Supplementation Regulations

Supplements 1

In the United States approximately thirty billion dollars per year are spent by consumers on dietary supplements, despite insufficient evidence to demonstrate health benefits.1,4   A recent study done by the American Medical Association suggests that more than half of US adults take dietary supplements.

Why do people take supplements?3

Table 2 illustrates the top reasons reported for taking dietary supplements recorded by the National Health and Nutrition Examination Survey from 2007- 2010. In addition to these results, supplement users are more likely to report themselves in very good health or excellent health.3

Supplements 2

These results illustrate a large population that appear to be health conscientious. What many consumers fail to understand is that the lower cost dietary supplements sold right down the aisle from FDA approved over the counter medications, are not tested for safety or efficacy. To make it more confusing, many labels claim the product ‘natural’ conveying ‘safety’ to the general population.1

Supplements 3

 

If supplement users report themselves  healthier, what’s all the buzz about? 3  Are supplements effective, potentially harmful or is this a classic case of placebo effects? 2

 

 

Who regulates supplements currently on the market?

The definition of a dietary supplements as defined by the U.S. Congress is:

“a product that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement.”2

The Federal Trade Commision monitors advertisements and marketing while the Food and Drug Administration regulates dietary supplement quality, safety and labeling.1,5,6 The quality and safety referred to here is the process in which supplements are manufactured and packaged, not the quantity and quality of the product itself.  Product testing and ingredient disclosure is left to the manufacture of the product without scrutiny of a second party.4 This leaves the general public vulnerable to the integrity and honesty of supplement manufactures, in which we can be certain are interested in better health for everyone, not the dollar.

All monitoring is done under the Dietary Supplement Health and Education Act  passed about 22 years ago.7  Prior to this act, herbal supplement manufacturers were required to demonstrate safety before selling on the market in comparison to now in which there is a presumption of safety and consequently a lowering of standards.1  The only authority that the FDA currently has is to remove a dietary supplement when evidence arises revealing it unsafe.1,4  A major problem with this is that many adverse effects go unreported.1  As research continues to grow confirming nutritional benefits of substances derived from food, utilization of supplements with no regulation gives little or no benefit to the consumer if we can not ensure the quality and quantity.

Given the potential health or harm associated with supplementing and the tremendous assortment available to consumers, a proposed amendment to the current DSHEA to give the FDA more authority and obligation to regulate the dietary supplement industry may be necessary to ensure essential regulations supervise the dietary supplement industry.1

Written by Idaho State University Dietetic Student,

Chrissy Andrus McGarry

References:
  1. Sax, JK. Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer (2015) American Journal of Law & Medicine, 41:374-394 https://www.questia.com/library/journal/1P3-3797383401/dietary-supplements-are-not-all-safe-and-not-all-food
  1. Gahche, J, Bailey,R., Burt, V., Hughes, J., Yetley, E., Dwyer, J., Mary Frances Picciano, M.F., McDowell, M., Sempos, C. Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES III (2011) NCHS Data Brief No. 61, April 2011  http://www.cdc.gov/nchs/data/databriefs/db61.htm
  1. Bailey RL, Gahche JJ., Miller PE., Thomas PR., Dwyer JT. Why US Adults Use Dietary Supplements (2013) American Medical Association, Vol 173, No. 5 http://www.ncbi.nlm.nih.gov/pubmed/23381623
  1. Starr, RR, Too Little, Too Late, Ineffective Regulation of Dietary Supplements in the United States. American Journal of Public Health (2015) American Journal of Public Health, Vol 105, No. 3 pp. 478-485 http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2014.302348
  1. Federal Trade Commission: https://www.ftc.gov/
  1. US Food and Drug Adminstration: http://www.fda.gov/ Page Last Updated: 02/19/2016
  1. US Food and Drug Adminsitation, Dietary Supplements http://www.fda.gov/Food/DietarySupplements/default.htm Page Last Updated: 01/21/2016
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