1. Regulation, Safety and Education
Lea-Ann Wadleigh
Kaplan University

2. Contents Definition Uses Types Industry Safety Regulations
Benefits & Usage
Common Botanical Supplements
Consumer Education

3. -Plant or plant derivative -Sought after for medicinal properties -Used with intention of improving health -Typically internal usage, but can be aromatic or topical
A botanical is a plant that is sought after for its unique properties that can be used in medicinal type manners for the purpose of improving upon health (Supplements, 2011).

4. Uses Intended to be used internally Contain pill tincture oil
Vitamins, minerals, amino acids
Must be labeled as a supplement
 Botanical supplements are used as dietary supplements, and contain ingredients such as vitamins, minerals, or some form of identifiable amino acid. They are used in pill form, tincture form, and designed to be used internally. Botanical supplements must be labeled as supplements. (Supplements, 2011)

5. Types of Botanical Supplements
Tinctures
Extracted with alcohol, liquid form
Pills
Powder or gel encapsulated
Oils
Aromatic compounds extracted from botanicals by various methods
Types of Botanical Supplements
Tinctures: alcohol based plant extractions. Liquid form with various concentration ratios (Supplements, 2011)
Pills: typically powdered, or gel encapsulation of botanical product. Taken internally at a dosage.
Oils: aromatic compounds extracted from plants by various methods. For therapeutic usage internally, topically, or aromatically. When used internally, must be labeled as a supplement (doTerra, 2017).
Other forms of botanical supplements might be liquid juice, creams, powder and teas.

6. Industry A multibillion dollar industry
No standardization of the industry set by government
Companies provide their own quality control measures
Labels must meet supplement guidelines
Cannot make claims to cure or prevent disease
Not regulated for safety or efficacy
There is no standardization of botanical supplements in the United States. Ethical companies may find standard tests and quality control to be beneficial to maintaining reputation; however, the government does not mandate it. Labeling as supplements without claims to cure disease. Supplements make up a multibillion dollar industry; yet they are not regulated for safety or efficacy (McCormick, 2010)

7. Safety
Consumers often feel “safe” taking supplements due to their availability. This leads to complacency.
Some botanical supplements create toxic reactions
Liver, kidney and gastrointestinal issues
Hormone and electrolyte imbalances
Vitamin and mineral deficiencies
Most botanicals alone, when used according to directions have very few interactions or side-effects; however some can create toxic combinations in conjunction with other substances or health issues.
Safety should be considered when consumers are self-treating
Caution should be used with chronic conditions, or with unknown health history, and self-diagnosing
Practitioners should be consulted: herbalists, homeopathic doctors, traditional doctors or dieticians
Safety can often be misconstrued with supplements due to their over the counter availability unlike prescribed pharmaceuticals. Consumers may not be educated or aware of some of the safety issues that may arise when using supplements and herbs. Many botanical supplements can be used with little side-effects; however certain botanicals may create toxic combinations when used in conjunction with other medications, or when disease process is present.
Some botanical supplements can have negative effects on liver, kidneys, gastrointestinal tracts, and can also potentially create imbalances to hormones, electrolytes, and deficiencies. It is important that safety be considered when consumers have chronic health issues, are self-diagnosing and treating ailments without proper guidance from a practitioner.
(Dietz & Bolton, 2007)

8. Supplements are not regulated in the same fashion as pharmaceuticals
2007: FDA creates Good Manufacturing Practices (GMP) for supplement guidelines
Supplements are not regulated in the same fashion as pharmaceuticals
Guidelines are in place for labeling by the Federal Trade Commission
Provides a small amount of consumer awareness, and expectation to the industry
Quality and identification of herbal plants falls under the World Health Organization (WHO) and NCCIH policy for Natural Product Integrity
GMP and integrity are practiced by each company, and set their standards
Consistency must exist in order for clinical trials to produce desired outcomes and scientific research
It is in the best interest of the company to maintain quality and efficacy standards
Mechanism of action, absorption rates, metabolism and efficacy are all beneficial to clinical studies
Not all supplement companies conduct clinical trials in the correct manner
Ingredients may not be consistent
In 2007 the FDA made a standard that supplements must be made using Good Manufacturing Practices (GMP); however, this does not translate into the FDA regulating the supplements industry in the same fashion as they regulate the pharmaceutical industry. Federal Trade Commission controls the labeling of supplement products; and the GMP goes hand-in-hand with those requirements. The labeling and GMP practices intention is to bring about some level of consumer awareness, and safety to the industry. Quality and identification of herbal plants falls under World Health Organization advisement, as well as “NCCIH Policy: Natural Product Integrity” (VanFreeman, 2015). These guidelines are establishing industry standards, but beyond that the standards for GMP are upheld by each company. In order to establish consistency for purposes of clinical trials; a product must possess the same chemical makeup and quantities each time they are produced; these qualities also assist in identifying mechanism of action, absorption rates, metabolism, and efficacy for desired effect. Although the FDA does not regulate supplements to the extent of the pharmaceutical industry there are guidelines and ethical practices for companies to follow. (VanFreeman, 2015)

9. A botanical supplement advertising and label can only make “structure function” claims and not claims that identify a diagnosis, treatment or cure
Example: “Lavender oil can assist with relaxation” versus “Lavender cures insomnia”
One is a structure and function claim and the other is identifying a diagnosis and a cure
Common uses
Sleep
Stress
Weight Loss
Dermatological Issues
Pain and Inflammation
Common Botanicals
Aromatic: Lavender, Peppermint, Cinnamon
Internal: Black Cohosh, Echinacea, Cranberry
Topical: Tea Tree, Cedarwood, Fruit acids
Botanical dietary supplements advertising and labels can make claims related to structure and function, but not to diagnosis, curative, or treatment properties. Such as “Lavender oil can assist with relaxation” versus “Lavender cures insomnia” (Supplements, 2011).
Common uses of botanical supplements are for sleep, stress, weight loss, dermatological issues, and pain. Common botanical supplements for aromatherapy uses include essential oils such as Lavender, Eucalyptus, Peppermint, and Cinnamon. Common botanical supplements used for internal usage include things like Black Cohosh, Echinacea, Garlic, and Cranberry. Topical botanical supplements include creams and oils derived from plant based products; generally essential oils such as Tea Tree, and Cedarwood or Fruit acids (Shenefelt., 2011).

