The information regarding herbal formulas on the following pages is intended for use by licensed healthcare practitioners only, as professional training and expertise are essential for correct interpretation of the material and optimal use of the herbs. All information is presented in an accurate and truthful manner. Therapeutic claims are supported by modern research and referenced accordingly throughout the entire text. The advantages and disadvantages of each herbal formula are disclosed in full so that practitioners and their patients can make informed decisions.

 

Traditional Chinese Medicine (TCM) Terminology

Because traditional Chinese medicine and Western medicine have distinct cultural and philosophical influences, it is challenging to accurately convey some TCM terms and concepts by using English or allopathic clinical language.  We have made sincere efforts to provide consistent standards for terms and concepts to bridge the gap, as follows:

* Terms that have become an accepted part of English language discourse and are well understood by the general public, such as qi, yin and yang, are neither italicized nor capitalized.

* Terms unique to the profession, understood primarily by TCM practitioners, are given in pinyin, italicized and translated, but not capitalized; for example, bi zheng (painful obstruction syndrome), xiao ke (wasting and thirsting) syndrome, and lin zheng (dysuria syndrome).

* Nouns distinct to herbal medicine are italicized, capitalized and translated, such as Ren Shen (Radix et Rhizoma Ginseng) and Bu Zhong Yi Qi Tang (Tonify the Middle and Augment the Qi Decoction).

* It is important to note that anatomical organ names in TCM imply functions distinct from their common understanding in Western medicine.  Therefore, organ names are capitalized when discussed within the context of traditional Chinese medicine but not when referring exclusively to anatomical function. For example, Huang Qin (Radix Scutellariae) is commonly used to clear Lung heat because the herb has shown antibiotic effective to treat infection of the lungs.

 

CLINICAL APPLICATIONS

This section outlines the indications for use of the herbal formulas, including symptoms, diseases, and diagnoses according to Western and traditional Chinese medicine.

 

WESTERN THERAPEUTIC ACTIONS

The functions of the herbal formulas are summarized according to allopathic criteria. Therapeutic functions and clinical effects stated are supported by modern research and clinical studies. Additional information and a detailed explanation are provided in the Modern Research section.

 

CHINESE THERAPEUTIC ACTIONS

This section summarizes the functions of the herbal formulas according to traditional Chinese medicine. Diagnoses, therapeutic functions, and clinical effects are stated in Chinese medical terminology and are supported by historical references and modern textbooks.

 

DOSAGE

The dosage of herbal extract for an average adult ranges from 4 to 8 capsules [2 to 4 grams] three to four times daily, taken with warm water on an empty stomach, one hour before or two hours after meals. However, it is important to keep in mind that the dosage must be adjusted to reflect the age and body weight of the patient, and the severity and nature of the illness.

        The average adult is roughly defined as an individual between 18 and 60 years of age, with a body weight of 120 to 180 pounds. However, since not everybody is an ¡§average adult,¡¨ dosing of herbs must be individualized based on age and body weight. Generally speaking, the dosage should be reduced if the patient is younger than 18 years of age or weighs less than 120 pounds. Conversely, the dosage should be increased if the patient weighs more than 180 pounds. For more information on dosing, please refer to Strategic Dosing Guidelines on page 14.

        The dosage should be adjusted according to the type and severity of the illness. For treating acute or severe illnesses, such as severe low back pain, the dosage may be doubled to enhance the therapeutic effect. Depending on the patient and the disease, some herbal formulas may be taken in dosages of up to 40 capsules [20 grams] per day. Similarly, the dosage frequency may be adjusted to reflect the nature of the illness. For example, a person with insomnia should take more herbs before bedtime and less during the day. Finally, for patients who have allergies or food sensitivities, or for someone who has never taken herbs before, it is prudent to start with a lower dosage of herbs.

 

INGREDIENTS

The ingredients of the formulas are listed in alphabetical order by their pinyin and pharmaceutical names. The nomenclature of herbs and formulas are taken from the following primary sources:

* Zhong Hua Ren Min Gong He Guo Yao Dian (Chinese Herbal Pharmacopoeia by People's Republic of China), People's Republic of China, 2010.  Our standard reference for nomenclature of pinyin and pharmaceutical names, this text offers the most precise, accurate, and current information on the identification of Chinese herbs and other medicinal substances. 

