Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

ACKNOWLEDGMENT:

This complaint was worked up by a Monash Honours research student, then checked and submitted by Assoc Prof. Ken Harvey.

COMPLAINT SUMMARY:

We are concerned about the safety of this product. The formulation, dose and ratio of ingredients appear to depart from Chinese Traditional Medicine formulations used for menopause (Da Bu Gan Tang and Da Bu Xin Tang). The dose recommended seems extreme (12 tablets a day). The Natural Medicines database notes that for many of the ingredients used there is insufficient reliable information available about effectiveness, toxicology, and adverse effects. The TGA ingredient summaries state:

“Please note: Only the name and definition of a substance have been reviewed to allow it to be included in the ingredient repository. The approval for use of the ingredient in therapeutic goods is a decision made by the relevant TGA regulatory area. This approval process may require submission of further information, for example safety data for the ingredient or for the finished goods, to meet legislative and regulatory requirements”.

We ask that the formulation of this product (and other Thisherb products) be assessed for safety (and compliance with the regulations) as a matter of urgency.

We also allege that advertisements for Anti-Meno Capsule breach s.9(a), (b), 9(c), 9(d), 12(3)(f), 10(a)(ii), 10(d)(i), 15(2), (3), 16(2)(a) and 17 of the Therapeutic Goods Advertising Code (No.2) 2018.

These multiple and serious breaches of the Code require a product recall, directions notices to cease the representations and place a retraction on the website, fines issued by infringement notices and possibly civil penalties as well.

Finally, this is an illustrative complaint of a general problem. We have found many products are making traditional claims for the relief of menopausal symptoms.

Traditional claims that herbal products are efficacious in relieving menopausal symptoms are NOT in accord with current scientific evidence or medical opinion. To assist informed consumer choice, at the very least, these products require an educational statement on their labels and promotion, “These claims are based on traditional beliefs and practices, not modern scientific evidence”.

We note the TGA has an ongoing review of listed medicines with traditional indications. This requires a published outcome.

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

COMPLAINT DETAILS:

Product information:

Product name: Anti-Meno Capsule Sponsor: Thisherb Health Pty Ltd Address: Suite 12 / 1 Ricketts Road, Mount Waverley, VIC, 3149 Australia ARTG no: 277949

Product Ingredients

- Cinnamomum cassia 24.73 mg Equivalent: Cinnamomum cassia 165 mg Equivalent: coumarin 1.5 microgram gui zhi

- Codonopsis pilosula 37.48 mg Equivalent: Codonopsis pilosula 250 mg dang shen - Cornus officinalis 37.48 mg Equivalent: Cornus officinalis 250 mg shan zhu yu - Gardenia jasminoides 12.44 mg Equivalent: Gardenia jasminoides 83 mg cao zhi zi - Inula britannica 37.48 mg Equivalent: Inula britannica 250 mg xuan fu hua - Lophatherum gracile 56 mg Equivalent: Lophatherum gracile 373.5 mg dan zhu ye - Paeonia suffruticosa 37.48 mg Equivalent: Paeonia suffruticosa 250 mg Bai Shao - Rehmannia glutinosa 37.48 mg Equivalent: Rehmannia glutinosa 250 mg Shu Di Huang - Schisandra chinensis 37.48 mg Equivalent: Schisandra chinensis 250 mg wu wei zi - Zingiber officinale 12.44 mg Equivalent: Zingiber officinale 83 mg gan jiang - Ziziphus jujuba 12.44 mg Equivalent: Ziziphus jujuba 83 mg Ziziphus jujuba var. spinosa 37.48 mg

Dazao

Permitted Indications: - Decrease/reduce/relieve symptoms of menopause

Advertisement Website Date Accessed

“Anti-Meno Capsule” – ThisHerb Website

https://thisherb.com.au/Anti-Meno-Capsule~101 https://thisherb.com.au/WOMEN-S-HEALTH-IN-TCM~1250 https://thisherb.com.au/ThisHerb-Products~11

19/10/2020

Disputed Claims (screen shots in Appendix A):

ThisHerb Website “Anti-Meno Capsule”

• “provide an energy boost” • “improve motivation” • “rekindle zest for life” • “Reduce the negative effects of some of the major symptoms” • “effective relief from the symptoms of menopause”

o Night sweats o Hot flushes o Pain and discomfort o Vaginal dryness o Irritability o Tiredness

• “Other menopause pills dull the symptoms”

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

• “Free from side effects and safe for all women to use” • “Those women who do not wish to pursue Hormone Replacement

Therapy or other invasive methods of managing menopause may find Anti-Meno Caps provide an effective alternative.”

