Dietary Supplements Study Guide PDF

Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 21st Edition Chapter: Introduction to Dietary Supplements Introduction to Dietary Supplements: Introduction 1.​ Define dietary supplement. a.​ A dietary supplement (DS) is defined by t...

Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 21st Edition Chapter: Introduction to Dietary Supplements Introduction to Dietary Supplements: Introduction 1.​ Define dietary supplement. a.​ A dietary supplement (DS) is defined by the FDA as a product intended to supplement the diet and taken orally, that may include dietary ingredients such as vitamins, minerals, herbs and other botanicals, amino acids, enzymes and live microbials (such as probiotics). 2.​ List terms that are used to describe dietary supplements. a.​ Nutraceuticals b.​ natural products c.​ supplements d.​ herbs e.​ botanicals f.​ phytochemicals Use of Dietary Supplements 3.​ What are the three most common reasons that adults are motivated to use dietary supplements? a.​ To improve overall health (45%) b.​ To maintain health (33%) c.​ To promote bone health (25%) 4.​ How do people obtain information about dietary supplements? a.​ television (73%) b.​ magazines and radio (both 30%) c.​ newspapers (13%) d.​ friends (8%) e.​ store displays (5%) 5.​ What percentage of people do not report dietary supplement use to health care providers? a.​ 25% Legislation and Regulatory Issues 6.​ Which act provides regulations related to dietary supplements? a.​ The Dietary Supplement Health and Education Act (DSHEA) of 1994 7.​ The Food and Drug Administration (FDA) oversee dietary supplements. Describe the standards that must be met, particularly compared to other products. a.​ Dietary supplements are regulated under food standards rather than the stricter purity and potency standards applied to prescription and nonprescription drugs. Clinical trials are generally not required to prove safety and efficacy prior to marketing, unlike drugs. The Food and Drug Administration (FDA) oversees dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). The standards that dietary supplements must meet are less stringent compared to those for prescription and nonprescription drugs. Specifically: 1. **Manufacturing Standards**: Dietary supplements are required to meet current Good Manufacturing Practices (cGMP) standards, but these are less rigorous than the standards applied to pharmaceuticals. While manufacturers must ensure the quality of their products, they are not subject to the same strict purity and potency standards as drugs. 1 2. **Evidence for Safety and Efficacy**: Unlike prescription and nonprescription drugs, which must undergo clinical trials to demonstrate safety and efficacy before marketing, dietary supplements do not require such evidence prior to their sale. Manufacturers are prohibited from marketing unsafe or ineffective products, but they are not required to provide clinical trial data to the FDA before marketing their supplements. 3. **Labeling Requirements**: All dietary supplements marketed in the United States must comply with specific labeling requirements, which include listing the product name, the term "dietary supplement," and the net quantity of each ingredient. However, the claims made on dietary supplement labels are not subject to the same level of scrutiny as those for drugs. These differences create a "buyer-beware" market for dietary supplements, placing the onus of safety and efficacy largely on the manufacturers and consumers. 8.​ What type of restrictions are placed on marketing of dietary supplements? What limits the ability of these restrictions to be implemented? What are exceptions? a.​ Dietary supplement manufacturers are prohibited from marketing unsafe or ineffective products. However, clinical trials are not generally required to prove safety and efficacy prior to marketing, except for new dietary ingredients or supplements with health claims. The FDA assumes a post-marketing surveillance role. Marketing of dietary supplements is subject to certain restrictions, but these are less stringent than those for pharmaceuticals. Here are the key points regarding these restrictions and their limitations: 1. **Marketing Restrictions**: - Dietary supplements cannot be marketed with claims that they diagnose, treat, cure, or prevent any disease. Instead, they can make structure-function claims, which describe how a product may affect normal body functions (e.g., "supports healthy cholesterol levels") without implying a specific disease state. - The Federal Trade Commission (FTC) requires that all advertising be truthful and not misleading, based on sound scientific evidence. 2. **Limitations on Implementation**: - The lack of rigorous pre-market approval processes for dietary supplements means that many products can enter the market without sufficient evidence of safety or efficacy. This creates challenges in enforcing marketing restrictions, as claims may be made based on anecdotal evidence or insufficient scientific backing. - The "buyer-beware" market environment places the onus on consumers to discern the validity of claims, making it difficult for regulatory bodies to monitor and enforce compliance effectively. 