* Xian Dai Zhong Yao Yao Li Xue (Contemporary Pharmacology of Chinese Herbs) by Wang Ben-Yang, Tianjing Science and Technology Press, 1999.

* Chinese Medical Herbology and Pharmacology, by John Chen and Tina Chen, Art of Medicine Press, 2004.

* Chinese Herbal Formulas and Applications, by John Chen and Tina Chen, Art of Medicine Press, 2009.

* Chinese Herbal Medicine Materia Medica, by Dan Bensky and Andrew Gamble, Eastland Press, 2004.

* Chinese Herbal Medicine Formulas & Strategies, by Dan Bensky and Randall Barolet, Eastland Press, 2009.

* A Practical Dictionary of Chinese Medicine 2^nd Edition, by Nigel Wiseman and Feng Ye, Paradigm Publications, 1998.

 

BACKGROUND

This section provides introductory and background information on the disease.

 

FORMULA EXPLANATION

This section explains the rationale for and the treatment strategy of the herbal formula. The therapeutic function of each ingredient is discussed in detail to provide a comprehensive understanding of each herbal formula. The explanations include both Chinese and Western medical terminology and are intended for readers with medical training.

 

CAUTIONS & CONTRAINDICATIONS

This section discusses relevant cautions for use of the herbal formula, including (but not limited to) side effects, adverse reactions, contraindications and herb-drug interactions. In addition, this section addresses how to discern circumstances in which to treat or not to treat with a particular formula. It provides valuable information for prevention of wrong diagnosis and malpractice. Information is presented in an accurate and truthful manner so that healthcare practitioners can evaluate risks versus benefits, and so that their patients can make informed decisions. Lastly, the use of herbs during pregnancy or while nursing is not recommended.

 

CLINICAL NOTES

This section includes quick and easy tips for practitioners to boost the effectiveness and overall success of the treatment. This section also provides valuable information on differential diagnosis, treatment, and prognosis based on the clinical experience of masters of traditional Chinese medicine.

 

Pulse Diagnosis by Dr. Jimmy Wei-Yen Chang:

This section provides the pulses associated with the disease. Dr. Jimmy Wei-Yen Chang, a renowned pulse diagnostician and herbalist with over 30 years of innovative, clinical, and practical experience, is one of the very few licensed practitioners who is able to integrate TCM pulse diagnosis with Western biomedical conditions and correlate definitive pulses with herbal prescriptions. He has made pulse diagnosis, Chinese medicine¡¦s cardinal diagnostic technique, into a reliable diagnostic tool in itself.

        Dr. Chang¡¦s unique pulse diagnostic method has some differences from the pulse diagnosis that is traditionally taught in TCM schools. The biggest and probably the most crucial difference is the location of the cun, guan, and chi positions of the pulse. For Dr. Chang¡¦s pulse diagnosis, the pulse positions are found by first locating the styloid process. The index finger is then placed distal to the styloid process, which corresponds to the cun position and relates to the Lungs on the right hand and to the Heart on the left hand; the middle finger is placed proximal to the styloid process, which corresponds to the guan position and relates to the Stomach on the right hand and to the Liver on the left hand; lastly, the ring finger is then placed proximal to the middle finger and corresponds to the chi position, which relates to the Kidney¡¦s urinary function and upper body on the right hand, and to the Kidney¡¦s reproductive function and lower body on the left hand. With this slight difference between Dr. Chang¡¦s pulse positions and the traditional pulse positions, it can make the difference between reaching the correct or incorrect diagnosis.

 

According to Dr. Chang, a complete pulse is made up of three basic components: 1) the shape of the pulse, 2) the jump of the pulse, and 3) the level of the pulse. The shape of the pulse includes convex-shaped pulses (i.e., turtle pulse, bird¡¦s beak pulse), concave-shaped pulses, straight wiry pulses (i.e., pulse within a pulse, taiyang pulse, big pulse), and shapeless pulses (i.e., dispersing pulse, greasy pulse). The jump of the pulse includes its velocity (fast or slow), strength (i.e., forceful, weak, impetuous), resistance (i.e., tight, flowing), and amplitude (high or low). The level of the pulse describes the depth at which the pulse can be felt ¡V superficial (floating) or deep (sunken). Based on these three components and the position in which the pulse is felt, Dr. Chang is able to arrive at a definitive pulse and its diagnosis. For additional information, please attend his online courses or read his book:

* Online courses: http://www.elotus.org/speaker-bio

* Book: Pulsynergy by Dr. Jimmy Wei-Yen Chang and Marcus Brinkman.

