1. Herbal Products Presented by Janice Hermann, PhD, RD/LD
OCES Adult and Older Adult Nutrition Specialist

2. Herbal Products Herbs 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.
HERBAL PRODUCTS
Herbs have been used for centuries to cure or ease a variety of problems. In fact some herbs are the original source of important medicines. As a result, consumers often assume that herbs and herbal products have only benefits and no side effects.

3. Two Sides to Herbal Products
The 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.
However, there are two sides to herbal products. The 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.

4. Two Sides to Herbal Products
Pharmaceutical 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.
In this century, pharmaceutical 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.

5. Regulations of Herbal Products
The 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.
The 1994 Dietary Supplement Health and Education Act (DSHEA) set up a new framework for FDA regulation of dietary supplements. The law gives dietary supplement manufacturers freedom to market more products as dietary. Traditionally, dietary supplements referred to products made of one or more of the essential nutrients, such as vitamins, minerals, and protein. But DSHEA broadened the definition to include herbs, botanicals, and other plant-derived substances.

6. Regulation of Herbal Products
FDA‘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.
FDA's requirement for pre-market review of dietary supplements is less than that of drugs and many food additives. One thing dietary supplements are not are drugs. A drug, which sometimes can be derived from plants used as traditional medicines, is an article that, among other things, is intended to diagnose, cure, mitigate, treat, or prevent diseases. Before marketing, drugs must undergo clinical studies to determine their effectiveness, safety, possible interactions with other substances, and appropriate dosages, and FDA must review these data and authorize the drugs' use before they are marketed. Unlike food additives or drugs; however, supplements do not need FDA's approval before being marketed. Manufacturers alone determine if their product is safe and effective.

7. Regulation of Herbal Products
If 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.
If 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.

8. Belief Herbs Are Safe
False sense of security that herbal products are safe because they are natural
Herbs 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 That Herbal Products Are Safe Because They Are Natural
There seems to be a false sense of security that herbal products are safe because they are in their natural state. In fact almost the opposite is true. Some of medicine's most potent drugs come from herbs, digitalis from foxglove, morphine and strong painkillers from poppy seed. Although both morphine and digitalis are extremely useful, they are also both potentially fatal. Just because herbs are “natural” does not mean they are beneficial or even safe. Nothing could be more natural – and deadly – than the poisonous herb hemlock.
Unfortunately, promotional literature for herbs often recommends harmful or even deadly poisonous herbs. These claims are often based on outdated or misunderstood literature, hearsay, folklore or tradition. There seems to be a false sense of security that herbs, because they are in their natural state are not harmful. In fact almost the opposite is true. Most compounds have the potential to be harmful, if consumed improperly or in excessive amounts.
There seems to be a false sense of security that herbal products are safe because they are in their natural state. In fact almost the opposite is true. Some of the most potent pharmaceutical medications are from herbs, digitalis from foxglove, morphine and strong painkillers from poppy seed. Although both morphine and digitalis are extremely useful, they are also both potentially fatal. Just because herbs are “natural” does not mean they are beneficial or even safe. Most compounds have the potential to be harmful, if consumed improperly or in excessive amounts. Nothing could be more natural – and deadly – than the poisonous herb hemlock. Unfortunately, some promotional literature recommends harmful or even deadly poisonous herbs. Some claims are often based on outdated or misunderstood literature, hearsay, folklore or tradition.

9. Belief Herbs Are Safe “Natural” isn’t superior to synthetic
Natural only refers to source not superiority
Body doesn’t know the difference
“Organic” doesn’t imply superior
Organic only refers to conditions grown
Plants don’t know the difference between nutrients from organic or inorganic sources
Claims are often made that natural compounds are superior to synthetic. The term “natural” identifies only the source and does not indicate superiority. There is no difference in how the body uses a natural or synthetic compound; for example the body uses synthetic vitamin C the same way it uses vitamin C from natural sources.
“Organic” is another term associated with herbal remedies that implies superiority. “Organic” indicates that the product was grown under conditions utilizing natural fertilizers, such as manure, and that no pesticides were applied. Plants can not distinguish, just as the human body can not distinguish, between nutrients such as calcium, potassium, and nitrogen from organic or inorganic sources. If anything, organic forms are less available and may have to be acted on by microorganisms in the soil before they can be used by the plant. Pesticide residues may pose health hazards if present in sufficient concentrations. Fortunately, most can be removed by proper cleaning, and appropriate limits of safety have been established. Pesticide residue concentrations have been found to be similar in products grown both organically and inorganically.

