or other botanical
 an amino acid
 a dietary substance for use by people to
supplement the diet by increasing the total
dietary intake
 a concentrate, metabolite, constituent, or extract
(FDA.gov, 2014).

3. Regulation?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the
Federal Food, Drug, and Cosmetic Act, and created a new regulatory framework for the
safety and labeling of dietary supplements.
 Dietary supplements are under the "umbrella" of foods.
 FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the
agency's oversight of these products.
 Under the act, supplements are largely unregulated, without proof of effectiveness or
safety needed to market a supplement, as well as dietary supplements being classified
as foods instead of as drugs (NY Times, 1998).
 Federal law does not require dietary supplements to be proven safe to FDA's
satisfaction before they are marketed.
 After a dietary supplement is on the market, FDA has certain safety monitoring
responsibilities.

4. Regulation? (Part II)
FDA establishes regulations to require Good Manufacturing Practices
(cGMP) August 24, 2007:
 Manufacturers are required to :
Evaluate the identity, purity, strength, and composition of their dietary
supplements.
If dietary supplements contain contaminants or do not contain the dietary
ingredient they are represented to contain, the FDA would consider those
products to be misbranded (FDA.gov, 2013).

5. Safety & Quality Concerns
The DSHEA 1994 Act creates major obstacles for the FDA’s ability to detect & eliminate contaminated
supplements.
A vast amount of dietary supplements have been found to be contaminated with:
 Toxic plant material
 Heavy metals
 Bacteria
 Prescription medications
 Controlled substances
 Experimental compounds ( such as GMO’s)

6. Safety & Quality Concerns
The article “American Roulette- Contaminated Dietary Supplements” release by The New England Journal of Medicine
 “contaminated supplements present an emerging risk to public health (Cohen, 2009).”
 In 2009, more than 140 contaminated products have been identified, but these represent only a fraction of the
contaminated supplements on the market today (Cohen, 2009).
 Even after 2007 cGMP manufacturers have not reported the estimated 50,000 + adverse events that occur annually
(Cohen, 2009).
 Many harmful ingredients are not listed on the dietary supplement’s label
 Many contaminated dietary supplements are sold over the Internet as well as in mainstream retail stores in the U.S.
 Contaminated supplements have also been found to be manufactured in China as well as closer to home.
Article Link:
http://www.nejm.org/doi/full/10.1056/NEJMp0904768
 (Article provides specific documented events of contaminated supplements)

7. Heavy Metal Contaminated Brown Rice Protein Powder
Mike Adams & the Natural News Forensic Food Lab completed a study and released these
results:
 “Natural News has confirmed, via three different laboratories, the presence of significant
levels of the heavy metals tungsten, lead and cadmium in Garden of Life “beyond organic”
raw protein products. This has been confirmed across multiple lots of Garden of Life
Original, Vanilla and Chocolate Cacao and Vanilla Spiced Chai. Tungsten has also been found
and confirmed in Garden of Life “Raw Fit” products (Adams, 2014).”
Even more surprising:
 “Of all the products we have tested at the Consumer Wellness Center laboratories, I have
never seen any product with higher levels of tungsten, lead and cadmium. Garden of Life
products we tested showed the highest levels of heavy metals that we’ve ever seen across all
foods including junk foods, dairy products and fast food (Adams, 2014).”
Unfortunately, the lab print out of all the products were no longer available on Adam’s news site
as he came to an agreement with Garden of Life and other top brown rice protein powder
manufacturers to screen the quality of product released and set levels for the amount of heavy
metals allowed.

9. “Time For The FDA To Muscle Up?”
In the article released in Newsweek Global, by Susan Scutti:
Popular bodybuilding supplement Craze pulled from U.S. military base
& stores due to scientific study showed it contained an ingredient
related to methamphetamine.
There were recent deaths related to the fitness supplement– suggests
the industry needs regulation!
Craze is a powder people add to water before a workout in order to get
more energy and focus.
Unlike the FDA, the military reacted quickly to the news that Craze
contained something resembling meth. This is not the first time the
armed forces have banned or advised against use of a supplement
(Scutti, 2013).

