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Vitamins and Dietary Supplements
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Group4 padgett&becoatm6a1
- 1. Public Safety Through Regulation of Vitamins and Dietary Supplements Henry Becoat and Stephen Padgett
- 2. 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/
- 3. 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
- 4. 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.
- 5. 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.
- 6. 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/.
- 7. Effects of the Problem Vitamins 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).
- 8. Project Plan Facilitate 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 start by casing a wide net to facilitate meetings with FDA and multiple manufacturers. Ultimately through our research and analysis, we produce sound deliverables. Pre-market regulations 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.
- 9. Steps in the Process Pre-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.
- 10. 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
- 11. Conclusion Growing 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.)
- 12. Benefits Research and regulations Accountable Safety Decrease 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.
- 13. Importance of the Project FDA research and regulations 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.
- 14. Contact Information Henry Becoat, Student Excelsior College Stephen Padgett, Student Excelsior College
- 15. 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/.
- 16. References Money 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.
Editor's Notes
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.