10. Safety and Efficacy Testing
Because 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
Are herbs well tested?
As previously mentioned, herbal products do not undergo the safety and efficacy testing required of pharmaceutical medications. Unlike pharmaceutical medications, information is lacking about the safety or effectiveness of most herbal products. It is not unrealistic to expect that of the 13,000 plants that have been used for medicinal purposes that may have not been tested. The effect of the active agents is often the result of observation and tradition, rather than from extensive clinical testing.

11. Quality Control
Because 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
Unlike pharmaceutical medications, FDA does not enforce any standards of quality for herbal products. Since it is almost impossible for the lay person to determine the quality or even to identify an herb by visual inspection, this means that the consumer is totally dependent upon the reputation of the seller for product quality.

12. Quality Control Potency of an herbal products can vary
plant variety
part of plant used
environmental conditions grown
how processed
Concentration of active ingredients can differ dramatically from batch to batch.
Are herbal dosages precise?
Unlike pharmaceutical drugs, the concentration of the active ingredient in herbal products is not controlled or standardized. Concentrations of active ingredients of plants varies considerably depending on several factors including plant variety, part of the pant used (leaves, roots, or oil), conditions under which the plant is grown (soil, growing season, temperature, moisture), maturity of the plant at harvest, and how the plant is processed (dried and stored). Thus the concentration of active ingredients can differ dramatically from batch to batch.

13. Quality Control A report on 10 brands of a leading herbal product:
Three brands had approximately half the potency listed on the label
Four brands had less than 90 percent of the potency listed.
A study if 10 brands of a leading herbal product reported that three brands had approximately half the potency listed on the label and four brands had less than 90 percent of the potency listed.

14. Quality Control
Since 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.
In addition, herbs may contain many natural compounds with totally different activities.
This can make using herbal products unpredictable. Consumers are not warned that herbal products can contain varying amounts of active ingredients. This can lead to a dangerous situation when the consumer uses an herbal product that may have a low potency and feels all right, but the next time they use the product the potency is different.

15. Quality Control
Herbal 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.
Consumers are also not warned that herbal 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. In response to this issue some manufactures are now introducing standardized herbal products with known concentrations of active ingredients.

16. Quality Control Contamination 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.
Contamination of herbal products is also 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.

17. Interact With Medications
Because 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
Herbal Products Can Interact With Pharmaceutical Medications
Because herbs contain active ingredients that act like drugs, they can interact with other herbs or pharmaceutical medications an individual is taking causing dangerous results. For example, St. John’s wort can interact with medicines to treat heart disease, depression, seizures and certain types of cancer and can decrease or exaggerate the intended effects. Information on how pharmaceutical medications interact with foods or other medications is available, but this type of information is not available for most herbs.

18. Interact With Medications
Important 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.
Thus it’s important that consumers inform their health care providers about herbal products they may be using. In addition, the consequences can sometimes be serious when people self-treat themselves with herbal products instead of seeking effective medical treatment.

19. Are Herbal Teas Safer?
Herbal teas contain the same active ingredients as herbs
Active 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
Belief That Herbal Teas Are Safer
Many people believe that because herbal tea’s can be bought at the grocery stores they must be safe. Herbal teas contain the same active ingredients as the herbs. Some herbal teas can produce a variety of symptoms including insomnia, headaches, diarrhea, heart difficulties, and even cancer. The active ingredients are generally present in small amounts and hence pose few risks for healthy individuals when used in moderation. Most cases of herbal tea poisonings occur when individuals grow or mix their own herbal teas; however, cases have occurred with consumption of commercial brands.

20. 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.
One problem with herbal teas is determining what amount is safe. There is no way to tell what concentration you are getting because different sources of the same herb can vary in the chemical concentration. In addition, how people react to a given herb varies greatly.
One of the most dangerous herbal tea preparations is the commonly consumed comfrey tea, which can cause potentially fatal liver damage. Other teas, which can be harmful to the liver, include gordologo, grounsel, mate, and tansy ragwort. Teas made from buckthorn, pokeroot (pokeweed), and senna can cause gastrointestinal side effects. Teas containing pure licorice can raise blood pressure. Foxglove, lily-of-the-valley, yellow and common orleander and squill contain glycosides that can affect heart function. Mandrake, lobelia, burdock, and thorn apple (jimson weed) can cause blurred vision, dry mouth, dilated pupils, disorientation and delirium.

