Introduction to Dietary Supplements

Dietary Supplements definition (per the FDA)

"Vitamins, minerals, herbs or other botanicals, and amino acids... used to supplement the diet by increasing dietary intake or concentrates, metabolites, constituents, and extracts; or any combination of these stated ingredients"

What are the 3 categories of drug supplement claims?

(1) health claim, (2) nutrient content claim, or (3) structure-function claim

What 4 parts are required to be on the dietary supplement label in the US?

(1) the name of the product as well as the word dietary supplement; (2) the net quantity of contents; (3) the manufacturer's, packer's, or distributor's name and place of business; and (4) directions for use. In addition, each label must also contain a supplement facts panel (that describes the serving size, the list of dietary ingredients, amount per serving size, and the percent daily value, if one is established)

A manufacturer must notify FDA of the exact wording of any structure-function claim within _________ days after the product is marketed.

30

For any new DS ingredient that was not on the market prior to October 15, 1994, a manufacturer must notify FDA ______ days in advance of its intent to market the product.

75

Dietary supplements are excluded from strict purity and potency standards and instead regulated as food products due to the signing of the _____________________ in 1994.

Dietary Supplement Health and Education Act (DSHEA)

What did the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 mandate?

Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), which was signed into law on December 22, 2006.17 This law requires manufacturers, packers, or distributors of DS to submit to FDA reports of serious adverse events that are based on specific information received from the public. Serious adverse events are defined as death, a life-threatening situation, a hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an adverse event that, based on reasonable medical judgment, requires medical or surgical intervention to prevent such serious outcomes.

Nutraceuticals, natural products, supplements, herbs, botanicals, and phytochemicals are examples of __________.

Dietary Supplements (DS)

True/False: dietary supplements are not regulated by the FDA

FALSE: The FDA regulates both finished (ready to be sold) DS products and individual dietary ingredients that are used to make DS products. Importantly, FDA regulates DS under a different set of regulations than those covering conventional foods and medications

Complaints against the advertising of dietary supplements may be filed with the _________ online.

FTC

The __________________ has primary responsibility for advertising claims made through print and broadcast advertisements, infomercials, catalogs, and other direct marketing materials.

Federal Trade Commission (FTC) - The FTC requires DS claims of safety and efficacy to be supported by "competent and reliable scientific evidence." This evidence is defined as "tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area that have been conducted and evaluated in an objective manner by qualified individuals, using procedures generally accepted to yield accurate and reliable results."

________________ claims describe the relationship between a food, food component, or DS ingredient and the resulting reduction in risk of a disease or health-related condition.

Health

Which 2 types of claims require FDA approval?

Health claims and nutrient content claims require FDA approval

What is a proprietary blend?

Manufacturers may market a combination of DS ingredients as a proprietary blend. Although the individual ingredients in the proprietary blend are listed, the actual quantity of each ingredient is not disclosed.

What are some examples of misbranding?

Other examples of misbranding include DS that do not conform to labeling requirements; fail to contain the name or place of business of the manufacturer, packer, or distributor; or fail to include accurate statements regarding the quantity of the contents.

True/False Plant-based DS should indicate the plant's scientific name, or Latin binomial (i.e., genus and species), and the specific plant part used.

Plant-based DS should indicate the plant's scientific name, or Latin binomial (i.e., genus and species), and the specific plant part used.

True/False: Claiming that a diet low in saturated fat and cholesterol that includes 25 g of soy protein daily may reduce the risk of heart disease is an example of an approved health claim

TRUE

True/False: The FDA has primary responsibility for regulating claims found on packaging, package labeling, inserts, and other promotional materials that are distributed at the point of sale.

TRUE

True/False: The dietary supplement's manufacturer is responsible for the product's safety & efficacy.

TRUE: The DS manufacturer is responsible for the product's safety and efficacy; FDA assumes a post-marketing surveillance role and must prove that a particular DS is not safe in order to restrict its use or remove it from the market.

True/False: Drug supplement INGREDIENTS that were sold in the United States prior to October 15, 1994 are not required to be reviewed for safety by FDA before being marketed

TRUE: they are assumed to be safe based on a history of use in humans.

True/False: Drug supplement manufacturers are not allowed to make claims that their product will diagnose, cure, mitigate, treat, or prevent disease

True

_________________ standards state that a DS must be manufactured in a quality manner without adulterants or impurities; they must be labeled accurately; and raw materials need to be evaluated by the manufacturer.

current good manufacturing practice (cGMP)

When a dietary supplement does not follow labeling requirements, the product is considered _________________.

misbranded

____________ content claims describe the relative amount of a nutrient or dietary substance in a product. For example, "very low sodium" means the product is required to have 35 mg or less of sodium per reference amount.

nutrient

Product labels that contain _____________ claims must also carry a disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease."

structure-function

Which type of claim does not require FDA approval?

structure-function claims

Among all DS, _____________ remain the top-selling supplements, primarily because they are used across all life stages.

vitamins & minerals