3. **Exceptions**: - Certain dietary supplements may be subject to more stringent regulations if they contain new dietary ingredients that have not been previously marketed. In such cases, manufacturers must provide evidence of safety to the FDA before marketing. - Additionally, if a dietary supplement is found to be unsafe or if it makes false claims, the FDA can take action against the manufacturer, including issuing warnings or recalls. These factors contribute to a complex regulatory landscape for dietary supplements, balancing consumer access with the need for safety and truthful marketing. 2  9.​ What does the Food and Drug Administration and Federal Trade Commission oversee as it related to labelling? a.​ The FDA has primary responsibility for regulating claims on packaging, labeling, and point-of-sale materials. The FTC has primary responsibility for advertising claims in print, broadcast, infomercials, catalogs, and other direct marketing materials. The FTC requires that all claims of safety and efficacy for dietary supplements be supported by "competent and reliable scientific evidence". 10.​ What information must be included on supplement labeling? a.​ Name of the product and "dietary supplement" b.​ Net quantity of contents c.​ Manufacturer's name and place of business d.​ Directions for use e.​ Supplement Facts panel with serving size, list of ingredients, amounts, and percent daily values 11.​ Define and provide examples of misbranding. -​ Misbranding refers to the labeling that does not comply with the required regulations, leading to misleading or false information about the product. a.​ Follow labeling requirements b.​ Failing to include manufacturer information c.​ Making false or misleading statements about the product 12.​ What are the three types of claims for dietary supplements? Which require FDA approval? What wording must be included on products with “structure-function” claims? a.​ 1. Health claims b.​ 2. Nutrient content claims c.​ 3. Structure-function claims d.​ Health claims and nutrient content claims require FDA approval. e.​ Structure-function claims must include the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease." 13.​ Where should consumers and health care professionals report dietary supplement related adverse effects? a.​ Consumers and health care professionals should report dietary supplement-related adverse effects to FDA's MedWatch program. Common Quality Control Issue: Adulteration 14.​ What is the definition of adulteration? a.​ Adulteration occurs when a supplement presents unreasonable risk, lacks safety evidence, is declared hazardous, or contains ingredients that render it poisonous or deleterious. 15.​ What is an example of intentional and unintentional adulteration? a.​ Unintentional adulteration: Contamination with heavy metals or microbes during manufacturing. b.​ Intentional adulteration: Adding prescription drugs to enhance efficacy. Quality Assurance Programs 16.​ What is the purpose of quality assurance programs? What are the limits of its usefulness? a.​ Quality assurance programs assess analytical standards and certify supplement composition. They indicate if contents match the label but do not ensure safety or efficacy. 17.​ List 3 independent organizations that test dietary supplements to ensure the content and purity of products. a.​ U.S. Pharmacopeia (USP) 3  b.​ ConsumerLab.com c.​ NSF International Hazards of Dietary Supplements 18.​ What are characteristics of supplements making fraudulent or misleading claims? Summarize table 1. a.​ Listing specific diseases (Disease claims) b.​ Claiming efficacy similar to drugs (Efficacy comparisons) c.​ Listing many unrelated conditions (Unrelated conditions) d.​ Labeling issues e.​ Using terms like "miraculous discovery" (Exaggerated claims) f.​ Providing only benefits and no risks (Omission of Risks) g.​ Using personal testimonials instead of scientific evidence (Personal testimonials) h.​ Pseudo-medical terminology Ex. “detoxify”, “purify” or “improves body chemistry” i.​ Price Justification. Meaning higher price better effectiveness j.​ Quick Relief Promises 19.​ List categories of supplements that the FDA considers “clearly problematic.” Summarize table 2. a.​ Treatments for serious diseases (e.g. cancer, HIV) b.​ Weight loss products c.​ Body building/athletic performance enhancers d.​ Sexual enhancement supplements e.​ Treatments for behavioral disorders Communication Issues 20.​ Summarize counseling points for patients desiring to use dietary supplements. Summarize table 50-4 and information in text. a.​ Read labels carefully and follow dosing instructions b.​ Inform healthcare providers about supplement use c.​ Be aware supplements are not strictly regulated d.​ Report adverse effects e.​ Do not expect unrealistic results f.​ Keep a diary to track effectiveness and side effects 21.​ What is a general recommendation regarding use of dietary supplements in pregnancy and lactation? a.​ Providers should advise limiting supplement use during pregnancy and lactation to products with reasonable proof of safety and efficacy. ​ Read cases 50-1 and 50-2 for examples. THINK ABOUT IT… 22.​ What are your attitudes about using dietary supplements as supplements to the diet? As therapeutic agents to prevent or treat disease? Personal reflection here. 4