Outline

1. The Dietary Supplement health and Education Act (DSHEA) of 1994.

1. Who signed the act?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted by Congress and signed into law on October 25, 1994, by President Clinton. 

2. This act made amendments to what other act?

The DSHEA amends the Federal Food, Drug, and Cosmetic Act of 1938 and alters the manner in which dietary supplements are regulated and labeled (“Dietary Supplement Health and Education Act of 1994,” n.d). 

3. List the 13 parts to this act. (Please be sure you READ the specific parts of the act so that you get an accurate account of what this act changes, allows, etc…) please be sure to check several sources regarding this and read the parts of the act carefully.

The Act contains the following major provisions as contained in 13 sections of the Act (“Dietary Supplement Health and Education Act of 1994,” n.d). 

1. Short Title, Reference, table of Contents. The section contains the introductory part of the Act.
2. Congressional Findings. This section includes the 15 Congress findings that informed DSHEA and formed the conceptual framework for Federal regulatory policy on dietary supplementary. 
3. Definitions. In this part, DSHEA defines the dietary supplements and lists the ingredients contained in dietary supplements. 
4. Safety of Dietary Supplements and Burden of Proof on FDA. Under this section, DSHEA establishes separate standards for safety and dietary supplements. The part gives a comprehensive description of the conditions under which dietary supplements can be considered unsafe. 
5. Dietary Supplement Claims. This part contains information on dietary supplements publications of an article, official abstract of a peer-reviewed scientific journal, or a book chapter. The section clearly states that such a publication cannot be used as labeling or be used in connection with the sale except when proven truthful and not misleading. In addition, the publication should not be used to promote a brand or a manufacturer; rather it should contain balanced information about the product.
6. Statements of Nutritional Support. This Section amends the Nutrition Labeling and Education Act of 1990 that allows dietary supplements labels to carry statements of nutritional support but without premarketing authorization from FDA.
7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling. Section 7 dictates the specific requirements for supplement labeling and the various circumstances under which dietary supplements can be misbranded.
8. New Dietary ingredients. This section describes the conditions under which new ingredients in a dietary supplement may be used.
9. Good manufacturing Practices. Section 9 provides FDA with the relevant authority to propagate good manufacturing practice regulations for dietary supplements.
10. Conforming Amendments. Section 10 amends Section 201 of FDCA. The section states that a dietary supplement bearing a statement of nutritional support in accordance with DSHEA cannot be classified as a drug based on the labeling.
11. Withdrawal of the Regulations and Notice. The section gives the secretary of the Department of Health and Human Services the authority to render null and void the Advance Notice of Proposed Rulemaking of 1993.
12. Commission on Dietary Supplement Labels. Grants authority to the President to appoint a commission to study and make recommendations regarding label claims and statements of supplements.
13. Office of Dietary Supplements. This section grants the establishment of the Office of Dietary Supplements within the NIH to explore the role of dietary supplements in promoting health care and scientific study of dietary supplements benefits in the United States.
14. What is the FDA’s responsibility after the passage of the act in regards to regulation of supplements? 

The FDA has a responsibility to regulate ingredients and finished dietary supplement products, under a different set of regulations separate from those covering conventional and drug products under DSHEA (U.S Food & Drug Administration, 2017). 

1. At what point can the FDA take action?

Manufacturers and distributors are prohibited from marketing unadulterated or misbranded products. The FDA is mandated to take action against unadulterated or misbranded dietary supplement products after they have been released to the market. 

2. Who is ultimately responsible for testing supplements for safety?

The manufacturers and distributors are responsible for testing dietary supplements for safety and ensure they meet the requirements outlined by DSHEA and FDA.

