The document provides a comprehensive overview of dietary supplements in the United States, including their definition, regulatory framework by the FDA, pros and cons, as well as safety warnings. It highlights the importance of using supplements responsibly, particularly regarding potential interactions with medications and adverse effects, especially for vulnerable populations like pregnant women. Additionally, it emphasizes that supplements should not replace a healthy diet and includes resources for further information.

1. Dietary Supplements:
What You Need to
Know
By Necola Avery
Kaplan University

2. Dietary Supplements
What are they?
How are they regulated?
Pros and Cons
Warnings and Safety
Healthy Diet and Fitness
Resources

3. Dietary SupplementsIn the United States, dietary supplements are substances you eat or drink. It is also a product intended
for ingestion that contains a "dietary ingredient" to add further nutritional value to (supplement) the diet. A
"dietary ingredient" may be one, or any combination, of the following substances (U.S. Food and Drug
Administration, 2015):
 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
These supplements can be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or
powders. “Some dietary supplements can help ensure that you get an adequate dietary intake of essential
nutrients; others may help you reduce your risk of disease” (U.S. Food and Drug Administration, 2015).

4. FOOD AND DRUG ADMINISTRATION
(FDA)“The FDA regulates both finished dietary supplement products and dietary ingredients. Moreover, the “FDA regulates dietary
supplements under a different set of regulations than those covering "conventional" food and drug products. Under the Dietary Supplement
Health and Education Act of 1994 (DSHEA)” (U.S. Food and Drug Administration, 2015).
FACTS:
 Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are
adulterated or misbranded. In short, this means that these companies are responsible for evaluating the safety and labeling of their
products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations (U.S. Food and Drug
Administration, 2015).
 The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market
(U.S. Food and Drug Administration, 2015).
 Although dietary supplement manufacturers must register their facilities with FDA, they are not required to get FDA approval before
producing or selling dietary supplements. It is the responsibility of the Manufacturers and distributors to ensure all claims and
information on the product label and in other labeling are truthful and not misleading (U.S. Food and Drug Administration, 2015).
 Under FDA regulations at 21 CFR part 111, all domestic and foreign companies that manufacture, package, label or hold dietary
supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with
the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control (U.S. Food and Drug Administration,
2015).
 The manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is
required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States (U.S.
Food and Drug Administration, 2015).
 FDA regulates dietary supplement labels and other labeling, such as package inserts and accompanying literature. The Federal Trade
Commission (FTC) regulates dietary supplement advertising (U.S. Food and Drug Administration, 2015).

5. WARNINGS AND
SAFETY
Many supplements contain active ingredients that can have strong effects to your body. It is best to be alert to the possibility of unexpected side
effects, especially when taking a new product (National Institute of Health, 2011). Supplements are most likely to cause side effects or harm you when
you take them instead of prescribed medicines or when you take many supplements in combination (National Institute of Health, 2011). Above all,
some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person's response to anesthesia
(National Institute of Health, 2011). To add, Dietary supplements can also interact with certain prescription drugs in ways that might cause problems,
for example:
 Vitamin K can reduce the ability of the blood thinner Coumadin to prevent blood from clotting (National Institute of Health, 2011).
 St. John's Wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs'
effectiveness (National Institute of Health, 2011).
 Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy (National Institute of
Health, 2011).
Always keep in mind that some ingredients found in dietary supplements are added to a growing number of foods, including breakfast cereals
and beverages; therefore, taking more than you need is always more expensive and can also raise your risk of experiencing side effects (National Institute
of Health, 2011). More importantly, be cautious about taking dietary supplements if you are pregnant or nursing.
IMPORTANT: If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report
your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088. In addition, report your reaction to the dietary
supplement company by using the contact information on the product label (National Institute of Health, 2011).
This link provides a list of warnings and recalls of vitamins and dietary supplements https://www.consumerlab.com/recalls.asp

6. WARNINGS AND
SAFETYDon’t fall for fad weight-loss claims, FTC warns
Dated January 10, 2014
The Federal Trade Commission this week cracked down on four marketers of those
weight-loss products, announcing that they will have to refund consumers a total of $34
million. The products were (Consumer Reports, 2014).
 Sensa, a food additive ($26.5 million)
 LeanSpa, which promoted acai berry and “colon cleanse” weight-loss supplements ($7.3
million)
 L’Occitane, which claimed that its skin cream would slim users’ bodies ($450,000)
(Consumer Reports, 2014)
 HCG Diet Direct, which marketed an allegedly unproven human hormone as a weight-
loss treatment (financial penalty was suspended, since the company is unable to pay, the
FTC says) (Consumer Reports, 2014) .