10. Common Botanical Supplements
Lavender: anxiety, pain, GI issues, stress
Peppermint: IBS relief, respiratory, headaches
Cinnamon: studies for MS, antiviral, bronchitis
Black Cohosh: menopausal symptoms
Echinacea: common colds and flu
Cranberry: UTI, bladder, stomach disorders
Tea Tree: AKA “Melaleuca”, infections, yeast, lice and nits
Cedarwood: calming, relaxing, anxiety reduction
Fruit Acids: acne treatments, dietary supplements in citric acid form
Common Botanical Supplements
Lavender: commonly used for anxiety reduction, pain, gastrointestinal issues, and managing stress. There are varying quality oils on the market, a reputable company with high internal quality standards should be sought out.
Peppermint: commonly used for relief from symptoms related to IBS, for respiratory support, and headache relief. Some studies have shown Peppermint to be effective for IBS relief.
Cinnamon: NCCIH is conducting studies on cinnamon for patients with Multiple Sclerosis. Cinnamon does show some antiviral properties, and historically was used in treatment for bronchitis.
Black Cohosh: generally used for menopausal symptoms. Out of many botanical supplements Black Cohosh is generally well studied with few side-effects and is fairly mainstream practice for usage.
Echinacea: typically used for common colds and flu symptoms; however, some studies are found to be fairly inconclusive. Echinacea has been used for a very long time, and each product varies in it’s quality.
Cranberry: Historically cranberry is used for urinary, bladder and stomach disorders. Generally consumed in a capsule, pill or even juice form. Concentrated forms in a capsule have been shown to reduce bacteria in urine, but may not be effective on active infections. (US Department of Health and Human Services National Insitute of Health, 2017)
Tea Tree: Sometimes referred to as “Melaleuca” is commonly used for infections, and yeast, as well as skin issues. Tea Tree has been found useful in preventing lice and nits when used regularly in shampoos. (doTerra, 2017)
Cedarwood: Commonly used for its calming effects, as well as tension relief. In the essential oil form, it can be diffused for anxiety reduction and calming. It can sometimes be found in personal care products.
Fruit acids: Commonly used for acne on skin, and as dietary supplement when it is in the form of citric acid. (Shenefelt., 2011).

11. When in doubt, always check with your health care professional.
Educate yourself on the benefits, side- effects, and clinical trials of a botanical supplement.
Find a trusted company who has long standing best practices and follows protocols to ensure safety and efficacy. Check their consumer reviews.
If it is too good to be true, it probably is. Be wary of claims of disease cures and magical overnight results. Results can happen with botanical supplements but typically due to their organic nature frequent use and application is necessary.
When in doubt, always check with your health care professional.
Educate yourself on the benefits, side-effects, and clinical trials of a botanical supplement.
Find a trusted company who had long standing best practices and follows protocols to ensure safety and efficacy, and also has favorable reviews from consumers.
If it is too good to be true, it probably is. Be wary of claims of disease cures and magical overnight results. Results can happen with botanical supplements but typically due to their organic nature frequent use and application is necessary.
When in doubt, always check with your health care professional.

12. Important Things to Keep in Mind 1
Important Things to Keep in Mind 1. Clinical trials are difficult to complete in Complementary and Alternative Medicine practices. Simply because they do not exist according to traditional methods does not mean that products should be completely discredited. It is more difficult to reproduce results from botanical products. A company must be highly efficient and have exceptional quality control, and consistency in order to produce a consistent finding. 2. Often two exact supplements from different companies are not created equal. 3. Consumers are at the mercy of the company; the purity of the product is not guaranteed. Buyer beware!
We must self-educate, and be informed consumers of botanical supplements. There is a level of trust that a consumer must place in the hands of a supplement company. Although botanical supplements are not regulated by the Federal Government, that is not necessarily a bad thing. Costs would increase, red tape would become greater and access would be limited. Education is key, and consumer safety is a must. Do not use supplements unless you have done your due diligence. Protect your health, and your body in the best way possible!

13. Dietz, B. M., & Bolton, J. L. (2007). Botanical Dietary Supplements Gone Bad. Chemical Research in Toxicology, 20(4), Retrieved 11 12, 2017, from
doTerra. (2017). What is an Essential Oil. Retrieved from doTerra:
McCormick, D. B. (2010). Vitamin/mineral supplements: of questionable benefit for the general population. Nutrition Reviews, 68(4), Retrieved 11 12, 2017, from
Shenefelt., P. D. (2011). Chapter 18Herbal Treatment for Dermatologic Disorders. Retrieved from National Center for Biotechnology Information, U.S. National Library of Medicine:
Supplements, N. I. (2011, June 24). Botanical Dietary Supplements. Retrieved from National Institutes of Health Office of Dietary Supplements:
US Department of Health and Human Services National Insitute of Health. (2017). Botanical Supplements Fact Sheet. Retrieved from US Department of Health and Human Services National Insitute of Health: Botanicals/
VanFreeman, R. B. (2015, November 12). Development of Safe and Effective Botanical Dietary Supplements. Retrieved from National Center for Biotechnology Information, U.S. National Library of Medicine:
References