5. What is your overall opinion of the act?
6. Do you agree or disagree with the act?

I disagree

1. Explain

Ideally, under DSHEA, manufacturers, and distributors of dietary supplements have a responsibility to ensure the safety of their products before it is marketed. The FDA is only responsible for taking action after the supplement has been released to the market. Manufacturers are also not mandated to register their products with FDA or get approval before producing or marketing their products. Critically, this can be interpreted to mean that manufacturers can sell anything they want, so long as the FDA does not catch them. It is even more frightening to realize that some of the products marketed under DSHEA claim to do the same thing as real medicines. Ultimately, this raises the question why does DSHEA allow them to get away with it, yet it can be harmful to the health of the U.S. citizens?

2. Visit www.eatright.org

1. What organization does this website belong to?

The website belongs to the Academy of Nutrition and Dietetics, which has its headquarters in Chicago – Illinois. 

2. What is the purpose of this organization?

The organization focuses on improving the health and nutrition of the public. With over 100,000 practitioners among them registered dietitian nutritionists, technicians, and other professionals, the body is dedicated to improving the health of the nation and advancing the profession of dietetics through education, research, and advocacy.  

3. Click on any ‘Public’ link (for kids, parents, men, women, or senior) at the top of their home page and select an article to ‘explore.’

1. What article did you select and why?

Article: “Hypertension:  Understanding a Silent Killer”

Hypertension is a risk factor for cardiovascular diseases in women. Unfortunately, the condition is often underestimated and undiagnosed due to a misconception that women are at a lower risk of high blood pressure as compared to men. 

2. Summarize what you read about. 

Hypertension is chronically high blood pressure that causes damage to the blood vessels and other internal organs of the body including the heart. In the United States, the condition affects at least 1 in 3 adults (Academy of Nutrition and Dietetics, 2017). Although the disease has no symptoms the abnormal force of blood via the arteries can have an impact on the body can be life-threatening. In light of this, it is important for individuals to have their blood pressure regularly monitored to determine if it is within healthy limits. Ideally, a blood pressure of over 80 and below 120 is considered healthy. Meanwhile, it is important to understand that age and ethnicity are some of the determining factors of high blood pressure. In particular, people who are 50 years and above are at a higher risk as compared to people below this age limit. People with diabetes or overweight are also at a higher risk of getting hypertension. Nonetheless, individuals at an increased risk of high blood pressure are advised to adhere to the recommended dietary approach to lower their blood pressure. 

4. Give your opinion of the article – liked/didn’t like it, etc.…

I liked it… because the article was informative about hypertension risk factors and the recommended diet that is appropriate for people with a high risk of developing high blood pressure.   

3. Visit www.consumerlab.com

1. What is the mission statement for this website?

Consumerlab seeks to identify the best quality health and nutritional products through independent testing. 

2. How do you specifically get more information about the full results of testing?

In order to get more information about a product test, click on the product tests and select one product that you need to view more details. If you are already a member, you will only need to sign in and proceed to see the report. Non-members are required to create an account and pay monthly subscriptions for either 24 months or 12 months. There is also an option for non-members paid only once for one product report.

3. C. Pick (1) item from the ‘Recent Reviews,’ ‘More Popular Reviews,’ or ‘Product Tests’ (to the best of your ability – see B)
4. What and why did you choose that review or product?

Product Review: Iron Supplements

Why: Iron is an essential mineral required by the body to produce hemoglobin, which helps the red blood cells transfer oxygen in the body tissues. Ideally, iron deficiency is the leading cause of anemia affecting about 2 percent of the women population. The topic interested me due to the recent reports that have been circulating about contaminated iron supplements. My interest was to learn more about the iron supplements contamination from Consumerlabs. 

2. Briefly, summarize the results of what you were able to read.

In 1997, the United States Food and Drug Administration (FDA) claimed that several iron supplements contained excessive levels of lead (ConsumerLab, 2017). Subsequent tests by the Consumer Lab found the same results and with tests in 2011 finding few instances of lead contamination. In light of this, and because no government agency routinely checks iron supplements for quality and content, CL has independently been evaluating iron products to test for contamination. According to Consumer lab, at least 11 out of 12 iron supplements contained the claimed amount of iron and did not go beyond the limit for lead, arsenic, and cadmium. They also tested an additional eight products, and all iron supplements were found properly disintegrated. However, one product was not approved; the Vitacost Iron because it contained lead contamination rising slightly above the 0.5mcg/day limit. The products tested were listed in a comprehensive list generated by the Consumer lab.  

