DIETARY SUPPLEMENTS

Natalie DeRusha and Ana Sesatty

What is a dietary supplement?

Product that contains a dietary ingredient

Intention: add further nutritional value to
the diet

One or any combination

Vitamin, mineral, or herb/botanical
Amino acid
Dietary substance to supplement diet
Extract
Constituent
Concentrate
Metabolite

Various forms of supplements

https://expertbeacon.com/sites/default/files/before_buying_dietary_supplemen
ts_follow_this_advice.jpg

Statistics

Substantial increase of dietary supplement

usage
1988-1994: 42%
2003-2006: 53%
2009-2012: 48.7% used at least
one prescription drug in the past
30 days

Contain the same or a higher amount of

nutrients than the recommended DRIs

Significantly contribute to total dietary

intake

Statistics

In 2008, a cross-sectional study on prevalence

and patterns of medication usage and possible
drug-drug interactions
3,005 community individuals
Ages: 57 to 85

The

results
81% used at least one medication
42% used one-over-the-counter medication
49% used a dietary supplement
52%: Prescription medication users &
concurrent use of dietary supplements

Public Health Issue

Dietary Supplement Health and Education Act (DSHEA)

Allows manufacturers to place products on the market as food products
FDA is unable to regulate as drugs & validate market claims

New Dietary Ingredient (NDI) application

FDA reviews and determines if safe to market
Safety data & product efficacy is not required
End result-> substantial health risk to the public

Misguided health claims & availability -> pose a health risk to the public
Consumers consider supplements safe because they are natural

Public Health Issue

Main reason supplements pose a health risk

Unsafe products have forced their way into the market
Detrimental adverse reactions are reported
Potency of dietary supplements
Dosage & purity: lack of federal standards
Standardization process
Lack of batch consistency
Result: variation of active ingredients
Prospective dangers to the public
Inadvertent drug reactions
Toxicity
Adulteration with contaminants
Dosage variability
Risk to special populations
http://www.ironmagazine.com/images/supplements-ban.jpg
Economic risks

Regulation

U.S. Food and Drug Administration (FDA)

o

Regulates the processing, manufacturing, packaging, handling, and labeling of dietary

supplement products.

under the Dietary Supplement Health and Education Act of 1994(DSHEA)

New dietary ingredients (NDI)

Good manufacturing practices (GMPs)

Labeling

Claims

Regulation

Public Health Security and Bioterrorism Preparedness and Response Act

Dietary Supplement and Non-prescription Drug Consumer Protection Act

Nutrition Labeling Education Act (NLEA)

Food Safety Modernization Act

Federal Trade Commission (FTC)

http://www.baronforex-edu.com/?page_id=276

New Dietary Ingredients (NDIs)

Defined as a dietary ingredient in a dietary supplement that was not sold in the U.S. prior
October 15, 1994.
o Before 1994, manufacturers were not required to inform the FDA of ingredients

Ingredient notification to the FDA 75 days before placed on market

NDIs must not be chemically altered or must have reasonable safety evidence
o What is considered reasonable evidence of safety?
o In 2011, drafted new guidelines mandating more comprehensive safety and toxicology
testing
o Received pushback from manufacturers and agreed to revise guidelines in 2012
o FDA has not published revised NDI guidelines

Good Manufacturing Practices (GMPs)

Minimum standards to ensure safety and quality of production, processing, packaging,

handling, and labeling of dietary supplement products

Goal
o
o
o
o

Require manufacturers to have a batch production record and a master manufacturing record
of batch size, weight, concentration, and strength of each dietary supplement

Designed to ensure a consistent product and not to ensure the safety of ingredients

is to prevent
Addition of wrong ingredients
Excess or not enough of an ingredient
Reduce risk of contamination
Inappropriate packaging and/or labeling of products

Labeling

FDA requires dietary supplement products to include the following information:

o

Name of dietary supplement

Dietary supplement amount

Supplement Facts Panel

Ingredient list

Name and location of manufacturing, packaging, or distributing business

www.justlabelit.org

Claims

Manufacturers can not make health claims

o FDA can approve health claims
Product must meet significant scientific agreement (SSA)
Significant scientific evidence
Well-established and recognized scientific procedures
Qualified experts support claim

Manufacturers are allowed to make structural and functional claims

o Examples:
Helps reduce weight and body fat
Improves memory, concentration, and learning
Boosts the immune system

Disclaimer is required stating that claim has not been evaluated by the FDA and the product
is not intended to diagnose, treat, cure or prevent disease

Drugs vs Dietary Supplements

Both regulated by the FDA

Drugs require FDA approval and must be proven safe and effective by substantial evidence
through various clinical trials before entering the market
o Required information in package labels:
Proven treatable conditions
Side effects
Contraindications
Unsafe interactions with other drugs

Dietary supplement manufacturers DO NOT require FDA approval to produce and/or sell
products
o Only requires reasonable safety proof for NDIs
o FDA recalls and acts against dietary supplements only after product has reached the
market and proves to have a significant health risk to the population

Programs

USP Verified Dietary Supplements

Ensure the dietary supplement supply
Set standards

National Nutritional Foods Association (NNFA)

TruLabel Program
GMP Certification Program

http://www.usp.org/usp-verification-services

National Sanitation Foundation International (NSF International)

NSF Dietary Supplements Certification Program

http://www.npainfo.org/NPA/Education
Certification/TruLabelProgram.aspx
http://www.nutrigrass.com

http://www.barwismethods.com

Proposed Regulation & Policy

Required rigorous scientific testing by FDA

Proof of purity, safety, efficacy, & nutrient value

FDA approval
Based on scientific evidence
Controls availability

Labeling authorization
FDA approval for labeling health claims & structural/functional claims
Must be scientifically proven through significant scientific agreement (SSA) standards

Dietary supplements
Remove from over-the-counter
Place behind the counter in pharmacies & retail stores
Controls accessibility

Proposed Regulation & Policy

Fact sheets
Include
DRIs for each population
Possible drug interactions
Vitamin/mineral toxicities
Reported adverse effects
Explanation of content prior to release

Evaluation
Dietary supplement use through NHANES
https://sciencebasedpharmacy.wordpress.com/2009/12/26/d
o-the-natural-health-products-regulations-benefit-canadians/

Proposed Initiative

Dietary Supplement Safety and Quality Initiative

o Create awareness that most dietary supplements have not proven:
Safety
Efficacy
Quality
o Dietary supplements DO NOT substitute food

Establish a government based campaign

o Similar to current CDC campaigns
o Nationwide TV advertisement
o Partner with state health organizations
o Website to include resources on:
Supplement Facts Panel labels
Current regulations

Evaluation
o Dietary supplement sales

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