This article describes tools and resources clinicians may use to distinguish between products, evaluate selected characteristics of product quality using public information, and educate patients on the safe use of supplements. This article addresses ways for clinicians to assess the quality of food additive products, assess manufacturers compliance with publicly available quality standards, and encourage the use of inspection and certification programs. By becoming aware of resources and tools that can assist in the identification of high-quality dietary supplements such as compliance with public standards and the use of verification programs clinicians can assist their patients in selecting appropriate products. Nearly all patients referred by their health care providers see a physician. The use of dietary supplements for diabetes requires cautious consideration, as nutritional deficiencies may cause disruptions in carbohydrate metabolism, and supplementation can increase risk for hypoglycemia. Patients should be educated about the potential risks and benefits of the dietary supplements that they are interested in using to manage their diabetes, including determining whether there is evidence supporting a products benefits in diabetes, as well as any statements from the American Diabetes Association or similar guidelines about their use.
Consumption of dietary and herbal supplements is common among inpatients, with interactions frequently missed by physicians and interactions are frequently missed. Although individual studies show benefits for A1C, glucose, and insulin levels, a meta-analysis by Althius et al found small effects on A1C, glucose, and insulin in patients with diabetes and nondiabetes. The American Diabetes Association has stated that inconclusive data are available about the benefits of chromium supplementation for diabetes. Patients need to be evaluated carefully before starting chromium to manage diabetes because of its interactions with multiple medications. The dietary supplement industry in the United States has grown from about 4000 products in 1994 to between 50 000 and 80 000 products in fiscal year 2021,1 with approximately 80% of U.S. adults reporting taking dietary supplements, according to a 2021 Consumer Reports survey. These increases in product numbers and consumer use underscore the importance of clinicians understanding potential quality concerns about products marketed as dietary supplements, given that the U.S. Food and Drug Administration (FDA) does not regulate supplements as rigorously as drugs.
Herbal and Natural Dietary Supplements
Under existing U.S. laws, all dietary supplements sold domestically, including botanical supplements, are regulated by FDA as a specific category of foods. The FDA regulates dietary supplements according to a set of regulations that differ from the regulations that cover conventional foods and drugs. The 1994 Dietary Supplement Health and Education Act, known as DSHEA, amended the federal Food, Drug, and Cosmetic Act to establish a separate regulatory structure for these supplements. The Act attempted to achieve a proper balance between providing consumers with access to the dietary supplements that they might want to use to maintain and enhance their health, while also giving the Food and Drug Administration regulatory power to act on supplements or dietary ingredient products that pose safety problems, make false or misleading claims, or are otherwise adulterated or misbranded.
The Dietary Supplement Health and Education Act of 1994, DSHEA, amended the Federal Food, Drug, and Cosmetic Act to set up A distinct regulatory framework for these ephedra products in an attempt to strike the right balance between providing consumers access to dietary supplements that they may be choosing to use to help maintain and improve their health, and giving the Food and Drug Administration regulatory authorities to take action against supplements or supplement ingredients that present safety problems, have false or misleading claims, or are otherwise adulterated or misbranded. Rather, the purpose of the DSHRA is to deliberately minimize the supervision by the U.S. Food and Drug Administration, focusing instead on the industrys economic benefit to the U.S. economy. To prevent patient harm and to facilitate evidence-based prescription drug use, FDA requires manufacturers to submit data showing a medication is effective and safe before it can promote a medication for a specific indication.
The authors found no impact of presence or absence of a disclaimer on consumers beliefs about whether the product will have the effects claimed, nor their belief that FDA has evaluated a manufacturers claims about efficacy–despite DSHEAs clear statement that FDA does not evaluate claims. This study also found no evidence that DSHEAs disclaimer, or the Food and Drug Administrations information on approvals or disapprovals, influenced participants assessment of a products efficacy. Other scientific evidence disclaimers did not affect consumers beliefs in a supplements link to treating illness either (p 0.30). Despite near-universal knowledge of FDA disclaimers, many participants believed supplement claims were subject to FDA review, and they were skeptical about FDAs ability to effectively regulate health products.
Subsequently, although developers of pharmaceutical drugs were required to submit to FDA regulations and conduct clinical trials to establish drug efficacy, dietary herbal supplements and botanicals were exempted from such requirements . Because manufacturers claims were frequently promising and entirely positive, Congress created guidelines addressing the definitions of supplements, safety concerns, ingredients and nutrition labels, supplement claims, best manufacturing practices, and novel food ingredients. Contaminants, adulterants, or levels of molecular oxidation can change the quality of plant products, or other chemical modifications that are not captured by many molecular fingerprinting methods; fourth, manufacturers of dietary supplements have been inconsistent about filing NDIs before marketing new products in the United States.
The fear that disclaimers can be overshadowed by other marketing content is especially pertinent for complex health products, including dietary supplements and prescription drugs promoted for use outside of their recommended indications. The use of multivitamin supplements in older adults nutritional programs is of concern, as is the potential use in nutritional programs as an alternative to diets following the American dietary guideline (69). In some cases, excess vitamin and mineral intake can be harmful or produce undesirable side effects; thus, maximal levels are needed to assure safe use of them as dietary supplements. In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods with specific uses and are regulated by food authorities.
FDAs Center for Drug Evaluation and Research (CDER) uses various chromatographic and spectroscopic instruments, the Drug Product Analysis Division (DPA) in the Office of Tests and Research (OTR) at the Center for Drug Evaluation and Research (CDER) is equipped to conduct a complete screening of commercial products, including dietary supplements, to detect drug-related or controlled substances adulterants.