7. DIETARY SUPPLEMENTS PROS
 Disease Prevention
“Different types of dietary supplements can help prevent certain diseases and other
medical conditions. For instance, folic acid taken during pregnancy can help to reduce
the risks of the baby developing any birth defects. There are various other dietary
supplements that help prevent the risks of simple to serious health conditions” (Health
Research Funding, 2014).
 Nutrient Deficiencies Correction
“Nutrient deficiency can lead to severe medical problems like bone fragility, anemia,
nervous system abnormalities, and poor immune system. If you have developed nutrient
deficiencies such as Vitamin B12 and iron deficiency, dietary supplements can help
reverse the medical conditions effects to your general health as well as help to prevent
them from developing” (Health Research Funding, 2014).

8. DIETARY SUPPLEMENT
CONS Not A Food Replacement
Dietary supplements are not food replacements. They do not contain the complex constellation of vitamins and
nutrients that foods contain, including phytochemicals. Phytochemicals are obtained from eating whole foods such
as fruits, grains, and vegetables. Getting your essential body minerals and nutrients from foods is still better
compared to relying on dietary supplements (Health Research Funding, 2014).
 Potential Toxicity
The more the better is a rule that is untrue to dietary supplements. Fat-soluble vitamins E, D, and A can
accumulate to toxic levels within the body if taken in doses exceeding the recommended daily allowance (Health
Research Funding, 2014). Also, botanicals and herbs can accumulate to toxic levels if you have underlying healthy
conditions including liver disease and chronic kidney (Health Research Funding, 2014).
 Side Effects
Some dietary supplements can cause adverse side effects that may interact with your prescription medication.
Make sure that the dietary supplement you are taking is prescribed by your doctor, or made by a reputable health
product manufacturer to ensure that you keep away from potentially dangerous side effects and interactions
(Health Research Funding, 2014).

9. Dietary Supplements
The Band Aid Approach
Some consumers mistakenly view
supplements as a way to make-up for their
poor diet!
Experts call this the Band Aid approach-
where you think you can eat poorly and
just take a vitamin and you’ll be equal to
another person who eats well and exercises
and takes care of their health and gets
regular check-ups!
(Health Research Funding, 2014).

10. TIPS TO HEALTHY WEIGHT-
LOSS
Eat early, weigh less.
Fast for 14 hours a day.
Serve yourself smaller portions.
Plan your meals and snacks ahead of time.
Cook your own meals.
Don’t shop for groceries when you’re hungry.
Out of sight, out of mind.
Get plenty of exercise.
Turn off the TV.
Drink more water.
All information cited by (Help Guide, 2015)

11. RESOURCES CLA is a naturally occurring fatty acid (a good fat present in foods such as meat, cheese and dairy
products at low levels). At least 1.4 to 3.0 grams per day dietary CLA is necessary to achieve body fat
loss. The link below contains a peer reviewed article of how CLA treats people with obesity
http://www.jlr.org/content/44/12/2234.short
 What ingredients are in your dietary supplements? Are they truly effective? This website discusses some
of the U.S. top weight loss ingredients and their safety concerns
https://nccih.nih.gov/health/providers/digest/weightloss-science#acai
 All you need to know about food and drugs pertaining to weight loss is right here at
http://www.fda.gov/default.htm
 How to design a well balanced healthy meal begins here! Check this site out:
http://www.choosemyplate.gov/
 What are your daily nutrient needs? How much? This site will outline the DRI for vitamins, water and
macronutrients http://ods.od.nih.gov/Health_Information/Dietary_Reference_Intakes.aspx
“Making smarter choices every day, adopting healthy lifestyle changes, and developing new eating habits,
you’ll not only lose weight and be able to keep it off, you’ll also improve your outlook and mood and have
more energy” (Help Guide, 2015).

12. DIETARY
SUPPLEMENTS
QUESTIONS?

13. REFERENCES
Consumer Reports. (2014, Jan 10). Don’t fall for fad weight-loss claims, ftc warns. Retrieved from
http://www.consumerreports.org/cro/news/2014/01/don-t-fall-for-fad-weight-loss-claims/index.htm
Health Research Funding. (2014, Mar 20). Pros and cons of dietary supplements. Retrieved from
http://healthresearchfunding.org/pros-cons-dietary-supplements/
Help Guide. (2015, Apr). Healthy weight loss and dieting tips. Retrieved from http://www.helpguide.org/articles/diet-
weight-loss/healthy-weight- loss-and-dieting.htm
National Institute of Health. (2011, June 17). Dietary supplements: What you need to know. Retrieved from
http://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx
U.S. Food and Drug Administration. (2015, Apr 15).Dietary supplements. Retrieved from
http://www.fda.gov/Food/DietarySupplements/
U.S. Food and Drug Administration. (2015, June 8).What is a dietary supplement?. Retrieved from
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm195635.htm