• “Cornus officinalis – Small, fruit-producing tree, Japanese Dogwood or Dogwood. Used for sweat reduction.”

• “Inula Britannica – A yellow flower that is part of the daisy family. Used for pain and discomfort, bloating and vaginal health.”

• “Cinnamomum Cassia Twig – An evergreen tree originating in Southern China. Cinnamon supports blood circulation and uplifts mood.”

• “Ziziphus jujubar var. spinosa – Most commonly used as a dried fruit. Supports digestion, has sedative and anti-anxiety properties. Nourishes the heart and calms the spirit.”

• “Rehmannia glutinosa – One of the 50 fundamental herbs used in Chinese herbal medicine. It’s a flower which looks like a foxglove. Supports the blood, kidneys and adrenal glands.”

CONCERNS:

First, the permitted indications for this product on the TGA Public Summary document (appended) merely states, “Decrease/reduce/relieve symptoms of menopause“. This indication (no. 15, Table 10, Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019)) can be either scientific or traditional.1

However, the following claims made for the ingredients are not symptoms of menopause and are not in accord with the permitted indications, a breach of s.9(d) of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).2

“Cinnamon supports blood circulation and uplifts mood” and “Rehmannia glutinosa, supports the blood, kidneys and adrenal glands”.

Second, the advertisement claims,

“Anti-Meno is a unique formula of 12, carefully-selected Chinese herbs, designed to offer effective relief from the symptoms of menopause. Based on Traditional Chinese Medicine (TCM)… “

“The formula is our best kept secret and actually originated from classical Chinese medicinal literature ‘Fu Xing Jue’ dating as far back as 220AD-589AD. The remedy is based on two ancient and proven Traditional Chinese Medicine (TCM) formulas: Da Bu Gan Tang which focuses on strengthening the liver; and Da Bu Xin Tang which focuses on strengthening the heart. This particular formula is the result of the combination of extensive pharmaceutical research and over 10 years of clinical experience in Australia”.

In addition, a link to ‘More info on Wemen’s health in TCM’ notes,

“Qi and blood are the foundation of human life. The Liver is the organ responsible for the smooth flow of Qi and blood for all other organs. When the Liver is in low energy (Qi deficiency), it will lead the deficient blood and Qi (also known as Jing) in the Kidney, which may cause irregulate menstruation, menstruation pain”.

1 https://www.legislation.gov.au/Details/F2019L01455 2 https://www.legislation.gov.au/Details/F2018L01524

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

In short, these claims refer to TCM indications in Table 14 of the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019 such as no 67, 69, 81, 94 and 121, but these are not mentioned in the TGA Public Summary document. More importantly, these permitted indications state that if TCM terminology is used, a label statement is required:

“Talk to a TCM practitioner/health professional if you are unsure if this medicine is right for you”.

This required statement is missing, a breach of s.12(3)(f) of the Code.

Third, the advertisement claims the product is,

“free from any known side-effects”.

A serious breach of s.10(d)(i) of the Code.

Fourth, the advertisement claims that,

“Other menopause pills dull the symptoms. Our unique blend of 12 carefully selected Chinese herbs targets the cause, at the same time providing an all-natural vitality boost”. “Those women who do not wish to pursue Hormone Replacement Therapy or other invasive methods of managing menopause may find Anti-Meno Caps provide an effective alternative”.

A breach of s.9(c) of the Code.

Fifth, the advertisement claims that,

“This particular formula is the result of the combination of extensive pharmaceutical research and over 10 years of clinical experience in Australia”.

