Public Safety Through Regulation of Vitamins and Dietary SupplementsHenry Becoat and Stephen Padgett

INTRODUCTION• The United States' dietary vitamins and supplements industry is a billion dollar industry, which in 2014, made

approximately $36.7 billion.• Vitamins and dietary supplements can actually be detrimental to one's health instead of beneficial. To ensure the

public's safety, the Food and Drug Administration should better regulate the dietary vitamins and supplements industry. Healthline News, (2015). 2/11/2017. Retrieved from http://www.healthline.com/health-news/americans-spend-billions-on-vitamins-and-herbs-that-dont-work-031915/

Purpose• The Food and Drug Administration has done a thorough job in regulating the pharmaceutical companies

and prescribed medications (Belbey, 2016). • The FDA needs to become increasingly proactive and improve regulations regarding the dietary vitamins

and supplements industry. This should be done before the products make it to the shelves. Now, (2017). 2/11/2017. Retrieved from https://www.nowfoods.com/now/quality-safety/supplement-safety-regulation

Significance and Background• The Food and Drug Administration classifies dietary vitamins and supplements under foods, translations of documented

uses indicated dietary vitamins and supplements were used to treat diagnoses and health issues.• Improving regulations to govern the dietary vitamins and supplements industry will ensure the products are reliable and

of good quality. It will also decrease mortality caused by the products. FDA warning letters: Seafood HACCP and labeling violations, (2016). 02/11/17. Retrieved from http://www.foodsafetynews.com/2016/10/fda-warning-letters-seafood-haccp-and-labeling-violations/#.WJ-SBk-7q70.

Current Situation• Due to dietary vitamins and supplements being under foods instead of medications, the Food and Drugs Administration

regulations are less stringent. Any manufacturer can create a product and put it on the market.• The FDA does not require proof of safety or proof of testing of the dietary vitamins and supplements, monitoring is not

done until such products are marketed. Unless there is a major event such as death or a number of related illnesses to a identified product the Food and Drug Administration will not take any action. FDA & Dietary Supplements: By the Numbers, (2016). 2/11/2017. Retrieved from https://www.truthinadvertising.org/fda-dietary-supplements-numbers.

Cause of the Problem• The Food and Drug Administration is trusting the manufacturers of dietary vitamins and supplements to produce safe

and quality products without any type of oversight prior to the products being purchased by the consumers.• Manufacturer are allowed to set their own standards. There are no consequences for the manufacturer who “cuts

corners” unless there is some negative event, or deceptive labeling, or false claims. FDA – 70% of Dietary Supplement Companies Violate cGMPs, (2013). 02/11/2017. Retrieved from http://www.expertbriefings.com/news/fda-70-of-dietary-supplement-companies-violate-cgmps/.

 

Effects of the ProblemVitamins and supplements are beneficial…I think not!- For years the FDA has refused to regulate vitamins and dietary supplements- Without regulations users are unaware of the benefits or dangers- The FDA unwillingness to regulate vitamins and supplements may lead to… DEATH

(Mortality, 2016).

Project PlanFacilitate

meetings

with

FDA

and

manufacturers

, ultimately

generating

sound

goods

Pre-market

regulations,

inform consumers, conduct

case studies

Safe

products

Our plan is like an inverted pyramid. We startby casing a wide net to facilitate meetings with FDA andmultiple manufacturers. Ultimately through our researchand analysis, we produce sound deliverables. Pre-marketregulations must be put in place by the FDA. Published standardized information on use and side effects will help the public make informed decisions. Increasing FDA case studies will help identify problems; the results of these studies could help hold manufacturers accountable. Bad products could be removed from retail stores. Our goal with this plan is to help manufacturers provide safe products.

Steps in the ProcessPre-market regulations

FDA pre-market regulations will ensure vitamins and supplements are safe

Informed Consumer

Standardizing doses and uses will arm consumer with appropriate information

Conduct case studies

Identify and increase case studies. Independent researchers keep manufacturers accountable. Remove substandard products

These steps will lead to actionable

deliverables.