4. Give your opinion of the article and explain why you liked it or did not like it

I liked it. Ideally,  the FDA is absolved the role of testing the safety of dietary supplements released into the market. Consumerlab takes the responsibility to test and inform the consumer on the safety of various supplements released to the market by various manufacturers and distributors. The article gave a comprehensive report on various iron supplements that were tested and passed the safety test. It is also categorical on the supplements that may contain lead contamination. Overall, the article helps the consumer have an informed decision when purchasing iron supplements. 

5. Tough time (this is an example of an applied question!)…
6. What do you think about the DSHEA Act and the findings of a website such as this? Explain.

The DSHEA Act gives the supplement industry the freedom to market untested products to the market with unsupported claims (National Institutes of Health, n.d). This means that unsafe supplements can be released to the market, as the FDA has a limited capacity to monitor adverse reactions from supplements. The result has been a market flooded with useless products and some with false claims. By taking on a step to test supplements released to the market, Consumer labs is taking on a brave step to help the public and protect them against manufacturers who may harm the health of the consumers. However, they are also taking a risk since these companies can take legal action on them backed up by the DSHEA Act. 

4. Monsanto

2. Who are they and what do they do?

Monsanto is a modern global company dealing with the development of agricultural products and tools to help farmers all over the world to grow crops while utilizing energy, water, and land in an effective way. The company believes that innovation can turn around the needs of humanity and balance them with the resources on the planet.  

2. What company purchased Monsanto?

In a $66 billion mega-deal, the seeds and chemical giant Bayer merged with Monsanto in a move they termed as one of the world’s biggest agriculture giants. 

3. What products do they sell?

Ideally, Monsanto has a portfolio of agricultural products and services customized to meet the farmers’ needs and wants and include the following.

Seed genetics. The company offers high-quality seeds to meet the demands of modern agriculture systems and to help farmers to achieve better crop harvests while preserving and protecting the natural resources. Virtually, through research and advanced plant-breeding methods, the company attempts to understand the genetic characteristics of plants in order to develop seeds that produce better harvests through tolerance to harsh weather conditions or improved disease resistance (“Seed genetics,” n.d). Ideally, the company achieves this through biotechnology for some row crops. Biotechnology helps the plant to develop tolerance to harsh weather conditions, increase their resistance to insects, and enable effective weed control among other farming practices. Lately, Monsanto is exploring the field of gene editing, in an attempt to make specific improvements on the DNA of plants to help farmers achieve better harvests.

Crop protection Solutions. Usually, crop protection uses a number of tools, products, and practices to help farmers protect crops from weeds, diseases, and pests. Farmers all over the world are concerned about crop protection. In response to this Monsanto has been providing farmers with a variety of solutions such as pesticides that protect crops from the danger of pests, weeds, and diseases (“Crop Protection,” n.d). For instance, Monsanto offers one of the most powerful crop protections, the glyphosate, which is the primary active ingredient in Roundup herbicides. For more than 40 years, the herbicide has enabled farmers to reduce soil erosion and carbon emissions. In particular, the glyphosate-based herbicides have also been used to reduce the necessity for tillage, which releases carbon into the atmosphere and in return contributes to soil erosion. For the farmers, this means that they can leave the soil remains intact and even the previous year’s, while ensuring soil health and reduction of greenhouse gas emission for a clean environment. 

2. List all of the agricultural and vegetable seeds they produce

The company provides farmers with row crops, which include alfalfa, corn, cotton, canola, soybeans, sorghum, sugar beets, and wheat. The company also produces at least 2,000 vegetable seeds with varieties of about 22 crops.

