Supplements

Beta-carotene and vitamin A supplement was increasing participants’ risk of lung cancer

Supplement vs. non-supplement users tend to: Have healthier habits More favorable health indicators

especially in amounts above recommended intake levels, may offer little benefit at best and may pose health risks at worst.

Dietary supplements -

a diverse array of products meant to “supplement the diet.” They include vitamins, minerals, herbals, botanicals, amino acids, and enzymes.

A food or substance that supplements the diet and contains one or more dietary ingredients or their constituents

FDA does not approve supplements for effectiveness or safety

DSHEA dictates that the manufacturer is responsible for ensuring safe, unadulterated, produced with good

Dietary ingredients found in supplements are federally regulated and GRAS (generally recognized as safe)

Manufacturers must notify FDA 75 days before a “new dietary ingredient” is introduced to the market

Manufacturers must notify FDA 75 days before a “new dietary ingredient” is introduced to the market

october 15, 1994

2011 Food Safety Modernization Act Expands the FDA’s authority over new dietary ingredients, but not all enforced

Certain details required by the FDA on labels

General information

  • Name of the product, The word “supplement” , Quantity of package contents, Manufacturer name and location, Directions for using the product,

Supplement Facts Panel

  • Serving size and amount of product per serving size, Percent Daily Value (%DV), Dietary ingredients, Plant materials, Nondietary components, May include cautionary statements about potential side effects

  • Describe a relationship between a dietary supplement ingredient and reduced risk of a disease or condition

  • FDA must preapprove claim based on Significant Scientific Agreement (SSA)

Supplement manufacturers can’t make health claims unless FDA approved

Organizations test dietary supplements for quality:

U.S. Pharmacopeial Convention (USP) NSF International (NSF)

High-Potency Supplements

  • Include one or more nutrients/ingredients significantly in excess of recommendations
  • No law caps supplement potency, except for potassium

Herbal Supplements

  • Botanicals are derived from plants
  • Herbal supplements are subset of botanicals

Nutraceuticals

Whole or processed foods Fortified foods “Engineered foods” – sports bars and drinks Might contain prebiotics