However, no citation is provided to identify this research, a breach of s.15(2) & 15(3) of the Code.

Sixth, a search for the two TCM formulas which were specifically mentioned, “Da Bu Gan Tang (DBGT) and Da Bu Xin Tang (DBXT)”, these different in ingredient combinations, ratios, and dosages from the ThisHerb product. It appears that the ThisHerb product formulation has altered the two formulas to a point where both can no longer represent the efficacy or safety of their original intended purposes. 3,4,5

We are particularly concerned about the safety of this product. The dose recommended seems extreme:

“There are 84 capsules in a bottle which will last a week [cost $ 69.95]. You should take 12 tablets a day, 4 three times a day at least half an hour before or after meals”.

The Natural Medicines database notes that for many of the ingredients used there is insufficient reliable information available about effectiveness, toxicology, and adverse effects.6 The TGA ingredient summaries state (Appendix B):

“Please note: Only the name and definition of a substance have been reviewed to allow it to be included in the ingredient repository. The approval for use of the ingredient in therapeutic goods is a decision made by the relevant TGA regulatory area. This approval process may require submission of

3 https://theory.yinyanghouse.com/theory/herbalmedicine/tcm-formulas/da-bu-gan-wan-major-liver-nutrition-pills 4 https://shenclinic.com/products/bu-gang 5 https://www.americandragon.com/Herb%20Formulas%20copy/BuGanTang.html 6 https://naturalmedicines.therapeuticresearch.com/

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

further information, for example safety data for the ingredient or for the finished goods, to meet legislative and regulatory requirements”.

Seventh, a video on the web site claims the product is,

“fully certified by Australia’s super tough Therapeutic Goods Administration”.

A breach of s.16(2)(a) of the Code.

Eighth, The testimonial used appears unlikely to be typical and lacks the necessary disclosures, a breach of s.17 of the Code

Ninth, many of the above claims lack either traditional or scientific evidence, a breach of s. 9(a), (b) and 10(a)(ii) of the Code

Given the above, we allege that advertisements for Thisherb Health Pty Ltd AntiMeno capsules breach s.9(a), (b), 9(c), 9(d), 12(3)(f), 10(a)(ii), 10(d)(i), 15(2), (3), 16(2)(a) and 17 of the Therapeutic Goods Advertising Code (No.2) 2018.

These multiple and serious breaches of the Code require a product recall, directions notices to cease the representations and place a retraction on the website, fines issued by infringement notices and possibly civil penalties as well.

We also ask that the formulation of this product (and other Thisherb products) be assessed for safety (and compliance with the regulations) as a matter of urgency.

In addition, a 2015 study titled, “Use of complementary and alternative medicines for menopausal symptoms in Australian women aged 40–65 year” noted that a significant number of women at midlife were using complementary and alternative medicines that are known to be ineffective for managing menopausal symptoms.7

A 2016 Cochrane review titled, “Chinese herbal medicine for menopausal symptoms” concluded, “We found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or hormone therapy for the relief of vasomotor symptoms. Effects on safety were inconclusive”.8

Current medical advice is consistent. The Royal Women’s Hospital, Melbourne states, “There is no evidence for efficacy of herbal supplements”.9 The Australian Menopause Society says, “There is currently insufficient evidence to support the use of herbal therapies”.10 The latter body also says, “For the majority of symptomatic menopausal women, tailored hormone therapy has benefits that outweigh the risks”.11

In short, traditional claims that herbal products are efficacious in relieving menopausal symptoms are NOT in accord with current scientific evidence or medical opinion. To assist informed consumer choice, these

7 https://www.mja.com.au/journal/2015/203/3/use-complementary-and-alternative-medicines-menopausal-symptoms-australian-women 8 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4951187/ 9 https://www.thewomens.org.au/health-information/menopause-information/managing-menopause 10 https://www.menopause.org.au/images/stories/infosheets/docs/ AMS_Complementary_and_Herbal_Medicines_Hot_Flushes.pdf 11 https://www.menopause.org.au/images/stories/infosheets/docs/AMS_Risks_and_Benefits_of_MHTHRT.pdf

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

products require an educational statement on their labels and promotion, “These claims are based on traditional beliefs and practices, not modern scientific evidence”.