21. Guidelines for Using Herbal Teas
Check the label for ingredients and for warnings about side effects
Don’t brew too strong or drink too much.
Buy only bagged tea, ready to brew from a reputable company
Don’t drink homemade teas or try to make your own
Tips For Using Herbal Teas
This doesn’t mean that you should avoid herbal teas altogether. If you drink herbal teas, or plan to try them, consider some of the following precautions:
Check the label to see if the ingredients are listed, and if there are warnings about possible side effects. If this information is not listed, write the manufacturer for the information.
Start slowly. Don’t brew teas too strong or drink too much.
Buy only bagged tea, ready to brew form a reputable company. Don’t drink homemade teas or try to make your own herbal teas out of berries, leaves, roots or flowers. Although one part of a plant may be safe, another part may not.
Practice moderation. As with most things, it is possible to get too much of a good thing.

22. Herbal Product Claims
Claims 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.
Claims 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.

23. Herbal Product Claims
Under 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.
Under DSHEA and previous food labeling laws, manufacturers are allowed to use, when appropriate, three types of claims: nutrient-content claims, disease claims, and nutrition support claims, which include "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.

24. Herbal Product Claims
Manufacturers 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."
Manufacturers can use structure-function claims without FDA authorization.  Structure-function claims 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."

25. Herbal Product Claims
Supplements, 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.
A drug is an article that, among other things, is intended to diagnose, cure, mitigate, treat, or prevent diseases. Supplements, including herbal products, can not make such claims on their product label. If an herbal product sold as a dietary supplement makes a claim on it’s label to treatment or cure for a specific disease or condition it would be considered an unauthorized--and thus illegal—drug. Unfortunately, most unfounded promotional claims for herbal products are found in books and pamphlets rather than on the official product label. The most valuable sources of herbal information evaluate the current scientific and professional literature and supply references to the scientific literature.

26. Why Herbal Products In Demand
Placebo effect - Mind over Matter
Placebos do what you think they will do
Placebos work about one-third of the time
Why Are Herbal Products In Demand
Why then are herbal products used so much and in such demand? The answer lies to some extent in the “placebo effect.” The placebo effect is a physiological improvement brought about by a psychological mechanism or “Mind over Matter.” Basically, a placebo does what you think it will do. Many scientific studies have shown that placebos work about one-third of the time. Placebos seem to work even better when the goal is a change in behavior, a sensation, or a response controlled by the endocrine gland or by the autonomic nervous system.

27. Guidelines For Using Herbs
Know which conditions can be safely treated and which require professional care
Chronic diseases or unknown disease conditions require professional care
Most consumers lack the background to accurately diagnose disease conditions
General Guidelines In The Use of Herbal Products
One of the most important things regarding self-medication with herbal products is to know which conditions can be safely treated and which ones require professional medical care. The occasional headache, strained muscle, a mild digestive upset, infrequent insomnia, or common cold are all conditions that are usually amenable to, and receive, self-treatment. On the other hand, chronic diseases or any unknown disease conditions require professional medial care. Generally speaking, most consumers lack the background to accurately diagnose most disease conditions. Because one disease can mimic another, potentially serious conditions can be misdiagnosed.

28. Guidelines For Using Herbs
Stop 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 women
infants or children under six years of age
elderly
General Guidelines In The Use of Herbal Products
Another safety recommendation is that consumers should stop taking an herb immediately if any adverse effects develop such as allergy, stomach upset, skin rash, or headache.
In general, herbal products are not recommended for pregnant women, lactating mothers, infants, or children under the age of six. In addition, the elderly should also be particularly cautious in using herbal products.

29. Guidelines For Using Herbs
Purchase standardized herbal products
specified amount of active ingredient
reputable company
provide the herb’s botanical scientific name
provide warnings about potential side effects
provide possible interactions with pharmaceutical medications
General Guidelines In The Use of Herbal Products
For safety, consumers are recommended to purchase standardized herbal products that contain a specified amount of an active ingredient marketed by a reputable company. Another indicator of quality is the label should contain the botanical scientific name of the herb, the name and address of the actual manufacture, and the expiration date. The label should also contain warnings about any potential side effects of the herb, and possible interactions between the herb and prescription medications.

30. Guidelines for Using Herbs
Look 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.
The United States Pharmacopeia (USP) is a group of experts that set standards for prescription and over-the-counter medication. Herbal companies that use USP guidelines for production and packaging can use the USP or NF (National Formulary) designation. A product with this designation will be required to meet the organization's standards for quality, strength, purity, and packaging.