 

 

SUPPLEMENTARY FORMULAS

This section emphasizes the modification of herbal treatment. As two or more patients having the same disease may have different clinical manifestations, it is often necessary to choose an alternate formula, combine two formulas for synergistic effects, or add another formula to treat complications or progression of the disease.

 

ACUPUNCTURE TREATMENT

 

Traditional Points:

These are textbook recommendations for body and ear points. This section lists and explains the suggested acupuncture treatments to be used with herbal therapy. The translation and abbreviations of the vessels follow the system established by the World Health Organization (WHO):

 

Lung (LU)

Large Intestine (LI)

Stomach (ST)

Spleen (SP)

Heart (HT)

Small Intestine (SI)

Bladder (BL)

Kidney (KI)

Pericardium (PC)

Triple Heater [San Jiao] (TH)

Gallbladder (GB)

Liver (LR)

Governor Vessel (GV) [a.k.a. Du Channel]

Conception Vessel (CV) [a.k.a. Ren Channel]

 

Classic Master Tung's Points:

This section highlights Master Tung's main treatment strategy and acupuncture points. Master Tung Ching-Chang (1916¡V1975) was born and raised in Shandong, China. He inherited generations of family-style acupuncture and continued the legacy after he moved to Taiwan in 1949. With his relocation to Taiwan, Master Tung was able to avoid the Cultural Revolution and preserved the clinical pearls of traditional healing. Tung Style Acupuncture is known for its outstanding therapeutic effects using very few refined acupuncture points. It is often grouped with the distal acupuncture style for its stress on points on the hands and feet. Even though many of Tung Style Acupuncture points still follow the 14 channel relationships, the locations and applications are very different from the unified TCM school tradition. Master Tung is best known for his ¡§Dao Ma¡¨ technique, which utilizes three needles in adjacent areas on the channel to enhance the treatment effect. He treated over 400,000 patients during his lifetime and trained many practitioners along the way. Master Tung is famous for the miraculous and spontaneous results he would obtain by using few needles. The acupuncture points and techniques he used are unique while remaining in accord with orthodox acupuncture. In most cases, the patient notices instant relief upon insertion of the needle. Even though Master Tung passed away in 1975, his students and disciples continue to practice his style of acupuncture around the world. Master Tung¡¦s life-long research and clinical experiences were complied into many books and other works. Tung Style Acupuncture has also been recognized by the NCCAOM and was added to the continuing education list in 2003.  For those who are interested in further study of Tung Style Acupuncture, the following books are available:

¡± Advanced Tung Style Acupuncture: The Dao Ma Needling Technique of Master Tung Ching Chang by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 2: Obstetrics & Gynecology by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 3: Nephrology Urology & Andrology by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 4: Neurology by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 5: Anesthesiology/Pain Management by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 6A: Internal Medicine by James H Maher

¡± Advanced Tung Style Acupuncture Vol. 6B: Internal Medicine by James H Maher

¡± Introduction to Tung's Acupuncture by Dr. Chuan-Min Wang

¡± Illustrated Tung's Acupuncture Points by Wei-Chieh Young

¡± Lectures On Tung's Acupuncture: Points Study by Wei-Chieh Young

¡± Lectures On Tung's Acupuncture: Therapeutic System by Wei-Chieh Young

¡± Practical Atlas of Tung's Acupuncture by Henry McCann & Hans-Georg Ross

¡± Pricking the Vessels: Bloodletting Therapy in Chinese Medicine by Henry McCann

¡± Mastering Tung Acupuncture ¡V Distal Imaging for Fast Pain Relief by Brad Whisnant

 

* Note: Though there are many books on Master Tung's style of acupuncture and Master Tung's points, there are still some points that have not been translated in English. These points are marked with (*) and additional information is available at the Lotus Institute website: www.elotus.org.

