Dietary Supplements

Disclaimer used on dietary supplements making structure/function claims:

"This statement has not been approved by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

*Federal Trade Commission (FTC)* has primary jurisdiction over:

*advertising* of food, dietary supplements, OTC drugs, and cosmetics

Dietary supplements are intended for ______ via:

*ingestion*; tablet, capsule, power, softgel, gelcap, or liquid

New ___________ has provided opportunity to increase confidence about the contents of dietary supplements

*legislation* ex. DSHEA, Dietary Supplement and Nonprescription Drug Consumer Protection Act

*Dietary Supplement Health and Education Act*

- *defined and set safety and labeling requirements for dietary supplements* - amended the Federal Food, Drug, and Cosmetic Act of 1938

2 outcomes of DSHEA:

- broaden products that could be sold in America - loosen legislation to get certain products approved

Dietary supplements may not be _________ foods or the _____ of a meal or diet

- conventional foods - sole item of a meal or diet (ex. meal replacement bars/beverages)

Dietary supplement labels must contain 6 things:

1. *Name* of the product 2. *Identification* as a "supplement" 3. *Name & place of business* of manufacturer, packer, or distributor 4. List of *ingredients* 5. *Net contents* of product 6. *"Supplement Facts"* panel --> Must identify each dietary ingredient in product

3 independent companies that evaluate supplement quality:

1. ConsumerLab.com 2. NSF International 3. US Pharmacopoeia (USP)

Current good manufacturing practices ensure that dietary supplements do NOT have (5 things):

1. Wrong ingredients 2. Too much or too little of a dietary ingredient 3. Improper packaging 4. Improper labeling 5. Contamination

According to the DSNDCPA, for how long must manufacturers maintain records of adverse events?

6 years

*CFSAN* (acronym)

Center for Food Safety and Applied Nutrition

*DSHEA* (acronym)

Dietary Supplement Health and Education Act (1994)

*FTC* (acronym)

Federal Trade Commission

*Dietary Supplement*

a product (other than tobacco) intended to *supplement* the diet, including one or more of: - vitamin - mineral - herb or other botanical - amino acid - dietary substance for use by humans to supplement the diet by increasing intake - concentrate, metabolite, constituent, extract, or combination of any ingredient above

Reports of adverse events are not:

an admission by the manufacturer that the product caused or contributed to the event

DSHEA may include label _______

claims (ex. structure/function)

Examples of "serious" adverse events that must be reported to FDA

death, hospitalization, significant disability, birth defect, etc.

____________ ____________ are not held to the same standards of testing as drugs

dietary supplements

Remember, bottom line on regulation:

dietary supplements *do not need approval* from the FDA before they are marketed!

If a dietary supplement makes a structure/function claim, it must include a __________

disclaimer

Dietary supplements (do/don't) need approval from the _____ before they are marketed

do not; FDA

Only a _____ can claim to diagnose, treat, cure, or prevent disease

drug

DSHEA statements do not require:

extensive scientific evidence or agreement among scientists

DSHEA mandates that dietary supplements must provide ___________ labeling

nutritional

*Center for Food Safety and Applied Nutrition (CFSAN)*

part of FDA that regulates dietary supplements as a subcategory of food

*Dietary Supplement and Nonprescription Drug Consumer Protection Act* (DSNDCPA, Dec 2007)

requires manufacturer to submit serious adverse event reports to the FDA within *15 business days* of receipt AND maintain records of all adverse event reports for *6 years*

Dietary supplements are regulated as a ______ of _____ by the _______

subcategory of food; FDA

Dietary supplements may contain a new dietary ingredient if:

there is *reasonable certainty* of its safety

Reports of adverse events has increase _____ since DFNDCPA was implemented

threefold

DSHEA statements must be ________ and not _______

truthful; misleading

If the adverse event is not "serious", reporting to the FDA is ________

voluntary

According to the DSNDCPA, how soon must manufacturers submit adverse event reports to the FDA?

within 15 business days