Nutrition Chapter 12

Herbal supplements include all of the following characteristics, EXCEPT:

the same approval process as drugs.

Academy of Nutrition and Dietetics 2013 Position Statement on Functional Foods

"All food is essentially functional at some level as it provides energy and nutrients needed to sustain life. However, there is growing evidence that some food components, not considered nutrients in the traditional sense, may provide positive health benefits."

Dietary supplements, including vitamins, minerals, herbs, botanicals, amino acids, and enzymes, are meant to_______ not replace nutrients that are best obtained through a varied and balanced diet.

"supplement the diet,"

dietary supplements

-Recent study shows dietary supplement industry contributes more than $60 billion to national economy. -> 60,000 products are marketed in the United States as dietary supplements. > 64% of Americans use dietary supplements regularly.

Reasons for supplements

-promote and maintain health -to improve energy -boost immune system

FDA requires notification ___days before a "new dietary ingredient" is introduced to the market.

75

Supplements may be beneficial for some individuals. (cont'd)

Adults older than 50 years (vitamins B12 and D) People with dark skin (vitamin D) Individuals on restricted diets (multivitamin) Smokers, alcohol-dependent individuals, and those taking some medications (multivitamin) Women with heavy menstrual periods (iron) Individuals who frequently donate blood, as well as those with stomach and intestinal conditions (iron)

Functional foods contain nutrients or other constituents that enhance their contribution to health and disease prevention.

Also called nutraceuticals May be whole foods or enhanced processed foods No statutory legal definition

Beta-Carotene and Retinol Efficacy Trial (CARET)

Beta-carotene and vitamin A supplement was increasing participants' risk of lung cancer. Trial stopped.

Manufacturers can't make claims unless approved by the FDA.

Can make structure/function claims Describe effect on the structure or function of the body and do not make reference to a disease Mandatory disclaimer Example: "Promotes healthy joints" or "Supports the immune system"

Health claims

Describe a relationship between a dietary supplement ingredient and reduced risk of a disease or condition Must be FDA approved based on the Significant Scientific Agreement (SSA)

Generally Recognized As Safe

Dietary supplement ingredients (and food additives) that were present in the food supply prior to October 15, 1994 are presumed safe and thus "grandfathered." There are published studies on their safe consumption. However, many dietary ingredients legally present in supplements have not been reliably demonstrated to be safe.

perception of benefits

Even if a government-funded study were to denounce claims made by supplement manufacturers, one-fourth of respondents said they would disregard it. More than 80% said it was important that they have access to supplements. Less than 25% take supplements on advice of or under supervision of a health care professional.

Once a dietary supplement is marketed, ______ has to prove that the product is not safe in order to restrict its use or remove it from the market.

FDA

The FDA does not monitor supplements for quality assurance, potency, purity, or efficacy.

FDA does track reports of illness, injury, or reactions. Supplement manufacturers are required to report serious harmful effects to the FDA. FDA does not regulate terms. "Pure" "Natural" "Quality assured

Def of dietary supplement

Food or substance that supplements the diet and contains one or more dietary ingredients or their constituents Vitamins, minerals, herbs, other botanicals, amino acids, or enzymes Intended to be taken by mouth Pill, capsule, tablet, liquid, powder, and bar

Selected approved health claims

For example, "Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord defect."

Dietary ingredients have to be federally regulated and

GRAS (generally recognized as safe).

FDA requires that manufacturers list certain details about their products on the label.

General information Name of the product Word "supplement" Quantity Manufacturer name and location Direction for using the product "Supplement Facts" panel Serving size Percent Daily Value (DV) Dietary ingredients Nondietary components May include cautionary statements about potential side effects

Supplements may be beneficial for some individuals.

Infants and children (vitamin D) Women who may become pregnant (folic acid) Pregnant women (folic acid, iron, multivitamin) Vegans (vitamin B12 and D, calcium, iron, zinc) Those who do not consume dairy products (vitamin D and calcium)

Dietary supplements are not without risk.

May be important for individuals who cannot get enough nutrients through diet alone Not well regulated Much to learn about positive and adverse effects Consumers must weigh benefits versus risks Seek guidance from health care provider Evaluate through credible sources

Supplement vs. non-supplement users:

More likely to report very good or excellent health Have lower BMIs Have health insurance Have higher educational and socio-economic level Use alcohol moderately Refrain from cigarette smoking Exercise more frequently than nonusers Are of Asian and non-Hispanic, white descent

The FDA allows use of qualified health claims on supplement labels.