10. “The 10 Worst Toxins Hidden in Vitamins, Supplements,
& Health Foods”
In the article “The 10 Worst Toxins Hidden in Vitamins, Supplements, & Health Foods” by
Mike Adams for Undergroundhealth.com advises:
Investigate what’s really in your dietary supplement and where it comes from
Unfortunately natural products industry suffers from a lot of hidden toxins
The 10 Worst Toxins List:
 1. Maltrodextrin (From GM Corn)
 2. Vitamin C / acorbic acid (from GM corn)
 3. Hexane-extracted soy and rice proteins (See article for safe US manufacturer)
 4. High levels of Aluminum in detox products
 5. Lead and arsenic in herbs from China
 6. Inorganic minerals in cheap vitamins
 7. Carrageenan- Linked to gastrointestinal inflammation)
 8. Acrylamides- Cancer-causing chemicals produced during the cooking of
carbohydrates
 9. Hidden MSG / yeast extract
 10. Fluoride in green tea (Adams, 2013).

11. Using Dietary Supplements Wisely
NCCAM’s Considerations for thinking about taking a dietary supplement:
 Tell all your health care providers about any complementary health approaches you
use or plan to use.
 For tips about talking with your health care providers about complementary health
approaches, see NCCAM’s Time to Talk campaign. Especially if:
You take any medications
Thinking of replacing your medication with 1 or more dietary supplements
Expect to have surgery
Are pregnant, nursing, or attempting to become pregnant
Have any medical conditions
NCCAM’s direct link:
http://nccam.nih.gov/health/supplements/wiseuse.htm

12. Using Dietary Supplements Wisely
NCCAM’s Considerations for taking a dietary supplement:
 Follow the label instructions
 “Natural” does not always mean safe
 Be aware an herbal supplement may contain dozens of compounds
An herbal supplement may not contain the correct plant species.
The amounts of the ingredients may be lower or higher than the label states.
(That means you may be taking less—or more—of the dietary supplement than
you realize)
May be contaminated with other herbs, pesticides, or metals, or even
adulterated with unlabeled, illegal ingredients such as prescription drugs
(NCCAM, 2104).

13. Additional Articles/ Journals
“Is you Herbal Supplement Safe?”
http://eds.b.ebscohost.com.lib.kaplan.edu/eds/detail?sid=f0298c07-9efb-4491-8563-
b63a224ecea3%40sessionmgr198&vid=1&hid=109&bdata=JnNpdGU9ZWRzLWxpdmU
%3d#db=hxh&AN=95235643
“New Concerns About the Safety and Quality of Herbal Supplements”
http://www.sciencebasedmedicine.org/new-concerns-about-the-safety-and-quality-of-
herbal-supplements/
“Consumer alert: Most common vitamins, including children's vitamins, found to contain
GMOs”
http://www.naturalnews.com/041416_gmo_vitamins_maltodextrin.html

14. References
Cohen, Pieter M.D. (2009). “American Roulette — Contaminated Dietary Supplements.”
Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMp0904768
FDA.gov. (2014). “What is a dietary supplement?” Retrieved from
http://www.fda.gov/aboutfda/transparency/basics/ucm195635.htm
NCCAM. (2014). “Using Dietary Supplements Wisely.” Retrieved from
http://nccam.nih.gov/health/supplements/wiseuse.htm
Adams, Mike. (2013). “The 10 Worst Toxins Hidden in Vitamin Supplements and Health Foods.”
Retrieved from http://www.undergroundhealth.com/the-10-worst-toxins-hidden-in-
vitamins-supplements-and-health-foods/
Scutti, Susan. (2013). “Time for the FDA to Muscle Up?” Retrieved from
http://eds.b.ebscohost.com.lib.kaplan.edu/eds/detail?sid=bfa53ca5-0e58-44d3-895d-
c583bb597224%40sessionmgr112&vid=1&hid=109&bdata=JnNpdGU9ZWRzLWxpdmU%3d#
anchor=toc&db=f5h&AN=92720507