Herbal Products

Presented by Janice Hermann, PhD, RD/LD

OCES Adult and Older Adult Nutrition Specialist

Herbal ProductsHerbs have been used for centuries.Herbs are the original source of important

medicines. As a result, consumers often assume herbal

products have only benefits and no side effects.

Two Sides to Herbal ProductsThe majority of herbs have mostly placebo

effects, with minimal good and bad effects. Some herbs are more beneficial than

harmful, while others are more harmful than beneficial.

Two Sides to Herbal ProductsPharmaceutical medications have largely

replaced herbs. However, the use of herbal products has reappeared in recent years.

While some herbs seem to be safe and effective, the use of herbs has created several problems.

Regulations of Herbal ProductsThe 1994 Dietary Supplement Health and

Education Act (DSHEA) set the framework for FDA regulation of dietary supplements.

DSHEA broadened the definition of supplements to include herbs, botanicals, and other plant-derived substances.

Regulation of Herbal ProductsFDA‘s pre-market approval of dietary

supplements, including herbal products, is different from drugs.Before marketing, drugs must undergo clinical

studies to determine their safety and effectiveness.

Supplements do not need FDA's approval before being marketed. Manufacturers determine if product is safe and effective.

Regulation of Herbal ProductsIf a problem occurs, FDA must prove the

supplement poses a risk and should be removed from the market.

This means that consumers have responsibility for checking the safety of dietary supplements.

Belief Herbs Are SafeFalse sense of security that herbal products are

safe because they are naturalHerbs are the source of some potent

pharmaceutical medications“Natural” doesn’t mean something is

beneficial or even safe. Compounds have the potential to be harmful, if consumed improperly or in excessive amounts.

Belief Herbs Are Safe“Natural” isn’t superior to synthetic

Natural only refers to source not superiorityBody doesn’t know the difference

“Organic” doesn’t imply superiorOrganic only refers to conditions grownPlants don’t know the difference between

nutrients from organic or inorganic sources

Safety and Efficacy TestingBecause herbs are classified as a “dietary

supplements” not “food” or “drugs” they do not have to have go through the pre-market testing that drugs and food additives do

Effects of herbs based on observation rather than clinical testing

Quality ControlBecause herbs are classified as “dietary

supplements” they do not have the quality control standards “drugs” do

It is almost impossible for the lay person to determine the quality or even to identify an herb by visual inspection

Quality ControlPotency of an herbal products can vary

plant varietypart of plant usedenvironmental conditions grownhow processed

Concentration of active ingredients can differ dramatically from batch to batch.

Quality ControlA report on 10 brands of a leading herbal

product:Three brands had approximately half the potency

listed on the labelFour brands had less than 90 percent of the

potency listed.

Quality ControlSince the concentration of active

ingredients in herbal products can vary considerably, using herbal products can be unpredictable.

Can be dangerous situation, when use an herbal product that may have a low potency and feel all right, but the next time use the product the potency is different.

Quality ControlHerbal products can contain active

ingredients that have powerful or even toxic effects if consumed in large amounts.

This can lead to a dangerous situation when a consumer takes a small dose and feels all right, and then decide if they take a lot more they will feel a lot better.

Quality ControlContamination is a safety concern.

Studies of herbal products have reported that 10 to 15% were contaminated with heavy metals.

In addition, adulteration is a serious concern.Studies of herbal products have reported

contamination with pharmaceutical medications.

Interact With MedicationsBecause herbs contain active ingredients that

act like drugs they can interact with other herbs or pharmaceutical medications

Little information is available on how herbs interact with medications

Interact With MedicationsImportant to inform health care providers

about herbal products being used.Consequences can sometimes be serious

when people self-treat themselves with herbal products instead of seeking effective medical treatment.

Are Herbal Teas Safer?Herbal teas contain the same active

ingredients as herbsActive ingredients generally present in small

amounts and pose few health risks if used in moderation

Most cases of herbal tea poisonings occur when individuals grow or mix their own herbal

Are Herbal Teas Safer?Problem with herbal teas is determining what

amount is safe.No way to tell what concentration getting

because different sources of the same herb can vary in the chemical concentration.

How people react to herbs varies.

Guidelines for Using Herbal TeasCheck the label for ingredients and for

warnings about side effectsDon’t brew too strong or drink too much.Buy only bagged tea, ready to brew from a

reputable companyDon’t drink homemade teas or try to make

your own

Herbal Product ClaimsClaims that tout a products healthful benefit

have always been a controversial feature of herbal products and dietary supplements.

Manufacturers often rely on them to sell their products. But consumers often wonder whether they can trust them.

Herbal Product ClaimsUnder DSHEA manufacturers are allowed to

use "structure-function claims." Structure-function claims refer to the

supplement's effect on the body's structure or function, including its overall effect on a person's well being.

Herbal Product ClaimsManufacturers can use structure-function

claims without FDA authorization. Must be accompanied with 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."

Herbal Product ClaimsSupplements, including herbal products, can

not make claims to diagnose, cure, mitigate, treat or prevent disease on the product label.

Unfortunately, most unfounded promotional claims for herbal products are found in books and pamphlets rather than on the official product label.

Why Herbal Products In DemandPlacebo effect - Mind over MatterPlacebos do what you think they will doPlacebos work about one-third of the time

Guidelines For Using HerbsKnow which conditions can be safely treated

and which require professional careChronic diseases or unknown disease

conditions require professional careMost consumers lack the background to

accurately diagnose disease conditions

Guidelines For Using HerbsStop taking an herb if any side effect

develops such as allergy, stomach upset, skin rash or headache

Herbal products are not recommended for:pregnant or lactating womeninfants or children under six years of ageelderly

Guidelines For Using HerbsPurchase standardized herbal products

specified amount of active ingredientreputable companyprovide the herb’s botanical scientific name provide warnings about potential side effectsprovide possible interactions with pharmaceutical

medications

Guidelines for Using HerbsLook for USP

The United States Pharmacopeia (USP) is a group of experts that set standards for prescription and over-the-counter medication.

A product with this designation will be required to meet the organization's standards for quality, strength, purity, and packaging.