 

Master Tung¡¦s Bloodletting Therapy

While the use of special points and synergistic needling (dao ma) are hallmarks of Master Tung¡¦s acupuncture style, any discussion of his approach is incomplete without mention of his bloodletting techniques. Especially in chronic, severe, or difficult cases that do not respond well to acupuncture and herbs, bloodletting is indispensible.

Points for bloodletting are found in two main areas. First, individual points, usually found on the trunk of the body, can be used for bloodletting based on specific indications. Second, various zones of the limbs have corresponding effects on the zang and fu organs, allowing the practitioner to treat according to organ patterns. The best areas for bloodletting will show local signs of blood stasis, such as visible spider nevi or small dark purple veins. Veins that are thick, distended, and may be green in color should not be bled. Upon palpation, the skin in these areas may feel rough, indicating blood stasis, or hot, indicating heat. It is important that bloodletting is done on the veins, not the arteries. Unlike Tung¡¦s needling technique, bloodletting is applied ipsilaterally to the site of disease.

Master Tung used three-edged needles exclusively for bloodletting. However, lancet needles are safer for beginners because the depth can be controlled. Advanced practitioners may choose to use three-edged needles, body piercing or syringe needles.

Bloodletting is contraindicated in patients with bleeding disorders (i.e., hemophylia), and patients on who are on anticoagulant or antiplatelet therapies, such as Coumadin (warfarin), or on any medications that may cause excessive bleeding. Caution should be taken in deficient patients, patients who are hungry, anemic, and pregnant, and also elderly patients. Bloodletting should be stopped when the following signs are presented: pale face, fainting pulse, cold limbs, sweating, lowering blood pressure, or unconsciousness.

Note: State regulatory boards and agencies have differing perspectives on whether bloodletting is part of your acupuncture scope of practice. Understanding this skill and its therapeutic value does not guarantee that it is legal for you to practice it in your state. Please check with your licensing board.

In addition, adhere to clean needle technique protocols, including but not limited to wearing disposable gloves, using disposable needles, and using one needle per point, when bloodletting. Please review your clean needle technique for bloodletting.

For more information on bloodletting, please visit www.elotus.org

 

Chart 1: Zones of the Trunk

 

Chart 2: Zones of the Lower Limbs

 

Master Tung¡¦s Numbering System

Throughout the manual, the letter ¡§T¡¨ will appear in front of the numbers indicating it¡¦s a Master Tung point. The numbers below give a general idea where the points are located on the body.

 

T 11.00          Fingers

T 22.00          Hand

T 33.00          Forearm

T 44.00          Upper arm

T 55.00          Plantar of the foot

T 66.00          Dorsum of the foot

T 77.00          Lower leg

T 88.00          Thigh

T 99.00          Ear

T 1010.00     Head/Face

T DT.00         Back

T VT.00         Chest

 

Master Tung¡¦s Points by Dr. Chuan-Min Wang:

This section illustrates clinical application of Master Tung¡¦s points by Dr. Chuan-Min Wang, an official apprentice who learned Tung's acupuncture directly with Master Ching-Chang Tung from 1972-1974. Born in Taiwan, Dr. Chuan-Min Wang received a Philosophy B.S. degree from Fu-Jen Catholic University in 1974 and an Education Master degree from National Taiwan Normal University in 1977. During his college years, Dr. Wang studied Chinese Philosophy and I-Ching from Master Hwai-Jin Nan. After his studies, Dr. Wang taught philosophy at a local college and practice acupuncture at home in Taiwan. After immigrating to the U.S., Dr. Wang studied chiropractic techniques and received a Doctor of Chiropractic degree in 1999. Soon after, Dr. Wang received his chiropractic physician and acupuncture licenses and began a practice in Illinois. Dr. Wang has also visited Peru, El Salvador, the Dominican Republic, and Bolivia as a volunteer physician 7 times and received the Humanitarian Physician Award from the Buddhist Compassion Relief Tzu Chi Foundation Taiwan in 2004 for his volunteer works. In addition, Dr. Wang was invited to promote Tung¡¦s Acupuncture three days in He¡¦nan Traditional Chinese Medicine by The World Federation of Acupuncture-Moxibustion Society (WFAS). For additional information, please attend his online courses and read his book:

