Description
Food is your primary source for essential nutrients.
A dietary supplement means it 'supplements' the diet by increasing the total dietary intake of nutrient essential for the body to grow, function and to maintain overall health.
Per SAFEST BRAINS, supplements are important for brain development, maintenance, resilience starting from the unborn baby
They are meant to be part of a well-balanced diet.
Infant
For growth, development.
Supplement breastmilk or formula, baby food.
Childhood-Adolescence
For growth, development.
Supplement school nutrition, food choices.
Adulthood
For general health, performance. Supplement dietary, food choices.
Elderly
For daily living activities.
Supplement diet, home food programs.
FDA does not
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Review and approve dietary supplements for safety, effectiveness, quality prior to marketing.
FDA does
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Review scientific data to grant ‘qualified claims’ for health for some supplements
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Require label information on % Daily Value (DV) for each nutrient
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Limit product claim to affecting structure/function of body, general well-being claim, or classical nutrient deficiency disease claim - all rewuire a disclaimer.
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Take enforcement action against adulterated (unsafe) products.
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Take enforcement action against misbranded products that make 'drug' claims to mitigate (lessen), treat, cure, or prevent a specific disease or class of diseases.
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Works with Federal Trade Commission (FTC) on enforcement actions.
MAKE THE RIGHT CHOICES
Check Daily Values (DV)
Developed by the FDA to help consumers determine the level of various essential nutrients in Supplements as well as Packaged Food, Drinks. The product label provides the %DV so that you can see how much a serving of the product contributes to your daily diet.
DV includes added sugars, biotin, calcium, chloride, choline, cholesterol, chromium, copper, dietary fiber, fat, folate/folic acid, iodine, iron, magnesium, manganese, molybdenum, niacin, pantothenic acid, phosphorus, potassium, protein, riboflavin, saturated fat, selenium, sodium, thiamine, total carbohydrate, Vitamins A, B6, B12, C, D, E, K, Zinc
TIP
Low or high amounts of nutrients per serving
5% DV or less: LOW
20% DV or more: HIGH
An ingredient should not be more than 200%
Caffeine should be less than 200 mg
Values are different for pregnant women, infants, young children
General Benefit-Risk of Supplements
Benefits
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Can help meet daily requirements of essential nutrients
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Important for brain development, maintenance, resilience
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Improve or maintain your overall health
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Some have FDA 'qualified claims'
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Can be affordable
Risks
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Efficacy and safety are not FDA reviewed
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Companies expected to do their own studies, make truthful claims, manufacture quality products
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Amount of active ingredient(s) in each dose may vary, be lower than claimed
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May have hidden drugs, other unsafe ingredients, may cause strong side effects
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May also have sweeteners, fillers, binders, preservatives, artificial colors, flavorings and other 'inactive' ingredients
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May interfere with prescribed medicines, diagnostic testing, medical procedures
Do your own Check
Make the Right Choice
1. Read product Label
Information on the package, product container, package inserts (if provided)
Health claim(s) and appropriate disclaimers. Must have the word 'supplement'
Nutrient information:
• Serving size
• Number of servings per container
• Each dietary ingredient in the product
• Amount in milligrams or micrograms and the % Daily Value (DV) per serving
• Information about dietary ingredients contained within proprietary blends
• Other ingredients (fillers, binders, preservatives, sweeteners, flavorings)
Use information such as dose, how many times/day, with or without food
Cautions and Warnings like side effects, interactions
Manufacturing, testing information
2. Check the Truthfulness of Health Claims and Product Safety
They are not meant to diagnose, treat, cure, cure, prevent medical conditions. These are 'drug' claims requiring FDA review and approval.
For structure/function claims, they are required to include disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease".
They may have claim(s) 'qualified' by FDA but need to match the language provided by FDA
They may have harmful effects particularly for ingredients that are marketed 'proprietary', 'blend', 'matrix', 'complex'
They may have hidden drugs , caffeine
They may interact with prescribed/OTC medications
They may interfere with testing, surgical procedures
Use the 'Resources for you' provided below to check
Talk to doctor, pharmacist, or other healthcare professional to get additional information as needed.
Talk to a doctor if you have health concerns.
3. Check Manufacturing and Testing for Product Quality
Manufacturer History:
Has been in the market for years, makes other consumer products, makes pharmaceuticals
Third-Party Certification Seal:
Quality and reliability certification from independent parties such as NSF, USP, Eurofins, BSCG
Do Your Own Check:
Expiration date, change in appearance, smell, taste before expiry.
Contact company.
NOTE: There are no FDA ‘Approved’, ‘Licensed’, 'Cleared’ manufacturing sites. Use of FDA logo anywhere on product or website is illegal.
RESOURCES FOR YOU
FDA Qualified Claims, Compliance Actions
Health claims, safety communications, compliance and enforcement actions
NIH Dietary Supplement Fact Sheets
Search for vitamins, minerals, herbs and botanicals, probiotics, general information and supplements for specific purposes
DoD Operation Supplement Safety
Search for supplements and educational resources on wellness promotion, rehabilitation, performance enhancement
FDA Consumer Update: Mixing Medications and Dietary Supplements
Supplements can change the efficacy & safety of medications
If you are experiencing a harmful effect
CALL 911 if unresponsive
REPORT SERIOUS PROBLEMS TO FDA
Online through Safety Reporting Portal →
Call 1-888-SAFEFOOD (1-888-723-3366)
To report false product claims
Write to FDA Office of Dietary Supplement: ODSP@fda.hhs.gov