FDNS 4600 1st EditionFinal Exam Study Guide Lectures: 30-44Lecture 30, 31, and 33 - Dietary Supplements1. What are the similarities and differences among sources of information about dietary supplements, e.g., government, marketing, consumer action groups?1. FDA and Dietary Supplements1. Regulates supplements but does not do pre-market approval unless it hasa “new dietary ingredient.”2. FDA can issue a warning label if the dietary supplement is “unsafe.”3. Manufacturer responsible for ensuring its dietary supplement is safe before it goes on the market.2. FTC Federal Trade Commission1. Protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace, including advertising2. Do investigations, sue companies and people that violate the law, educateconsumers and businesses about rights and responsibilities.3. National Institutes of Health (NIH) Office of Dietary Supplements (ODS)1. Mission: strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for US2. Important to have food first and supplements as needed.3. Caffeine intake in new 2015 dietary guidelines. 4. US Preventative Health Services Taskforce1. Non- federal specialists to conduct scientific evidence are people such as professors, or university faculty.2. Focus on preventive health rather than regulation and on benefits vs. outcomes.3. ARHQ helps conduct research to help America make better health care choices.4. USPSTF assembles non-federal specialists to do scientific evidence reviews of clinical preventative health care services.1. Makes recommendations based on evidence of benefits and harms about effectiveness of specific clinical preventive services 2. Contamination and Adulteration 1. What is a systematic review? 1. More of a literature review, well define the articles that were accurate, just below a meta-analysis2. What is a database? 1. Have all of the articles: Pubmed, web of science, Cochrane Reviews, Google Scholar, Science Direct3. How to avoid these health risks?1. Consumerlab.com!!!!4. Most common adulterants or contaminants? 1. Dust, pollens, insects, rodents, parasites, microbes, fungi, mold, toxins, pesticides, toxic heavy metals, and prescription drugs.5. What were most severe adverse effects reported?1. Agranulocytosis, meningitis, multi-organ failure, perinatal stroke2. Lead or mercury poisoning3. Malignancies or carcinomas [à cancer]4. Liver encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema [à bad news for brain, liver, kidney]6. What groups of products were most problematic?1. Traditional Indian or Chinese Remedies3. What are some helpful dietary supplements?1. Pregnancy 1. Folic acid, iron 2. Older adults 1. Calcium, vitamin D, B12* 3. Vitamin D1. People with light skin, regional areas (Boston vs Florida), older people, women4. How will you find information about dietary supplements in the future?1. Consumerlabs.com is an independent chemical analysis of supplements that provides information about dietary supplements.2. Dietary Supplement Ingredient Data Base 5. How enthusiastically will you recommend supplements to yourself, friends, family, and clients?1. When deciding whether or not to recommend supplements, it is important to refer to the ASHP Statement on Use of Dietary Supplements.2. Keep in mind the 5 Dangers to Public Health1. Naturally Unsafe2. Lax regulation of manufacturing: risk contamination and variability3. May compromise, delay, or supplant treatment with therapies of proven efficacy4. Possible dangers to: children, pregnant women, surgery patients, poor organ or immune function.5. Spending is enormous health cost with unproven valueLecture 32 - Student Presentation on Food Additives1. What are food additives?1. Anything added to the food to enhance flavor or appearance or to preserve it. 2. Direct food additives are added to food for a specific purpose.3. Indirect food additives become part of the food in trace amounts from packaging, storage, or handling. 2. What are color additives?1. Any dye, pigment, or substance that adds color to the food. 2. FDA is responsible for regulating all color additives.3. Safe or Unsafe?1. Hydroxyquinoline- is unsafe and is banned.2. Ammoniated glycyrrhizin- is safe (GRAS) 4. Certified or Exempt?1. Certified colors: synthetically produced and used for color. There are nine certified color additives approved in the U.S.5. Why are food additive used?1. To maintain and improve safety and freshness: preservatives.2. To improve or maintain nutritional value: addition of vitamins and minerals.3. Improve taste, texture, or appearance: spices, natural and artificial flavors, and sweeteners.6. What does the Federal Food, Drug, and Cosmetic Act (FFDCA) do?1. Helps maintain assuring that the food additive ingested are safe.2. It also defines “food additive”7. What does GRAS mean?1. Generally recognized as safe.2. Manufactures notify FDA of GRAS determination and provide evidence. 8. What is Clean Labeling?1. No legal definition, but it is widely used.2. Involves the replacement of unfamiliar or “chemical” sounding ingredients with those that the consumer is more likely to recognize.3. An example is using celery seeds for preserving meat rather than using nitrates for preserving. However, the celery seeds might have more nitrate than the food.Lecture 33 - Kava Case Study1. What are the main conclusions about the safety and efficacy of kava from these researchers and clinicians (mainly MDs)?1. “There is substantial evidence that kava has a positive effect on the symptoms of anxiety disorders.” 2. It may potentially alter other medications and there may be some long term effects if the product is used long term.3. Short term use can lead to some improvement in anxitey and the short term risks do not outweight the benefits.2. What other dietary supplements might be beneficial for mental health?1. Use of Inositol (dosage of 12-18 g/day) is a treatment option for panic disorder.2. Insitol (dosage 12-18 g/day) may be used to treat obsessive-compulisve disorder (but not in combination with SSRIs)3. What are the advantages of using RCT studies and conducting a meta-analysis?1. RCT studies are the gold standard for research2. Meta- analysis pulls many