Exam 4-Integrative Nutrition

health claim example

"Calcium may reduce the risk of osteoporosis."

Any products with structure/function claims should include the 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."

When there is a structure/function claim the following must be provided:

"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. "

structure/function claim example 2

"calcium builds strong bones and teeth"

structure/function claims example

"calcium builds strong bones."

nutrient content claims example

"reduced fat" "low-calorie"

Dietary supplement label must include: (general information)

- name of product -net quantity of contents -name and place of business of manufacturer, packer or distributor - directions for use

Approaches to evaluate dietary supplement for their potential health benefits:

- to investigate history of use, conduct laboratory studies using cell or tissue cultures, and experiment w/animals -studies on people through case reports, observational studies, and clinical trials

The Ps of GMP

-People -Physical Plant -Processing Equipment -Processes and Procedures -Products

Specialty supplements most consumed:

-Prebiotics -omega-3 fatty acids -fiber -melatonin

Most popular category consumed:

-Vitamin/mineral supplements 76% -Specialty supplements 40% -Herbals and botanicals 39% -Sports nutrition supplements 28% -Weight management supplements 17%

three types of claims of a label of a dietary supplement

-a health claim - nutrient content claim - structure/function claim

Most popular herbals and botanicals:

-green tea -turmeric -CBD

Dietary supplement label must include: (supplement facts panel)

-serving size -list of dietary ingredients -amount per serving size (by weight) -percent of daily value (%DV, if established)

the research questions from Canadian researcher from testing 44 bottles of popular supplements:

1. Authentication: is the herbal species on the label found in the product? 2. Substitution: is the main herbal ingredient substituted by other species? 3. Fillers: are there any unlabeled fillers used?

DSHEA grants the FDA the authority to regulate dietary supplements:

1. FDA regulates product labeling 2. DSHEA holds supplement manufactures to what are known as "good manufacturing practices."

Top selling herbal supplements in 2019

1. Horehound (cough drops) 2. Echinacea 3. Elderberry 4. Turmeric 5. Cranberry

Problems of bottle and labeling

1. Quality issues 2. Quantity issues

In order to qualify as a dietary supplement it must:

1. supplement the diet 2. contain one or more dietary ingredients 3. taken by mouth, pill, capsule, tablet, powders, or liquid 4. labeled as a dietary supplement 5. not represented for use as food or a meal, or diet

Three main component in NSF DS certification program:

1. to confirm actual contents 2. toxicology review 3. contaminant review

who takes CBD?

12% users take CBD 19% under age 35

Top reasons Americans take supplements:

24% Energy 20% Immune Health 19% To fill nutrient gaps 18% Healthy aging 18% Heart Health

___ of U.S. adults take dietary supplements as opposed to __ in 2009.

77%, 65%

___ percent of U.S. adults with children under 18 in the household take dietary supplements.

83%

What is a new dietary ingredient?

A dietary ingredient that was not sold in the US in a dietary supplement before October 15, 1994

Who takes vitamin D?

Among the 55+ age category with nearly 50% of supplements user taking it in 2019.

2019 CRN Consumer Survey on Dietary Supplements, commissioned by _______ and conducted by Ipsos Public Affairs.

Council for Responsible Nutrition (CRN)

DSHEA

Dietary Supplement Health and Education Act

FDA regulates dietary supplements under the same set of regulations than those covering "conventional" foods and drug products.

FALSE, FDA regulates under a different set of regulations

Good Manufacturing Practices

Federal guidelines that must be followed by all entities that prepare and package medication or medical devices

If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name is listed in ....

Herbs of Commerce and the name of the plant part is used

ephreda

Ma Huang, raises blood pressure and puts additional stress on the cardiovascular system

Under the Dietary Supplement Health and Education Act of 1994:

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded

Dietary supplements are ___required to be standardized in the United States.

NOT

Who takes protein?

People aged 18-34 Men 30% > Women 24%

Supplement for sports nutrition and weight management most consumed:

Protein

What's in the bottle does not always match what's on the label

TRUE

Dietary supplements are considered safe until proven unsafe

True

Drugs are considered unsafe until proven safe.

True

What is the second most popular supplement?

Vitamin D

Who takes probiotics?

Women age 35-54 and Men age 18-34

a proprietary blend

a blend exclusive to the manufacturer, secret formula

consumerlab.com

a privately held American company, publisher of test results and guides for dietary supplement, products that pass the certification can use the CL seal of approval

Standardization

a process to ensure batch-to-batch consistency of the active ingredients

health claims

a relationship between a nutrient, food, food component, or dietary supplement and reduced risk of a disease or health-related condition, The FDA must pre-approve all health claims

FDA is responsible for taking action against any adultered or misbranded dietary supplement product before or after it reaches the market?

after

Excipient

an inactive substance used as a carrier for the active ingredients of a medicine or dietary supplement

US Pharmacopeia

an independent organization dedicated to quality control for the strength, quality, and purity of pharmaceutical or supplements

Firms are responsible for evaluating the safety and labeling of their products (before or after) marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

before

types of excipients

binders, coatings, disintegrants, fillers, lubricants, preservatives, sweeteners, flavors and colors

ginseng

boost energy

Echinacea purpurea

coneflower

structure/function claim

describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, and it cannot mention any specific diseases. Not reviewed by the FDA

The FDA regulates both __ and ___.

dietary supplement and dietary ingredients

DSHEA, 1994, defines ___ as food and not drugs

dietary supplements

metabolife contained ___ for weight loss

ephedra, ephedrine

Manufacturers are expected to guarantee __, __, ___, and ____ of their dietary supplements.

identity, purity, strength, and composition

Echinacea

improve immune function to prevent cold

ginkgo biloba

improve memory

2019 CRN Consumer Survey on Dietary Supplements show that the use of dietary supplements ______ by ___ over the past decade.

increased, 12%

National Science Foundation

independent, third party testing organization

Quantity issues

lack of optimal dosage schedules, interaction

garlic

lower blood lipid levels

Quality issues

manufacturing not standardized, lack of adequately defined products, adulteration

standardization involves identifying specific chemicals known as ___ to ensure a consistent product and also provide a measure of quality control

markers

geranium was sold as ____ , but turned out to contain the stimulant durg dimethylamlamine (DMAA) a man made drug

natural stimulant

some "herbal" supplements have been found to contain ___ or other compounds that are not listed on their labels.

prescription drugs

weight loss supplements contain ___ which was banned in the U.S. because of the risk of heart attack and stroke.

sibutramine

the manufacturer needs to submit __ to show that this dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended for labeling.

specific safety information

misbranded

that the labeling is false or misleading

adulterated

that the product is unsafe

nutrient content claims

the relative amount of a nutrient or dietary substance in a product. Does not need to be approved by the FDA

in TCM ephedra herb is used for...

upper respiratory infections and asthma

Melatonin

used to improve sleep

saw palmetto

used to treat enlarge prostate gland, chronic pelvic pain, decreased sex drive, migraine, hair loss

St. John's Wort

used to treat several conditions including kidney and lung disorders, and has been used widely in Germany for the treatment of anxiety, depression, and sleep disorders