Dietary Supplements Regulations Flashcards
Describe: Food, Drug, Cosmetic Act (1938)
-articles recognized in the official US Pharmacopoeia, official Homoeopathic Pharmacopoeia of the US, or official National Formulary, or supplement to any of them
-article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
-articles other than food intended to affect the structure of any function of the body of man or other animals
Describe: Kefauver Harris Amendment (1962)
-“New Drugs” (RX and OTC) must be proven safe and effective prior to FDA approval and marketing
Describe: Dietary Supplement Health and Education Act of 1994
-dietary supplements were to be regulated under the Center for Food Safety and Applied Nutrition
-product taken by mouth that contains a “dietary ingredient” intended to supplement the diet
-“dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissue, glandulars, and metabolites
What are the requirements to market a Dietary Supplement?
FDA does not “approve” dietary supplements
-must meet standards that apply to food preparation
-additional standards regarding purity and potency are the responsibility of the manufacturer
Define: Dietary Supplement
-a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake
-intended for ingestion in pill, capsule, tablet, or liquid form
-not represented for use as a conventional food or as the sole item of a meal or diet and is labeled as a dietary supplement
What are the labeling requirements for dietary supplements?
-identify the product as a “dietary supplement”
-net quantity of contents
-manufacturer’s, packer’s, or distributor’s name and place of business
-directions for use
-supplement facts: serving size and amount per serving, percent daily value (if established), ingredients (name and quantity)
Dietary Supplements CANNOT claim:
the use of dietary supplements can diagnose, prevent, mitigate, treat, or cure a specific disease
What can Dietary Supplements claim?
describe the supplements effect on the “structure or function” of the body or the “well-being” achieved by consuming the product
Define: Current Good Manufacturing Practices (CGMPs)
processed in a consistent manner to meet quality standards
regulations: contaminants/wrong ingredients, too much or too little stated ingredients, improper packaging or labeling
What authority does the FDA have over dietary supplements?
-GMP regulations
-pull unsafe products from market
-product labeling
What authority does the Federal Trade Commission (FTC) have over dietary supplements?
advertising
What is the responsibility of the USP DS Verification Program?
-audit the manufacturer’s facilities, quality control measures, records, ect
-test supplements against USP-set standards
-test random marketplace samples (insures strength and stability over shelf-life and evaluate for contamination)
-review supplement labels (ingredients are properly listed and appropriate dosage information)
Describe: Consumer Labs
conduct product review by independently purchasing several different brands with the same active ingredient conducted at commercial or academic laboratories, testing is repeated every 12-36 months, results made public (positive or negative)
In Consumer Labs, what are products specifically tested for?
-identify
-strength (quantity)
-purity
-bioavailability
How does a dietary supplement receive National Sanitation Foundation (NSF) Certification?
-verify the identity and quantity of dietary ingredients declared on product label
-ensure the product does not contain undeclared ingredients or unacceptable levels of contaminants
-demonstrate conformance to currently recommended industry GMPs for dietary supplements
