Statement of Informed Consent Regarding Nutritional and Herbal Supplements
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, Section 201(g)(1), a “drug” is defined as an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. In contrast, dietary supplements—including vitamins, minerals, trace elements, amino acids, botanicals, and certain homeopathic preparations—are regulated under a distinct framework established by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which classifies them as a category of food rather than drugs (U.S. Food and Drug Administration [FDA], 1994; FDA, 2022).
Although not classified as pharmaceuticals, nutritional supplements can exert measurable physiological effects and should therefore be used judiciously and in accordance with current evidence-based practices (Manson et al., 2019; NIH Office of Dietary Supplements, 2023). At Radiance Health Center, we may provide nutritional and whole-body wellness coaching which may include and individualized supplement recommendations designed to enhance dietary quality and support optimal physiological and biomechanical function. While certain products may be suggested with targeted therapeutic intent, their primary role is to support or promote overall health and resilience.
Nutritional supplements may often be used safely alongside prescribed medications; however, clinically significant interactions can occur (Izzo & Ernst, 2009; NIH Office of Dietary Supplements, 2023). Accordingly, the public is strongly advised to disclose all medications, supplements, botanicals, and hormones to each of their healthcare providers to ensure coordinated and safe care. And always, consult with your physician, or licensed health care provider before taking any nutritional supplement, botanical, wether on a prescribed medication or otherwise.
Provision of Nutritional Supplements
Customers are under no obligation to purchase nutritional supplements through our platform. As a professional service, we offer access to a curated selection of products sourced from manufacturers that meet rigorous standards for quality, safety, and scientific integrity. Our evaluation criteria include:
- The strength and validity of the scientific evidence supporting the formulation
- The purity, potency, and sourcing of raw ingredients
- Compliance with Good Manufacturing Practices (GMP) as outlined by the U.S. Food and Drug Administration(FDA) (FDA, 2022)
- The degree of synergistic interaction among product components
The supplement brands recommended are selected based on consistent performance, bioavailability, and reliability in clinical application. While these products may represent a higher investment than those commonly available through retail channels, their value reflects enhanced quality assurance, including verified purity, stability, and effective absorption (NIH Office of Dietary Supplements, 2023).
The primary purpose of offering these products is to maintain a high standard of care and consistency in outcomes. Consumers should be aware that, due to regulatory limitations under DSHEA, dietary supplements are not subject to the same pre-market approval requirements as pharmaceuticals, resulting in substantial variability in quality across the general marketplace (FDA, 2022; Manson et al., 2019). While products obtained from other sources may provide benefit, they may not meet the same standards for efficacy, purity, and manufacturing integrity.
References
- U.S. Food and Drug Administration (FDA). (2022). Dietary Supplements: What You Need to Know.
- National Institutes of Health Office of Dietary Supplements. (2023). Dietary Supplement Fact Sheets.
- Manson, J. E., et al. (2019). Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer. Annals of Internal Medicine.
- Izzo, A. A., & Ernst, E. (2009). Interactions between herbal medicines and prescribed drugs. Drugs.