Dietary Supplements: Introduction & Regulation

Dietary supplement, a product intended to supplement the diet, taken orally, including ingredients like vitamins, minerals, herbs, botanicals, amino acids, enzymes, and probiotics.

Nutraceuticals, natural products, supplements, herbs, botanicals, and phytochemicals.

The three most common reasons are to improve overall health, maintain health, and promote bone health.

Television, magazines, radio, newspapers, friends, and store displays.

The Dietary Supplement Health and Education Act (DSHEA) of 1994

Dietary supplements are regulated under food standards, meaning they don't have the same strict purity and potency standards as prescription or nonprescription drugs. Clinical trials for safety and efficacy aren't usually required before marketing.

The Food and Drug Administration (FDA)

They are regulated under food standards, which are less rigorous than the standards for prescription and over-the-counter drugs. They do not typically require clinical trials for safety and efficacy before being marketed.

Dietary supplements must meet Good Manufacturing Practices (cGMP) standards, but they are less rigorous than drug standards, which are subject to strict purity and potency requirements.

Unlike drugs, dietary supplements do not require clinical trials to demonstrate safety and efficacy prior to marketing, except for new ingredients or supplements with health claims. The FDA relies heavily on post-marketing surveillance.

Dietary supplements cannot be marketed with claims that they diagnose, treat, cure, or prevent any disease. They can only make structure-function claims describing how a product may affect normal body functions without implying a specific disease state.

Dietary supplements must comply with specific labeling requirements, including the product name, "dietary supplement," and net quantity of ingredients.

The FDA assumes a post-marketing surveillance role for dietary supplements, meaning they monitor safety and efficacy after they are marketed.

Dietary supplements can make "structure-function claims" but these are less stringent than drug claims. The claims are not subject to the same level of scrutiny as drug claims.

Manufacturers are prohibited from marketing unsafe or ineffective dietary supplements. However, they do not need to provide clinical trial data before marketing, except for new ingredients or supplements with health claims.

The differences in regulation for supplements and drugs create a buyer-beware environment, placing the onus of safety and efficacy largely on the manufacturers and consumers.

Dietary supplement claims that describe a relationship between a nutrient, food, or food component and a reduced risk of a disease or health problem. They require FDA approval before being used on labels.

Dietary supplement claims that describe the level of a nutrient in a product. These claims need FDA approval before being used on labels.

Dietary supplement claims that describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the body. These claims don't require FDA approval but need a specific disclaimer.

A situation where a dietary supplement poses an unreasonable risk to health, lacks safety evidence, is considered hazardous, or contains ingredients that make it harmful.

Occurs when contaminants like heavy metals or microbes are unintentionally introduced during manufacturing.

Occurs when harmful ingredients are intentionally added to a supplement to increase its effectiveness, even though these ingredients are not safe for that purpose.

A program that assesses the analytical standards of dietary supplements and verifies that the ingredients listed on labels match the actual contents of the product.

Independent organizations that test dietary supplements to ensure the quality, content, and purity of products.

The Federal Trade Commission (FTC) ensures all advertising related to dietary supplements is truthful and not misleading. It requires scientific evidence to support any claims.

Dietary supplements can be marketed without rigorous pre-market approval, increasing the risk of unsafe or ineffective products. This makes it hard to enforce marketing restrictions and consumers must often verify claims themselves.

Dietary supplements containing new, previously unmarketed ingredients face stricter regulations. Manufacturers must provide evidence of safety to the FDA before marketing.

The FDA can take action against manufacturers if a supplement is found to be unsafe or makes false claims. This may involve warnings or recalls.

The FDA is primarily responsible for regulating claims on supplement packaging, labeling, and point-of-sale materials.

The FTC oversees advertising claims for dietary supplements made in various media like print, broadcast, and online.

Misbranding occurs when a supplement's labeling doesn't comply with regulations, resulting in misleading or false information.

Supplement labeling must include information such as the product name, net quantity, manufacturer details, directions for use, and a Supplement Facts panel with ingredients, amounts, and daily values.

Claims that a dietary supplement can cure serious diseases or improve athletic performance are often highly problematic and should be viewed with skepticism.

The FDA considers supplements for serious diseases, weight loss, body building, sexual enhancement, and behavioral disorders to be particularly problematic due to the potential for harm and lack of rigorous scientific evidence.

Dietary supplements are not subject to the same rigorous testing and regulation as prescription drugs, so their safety and efficacy aren't always guaranteed.

Patients should inform their healthcare providers about any supplements they take, as these can interact with medications or affect medical conditions.

Claims based on personal testimonials are not reliable evidence of a supplement's effectiveness. Look for scientific studies and evidence-based information.

Dietary supplements are not magic solutions. They may support overall health, but they cannot replace a healthy diet, exercise, or medical treatment.

Supplement labels should be read carefully to ensure proper dosage and avoid potential harm.

Pregnant and lactating women should consult with their healthcare providers before taking any dietary supplements, limiting use to products with proven safety and efficacy.