Human Performance on Dietary and Natural Supplements
Safety Monitoring The primary mechanism for monitoring additive safety is a voluntary reporting system established by the FDA’s Center for Food Safety and Applied Nutrition called the Center for Food Safety and Applied Malnutrition Incident Reporting System (CAERS). The Food and Drug Administration (FDA) regulates the processing, manufacture, labeling and packaging of dietary supplements through the Dietary Supplements, Health and Education Act (DSHEA) of 1994, enacted as amendments to the federal food laws. The label’s claims are true and not misleading. The U.S. Food and Drug Administration (FDA) regulates food additives differently than traditional foods or drugs.
Dietary supplements do not require Food and Drug Administration (FDA) approval before being sold in the US market, meaning that consumers who fall victim to supplement advertisements may be at risk of injury. Dietary supplements are regulated differently by the US Food and Drug Administration (FDA) than “regular” foods and drugs. Drugs go through a rigorous FDA approval process before being released to the market; drugs are considered dangerous until proven safe. Dietary supplements may contain general claims about health benefits, nutrient content, or structure and function. Some scientific evidence must be submitted to the Food and Drug Administration only for health claims that establish direct relationship between supplement use and disease risk, decline.
Under the Food Labeling and Education Act (NLEA) of 1990, FDA can review and approve health claims (statements that describe the relationship between a food substance and a reduced risk of disease or health-related disease) of ingredients and dietary products. Supplement or dietary product companies wishing to provide a health claim or qualified health claim for supplements can submit research results to the FDA for review. By researching the literature, one can understand whether a nutritional supplement or method is based on sound scientific evidence.
Finally, the bulk of the work presented in this Nutrition Review Supplement introduces, into a broad military context, the simple concept of consumer education, labeling products in green, amber, and red to guide visitors to the best products that are considered most beneficial for optimizing performance based on current scientific evidence. The body of research presented in this appendix demonstrates a gap in the nutrition literature created by the prevalence of research focusing on dietary interventions for people with disease or at risk of short-term illness, rather than research focusing on such an optimized diet, human performance.
The number of nutritional supplements on the market continues to grow exponentially, making it impossible to get complete information about the safety and side effects of these products. Overall, the above statistics and case reports indicate that while generally safe, as is the consumption of prescription foods or drugs, the consumption of dietary supplements can lead to adverse effects despite DSHEA and the current FDA regulations outlined below. Perhaps more troubling is a 2015 Center for Disease Control report stating that 2,287,273 emergency room visits were due to prescription drug events, dwarfing the 3,266 emergency room visits due to for nutritional supplements (adjusted for 23,000 visits after excluding cases of the elderly), adults choking on pills, allergic reactions, unsupervised children consuming too many vitamins, and people consuming ingredients not defined as dietary supplements by DSHEA).
It is extremely important to keep in mind that for most nutritional supplements used as ergogenic adjuvants, the Food and Drug Administration has no statutory control over the efficacy or even the content of the products sold. The Food and Drug Administration regulates the quality, safety, and labeling of nutritional supplements, while the Federal Trade Commission controls advertising and marketing; however, huge enforcement challenges remain and optimal government oversight has not been achieved. As the supplement industry continues to grow and patients continue to use supplements, oversight of the supplement industry by the Federal Food and Drug Administration, the U.S. Food and Drug Administration, and the Federal Trade Commission needs to be reviewed and modernized.
According to DSHEA, supplement manufacturers are not required to demonstrate safety or efficacy; “instead, DSHEA deliberately minimizes FDA oversight and focuses on the industry’s value to the U.S. economy”. Our attorneys believe that due to the serious potential health risks of the products they sell, supplement manufacturers should meet higher standards and be responsible for conducting ingredient research and proactively recalling supplements when safety concerns arise. For example, the Food and Drug Administration does not require supplement labels to describe how their products interact with other medications, which could lead to unintended side effects or irritation without proper guidance from a doctor. For example, the U.S. Food and Drug Administration regulates the food and beverage industry in areas such as the addition of vitamins A and D to milk and the labeling of foods sold to consumers. As part of the MOB project, researchers wanted to explore the power of the literature on Nutrients in relation to nutrients that can optimize cognitive health in the US military through the consumption of selected nutritional ingredients or through some other farm-to-work process. They only apply to supplements containing vitamins and/or minerals if these products are regulated as food and address the supplement’s composition, including their safety, purity, and bioavailability. In Australia, most dietary supplements are regulated under the category of complementary medicines, which includes vitamins, minerals, herbs, aromatherapy and homeopathic products, although some products may be considered specialty products and regulated by the Food Administration. The Federal Food, Drug, and Cosmetic Act (FD&C) defines a dietary supplement as an oral product containing a food ingredient intended to supplement the diet. Dietary supplements are available in many forms, including tablets, capsules, powders, and energy bars. and liquids – and are available for purchase without a prescription in stores and online.