* Online courses: www.elotus.org/speaker-bio

¡P   Master Tung's Acupuncture: Five Zang System

¡P   Master Tung's Unique Points for Female Conditions

¡P   Top 30 Master Tung Points & Their Clinical Indications

* Website: www.acup-chiro.com/

* Book: Introduction to Tung's Acupuncture by Chuan-Min Wang 

 

Balance Method by Dr. Richard Teh-Fu Tan:

The late Dr. Richard Tan was a leading acupuncture authority in our profession. His skills represented the culmination of years of study. At age seven, he began his studies in Chinese Medicine with his family in Taiwan, and apprenticed with numerous masters in herbal medicine, five element theory, acupuncture channel theory, zang fu energetics, feng shui, and qi cultivation. Early in his career, he treated hundreds of patients who were also receiving Western medical care in an army hospital. Upon coming to the U.S., Dr. Tan revolutionized the acupuncture community with Balance Method Acupuncture. This school of acupuncture was derived from the I Ching, which consisted of six logical systems based on TCM Channel relationships and the Chinese Clock. Dr. Tan practiced in San Diego for over 25 years while leading many interns to become successful practitioners. Dr. Tan also lectured extensively throughout the U.S. and the world. For additional information, please attend his online courses, and read his books:

* Online courses: www.elotus.org/speaker-bio

¡P   Dr. Tan's Balance Method: As Simple As 1-2-3! [Introduction]

¡P   Intro to Master Tung's Acupuncture: Richard Tan's Applications [Introduction]

¡P   Master Tung's Acupuncture - Dr. Tan Style [Introduction]

* Books:

¡P    Twelve and Twelve in Acupuncture by Richard Teh-Fu Tan and Stephen Rush

¡P    Twenty-Four More in Acupuncture by Richard Teh-Fu Tan and Stephen Rush

¡P    Dr. Tan's Strategy of Twelve Magical Points by Richard Teh-Fu Tan

¡P    Acupuncture 1, 2, 3 by Richard Teh-Fu Tan

 

Ear Acupuncture:

These are the textbook recommendations for ear points.

 

Auricular Medicine by Dr. Li-Chun Huang:

This section highlights clinical applications of Auricular Medicine, a scientific medical system which can diagnose and treat many different diseases of the body and the mind solely through the ears. After more than 40 years of research and practice, Dr. Li-Chun Huang, an internationally renowned physician, founded this unique art of healing. Dr. Huang developed this complete system of auricular diagnosis with visual examination, palpation, and electrical probe diagnosis. Auricular medicine can precisely diagnosis and treat over 400 symptoms and over 200 diseases. The ears are one of the few areas where a practitioner can conduct diagnosis and treatment at the same time. It is very fast, effective, and safe. Dr. Huang is very generous in sharing her knowledge and has recommended point prescriptions associated with formulas and conditions mentioned in this Clinical Manual. For additional information, please attend her online courses and read her books:

* Online courses: http://www.elotus.org/speaker-bio

* Website: http://www.earmedicine.us/

* Books:

¡P   Auricular Medicine (second edition) by Li-Chun Huang

¡P   Handbook of Auricular Prescriptions and Formulae by Li-Chun Huang

¡P   Auricular Diagnosis with Color Photos by Li-Chun Huang

¡P   Color Ear Chart (Left Ear) by Li-Chun Huang

¡P   Color Ear Chart (Right Ear) by Li-Chun Huang

 

 

NUTRITION

This section describes the dietary changes recommended to facilitate short-term and long-term recovery. Detailed information is available on what foods to consume and what foods to avoid.

 

The Tao of Nutrition by Dr. Maoshing Ni and Cathy McNease:

This section highlights foods and nutrients that should be consumed and avoided. Recommendations include common foods, as well as those that are unique to Chinese culture and traditional Chinese medicine. For additional information, please attend her online courses or read their publication:

* Online courses: http://www.elotus.org/speaker-bio

* Book: The Tao of Nutrition by Dr. Maoshing Ni and Cathy McNease

 

LIFESTYLE INSTRUCTIONS

This section highlights lifestyle changes recommended to enhance herbal treatment. Lifestyle instructions are recommended to enhance the effectiveness of herbal treatment and to prevent recurrence of illnesses.

