The FDA should better regulate the dietary vitamins and supplements industry to ensure public safety. Currently, regulations are less stringent for supplements than pharmaceuticals because supplements are classified as foods. However, studies show supplements can be detrimental to health or lead to mortality when misused. The proposal calls for improved FDA regulations including requiring safety testing, standardizing labeling, and educating consumers so that supplements are reliable, manufacturers are accountable, and public safety is increased.

1. Our target audience would be the Public Hearing: Strategic Partnerships to Enhance the
Safety of Imported Foods, 14‐15 February, 2017, at the Center for Food Safety and Applied
Nutrition ‐ 5001 Campus Drive, College Park, MD 20740.
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2. The United States’ dietary vitamins and supplements industry is a billion dollar industry,
which in 2014, made approximately $36.7 billion (Multivitamin/mineral supplements,
2015). Therefore, many Americans are consuming these products. These products can
actually be detrimental to one's health instead of beneficial (Sinvani, Nouryan, Pekmezaris,
& Wolf‐Klein, 2013). To ensure the public's safety, the Food and Drug Administration (FDA)
should better regulate the dietary vitamins and supplements industry.
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3. The Food and Drug Administration has done a thorough job in regulating the
pharmaceutical companies and prescribed medications (Belbey, 2016). However with
today's frequent use of dietary vitamins and supplements as well as the many studies
showing how their use can harm one's health or ultimately lead to mortality (Sinvani,
Nouryan, Pekmezaris, & Wolf‐Klein, 2013). The Food and Drug Administration needs to
become increasingly proactive and improve regulations regarding the dietary vitamins and
supplements industry. The goal of this presentation is to prove such actions are needed.
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4. Improving regulations to govern the dietary vitamins and supplements industry will ensure
products are reliable and of good quality. It will also increase the industry's accountability.
In addition, it will assist the consumer in safe use of the products and decrease mortality
caused by the products.
Since 1800 BC, dietary vitamins and supplements have been used (Sinvani, Nouryan,
Pekmezaris, &Wolf‐Klein, 2013). Translations of documented uses indicated dietary
vitamins and supplements were used to treat diagnosed health issues (Sinvani, Nouryan,
Pekmezaris, & Wolf‐Klein, 2013). Despite the history of such uses, the Food and Drug
Administration classifies dietary vitamins and supplements under foods. The reason for the
classification is the assumption that dietary vitamins and supplements are to be used to
replace nutrients in one's diet which he or she may be lacking and to improve one's
wellness and health, not to treat a diagnosed condition (American Academy of Family
Physicians, 2014).
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5. Due to dietary vitamins and supplements being under foods instead of medications, the
Food and Drugs Administration regulations are less stringent. The Food and Drug
Administration does not require proof of safety or proof of testing of the dietary vitamins
and supplements prior to them being marketed unless there are new ingredients being
sold after 1994 in the United States (Sinvani, Nouryan, Pekmezaris, &Wolf‐Klein, 2013).
Monitoring is not done until such products are marketed. Then, if there is some negative
event, deceptive labeling, or false claims, the Food and Drug Administration may take
actions (US Food and Drug Administration, 2008). However, their actions may be too late
for those consumers who have purchased such products.
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6. Due to dietary vitamins and supplements being under foods instead of medications, the
Food and Drugs Administration regulations are less stringent. The Food and Drug
Administration does not require proof of safety or proof of testing of the dietary vitamins
and supplements prior to them being marketed unless they are new ingredients being sold
after 1994 in the United States (Sinvani, Nouryan, Pekmezaris, &Wolf‐Klein, 2013).
Monitoring is not done until such products are marketed. Then if there is some negative
event, or deceptive labeling, or false claims, the Food and Drug Administration make take
actions (US Food and Drug Administration, 2008). However, their actions may be too late
for those consumers who have purchased such products.
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7. Turning now to the effects of the problem, studies show that society’s obsession with
fitness leads to the use of dietary vitamins and supplement, which maybe harmful to one’s
health as they are unregulated. For years, the FDA has refused to regulate vitamins and
dietary supplements. Without regulations, users are unaware of the benefits or dangers.
FDA’s unwillingness to regulate vitamins and supplements is troubling for the consumer
and without proper oversight and regulation, consuming vitamins and supplements may
lead to death (Sinvani, Nouryan, Pekmezaris, & Wolf‐Klein, 2013).
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8. Take note of the upside down pyramid. Our plan is simple and straightforward. Regulations
must be put in place by the FDA (Makers Nutrition and Nutra Science Labs). Published,
standardized information on use and side effects will help the public make informed
decisions. Increasing FDA case studies will help identify problems; we anticipate the results
of these studies will help hold manufacturer’s accountable. Bad products could be
removed from retail stores. Our goal with this plan is to help manufacturers provide safe
products.
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9. The goal of our plan is to create actionable deliverables the FDA can use and easily
implement. First, we focus on the pre‐market regulations. The FDA must develop
guidelines for the manufacturers to follow…and manufacturers need to follow these
guidelines. Additionally, manufacturers will provide proof of test and submit their products
for random testing. Next, we must inform the consumer. Standardizing doses and uses will
arm consumer with appropriate and cautionary information. Standard terms and
information listed on the product will help keep consumers’ safe. Lastly, using independent
researchers to identify and increase the number of case studies will ensure companies are
producing products that meet standards with removal of inferior products. Now let’s look
at our deliverables.
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10. Through our research, we have demonstrated the need for FDA regulation. We have
developed four deliverables. First, we will review and validate various case studies. Next,
we will proactively and aggressively pursue new products coming into the market and
ensure these products follow strict production guidelines. Furthermore, we will shake up
the current regulations, by ensuring products are properly produced and labeled with
cautionary instructions. Lastly, we will ensure consumers are educated. This may be as
easy as standardizing the product language printed on the containers. All efforts will
ensure an informed consumer is purchasing and ingesting safe products.
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11. As we start to wrap up our proposal, we would just like to summarize the benefits and
importance of the project. There is a growing use of unregulated vitamins and supplements
that has led to abuse and sometimes death. This is alarming negative trend and something
must be done. Why would the FDA conduct rigorous testing and produce many regulations
on pharmaceuticals but not vitamins and supplements? It’s time for the FDA to protect
consumers using ingesting any product over‐the‐counter or prescribed by doctors to
include vitamins and supplements. Public safety depends on the FDA conducting more
research and ultimately regulating dietary vitamins and supplements. Now let’s look at the
benefits.
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12. In some cases, consumers have died from overdosing on dietary supplements. Everyone
consuming vitamins or dietary supplements will benefit from evidence‐based research and
regulations. First, research will inform consumers of the potential dangers. Next, well‐
written regulations will hold the producers accountable. Additionally, well‐informed
consumers will feel safe with recommended standard doses that are printed on the
product. Overall, consumers will feel safe using a well‐regulated product such as Tylenol or
Aspirin.
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13. The FDA currently regulates pharmaceuticals brought to market before the consumers use
the products. Increasing regulations on dietary vitamins and supplements will increase
public safety. The importance of this project can be easily stated and I would to end with
this simple equation. Well‐documented research and strong FDA regulations plus a well‐
informed consumer will ensure overall public safety for you, your family and future
generations.
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14. Thank you for your time. We appreciate the opportunity to present this proposal to you
and your staff. If you have further questions, we would be glad to answer them.
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