Finally, this is an illustrative complaint of a general problem. Other Menopause products making traditional claims have similar problems. We note the TGA Review of listed medicines with traditional indications.12 This requires a published outcome.

Dr Ken Harvey MB BS, FRCPA, AM

Associate Professor Department of Epidemiology and Preventive Medicine

School of Public Health and Preventive Medicine

Monash University Alfred Campus 553 St Kilda Rd

Melbourne VIC 3004 Mobile: +61 419181910

Email: kenneth.harvey@monash.edu WWW: www.medreach.com.au

19 October 2020

12 https://www.tga.gov.au/review-listed-medicines-traditional-indications

SIGNED AND DATED

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

APPENDIX A:

https://thisherb.com.au/Anti-Meno-Capsule~101

https://thisherb.com.au/Anti-Meno-Capsule~101

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

https://thisherb.com.au/Anti-Meno-Capsule~101

“They are fully certified by Australia’s super tough Therapeutic Goods Administration”

https://thisherb.com.au/Anti-Meno-Capsule~101

https://youtu.be/muzpDUrpeww

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

https://thisherb.com.au/Anti-Meno-Capsule~101

https://thisherb.com.au/Anti-Meno-Capsule~101

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

https://thisherb.com.au/Anti-Meno-Capsule~101

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

https://thisherb.com.au/ThisHerb-Products~11

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

https://thisherb.com.au/Salv-Tonic~2950

Etc.

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

APPENDIX B:

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Complaint to TGA – Thisherb Health Pty Ltd, Anti-Meno Capsules

Public Summary Summary for ARTG Entry: 277949 Anti-meno Capsule

ARTG entry for Medicine Listed 

Sponsor Thisherb Health Pty Ltd

Postal Address Suite 12 / 1 Ricketts Road, Mount Waverley, VIC, 3149 Australia

ARTG Start Date 19/07/2016

Product Category Medicine 

Status Active

Approval Area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the listof 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contractedto a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listedmedicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1 . Anti-meno Capsule

Product Type Single Medicine Product Effective Date 29/03/2018

Permitted Indications

Decrease/reduce/relieve symptoms of menopause

Indication Requirements

Label statement: If symptoms persist, talk to your health professional.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1 . Formulation 1

Dosage Form Capsule, hard

Public Summ

ary

Page 1 of 2 Produced at 20.10.2020 at 11:41:55 AEDTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Route of Administration Oral Visual Identification

Active Ingredients

Cinnamomum cassia 24.73 mg

Equivalent: Cinnamomum cassia 165 mg

Equivalent: coumarin 1.5 microgram

Codonopsis pilosula 37.48 mg

Equivalent: Codonopsis pilosula 250 mg

Cornus officinalis 37.48 mg

Equivalent: Cornus officinalis 250 mg

Gardenia jasminoides 12.44 mg

Equivalent: Gardenia jasminoides 83 mg

Inula britannica 37.48 mg

Equivalent: Inula britannica 250 mg

Lophatherum gracile 56 mg

Equivalent: Lophatherum gracile 373.5 mg

Paeonia suffruticosa 37.48 mg

Equivalent: Paeonia suffruticosa 250 mg

Rehmannia glutinosa 37.48 mg

Equivalent: Rehmannia glutinosa 250 mg

Schisandra chinensis 37.48 mg

Equivalent: Schisandra chinensis 250 mg

Zingiber officinale 12.44 mg

Equivalent: Zingiber officinale 83 mg

Ziziphus jujuba 12.44 mg

Equivalent: Ziziphus jujuba 83 mg

Ziziphus jujuba var. spinosa 37.48 mg

Equivalent: Ziziphus jujuba var. spinosa 250 mg

Other Ingredients (Excipients)

carrageenan

hypromellose

iron oxide red

maize starch

sodium lauryl sulfate

titanium dioxide

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 20.10.2020 at 11:41:55 AEDTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information