Qualified health claims FDA approved Emerging evidence Selected qualified health claims For example, "Vitamin C may reduce the risk of gastric cancer. The FDA has concluded that there is very little scientific evidence for this claim."

"High potency" supplements appear to pose the highest risk.

Significantly in excess of the Daily Values for one or more nutrients/ingredients Sometimes in excess of the "UL" (Tolerable Upper Intake Level) above which there are documented adverse effects No current law prohibits supplement potency, except for potassium Potential adverse effects Fatigue, diarrhea, hair loss Kidney stones, liver damage, nerve damage, birth defects Taking high levels for a prolonged time can be toxic Fat-soluble vitamins (A and D) Can result in nutrient-nutrient imbalances/interactions High doses of some nutrients may reduce absorption and utilization of other nutrients Copper can interfere with the absorption of zinc Iron can interfere with calcium absorption

1994 FDA's Dietary Supplement and Education Act (DSHEA) requires that:

Supplements be safe Unadulterated Be properly labeled Be produced with good manufacturing practices Promoted with label information that is truthful

Regulated by DSHEA

The manufacturer is responsible for ensuring that the product is safe, unadulterated, produced with good manufacturing practices, and properly and truthfully marked with a label

Independent labs may test supplements for strength, quality, and purity.

United States Pharmacopeia Convention (USP) sets standards and provides seals of quality. Some labs do product reviews. NSF International (NSF) ConsumerLab.com (CL)

Botanical or herbal supplements are derived from plants.

Usually consist of dried preparations of flowers, leaves, roots, bark, and/or seeds Less potent form of many drugs, but can still have drug-like effects

According to the Dietary Supplement Health and Education Act, what is considered a "new" dietary ingredient?

a dietary ingredient not sold in the United States in a dietary supplement before 1994

Supplements may also include health claims on the label that describe a relationship between a _____ and ---- These claims must be pre-approved for use on supplement labels by the FDA using Significant Scientific Agreement (SSA).

a dietary supplement ingredient and a reduced risk of a disease or condition.

Dietary supplements that have GRAS status:

are generally recognized as safe by the FDA.

The Dietary Supplement Health and Education Act of 1994

authorized the establishment of the Office of Dietary Supplements (ODS) at the NIH.

1994 Dietary Supplement Health and Education Act (DSHEA)

defines dietary supplement

Supplement manufacturers are responsible for—and accountable to the FDA for—

ensuring that supplements are safe, unadulterated, and produced with good manufacturing practices.

Food Safety Modernization Act (FSMA)

expands some of FDA's authority with supplement manufacturers

functional foods

foods may have a positive effect on health beyond that of basic nutrition.

Synthetic vitamins are:

generally chemically identical to vitamins labeled "natural."

Which of the following is an example of an acceptable structure/function claim that might appear on a dietary supplement label?

helps maintain cardiovascular health

Probiotics can be defined as:

live, beneficial bacteria found in fermented foods like yogurt.

The vitamins and minerals found in high-potency supplements:

may exceed the Tolerance Upper Intake Level.

The use of high-potency supplements may result in nutrient _____

nutrient intakes above the Tolerable Upper Intake Level and cause adverse effects.

Under the 1994 Dietary Supplement Health and Education Act (DSHEA), and more recently the 2011 Food Safety Modernization Act, the United States Food and Drug Administration (FDA) is responsible for ____

regulating the sale, labeling, and manufacturing of dietary supplements, as well as approving any health claims made for the supplements.

Dietary supplements in the United States are monitored by the FDA for:

reports of illness, reactions, or harmful effects.

Manufacturers must provide ____and _____ on the Supplement Facts Panel.

specific product information and ingredients

The mission of ODS is to

strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

In the United States, nutrition surveys indicate that the people who are most likely to use dietary supplements:

tend to already have healthful diets adequate in most nutrients.

what drives ppl to take them

the perception of benefits

All of the following are true in regard to functional foods, EXCEPT:

they are only whole foods; processed or packaged foods would not meet the criteria.

Dietary supplements do not have to be approved by the FDA for effectiveness or safety.

true

True or False : Current regulations do not require dietary supplements, including botanical supplements, to undergo the same rigorous testing for effectiveness, interaction, or safety requirements as conventional drugs.

true

Which of the following would NOT meet the criteria for being called a "dietary supplement" in the United States?

vitamin B12 injection or shot