Herbal Supplements
A botanical is a plant or part of a plant valued for its medicinal or therapeutic prop-
erties, flavor, and/or scent. Herbs are subsets of botanicals. To be classified as a
dietary supplement, a botanical must meet the following criteria:
2.4 Herbal Supplements 39
1. It is intended to supplement the diet.
2. It contains one or more dietary ingredients (including amino acids, vitamins,
minerals, herbs, or other botanicals, etc.).
3. It is intended to be taken orally as a pill, capsule, tablet, or liquid.
4. It is labeled as being a dietary supplement.
A herbal supplement labeled “Natural” does not mean it is safe or without any
harmful effects. Herbal products can act the same way as drugs. Their safety de-
pends on factors such as their chemical make-up, how they work in the body,
method of preparation, and dosage. In the US, the FDA regulates herbal and other
dietary supplements. This means that they do not have to meet the same standards
as drugs and over-the-counter medications, they are not required to be standard-
ized, and no legal or regulatory definitions exist for standardization. As a result,
manufacturers are not required to demonstrate the safety and effectiveness of their
products before they reach the market. In addition, they do not have to adhere to
any of the quality control measures applicable to drugs; hence the composition
may vary greatly from one batch to another.
The use of some herbal supplements has been reported to be associated with ail-
ments such as oral manifestations, including swelling, irritation, and bleeding of
the tongue. These potential effects of herbal supplements, in conjunction with fac-
tors related to regulation restrictions, suggest that the use of these products may be
associated with various adverse reactions that can affect health. The active ingredi-
ent(s) in many herbal supplements are not known, and some have been found to
be contaminated with metals, unlabeled prescription drugs, and microorganisms.
Under its current regulatory authority, the FDA can remove a herbal supplement
from the market only after it has been shown to be unsafe. There has been an in-
crease in the number of Internet websites that sell and promote herbal supple-
ments. Unfortunately, some of them make inaccurate claims and statements re-
garding their products and claim unsubstantiated effects in curing disease and dis-
ease conditions. In the US, distributors of herbal products are under the jurisdic-
tion of the Federal Trade Commission (FTC), which monitors advertising for
truthful statements that do not mislead.
A botanical is a plant or part of a plant valued for its medicinal or therapeutic prop-
erties, flavor, and/or scent. Herbs are subsets of botanicals. To be classified as a
dietary supplement, a botanical must meet the following criteria:
2.4 Herbal Supplements 39
1. It is intended to supplement the diet.
2. It contains one or more dietary ingredients (including amino acids, vitamins,
minerals, herbs, or other botanicals, etc.).
3. It is intended to be taken orally as a pill, capsule, tablet, or liquid.
4. It is labeled as being a dietary supplement.
A herbal supplement labeled “Natural” does not mean it is safe or without any
harmful effects. Herbal products can act the same way as drugs. Their safety de-
pends on factors such as their chemical make-up, how they work in the body,
method of preparation, and dosage. In the US, the FDA regulates herbal and other
dietary supplements. This means that they do not have to meet the same standards
as drugs and over-the-counter medications, they are not required to be standard-
ized, and no legal or regulatory definitions exist for standardization. As a result,
manufacturers are not required to demonstrate the safety and effectiveness of their
products before they reach the market. In addition, they do not have to adhere to
any of the quality control measures applicable to drugs; hence the composition
may vary greatly from one batch to another.
The use of some herbal supplements has been reported to be associated with ail-
ments such as oral manifestations, including swelling, irritation, and bleeding of
the tongue. These potential effects of herbal supplements, in conjunction with fac-
tors related to regulation restrictions, suggest that the use of these products may be
associated with various adverse reactions that can affect health. The active ingredi-
ent(s) in many herbal supplements are not known, and some have been found to
be contaminated with metals, unlabeled prescription drugs, and microorganisms.
Under its current regulatory authority, the FDA can remove a herbal supplement
from the market only after it has been shown to be unsafe. There has been an in-
crease in the number of Internet websites that sell and promote herbal supple-
ments. Unfortunately, some of them make inaccurate claims and statements re-
garding their products and claim unsubstantiated effects in curing disease and dis-
ease conditions. In the US, distributors of herbal products are under the jurisdic-
tion of the Federal Trade Commission (FTC), which monitors advertising for
truthful statements that do not mislead.
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