1. List the brand names they sell their products under

Monsanto has the following brands, Acceleron, Asgrow, Cannel, Corn States, De Ruiter, degree Xtra, Dekalb, deltapine, Fontanelle Hybrids, Gold Country Seed, Harness, Hubner Seed, Jung Seed, Kruger Seeds, Lewis Hybrids, Monsanto BioAg, Monsanto Traits, REA Hybrids, Roundup Custom, Roundup PowerMax, Roundup Pro Concentrate, Roundup PROMAX, Roundup QuickPro, Roundup WeatherMax, RT3, Seminis, Specialty, Stewart, StoneSeed, The Climate Corporation, TripleFlex, Warrant, and WestBred.

4. What is your overall opinion of this company? Briefly, explain. 

Farmers are facing several challenges every day as they try to move agriculture forward. As an agricultural company Monsanto is dedicated to helping farmers, grow food sustainably. Combined with cutting-edge technology and innovation Monsanto is dedicated to combating climate change and environmental challenges to ensure the agricultural system meets the needs of the world population. Ideally, as a company committed to bringing a broad range of solutions to help farmers all over the world, Monsanto is awesome and doing an excellent job helping farmers around the globe.

5. Center for Food Safety

1. What is the Purpose of this organization?

The Center for Food Safety is a national non-profit organization advocating human health rights and protection of the environment by curbing the use of harmful technology in the production of food. The company seeks to promote organic and various forms of sustainable agriculture. Ideally, CFS accomplishes these by educating consumers about the definition of organic foods and production, legal actions, scientific research, provision of educational materials, and grassroots campaigns among others. 

2. Select a topic under the issues tab and briefly summarize (1) article
3. What article did you choose and why? Explain.

Genetically Engineered Food & the Environment

In the United States, there has been misleading claims by companies selling genetically engineered (GE) crops. However, far from the misconception that GE crops eliminate pesticides, they have instead increased chemical pollution. In light of this, the article seeks to inform consumers about the new slate of environmental concerns caused by genetically engineered crops. According to the Center for Food Safety (n.d), altered genes in commercial plants are being transmitted into weeds and unaltered crops. The result is genetically enhanced weeds, which are more likely to cause an environmental problems in future. For instance, genetically engineered corn, and canola have been found to contaminate non-GE crops. As a result, this is currently raising major economic concerns to farmers and contributing by a larger margin the loss of crops. The situation is even worse because the biological contamination from GE crops will not be going away and will continue to reproduce and disseminate altering the ecosystem and threatening the natural plants. In addition to the above, the situation is even more worrying as the U.S. government is not concerned about trying to control the companies growing and selling genetically altered crops. No regulatory authority has been put in place or government agency committed to protecting the environment from the environmental harm. 

References

“Crop Protection.” (n.d). Monsanto. Retrieved from: https://monsanto.com/innovations/crop-protection/

“Dietary Supplement Health and Education Act of 1994.” (n.d). National Institutes of Health: Office of Dietary supplements. Retrieved from: https://ods.od.nih.gov/About/DSHEA_Wording.aspx#sec7

“Seed Genetics.” (n.d). Monsanto. Retrieved from: https://monsanto.com/products/seeds/

Academy of Nutrition and Dietetics. (2017). Hypertension: Understanding a Silent Killer. Retrieved from: http://www.eatright.org/resource/health/wellness/preventing-illness/understanding-a-silent-killer

Center for Food Safety. (n.d). GE Food & Environment. Retrieved from: https://www.centerforfoodsafety.org/issues/311/ge-foods/ge-food-and-the-environment

Consumerlab. (2017). Iron Supplements. retrieved from: https://www.consumerlab.com/reviewsample?j=342704&sfmc_sub=54468075&l=40_HTML&u=4516374&mid=7276525&jb=67

National Institutes of Health. (n.d). Dietary Supplement Health and Education Act of 1994
Public Law 103-417 103rd Congress. Retrieved from: https://ods.od.nih.gov/About/DSHEA_Wording.aspx

U.S. Food & Drug Administration. (2017). Dietary Supplements. Retrieved from: https://www.fda.gov/food/dietarysupplements/