The Federal Food, Drug and Cosmetic Act defines a
supplement as a vitamin, mineral, herb or other botanical, amino acid, or
dietary substance for use by man to supplement the diet by increasing the
dietary intake, concentrate, metabolite, constituent extract, or combination of
preceding substances. With the astronomical variety of supplements being
marketed it comes as a surprise to many that these products are not fully
regulated by the Food and Drug Administration (FDA). Supplements fall under the
Dietary Supplement Health and Education Act (DHSEA) of 1994 that prohibits
manufacturers and distributors from marketing false or unsafe products. Prior
to distribution, companies selling supplements must establish a safety plan and
proper labeling to meet the DHSEA regulations. Although meeting these
regulations are required, the FDA does not test these supplements to verify that
what is on the ingredient list is actually being sold.
While the FDA does not regulate such products, there are
independent organizations that test these products to determine if the
ingredients on the label are in fact what the supplement contains without the
addition of ingredients not listed. Unfortunately, these independent companies
do not test to see if the supplement has a particular health effect or if it is
safe. Organizations such as Consumer Labs, NSF Internationals and US
Pharmacopeia all have their own seal of approval that can be found on the front
of the supplement bottle indicating that the specific supplement has been
tested.
Under federal law dietary supplements cannot be promoted
for the treatment of disease because they are not proven to be safe and
effective. Label claims such as “address nutrient deficiency,” “supports health,”
“shrinks tumors,” “this product does it all” and scientific words being used
like “scientific breakthrough” and “secret Ingredient” must be followed by this
disclaimer “This supplement has not been evaluated by the FDA. This product is
not intended to diagnose, treat, cure or prevent any disease”. These label
claims can be tip-offs of a company looking to take advantage of the limited
knowledge of the general public and that supplements are simply not fully
regulated by the FDA.
Before purchasing a supplement, it is important to speak
with a doctor, registered dietitian or a pharmacist to determine a person’s
nutrition needs. Factors to consider may include age, diet, current medical
conditions or medical conditions a person may be at risk for such as
osteoporosis, heart disease, kidney disease, cancer, pregnancy and more. It is
also important to do your homework before purchasing any type of over the
counter supplement. Questions a person should ask include: What does this
supplement do? What are the risks and the benefits? How much do I take? How
long do I take it? When do I take it?
When researching supplements, it is important to consider
the risks. Speaking with a doctor, registered dietitian or pharmacist before
taking a supplement will be helpful in determining which are safe for specific
medical conditions. Many supplements can have interactions with current
medications a person may be taking. Examples include vitamin C and E with
cancer treatments; antidepressants and birth control with St. John’s Wort; vitamin
K with Coumadin; ginseng with Heparin; anticoagulants and NSAIDS; gingko biloba
with high blood pressure medications. Health conditions to be aware of when
taking supplements include surgery, pregnancy, breastfeeding, heart disease,
high blood pressure, and gastrointestinal issues. For example, during pregnancy
a prenatal vitamin is recommended as consuming the recommended dosage of specific
vitamins like folate can prevent long term birth defects such as spina bifida.
If a potential problem is suspected with a supplement it
can be reported to the Federal Trade Commission, State Attorney’s General
Office, State Department of Health, or your Local Consumer Protection Agency.
If an illness is suspected to be a result from taking a supplement, report to
your doctor immediately and a compliant can be filed with the FDA online.
Office of Food Additive Safety, Guidance for industry:
Distinguishing liquid dietary supplements from beverages. U.S. Department of
Health and Human Services. January 2014. Accessed March 26th, 2019.
Dietary
Supplement Products and Ingredients, FDA website. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm.
Accessed March 26, 2019
Dietary
Supplements. FDA Website. https://www.fda.gov/Food/DietarySupplements/default.htm.
Accessed March 26, 2019
Dietary
Supplements, What you need to know. National Institutes of Health website. https://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx.
Accessed March 26, 2019
FDA 101: Dietary
Supplements. FDA website. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm.
Accessed March 26, 2019
Medication
Interactions: Food, Supplements and Other Drugs. American Heart Association
Website. https://www.heart.org/en/health-topics/consumer-healthcare/medication-information/medication-interactions-food-supplements-and-other-drugs.
Accessed March 26, 2019
Medication and
Supplements that can raise your blood pressure. Mayo Clinic Website. https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/blood-pressure/art-20045245
Accessed March 26, 2019
15 Supplement
Ingredients to Always Avoid. Consumer Reports Website. https://www.consumerreports.org/vitamins-supplements/15-supplement-ingredients-to-always-avoid/
Accessed March 26, 2019
Mixed
Medications and Dietary Supplements Can Endanger Your Health. FDA website. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm420349.htm.
Accessed March 26, 2019
Guidance for
Industry. Distinguishing Liquid Dietary Supplements from Beverages. FDA
website. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/UCM381220.pdf
. Accessed March 26, 2019.