Regulate

Deliverables We will demonstrate the need for FDA regulation. Our proposal has four deliverables.

- Review and validate various case studies; our studies suggest three paths for the FDA to follow

- Proactively and aggressively pursue new products coming into the market

- Shake up the current regulations

- Ensure consumers are educated

INFORMED CONSUMER WITH SAFE PRODUCTS

Pursue

Educate

Review

ConclusionGrowing use of unregulated vitamins and supplements has led to abuse and sometimes death.

The FDA conducts rigorous testing and produces many regulations on pharmaceuticals (Belbey, 2016). It’s time for the FDA to protect consumers using vitamins and supplements.

Public safety depends on the FDA conducting more research and ultimately regulating dietary vitamins and supplements.

(Vitamins, 2015) (Law, n. d.) (Safety first, n. d.)

Benefits

Research and regulations

Accountable

SafetyDecrease abuse and

death

Informed consumer

In some cases consumers have died from overdosing on dietary supplements. The consumer will benefit from robust research and regulation governing the vitamin and supplement industry. Research will inform consumers of the potential dangers. The regulations will hold the producers accountable. Overall, consumers will feel safe using a well-regulated product.

Importance of the Project

FDA research

and regulati

ons

Informed

consumer

Public Safety

The FDA currently regulates pharmaceuticals brought to market before the consumers use the products. Increasing regulations on dietary vitamins and supplements will ensure public safety.

Contact Information

Henry Becoat, Student Excelsior CollegeStephen Padgett, Student Excelsior College

References Belbey, J. (2016). Supplements, FDA regulations and social media. Forbes. Retrieved from http://www.forbes.com/sites/joannabelbey/2016/09/22/supplements-fda-regulation-and-social-media/#6a95dd241854.

FDA/supplements [picture]. FDA & Dietary Supplements: By the Numbers, (2016). Retrieved from https://www.truthinadvertising.org/fda-dietary-supplements-numbers.

GMP [picture]. FDA – 70% of Dietary Supplement Companies Violate cGMPs, (2013). Retrieved from http://www.expertbriefings.com/news/fda-70-of-dietary-supplement-companies-violate-cgmps/.

Hospital [picture]. (n. d.) Retrieved from https://www.kidneybuzz.com/end-stage-renal-disease-patients-new-found-post-operation-risks/2013/12/30/end-stage-renal-disease-patients-new-found-post-operation-risks.

Lab [picture]. Now, (2017). Retrieved from https://www.nowfoods.com/now/quality-safety/supplement-safety-regulation.

Law [picture]. (n. d.) Retrieve from http://www.focolare.org/usa/professional-life/law-ethics/.

ReferencesMoney and Vitamins [picture]. Healthline News, (2015). Retrieved from http://www.healthline.com/health-news/americans-spend-billions-on-vitamins-and-herbs-that-dont-work-031915.

Mortality [picture]. (2016). Retrieved from https://www.thefix.com/real-culprits-rising-white-mortality.

Safety first [picture]. (n. d.). Retrieved from http://www.northbergen.org/Departments/Public-Safety/.

Sinvani, L. D., Nouryan, C. N., Pekmezaris, R., & Wolf-Klein, G. P. (2013). Vitamins and dietary supplements: controversy and confusion. Clinical Geriatrics, 21 (5). Retrieved from https://www.researchgate.net/publication/287917682_Vitamins_and_dietary_supplements_controversy_and_confusion.

Vitamins [picture]. (2015). Retrieved from http://www.focolare.org/usa/professional-life/law-ethics/.

Vitamins on plate [picture]. FDA warning letters: Seafood HACCP and labeling violations, (2016). Retrieved from http://www.foodsafetynews.com/2016/10/fda-warning-letters-seafood-haccp-and-labeling-violations/#.WJ-SBk-7q70.