 

CASE STUDIES

This section includes actual case reports submitted by healthcare practitioners. It enables the readers to understand the response to, and efficacy of, the herbal formulas in clinical settings, rather than in research studies alone. Note: As these are original reports submitted by practitioners, the formality of the presentation varies from one case study to another.

 

ADDITIONAL INFORMATION

This section provides any other additional and helpful information regarding the formula and the treatment.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

This section summarizes clinical and laboratory studies on the effectiveness of the herbs. Therapeutic claims are explained in detail and referenced accordingly in this section.

        References: The references cited include human clinical trials that are randomized, double-blind, and placebo-controlled, with a large number of subjects and sound statistical design. Such studies provide meaningful results with conclusions that can be extrapolated to patients with similar conditions. In addition to human clinical trials, references cited include clinical observations, case studies, credible textbooks, in-vivo and in-vitro studies, and clinical and laboratory studies.

        Scientific and Medical Terminology:  For the occasional allopathic term that readers might find puzzling, we recommend accessing any standard allopathic medical dictionary (see next entry for example).  Since there is no need for translation or interpretation of these terms, we concluded that it was unnecessary to explain such terms in this text.    Medical Abbreviations and Symbols are used in accordance with Dorland¡¦s Illustrated Medical Dictionary by Saunders.

        Drug Names are designated in this text by generic names only, or the combination of Proprietary (Generic) names.  The Proprietary (Generic) names are referenced according to Drug Facts and Comparisons, updated monthly by Facts and Comparisons, a Wolters Kluwer Company.

        Pharmacological Effects: Most pharmacological studies focus on the anatomical and physiological influences of the herbs 1) on the body, or 2) against pathogens.  For example, many herbs are described as having antihypertensive effects, as the administration of the herbs leads directly to a decrease in blood pressure.  Others are said to have antibacterial effects, as the introduction of the herb leads to the inhibition or death of bacteria.  However, the exact mechanisms of action for many herbs are still not well understood at this time.

 

COMPARATIVE ANALYSIS

Written by Dr. John Chen, who holds doctorate degrees in both Western pharmacology and traditional Chinese medicine, this section compares and contrasts the advantages and disadvantages of drug and herbal medicines. Dr. Chen strongly believes in ¡§medicine without borders,¡¨ and concludes without bias the ¡§bottom line¡¨ on the treatment options for any given condition, whether it is drugs, herbs, or both. Learning the benefits and risks of both medicines empowers practitioners and patients to make more educated and informed decisions for optimal treatment results.

        Dr. Chen is the author of three important textbooks: Chinese Medical Herbology and Pharmacology, Chinese Herbal Formulas and Applications, and Chinese Herbal Formulas for Veterinarians.  He is also the founder and president of Art of Medicine Press. For more information, please visit his website at www.aompress.com. He is also a regular speaker of the Lotus Institute, as well as many colleges and professional associations.

 

GENERAL DISCLAIMER

Great care has been taken to maintain the accuracy of the information contained in this Clinical Manual. The information as presented in this Clinical Manual is for educational purposes only. We cannot anticipate all conditions under which it may be used. In view of ongoing research, changes in governmental regulation, and the constant flow of information related to Chinese and Western medicine, the reader is urged to check with other sources for all up-to-date information. The staff and authors of the Lotus Institute of Integrative Medicine recognize that practitioners accessing this information will have varying levels of training and expertise; therefore, we accept no responsibility for the results obtained by the application of the information within this Clinical Manual. Nor are we liable for the safety and suitability of the products, either alone or in combination with others, with single herbs or with the products of other manufacturers. Neither the Lotus Institute of Integrative Medicine nor the authors of this Clinical Manual can be held responsible for errors of fact or omission, nor for any consequences arising from the use or misuse of the information herein.

 

PROFESSIONAL USE ONLY

This Clinical Manual of Oriental Medicine is intended as an educational guide for licensed healthcare practitioners only, as professional training and expertise are essential to the safe recommendation and effective guidance for use of herbs. All herbal products discussed within this Clinical Manual must be used only through licensed healthcare practitioners.

        The information in this Clinical Manual is presented in an accurate, truthful and non-misleading manner. The information is supported by modern research whenever possible and referenced accordingly throughout the entire Clinical Manual. Nonetheless, the FDA requires the following statements: