complaint to tga: brauer (homeopathic) products · complaint to tga: brauer (homeopathic) products...

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Complaint to TGA: Brauer (Homeopathic) Products Page 1 of 26 This is a high priority complaint to test the TGA's will to act on recalcitrant sponsors of complementary medicines. The CRP has upheld more than 15 complaints about homeopathic medicines from 2003 to 2017. A recent upheld complaint was (2017-06-019) Brauer Baby & Child Colic (determination appended). I now attach screen shots of an advertisement for this product taken on the 12/07/2018. While one claim has been removed from the pack (“for abdominal pain”) others continue despite the CRP determining they breached s.4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) of the Therapeutic Goods Advertising Code 2015. Arrows to point to ongoing claims that the CRP judged breached the Code. https://shop.brauer.com.au/products/baby-child-colic-relief-100ml

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Page 1: Complaint to TGA: Brauer (Homeopathic) Products · Complaint to TGA: Brauer (Homeopathic) Products Page 1 of 26 This is a high priority complaint to test the TGA's will to act on

Complaint to TGA: Brauer (Homeopathic) Products

Page 1 of 26

This is a high priority complaint to test the TGA's will to act on recalcitrant sponsors of

complementary medicines.

The CRP has upheld more than 15 complaints about homeopathic medicines from 2003 to 2017. A

recent upheld complaint was (2017-06-019) Brauer Baby & Child Colic (determination appended).

I now attach screen shots of an advertisement for this product taken on the 12/07/2018. While one claim has been removed from the pack (“for abdominal pain”) others continue despite the CRP determining they breached s.4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) of the Therapeutic Goods Advertising Code 2015.

Arrows to point to ongoing claims that the CRP judged breached the Code.

https://shop.brauer.com.au/products/baby-child-colic-relief-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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In addition, I include screen shots taken on the 12/07/2018 of other Brauer product about which I allege similar breaches of the Code to those determined by the CRP for the Baby & Child Colic product. It is particularly disappointing that Brauer have chosen not to apply the findings of determination 2017-06-019 to their other products.

Furthermore, certain of these ineffective homeopathic products are promoted for conditions for which there are effective allopathic medicines. For example, while Brauer promotes as an apparent virtue that their Baby & Child Products are free from paracetamol and ibuprofen; however, the latter are effective in reducing fever &/or pain while the former are not. Hayfever sufferers who choose ineffective homeopathic products rather than the clinically proven allopathic products, such as Sanofi-Aventis Telfast, would be at serious risk in the event of another Melbourne ‘thunderstorm asthma’ emergency.

https://shop.brauer.com.au/products/baby-child-stomach-calm-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-reflux-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://brauer.com.au/condition/baby-child-immunity

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/all-products/products/baby-child-sleep-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/all-products/products/baby-child-teething-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/all-products/products/baby-child-teething-gel-20g

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-runny-nose-relief-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-cough-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-cold-flu-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-pain-fever-relief-50ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-calm-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/baby-child-sleep-100ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/kids-manuka-honey/products/brauer-kids-manuka-honey-chesty-cough

https://shop.brauer.com.au/collections/kids-manuka-honey/products/brauer-kids-manuka-honey-dry-cough#content

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/kids-manuka-honey/products/brauer-kids-manuka-honey-cold-flu

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Complaint to TGA: Brauer (Homeopathic) Products

Page 16 of 26

https://shop.brauer.com.au/products/brauer-hay-fever-o-s-20ml

https://shop.brauer.com.au/products/brauer-allergy-oral-spray-20ml

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Complaint to TGA: Brauer (Homeopathic) Products

Page 17 of 26

https://shop.brauer.com.au/products/sleep-500ml

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Complaint to TGA: Brauer (Homeopathic) Products

Page 18 of 26

https://shop.brauer.com.au/products/sleep-o-s-20ml

https://shop.brauer.com.au/collections/all-products/products/sleep-tablets-60-vial

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/snore-eze-o-s-20ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/snoreeze-tablets-60-vial

https://brauer.com.au/condition/pain-relief-arnicaeze-arnica-oral-spray

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/products/brauer-arnicaeze-arnica-pilules-8g

http://shop.brauer.com.au/collections/lifestyle/products/menopause

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/lifestyle/products/brauer-elimitona-20-day-200ml

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Complaint to TGA: Brauer (Homeopathic) Products

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https://shop.brauer.com.au/collections/lifestyle/products/ibseze

https://shop.brauer.com.au/collections/lifestyle/products/new-elimitona-slim-detox-200ml

I submit that this is a "high priority" complaint because the sponsor (&/or other advertisers) are

recalcitrant, this class of products have had numerous upheld complaints and the sponsor (&/or

others) continue to make claims that I allege breach the Therapeutic Goods Advertising Code

2017. This clearly impacts on the consumers ability to appropriately use these goods.

Similar claims can be found at:

• https://amcal.com.au/brauer-baby---child-colic---50ml-p-9316120059950

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Complaint to TGA: Brauer (Homeopathic) Products

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• https://chemistwarehouse.com.au/buy/84478/Brauer-Baby-Child-Colic-Relief-100mL

• https://babybunting.com.au/brauer-baby-child-stomach-calm-100ml.html

• https://chemistwarehouse.com.au/buy/84479/Brauer-Baby-Child-Stomach-Calm-100mL

• https://naturalhealthorganics.com.au/brauer-baby-and-child-stomach-calm-100ml.html

• https://naturalhealthorganics.com.au/brauer-baby-and-child-stomach-calm-100ml.html

• https://babybunting.com.au/brauer-baby-child-stomach-calm-100ml.html N.B. ingredients

• https://amcal.com.au/brauer-baby---child-cold---flu-relief---100ml-p-9316120078401

• https://amcal.com.au/brauer-baby---child-cold---flu-relief---100ml-p-9316120078401

• https://amcal.com.au/brauer-baby---child-sleep---100ml-p-9316120100959

• https://priceline.com.au/brauer-baby-child-sleep-100-ml

• https://chemistwarehouse.com.au/buy/84477/Brauer-Baby-Child-Sleep-100ml

• https://amcal.com.au/brauer-baby---child-cold---flu-relief---100ml-p-9316120078401

• https://naturalhealthorganics.com.au/brauer-baby-and-child-cold-and-flu-relief-100ml.html

• https://priceline.com.au/brauer-children-s-cold-flu-relief-100-ml

• https://chemistwarehouse.com.au/buy/87370/Brauer-Baby-Child-Cold-Flu-100ml-Online-Only

• https://amcal.com.au/brauer-hay-fever-oral-spray---20ml-p-9316120139850

• https://pharmacyonline.com.au/brauer-hay-fever-oral-spray-20ml

• https://amcal.com.au/brauer-allergy-relief-oral-spray---20ml-p-9316120000266

• https://pharmacyonline.com.au/brauer-allergy-relief-oral-spray-20ml

• https://babybunting.com.au/brauer-baby-child-sleep-100ml.html

• https://amcal.com.au/brauer-baby---child-sleep---100ml-p-9316120100959

• https://pharmacyonline.com.au/brauer-sleep-and-insomnia-relief-spray-20ml

• https://vitaminsonly.com.au/products/menopause-oral-spray-20ml

• http://obornehealth.com.au/Brauer-Menopause-Oral-Spray-20ml

• And many, many more….

In 2003, the Expert committee report: Complementary Medicines in the Australian Health System

recommended (2.1.8) that,

“Homoeopathic medicines and related remedies that make therapeutic claims should be

regulated to ensure they meet appropriate standards of safety, quality and efficacy”.

They also noted that,

“A homoeopathic medicine should be adequately described to ensure that it is clearly

differentiated from those medicines not consistent with the homoeopathic or a related

paradigm. Any misrepresentation of homoeopathic medicines as other medicines needs to

be addressed as a priority”.

In 2008, a TGA Consultation on the “Regulation of homoeopathic and anthroposophic medicines in

Australia” also made many suggestions about improving the regulation of these products, none of

which were implemented.

In 2015, following a thorough review of the evidence, the NHMRC released a statement that

concluded that there was no good quality evidence to support the claim that homeopathy is

effective in treating health conditions. The U.K. NHS agreed, describing homeopathy as "at best a

placebo and a misuse of scarce NHS funds. Yet, enthusiasts of homeopathy continue to dispute

these conclusions with public campaigns and (failed) legal challenges.

The TGA accepts “traditional” evidence (use for over 75 years) to support claims. However, to ensure

advertising remains truthful, valid and not misleading, medicines invoking traditional claims are

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Complaint to TGA: Brauer (Homeopathic) Products

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meant to cede to the primacy of scientific evidence if the latter contradicts the former. In this

situation, the TGA Evidence Guidelines suggest including a statement in the labelling and advertising

material such as, “this traditional use is not supported by scientific evidence”. However, as this

guideline lacks legal status it is invariably ignored.

In 2017, the TGA held another consultation, “Options for the future regulation of 'low risk'

products”, which included homeopathic products, without any reference to the previous

consultation and submissions. This consultation document failed to document many long-standing

concerns about the supply and promotion of homeopathic products and, in my opinion, it failed to

provide a viable solution to the well documented problems of previous reviews.

At this consultation, I (and others) advocated that all products making therapeutic claims by invoking

the homeopathic tradition should be regulated as listed products with the addition of a mandatory

disclaimer / warning on their ARTG Public Summary documents, product packaging, labelling and

promotion like that recently suggested by the U.S. FTC,1 for example,

Warning: This product’s traditional claims are based only on theories of homeopathy from

the 1700s that are not accepted by most modern medical experts. There is no scientific

evidence that this product works.

Health Canada requires for children’s products: “This claim is based on traditional homeopathic

references and not modern scientific evidence” (below).

In June 2018, the TGA reported on the outcome of this consultation and noted that,

1 https://www.ftc.gov/news-events/press-releases/2016/11/ftc-issues-enforcement-policy-statement-regarding-marketing

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“The Government is yet to determine what would be an appropriate level of regulation for

aromatherapy and homoeopathic products. Further consultation with affected stakeholders

may be required”.

In short, unlike other regulators, the TGA has procrastinated for 15 years about improving the

regulation of these products.

I’ve appended a relevant U.S. lawsuit.

Finally, I note that the recently enacted Therapeutic Goods Information (Outcomes of Advertising

Complaints Investigations) Specification 2018 states that,

“The following specified kinds of therapeutic goods information may be released by the

Secretary to the public under subsection 61(5C) of the Act….”.

Regardless, I insist on an immediate response to me as to the priority allocated to this complaint,

the measures taken by the TGA to achieve compliance and the final outcome.

Sincerely, Ken --- Dr Ken Harvey MBBS, 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: [email protected] WWW: www.medreach.com.au 13 July 2018

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Page 1 of 10

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2017-06-019 Brauer Baby & Child Colic

Meeting held 17 August 2017

Complaint summary^

Complainant Requested anonymity

Advertisers Brauer Natural Medicine Pty Ltd

Subject matter of complaint Internet advertisement

Type of determination Final

Sections of the Code,

Regulations or Act found to

have been breached*

Code sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c)

Sections of the Code,

Regulations or Act found

not to have been breached*

None

Sanctions

Withdrawal of representations

Withdrawal of advertisement

* only sections of the Code, Act, or Regulations that were part of the complaint or were raised by the

Panel are listed.

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The advertisement(s)^

1. The complaint concerned an internet advertisement published at the website

https://shop.brauer.com.au/ and viewed by the complainant in June 2017.

2. The advertisement included representations such as “Baby & Child Colic includes ingredients such as

Chamomile and Magnesium Phosphate which are traditionally used in homeopathic medicine to

provide temporary relief from the pain, irritability and bloated tummy caused by colic”, “Baby &

Child Colic may be used from birth: the natural blackcurrant flavour and included oral measuring

dropper make it easy to give to your baby”, “Babies don’t come with an instruction manual and

sometimes it’s hard to pinpoint exactly what’s wrong. If your young baby has colic, they may: • cry a

lot, especially in the late afternoon or early evening; • pull their knees to their chest and go red in the

face when they cry; • have wind or a bloated tummy”, “if you are concerned about your baby’s health,

always talk to your healthcare professional”, and other representations.

3. An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

The product(s)

4. The advertisement promoted the product Brauer Baby & Child Colic.

The advertiser(s)

5. The advertiser was Brauer Natural Medicine Pty Ltd.

The complaint^

6. The complainant requested anonymity.

7. The complainant alleged that the advertisement breached section 4(2)(b) of the Code because it was

likely to lead to consumers self-diagnosing or inappropriately treating a potentially serious disease.

The complainant stated that the advertisement “requires the consumer to make a clinical diagnosis of

abdominal colic, and any of these signs or symptoms mentioned could be indicative of a serious

illness”.

Additional matters raised by the Panel

8. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified

in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates

contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or

the Code in other ways. The Panel was so satisfied and raised as additional matters, possible breaches

of:

a) sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code in relation to the claims of benefit in the

advertisement, such as “provide temporary relief from the pain, irritability and bloated tummy

caused by colic” and “FOR ABDOMINAL PAIN” (included on the product label, visible in the

advertisement);

b) section 4(2)(b) of the Code in relation to “FOR ABDOMINAL PAIN” as well as “the pain,

irritability and bloated tummy caused by colic” as raised by the complainant;

c) section 4(2)(c) of the Code because the product label, visible in the advertisement, does not

include any reference to the product being a homeopathic product.

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The advertiser’s response to the complaint^

9. The advertiser stated that the advertised product was “a homeopathic product, classified as a

therapeutic good exempt from listing on the ARTG”, and that the claims about it were “supported by

evidence of traditional use within the specified paradigm.” The advertiser stated that the advertised

product contained the ingredients “Bryonia 30C”, “Chamomilla 3C”, “Colocynthis 6C”, and “Mag.

Phos 6C”, and that the “traditional health benefits and rationale for inclusion” of these ingredients

included abdominal cramping, pain, and distension and infant colic.

10. In relation to the alleged breach of section 4(2)(b) of the Code, the advertiser stated that “the

advertisement clearly indicates that the product contains ingredients traditionally used in homeopathic

medicine to provide temporary relief from the pain, irritability and bloated tummy caused by colic”,

and that “Infant colic is not considered to be a serious disease and is commonly treated with

complementary medicines.” The advertiser stated that ‘the draft TGA Permitted Indications list for

listed medicines includes indications, “Helps decrease/reduce/relieve infant colic”,

“Decrease/reduce/relieve colic (wind/gas pain)” and “Helps decrease/reduce/relieve wind/gas

associated with intestinal colic”.’

11. The advertiser also noted that the advertisement included “guidance” through the words “If you are

concerned about your baby’s health, always talk to your healthcare professional” and “If symptoms

persist see your healthcare professional”.

12. In relation to the possible breaches of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code because of the

claims about abdominal pain and other symptoms, the advertiser stated that “both claims are based on

evidence of the traditional health benefits of each homeopathic ingredient as remedies for infantile

colic and abdominal symptoms of colic… The advertisement for Brauer Baby & Child Colic clearly

indicates that the ingredients are homeopathic and that product claims are based on traditional use (ie.

“ingredients traditionally used in homeopathic medicine”). These details are sufficient to adequately

inform consumers about the product and therefore the advertisement is unlikely to mislead or create

unrealistic expectations.”

13. In relation to the possible breach of section 4(2)(c) of the Code because of insufficient reference to the

product being a homeopathic product, the advertiser stated “Clause 3(15) of the Therapeutic Goods

Labelling Order (TG069) requires that, for homeopathic preparations, the container and primary pack

labels include a statement indicating that the active ingredients in the goods are homeopathic

preparations such as “homeopathic product” or “homeopathic preparation”. There is no requirement

for this statement to be on the front panel of the label. For Brauer Baby & Child Colic, the product

container and primary pack labels include the statement “Homeopathic Product” on the side panel

compliant with the requirements of the Labelling Order. Whilst this may not be visible in the website

advertisement, the statement that the product includes ingredients traditionally used in homeopathic

medicine is clearly visible and ensures that consumers are aware that the product is homeopathic in

nature.”

Findings of the Panel

14. Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and

the principles of the Code, and the total presentation and context of the advertisement. Section 3(2) of

the Code states that the conformity of an advertisement with this Code should be assessed in terms of

its probable impact upon the reasonable person to whom the advertisement is directed. In assessing

the advertisement, the Panel was mindful not only of the particular words cited by the complainant,

but of the entire context of the advertisement and its likely impact on a reasonable consumer.

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15. The Panel reviewed the advertisement as a whole and was satisfied that an ordinary and reasonable

consumer viewing the advertisement:

a) would take the product to be directed to colic in both babies and children older than babies;

b) would take it to convey that the advertised product could be expected to have therapeutic benefits

in relation to pain, irritability, and bloated tummy caused by colic;

c) would take the symptoms of “cry[ing] a lot, especially in the late afternoon or early evening”,

“pull[ing]… knees to their chest and go[ing] red in the face when they cry”, and “hav[ing] wind or

a bloated tummy” to be a sound basis for diagnosing colic;

d) would take the advertised product to contain ingredients including chamomile and magnesium

phosphate.

16. The Panel noted that an ordinary and reasonable consumer viewing an advertisement for a product

described as a “medicine” and referring to “ingredients” is very likely to conclude that the product

works in the manner of a conventional medicine – that is, by providing a dose of a therapeutically

active substance – and contains a measurable and significant amount (in a quantitative sense) of the

stated ingredients. This is so whether the formulation has been made on the basis of scientific research

or on the basis of traditional use, as for example in the case of herbal medicines. Where a product

does not work in this conventional manner, or does not contain such amounts of ingredients, a

consumer is likely to be misled unless the advertisement is very clear as to the manner in which the

product is said to have its effect, the evidentiary basis for the claimed effects, and the manner in

which the ingredients are “included” or “contained” in the product.

17. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or

through emphasis, comparisons, contrasts or omissions”.

18. The Panel raised with the advertiser a possible breach of this provision because the product label,

visible in the advertisement, did not include any reference to the product being a homeopathic

product.

19. The advertiser responded by noting that the full product label did include such a reference, and further

that the advertisement as whole clearly stated (as the advertiser put it) “that the product includes

ingredients traditionally used in homeopathic medicine is clearly visible and ensures that consumers

are aware that the product is homeopathic in nature.”

20. The advertisement in fact stated that the product “includes ingredients such as Chamomile and

Magnesium Phosphate which are traditionally used in homeopathic medicine to provide temporary

relief from the pain, irritability and bloated tummy caused by colic.”

21. In the Panel’s view, this statement was likely to be:

a) confusing to consumers who had an understanding of the successively diluted nature of

homeopathic ingredients; and

b) misleading to consumers who did not have such an understanding.

22. The Panel noted that chamomile is an herb used in complementary medicines (and for that matter, in

food products such as teas) that is well known to consumers and generally understood to have

traditional use, as an herb, to aid sleep. The homeopathic ingredient in the advertised product, which

the advertiser described as “Chamomilla 3C”, is conceptually entirely distinct from chamomile as a

herbal ingredient. The homeopathic dilution “3C” is a dilution of 10-6, or 1:1,000,000. Similarly,

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magnesium phosphate is a salt, and magnesium is well understood by consumers to be a mineral

nutrient. According to the advertiser, the product contained a homeopathic ingredient “Mag. Phos

6C”. A “6C” homeopathic dilution is a dilution of 10-12, or 1:1,000,000,000,000 and is entirely

incomparable to magnesium phosphate as a non-homeopathic substance.

23. The Panel noted that the advertised product could not properly be said to “include[] ingredients such

as Chamomile and Magnesium Phosphate” unless it were made very clear that the ingredients were

largely absent from the product in a chemical sense, and rather were included in radically diluted

homeopathic form. To put it another way, “chamomile” as an ingredient is wholly distinct from

“chamomilla 3C” as an ingredient, since “chamomilla 3C” is (in the homeopathic paradigm) not

merely a quantity of chamomile but rather a “mother tincture” of chamomile diluted through a very

specific process. Similarly, “magnesium phosphate” is wholly different from “Mag. Phos 6C”.

24. Although it was true that the advertisement described the product as including “ingredients

traditionally used in homeopathic medicine”, the Panel was satisfied that these words were unlikely to

be sufficient to displace an understanding, caused by the words “includes ingredients such as

Chamomile and Magnesium Phosphate”, that the product contained actual significant amounts of

substances such as the herbal ingredient chamomile and the salt magnesium phosphate.

25. The Panel therefore was satisfied that in the absence of clear words stating that the product itself was

homeopathic, in the context of either the label as it appeared in the advertisement or of the

advertisement as a whole, the advertisement misleadingly conveyed that the advertised product

contained meaningful amounts of the actual named substances, and that the advertisement therefore

breached section 4(2)(c) of the Code.

26. The Panel found, therefore, that this aspect of the complaint was justified.

27. The Panel noted that the radical and extreme dilution of ingredients used in homeopathic products is

contrary to ordinary consumer expectations, and that it would rarely, if ever, be appropriate to assume

that an ordinary and reasonable consumer will understand, merely because the word “homeopathic” is

used, that a product does not contain measurable or significant quantities of actual chemical

substances. An ordinary and reasonable consumer viewing an advertisement referring to homeopathic

ingredients is likely, in the Panel’s view, to be misled unless the advertisement clearly and expressly

states that the ingredients are included only at radically diluted levels, including in many cases at

levels that cannot be detected.

28. The Panel also noted that the question of whether products sold over the counter, without consultation

with a homeopath, could properly be regarded as being within the homeopathic paradigm at all was a

question that could merit discussion, although it had not arisen in the present complaint and was not

considered by the Panel.

29. Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and

balanced statements only and claims which the sponsor has already verified.” Section 4(2)(a) of the

Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of

product effectiveness”.

30. The Panel raised with the advertiser possible breaches of these provisions, and of section 4(2)(c) of

the Code, because the claims of benefit in the advertisement, such as “provide temporary relief from

the pain, irritability and bloated tummy caused by colic” and “FOR ABDOMINAL PAIN”.

31. The advertiser did not provide any evidence that the advertised product would have any benefits in

relation to colic, pain, irritability and bloated tummy caused by colic, or abdominal pain. The

advertiser did provide an extensive array of material that supported a view that some ingredients the

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product was said to contain were traditionally used in homeopathy in relation to such symptoms. The

advertiser also argued that words in the advertisement such as “ingredients traditionally used in

homeopathic medicine” were “sufficient to adequately inform consumers about the product and

therefore the advertisement is unlikely to mislead or create unrealistic expectations.”

32. The words used in the advertisement were “includes ingredients such as Chamomile and Magnesium

Phosphate which are traditionally used in homeopathic medicine to provide temporary relief from the

pain, irritability and bloated tummy caused by colic” without full disclosure of the dilution and its

implication. The advertisement also included the words “for abdominal pain” and “relief of pain from

colic”, without any clear qualification.

33. The Panel was satisfied, as noted above, that the advertisement conveyed that the advertised product

could be expected to have therapeutic benefits in relation to pain, irritability, and bloated tummy

caused by colic, and in relation to abdominal pain (without qualification as to the cause). The Panel

noted that, as it was described as “Baby & Child Colic”, a reasonable consumer would take such

benefits to be applicable to both babies and children older than babies.

34. The Panel was satisfied that an ordinary and reasonable consumer viewing the advertisement would

be led to the conclusion that there was some basis in evidence that the product would actually be

effective in relation to the named symptoms and in relation to colic. In the Panel’s view, the use of the

words “traditionally used in homeopathic medicine” were not sufficient, in the context of the

advertisement as a whole, to displace that conclusion. This was particularly so since, as noted above,

the advertisement also gave the strong impression that the advertised product contained meaningful

and measurably significant quantities of ingredients such as the herb chamomile and the salt

magnesium phosphate, making it far less likely that a consumer would seriously consider the import

of the reference to homeopathy.

35. In consequence, the Panel was therefore satisfied that:

a) an ordinary and reasonable consumer viewing the advertisement would take it to convey that the

advertised product to relieve the named symptoms;

b) an ordinary and reasonable consumer viewing the advertisement would take it to convey that the

advertised product worked in the manner of a conventional medicine – that is, that it worked

because it contained herbal, mineral, or other ingredients in a conventional form and in

measurable quantities rather than at radical, extreme dilutions;

c) the mere reference to “homeopathic medicine” was not sufficient to displace those views;

d) an ordinary and reasonable consumer viewing the advertisement, with an ordinary level of general

knowledge, would not understand from the advertisement that the advertised product had been

formulated on the basis of a traditional medicine paradigm that was at best highly controversial,

has no plausible mode of action in science, and involves references to ingredients that are included

only at vanishingly minute levels if they are included at all;

e) the evidence material provided by the advertiser was capable of supporting claims that the

homeopathic ingredients used in the advertised product – “Bryonia 30C”, “Chamomilla 3C”,

“Colocynthis 6C”, and “Mag. Phos 6C” – were ingredients that would be regarded in the

homeopathic paradigm as possible ingredients in homeopathic preparations formulated by a

homeopath for an individual suffering from abdominal pain, colic symptoms, and other such

concerns;

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f) the evidence material provided by the advertiser was not capable of supporting claims that the

advertised product could reasonably be expected to have any of the therapeutic benefits it was

stated to have.

36. The Panel found, therefore, that these aspects of the complaint were justified.

37. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-

diagnosing or inappropriately treating potentially serious diseases”.

38. The Panel was satisfied that an ordinary and reasonable consumer viewing the advertisement would

take the symptoms of “cry[ing] a lot, especially in the late afternoon or early evening”, “pull[ing]…

knees to their chest and go[ing] red in the face when they cry”, and “hav[ing] wind or a bloated

tummy” to be a sound basis for diagnosing colic. Moreover, the Panel was satisfied that such a

consumer would take this view in relation not only to babies but also to children as distinct from

babies. This was so notwithstanding some references to “babies”, because the advertised product was

expressly and prominently directed to children as well as babies.

39. The Panel was satisfied that symptoms such as “pull[ing]… knees to their chest and go[ing] red in the

face when they cry”, “hav[ing] wind or a bloated tummy” and, in the absence of any qualification,

“abdominal pain” could very readily be symptoms of potentially serious diseases, and were not

appropriate for self-diagnosis by parents.

40. The Panel noted the advertiser’s argument that the availability of indications about colic for Listed

medicines meant that colic was not a serious disease. The Panel was generally satisfied that colic in

infants would not be regarded as a serious disease. However, symptoms such as s “pull[ing]… knees

to their chest and go[ing] red in the face when they cry”, “hav[ing] wind or a bloated tummy” and

“abdominal pain” could clearly be caused by many health concerns besides colic, both in infants and

even more especially in children older than infants. The obvious risk, contemplated by section 4(2)(b)

of the Code, is that a potentially serious disease could be misdiagnosed as being colic by a consumer,

and that a potentially serious disease could be inappropriately treated with the advertised product

rather than a product of therapeutic benefit for that potentially serious disease.

41. The Panel found, therefore, that this aspect of the complaint was justified.

Sanctions

42. The Panel requests Brauer Natural Medicine Pty Ltd, in accordance with subregulation 42ZCAI(1) of

the Therapeutic Goods Regulations 1990:

a) to withdraw the advertisement from further publication;

b) to withdraw any representations found above to breach the Code, including that:

i) the advertised product offers therapeutic benefits in relation to the pain, irritability and bloated

tummy caused by colic, or abdominal pain, together with any representations that imply that

the advertised product works in the manner of a conventional medicine (that is, by containing

meaningful and significantly measurable quantities of actual ingredients);

c) to give a written undertaking not to use the representations in (b) above in any other

advertisement*;

d) where the representation has been provided to other parties such as retailers or website publishers,

and where there is a reasonable likelihood that the representation has been published or is intended

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to be published by such parties, to advise those parties that the representation(s) should be

withdrawn; and,

e) within 14 days of being notified of this request, to provide evidence to the Panel of its compliance,

including a response in writing that they will comply with the Panel’s sanctions, and where

appropriate, supporting material such as copies of instructions to advertising agents or publishers,

or correspondence with retailers and other third party advertisers.

43. The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which

permit the Panel to make recommendations to the Secretary in the event of non-compliance with this

request.

Dated 29 November 2017

For the Panel

Allan Asher

Chairman

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Appendix A: Definitions and footnotes

In this determination, unless otherwise specified:

a) “the Act” means the Therapeutic Goods Act 1989;

b) “the Regulations” means the Therapeutic Goods Regulations 1990;

c) “the Code” means the Therapeutic Goods Advertising Code;

d) “the Register” means the Australian Register of Therapeutic Goods;

e) “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to

advertisements in specified or broadcast media (in relation to which complaints may be made to

the Panel under Regulation 42ZCAB). It should be noted that HTML metatags and other

information which can be retrieved by internet search engines, whether or not it is ordinarily

viewed directly by consumers, constitutes advertisement material.

^Readers of the determination should note that the sections “complaint summary”, “the advertisement(s)”, “the complaint”,

and “[a party]’s response to the complaint”, are summaries that are intended to aid readers of this document. In reaching its

decision, the Panel considered all of the material before it, including material that may not be mentioned specifically in the

summaries. The summaries do not form part of the Panel’s reasoning.

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other

advertisement unless the advertiser satisfies the Panel that the use of the representation would not result in a contravention of

the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code. Under

the Panel’s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new

material that was not available at the time of the Panel’s determination has become available, or until at least 12 months have

passed since the Panel’s request was made.

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Appendix B: Excerpt of the Advertisement

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SUPERIOR COURT OF THE DISTRICT OF COLUMBIA

CIVIL DIVISION

CENTER FOR INQUIRY, INC.,

1012 14th St., NW, Suite 205, Washington,

DC, on behalf of the general public,

Plaintiff,

v.

CVS Health Corporation,

One CVS Drive, Woonsocket, RI 02895;

And CVS Pharmacy, Inc.,

One CVS Drive, Woonsocket, RI 02895

Defendants.

)

)

)

)

)

)

)

)

)

)

)

No.

COMPLAINT

Plaintiff Center for Inquiry, Inc. (“Plaintiff”), by and through its counsel, brings this

action against Defendants CVS Health Corporation and CVS Pharmacy, Inc. (“Defendants”) on

behalf of the general public, and alleges the following based upon information, belief, and the

investigation of counsel:

NATURE OF THE CASE

1. Plaintiff brings this action on behalf of the general public of the District of

Columbia to seek to redress a continuing pattern of fraudulent, deceptive, and otherwise

improper marketing practices engaged in by Defendants in the District of Columbia, both

through its physical, bricks and mortar stores, and through its online sales presence, regarding

the marketing and sale of homeopathic products. Defendants use marketing, labeling, and

product placement to falsely present homeopathic products as equivalent alternatives to science-

based medicines, and to represent homeopathic products as effective treatments for specific

diseases and symptoms.

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JURISDICTION

2. This Court has subject matter jurisdiction over this action and venue is

appropriate in this Court pursuant to D.C. Code § 11-921 and § 28-3905(k)(1).

3. This Court has personal jurisdiction over Defendants pursuant to D.C. Code § 13-

423. This Court has personal jurisdiction over the parties because, inter alia, Defendants market

and retail products in Washington, D.C. and are engaged in deceptive schemes and acts directed

at persons residing in, located in, or doing business in Washington, D.C.

4. Plaintiff maintains an Executive Office and a membership branch in Washington,

D.C.

5. A substantial part of the actions that give rise to Plaintiff’s causes of action

occurred in this jurisdiction.

PARTIES

6. Plaintiff, The Center for Inquiry, Inc. (CFI) is a New York non-profit

organization, authorized to do business in Washington, D.C., headquartered in the State of New

York. The Center for Inquiry has over 30,000 members across the nation who have subscribed

to its publications or donated to the organization. The Center for Inquiry operates an active

branch in Washington D.C., holding regular meetings and events for its members and others. The

Center for Inquiry operates an executive office in Washington, D.C., located at 1012 14th St.

N.W., Suite 205, Washington, D.C. 20005.

7. Plaintiff’s mission is to foster a secular society based upon science, reason,

freedom of inquiry, and humanist values. Plaintiff’s vision is a world where people value

evidence and critical thinking, where superstition and prejudice subside, and where science and

compassion guide public policy.

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8. Plaintiff has long worked to counter the negative impact of pseudoscientific

alternative medicine upon society. In the area of homeopathic products, Plaintiff has sought to

ensure that such products are effectively tested to ensure consumer safety; that manufacturers

and retailers are prevented from making claims as to the products’ effectiveness without

scientific evidence to support such claims; and that labeling and marketing materials properly

inform customers of the nature of the products.

9. Defendant CVS Health Corporation (“CVS”) is a corporation incorporated in

Delaware, with its headquarters at One CVS Drive, Woonsocket, RI 02895. Its subsidiary, CVS

Pharmacy, Inc. (“CVS Pharmacy”) is a corporation incorporated in Delaware, with its

headquarters at One CVS Drive, Woonsocket, RI 02895.

10. Defendant CVS Pharmacy operates more than 9,800 pharmacy stores, with 60

pharmacy stores within the District of Columbia.

11. Defendant CVS operates a website, https://www.cvs.com/, through which

products including homeopathic products are marketed and sold direct to customers, including

those within the District of Columbia.

THE INTERESTS OF CFI & THE GENERAL PUBLIC

12. Defendants deceptively marketed homeopathic products, including both their own

line of homeopathic products and those manufactured and sold under the labels of other

producers to District of Columbia residents by deliberately fostering the impression through

display and placement that they are effective to treat particular complaints, and that they are

comparable in efficacy, and regulation to science-based medical products.

13. Upon information and belief, Defendants have caused damage and adverse effects

to residents of this District.

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14. Plaintiff acts for the benefit of the General Public as a Private Attorney General

pursuant to District of Columbia Code §28-3905(k)(1).

15. CFI has worked diligently to promote accurate labeling and marketing of

homeopathic products as part of its campaign to ensure that homeopathic products and other

pseudoscientific alternative medical products are not presented to the public in a false and

misleading manner.

16. CFI has petitioned the Food and Drug Administration (FDA) to better and more

effectively regulate the trade in homeopathic products in the United States.1

17. CFI has repeatedly submitted comments to both the FDA2 and the Federal Trade

Commission (FTC)3 regarding the regulation, testing, marketing, and labeling of homeopathic

products.

18. In April 2015, CFI delivered invited testimony regarding homeopathy to the

FDA.4

19. In regard to this specific matter, CFI has requested that action be taken by the

FTC. CFI further contacted Defendants and sought to resolve the matter through discussions.

CFI also filed an official complaint with the D.C. Department of Consumer Protection.

FACTUAL ALLEGATIONS

A: Homeopathy is a Pseudoscience

1

https://centerforinquiry.org/news/cfi_and_csi_petition_fda_to_take_action_on_homeopathic_dru

gs/

2 https://goo.gl/CajXaN

3 https://centerforinquiry.org/docs/opp/CFI_RDF_FTCComments_Homeopathy.pdf

4 https://www.fda.gov/downloads/Drugs/NewsEvents/UCM443495.pdf

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20. Pseudoscience is defined as “a system of theories, assumptions, and methods

erroneously regarded as scientific.”5

21. Homeopathy is an alternative medical idea of treatment developed in the 18th

century in Germany.

22. Central to the idea of homeopathy is the concept that “like treats like.” If

something can be shown to cause a symptom in an individual, homeopathy holds that the same

substance can be used to treat the symptom.6

23. Further to this notion is homeopathy’s belief in the supposed “law of minimum

(or infinitesimal) dose.” Under this belief, the power of a substance in a homeopathic preparation

is increased the greater the level of dilution.7

24. For this reason, homeopathic products are often massively diluted with water or

other inert substances, often to the level where no molecules of the original substance can be

found in the final product.

25. An example of a homeopathic product is Oscillococcinum, produced by the

French company Boiron, which claims that it “relieves flu-like symptoms such as body aches,

headache, fever, chills, and fatigue.”8

26. On Boiron’s corporate website, the ‘active ingredient’ of Oscillococcinum is

listed as “Anas barbariae 200CK HPUS.”9

5 https://www.merriam-webster.com/dictionary/pseudoscience

6 National Center for Complementary and Integrative Health, Homeopathy (April 2015),

available at https://nccih.nih.gov/health/homeopathy#hed8

7 https://medical-dictionary.thefreedictionary.com/law+of+minimum+dose

8 https://www.oscillo.com/about/facts-about-oscillo/

9 Id.

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27. This ingredient, in a form which can be understood by those without knowledge

of the details of homeopathy, is the heart and liver of the Muscovy duck.

28. The notation ‘200CK’ refers to the level of homeopathic dilution – a 200C

dilution constitutes one part duck offal to 10400

water.

29. To place this level of dilution in an understandable perspective, current estimates

place the number of atoms in the known universe at up to 1082

.10

30. According to homeopaths, the potency of a particular product is preserved even at

these staggering levels of dilution through the process of ‘succussion.’

31. In succussion, after each dilution, the resulting solution is shaken vigorously, and

hit against an elastic surface, such as a leather covered book.11

32. In addition, homeopaths rationalize the extreme dilutions (to the extent of there

not being sufficient atoms in the entire universe for a single trace of the original allegedly active

ingredient to remain in the diluted product) through the concept of ‘water memory,’ or the idea

that water can “physically remember the chemical properties of substances that have been diluted

in it,” even after the dilution is such that not a single molecule of the original substance

remains.12

10

John Carl Villanueva, How Many Atoms are there in the Universe? (December 24, 2015),

available at https://www.universetoday.com/36302/atoms-in-the-universe/

11 Judith Reichenberg-Ullman, Homeopathy: The Unique Preparation of Homeopathic

Medicines, available at

http://www.healthy.net/Health/Article/The_Unique_Preparation_of_Homeopathic_Medicines/66

4

12 Steven Novella, The Memory of Water, Skeptical Inquirer Vol. 35.3 (May/June 2011),

available at https://www.csicop.org/si/show/the_memory_of_water

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33. Homeopathy is a pseudoscience because, despite dressing itself in the clothing of

scientific language, there is not a shred of credible scientific evidence that it works, or indeed

could possibly work.

34. The concepts on which homeopathy is based contradict the most fundamental

understanding of science that is known.

35. Individual refutations of the notions of the law of minimum dose, of homeopathic

succession, and of water memory can be found throughout scientific literature. They are no more

accepted by the scientific community than the notion of a flat Earth.

36. The National Center for Complementary and Integrative Health (NCCIH), a part

of the National Institutes of Health and a federal body that researches alternative medicine,13

notes on its website that “[t]here is little evidence to support homeopathy as an effective

treatment for any specific condition.”14

37. An exhaustive meta-study performed by Australia’s National Health and Medical

Research Council (NHMRC) in 2015 assessed more than 1,800 papers on homeopathy, finding

225 of them to meet the criteria for inclusion in the study.15

38. The study “found no good quality, well-designed studies with enough participants

to support the idea that homeopathy works better than a placebo, or causes health improvements

equal to those of another treatment.”16

13

https://nccih.nih.gov/about

14 National Center for Complementary and Integrative Health, Homeopathy (April 2015),

available at https://nccih.nih.gov/health/homeopathy#hed8

15 National Health and Medical Research Council, NHMRC releases statement and advice on

homeopathy (March 11, 2015), available at

https://www.nhmrc.gov.au/media/releases/2015/nhmrc-releases-statement-and-advice-

homeopathy

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39. The study’s conclusion was blunt. “There are no health conditions for which there

is reliable evidence that homeopathy is effective.”17

40. In the United Kingdom, a 2010 House of Commons Science and Technology

Committee report on homeopathy noted that homeopathic remedies performed no better than

placebos, and concluded that “[t]he [British] government should stop allowing the funding of

homeopathy on the NHS [National Health Service].”18

41. In July 2017, NHS England, the state provider of health care, announced it would

no longer fund homeopathic prescriptions.19

42. Multiple U.S. governmental bodies have recognized the failure of homeopathy to

provide effective treatment for specific conditions.

43. The NCCIH warns people that they should not “use homeopathy as a replacement

for proven conventional care or to postpone seeing a health care provider about a medical

problem.”20

44. The Food and Drug Administration (FDA) has issued warnings about the dangers

of relying on homeopathic products to deal with serious conditions.

16

Id.

17 Id.

18 House of Commons, Science and Technology Committee Fourth Report: Evidence Check 2 –

Homeopathy (Feb 8, 2010), available at

https://publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4502.htm

19 Nicola Davis and Denis Campbell, ‘A misuse of scarce funds’; NHS to end prescription of

homeopathic remedies, The Guardian (July 21, 2017), available at

https://www.theguardian.com/lifeandstyle/2017/jul/21/a-misuse-of-scarce-funds-nhs-to-end-

prescription-of-homeopathic-remedies

20 National Center for Complementary and Integrative Health, Homeopathy (April 2015),

available at https://nccih.nih.gov/health/homeopathy#hed8

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45. For example, in 2015, the FDA warned against over-the-counter homeopathic

asthma products.21

46. More recently, the FDA announced it would crack down on “situations where

homeopathic treatments are being marketed for serious diseases and/or conditions but where the

products have not been shown to offer clinical benefits.”22

47. In October 2016, the Federal Trade Commission (FTC) issued an Enforcement

Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs,

requiring that when a homeopathic product claims efficacy in particular medical situations

without “competent and reliable scientific evidence” of such efficacy, such claims would be

considered misleading in the absence of a warning informing consumers that “1) there is no

scientific evidence that the product works; and 2) the product’s claims are based only on theories

of homeopathy from the 1700s that are not accepted by most modern experts.”23

B: The Harm Caused by Homeopathy

48. Homeopathic products do not work and cannot work. There is no evidence they

are any more effective than a placebo.

21

U.S. Food and Drug Administration, Over-the-Counter Asthma Products Labeled as

Homeopathic: FDA Statement – Consumer Warning About Potential Health Risks (Mar. 19,

2015), available at

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProduc

ts/ucm439014.htm

22 U.S. Food and Drug Administration, FDA proposes new, risk-based enforcement priorities to

protect consumers from potentially harmful, unproven homeopathic drugs (Dec. 18, 2017),

available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm

23 Federal Trade Commission, FTC Issues Enforcement Policy Statement Regarding Marketing

Claims for Over-the-Counter Homeopathic Drugs (Nov. 15, 2016), available at

https://www.ftc.gov/news-events/press-releases/2016/11/ftc-issues-enforcement-policy-

statement-regarding-marketing

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49. This ineffectiveness itself harms American consumers. They are paying money

for products that do not effectively treat the ailments for which they are being taken.

50. Where those products are marketed as cures for illness, either directly or through

suggestion, this is perpetrating a fraud on consumers.

51. The financial harm is far from de minimis. According to the Economist magazine

in 2014, Americans spend $3 billion annually on homeopathy.24

52. Consumers suffer greater harm than this financial loss.

53. Homeopathic products may be tainted, or contain harmful ingredients. In its 2012

report, the American Association of Poison Control Centers noted that there were 10,311

reported cases of poison exposure related to ‘homeopathic agents,’ with 8,788 of those cases

attributed to children aged 5 years or younger. Of these cases, 697 required treatment in a

healthcare facility.25

54. The FDA requested that Standard Homeopathic Company recall its Hyland’s

Baby Teething Tablets after concluding that the products had “been found to contain inconsistent

amounts of belladonna alkaloids that may differ from the calculated amount on the products’

labels.”26

24

Why Homeopathy is Nonsense, The Economist (Apr. 2, 2014), available at

https://www.economist.com/blogs/economist-explains/2014/04/economist-explains

25 James B Mowry, Daniel A. Spyker, Louis R. Cantilena, Jr., J. Elise Bailey, and Marsha Ford,

2012 Annual Report of the American Association of Poison Control Centers’ National Poison

Data System (NPDS): 30th Annual Report (2013), available at

https://aapcc.s3.amazonaws.com/pdfs/annual_reports/2012_NPDS_Annual_Report.pdf

26 U.S. Food and Drug Administration, Standard Homeopathic Company Issues Nationwide

Recall of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets Due to

Mislabeling (Apr. 13, 2017), available at https://www.fda.gov/safety/recalls/ucm552934.htm

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55. Hundreds of adverse effects were reported.27

56. Homeopathy also harms consumers even when properly prepared, by encouraging

them to rely on such products to the exclusion of proven scientific remedies.

57. As the Australian NHMRC study states, “[p]eople who chose homeopathy may

put their health at risk if they reject or delay treatments for which there is good evidence for

safety and effectiveness.”28

58. By eschewing effective treatment in place of homeopathic products, sick people

suffer symptoms unnecessarily for longer. They may suffer long-term consequences, up to and

including death.

59. This is particularly true for children, who, importantly, do not make the decision

to use homeopathic products themselves. Most parents have seen the pain that a child suffers

with an ear infection; this can often be treated rapidly and safely through the use of antibiotics.

When a parent instead relies on belladonna (also known as deadly nightshade),29

or through the

use of the commercially sold homeopathic product Similisan Kids Ear Relief Drops, as sold at

27

Sheila Kaplan, Hundreds of Babies Harmed by Homeopathic Remedies, Families Say,

Scientific American (Feb, 21, 2017), available at

https://www.scientificamerican.com/article/hundreds-of-babies-harmed-by-homeopathic-

remedies-families-say/

28 National Health and Medical Research Council, NHMRC releases statement and advice on

homeopathy (March 11, 2015), available at

https://www.nhmrc.gov.au/media/releases/2015/nhmrc-releases-statement-and-advice-

homeopathy

29 Homeopathy Plus!, Middle Ear Infection, available at https://homeopathyplus.com/middle-

ear-infection/

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CVS stores,30

not only does the child suffer unnecessarily, but the failure to properly treat may

also result in long-term hearing damage or deafness.31

60. Reliance on homeopathic products to the exclusion of science-based medicines

can therefore have serious consequences for both children and adults.

61. The website What’s the Harm details many of such cases.32

62. For example, Isabella Denley, a toddler from Melbourne, Australia, was an

epileptic whose neurologist prescribed her anti-convulsant medication; her parents, instead,

chose to treat her with exclusively homeopathic products, and she died aged 13 months.33

63. Lucille Craven of New Hampshire was diagnosed in 1997 with a small, pea-sized

carcinomatous breast tumor. Her doctor recommended mastectomy and lymphectomy, but

instead Lucille sought homeopathic and other alternative medical treatments. She died within 36

months.34

64. Homeopathic products risk harming patients in three ways. Patients suffer a

financial loss, by spending money on a product that does not perform in the way in which they

have been lead to believe it will. They may suffer damage from adulterated and dangerously

30

https://www.cvs.com/shop/similasan-kids-ear-relief-drops-0-33-oz-prodid-

1010815?skuId=449150

31 American Academy of Otolaryngology-Head and Neck Surgery, Middle Ear Infection

(Chronic Otitis Media) and Hearing Loss (2016), available at

http://www.entnet.org/content/middle-ear-infection-chronic-otitis-media-and-hearing-loss

32 http://whatstheharm.net/homeopathy.html

33 Lucy Atkins, When there’s no real alternative, The Guardian (Dec. 16, 2003), available at

https://www.theguardian.com/society/2003/dec/16/health.medicineandhealth

34 Richard Craven, My Wife’s Death from Cancer (Feb. 27, 2002), available at

https://www.quackwatch.org/01QuackeryRelatedTopics/Victims/craven.html

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manufactured products. And they may suffer longer and greater harm from diseases that could

have been adequately treated or cured by science-based medicine.

C: CVS Health Retails Homeopathic Products Both Online and in its Physical

Stores

65. CVS Health, through CVS Pharmacy operates 9,800 physical stores nationwide,

including 60 in the District of Columbia.

66. Within those stores, CVS Health retails a significant range of over-the-counter

pharmaceutical products, including both science-based remedies and alternative medicines,

including homeopathic products.

67. These homeopathic products include both “name brand” products, such as Boiron

Oscillococcinum, and CVS “own-brand” products, such as CVS Health Homeopathic EarAche

Ear Drops.

68. CVS Health also operates an internet site through which customers, including

those in the District of Columbia, may order products for home delivery.35

69. This internet site also offers for sale to residents of the District of Columbia both

science-based remedies and alternative medicines, including homeopathic products.

70. Residents of the District of Columbia may access the internet site and purchase

both “name brand” products, such as Boiron Oscillococcinum,36

and CVS “own-brand” products,

such as CVS Health Homeopathic EarAche Ear Drops.37

35

https://www.cvs.com/

36 https://www.cvs.com/shop/oscillococcinum-quick-dissolve-pallets-prodid-

1011994?skuId=926229

37 https://www.cvs.com/shop/cvs-health-homeopathic-earache-ear-drops-0-33-oz-prodid-

972673?skuId=972673

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D: CVS Health Places Homeopathic Products Alongside Science-Based, Tested

Medicine

71. In a CVS retail store, over-the-counter medical products are arranged in labelled

aisles, informing the customer of the symptoms and conditions for which that aisle contains

relevant products.

72. The individual aisles are then broken down into individual sections.

73. For example, the CVS store located at 1199 Vermont Ave., Washington, D.C.

20005 displays products in the following way.

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74. Within each individual section, homeopathic products are displayed alongside

science-based medicines with no distinction drawn between them.

75. For example, in the ‘cold & flu’ section, FDA approved and tested over-the-

counter remedies such as Tylenol Sinus & Headache are not separated nor distinguished from

homeopathic remedies such as Oscillococcinum.

76. Oscillococcinum can be seen here on the bottom shelf.

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77. The same situation can be found in the pain relief section of CVS stores.

78. Science-based remedies such as Tylenol and Advil are found alongside

homeopathic products including Arnicare, which contains multiple homeopathic claimed active

ingredients (see back of box, below) without any indication to the potential consumer of the

difference between the products.

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79. The situation is as bad, if not worse, on CVS’s website which offers homeopathic

products for sale and delivery to residents of the District of Columbia.

80. The homeopathic products Oscillococcinum Quick Dissolve Pallets is nested for

sale under the following category path: Health and Medicine > Cough, Cold, & Flu >Flu

Remedies.38

81. The science-based, tested remedy, Tylenol Cold + Flu SevereCaplets, 24 CT, is

nested under the same path: Health and Medicine > Cough, Cold, & Flu >Flu Remedies.39

38

https://www.cvs.com/shop/oscillococcinum-quick-dissolve-pallets-prodid-

1011994?skuId=926229

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82. However, the science-based remedy, while listed on the website, is only available

for purchase in the physical store.

83. Similarly, Arnicare Arthritis Tablets are nested as follows: Health & Medicine >

Pain & Fever > Arthritis Relief.40

84. The science-based remedy, Tylenol 8 Hour Arthritis Pain Caplets 650 mg is

nested in the same path: Health & Medicine > Pain & Fever > Arthritis Relief.41

85. The children’s homeopathic cough syrup, Hyland’s 4Kids Cold’n Cough Syrup is

sold by CVS on its website under the path: Health & Medicine > Cold, Cough, & Flu > Cold &

Cough For Children.42

86. The science-based remedy, Mucinex Children’s Multi-Symptom Nighttime Cold

Liquid Very Berry is nested under the same path: Health & Medicine > Cold, Cough, & Flu >

Cold & Cough For Children.43

87. If a search is entered on CVS’s internet site for the term “Flu treatment,” a series

of products is suggested, including on the first page the homeopathic products NaturaBio

39

https://www.cvs.com/shop/tylenol-cold-flu-severe-caplets-24ct-prodid-

1011799?skuId=897402

40 https://www.cvs.com/shop/arnicare-arthritis-tablets-60ct-prodid-1012203

41 https://www.cvs.com/shop/tylenol-8-hour-arthritis-pain-caplets-650mg-prodid-

1080137?skuId=313546

42 https://www.cvs.com/shop/hyland-s-4kids-cold-n-cough-syrup-natural-grape-flavor-4-oz-

prodid-1710277?skuId=236259

43 https://www.cvs.com/shop/mucinex-children-s-multi-symptom-nighttime-cold-liquid-very-

berry-4-oz-prodid-1011662?skuId=939534

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Children’s Cold and Flu Liquid and Oscillococcinum, alongside science-based treatments such

as Infants Tylenol Oral Suspension and Mucinex Fast Max.44

D: CVS Health’s Product Placement of Homeopathic Products Makes Material

False and Misleading Claims Regarding the Effectiveness of Those Products

88. CVS Health portrays itself as a partner in the health care decisions made by its

customers. It publicly announces its purpose as “Helping people on their path to better health.”45

89. CVS Health announces that its aim is to reinvent “pharmacy to have a more

active, supportive role in each person’s unique health experience and in the greater health care

environment – from advising on prescriptions to helping manage chronic and specialty

conditions to providing quality walk-in medical care and pharmacy benefits management.”46

90. CVS Health emphasizes its important role in an individual customer’s health care

and lifestyle choices: “Because we’re present in so many moments, in ways that are more

affordable and effective, we’re able to positively influence health behavior and shape the future

of health care for people, businesses, and communities.”47

91. CVS Health’s role in assisting customers with health decisions goes far beyond

filling prescriptions. It is also a major retailer of over-the-counter medicines, for which no

prescription is required.

44

https://www.cvs.com/search?cp=%5B%7B%22key%22:%22source%22,%22value%22:%22sayt

%22%7D%5D&searchTerm=Flu%20treatment

45 https://cvshealth.com/about/purpose-statement

46 Id.

47 Id.

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92. When a person is suffering an ailment and does not wish to go to the doctor, they

will often turn to their neighborhood drug store for relief, whether it is from headaches, cold and

flu symptoms, constipation, or ear pain.

93. In all of these categories and many more, CVS Health offers a wide range of

products to treat the problem or relieve the symptoms, both on its internet site and in its physical

stores.

94. In its physical stores, CVS Health displays products in aisles and sections broken

down by the symptoms to be treated.

95. On its website, CVS Health organizes its products in categories, nested according

to the symptoms to be treated.

96. Through its marketing and product placement, both in its physical stores and on

its internet site, CVS is sending a clear and false message to its consumers.

97. This message is that homeopathic products are no different than science-based

medicines.

98. A customer suffering from flu-like symptoms is informed by CVS that Tylenol

Cold and Flu medicine, containing acetaminophen, tested and approved by the FDA, is an

equivalent solution to Oscillococcinum (containing the organs of a Muscovy duck diluted to the

power of 10400

).

99. By displaying the product Oscillococcinum under a sign reading “cold & flu” and

alongside science-based remedies for cold and flu symptoms, CVS is actively claiming to

customers that Oscilloccoccinum treats cold and flu symptoms.

100. Oscillococcinum does not provide relief for cold and flu symptoms at any level

greater than a placebo.

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101. For the relief for the pain from arthritis, CVS’s marketing and product placement

indicates to customers that ibuprofen, as listed on the World Health Organization’s Model List of

Essential Medicines,48

is no more effective than the homeopathic remedy displayed beside it,

Arnicare Arthritis.49

102. By displaying Arnicare Arthritis under a sign reading “pain relief” and alongside

science-based remedies for arthritis pain, CVS is actively claiming that Arnicare Arthritis

provides relief for arthritis pain.

103. Arnicare Arthritis does not provide relief for arthritis pain at any level greater

than a placebo.

104. Similar comparisons can be made for each homeopathic product sold by CVS

Health both in its physical stores and on its internet site.

105. CVS’s own marketing indicates it views itself as a partner in the health care

decisions of its customers.

106. When a customer enters a CVS store in the District of Columbia, or visits CVS’s

internet site, he or she is relying on CVS to provide adequate and accurate information about the

products on display.

107. By intermingling homeopathic products, which have no scientific basis and no

demonstrable efficacy, with science-based medicines, CVS Health is deliberately sending a

message that they are equally efficacious in the treatment of the conditions for which CVS

Health labels that section of the store or internet site.

48

World Health Organization, WHO Model Formulary (2008), available at

http://apps.who.int/medicinedocs/documents/s16879e/s16879e.pdf

49 http://www.arnicare.com/about/arnicare-arthritis/

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108. CVS Health is advertising homeopathic products to the public as effective

treatments for particular symptoms and diseases but is failing to inform the public that there is no

scientific evidence that the products have any value in treating those symptoms and diseases.

109. In both its physical stores in the District of Columbia and its online presence,

CVS Health is marketing homeopathic products to customers as being treatments for specific

conditions.

110. There is no scientific evidence that these homeopathic products have any

beneficial effect on these conditions, and CVS Health is aware of this.

111. Absent this credible scientific evidence, CVS Health is not permitted to make

such claims regarding the efficacy of homeopathic products for particular uses.

112. CVS Health, by its marketing and placement of these products, is deceiving

customers and deliberately creating the impression that homeopathic products can be used

interchangeably with science-based medicines for the treatment of specific conditions.

113. This violates D.C customers’ “enforceable right to truthful information from

merchants about consumer goods and services that are or would be purchased, leased, or

received in the District of Columbia.” D.C. Code § 280-3901(c). CVS Health retails

homeopathic products in both its physical stores and its internet site to residents of the District of

Columbia.

114. There is no scientific evidence that these homeopathic products have any effect

above that of a placebo

115. Defendants are aware, or should be aware, that there is no scientific basis to claim

that these products are effective for the treatment of specific symptoms and diseases.

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116. Despite this, Defendants displays homeopathic products both in their physical

stores and on their internet site underneath signs listing specific symptoms and diseases, and

alongside science-based remedies containing active ingredients tested by the FDA and

scientifically demonstrated to have beneficial effects.

117. A reasonable consumer would purchase these homeopathic products believing

that they were equally as effective for the treatment of the listed symptoms or diseases as the

science-based remedies displayed beside them.

118. Defendants deliberately take advantage of the reputation and effectiveness of the

science-based medicines to imply to customers that the homeopathic products have a similar

efficacy.

119. There is no scientific evidence of efficacy of homeopathic products.

CAUSE OF ACTION

D.C. CONSUMER PROTECTION ACT – D.C. OFFICIAL CODE §§ 28-3901, et seq.

120. Plaintiff incorporates by reference and realleges all previous paragraphs.

121. This Count is brought pursuant to the District of Columbia Consumer Protection

Procedures Act (CPPA). D.C. Code § 28-3901 et seq. This Count is alleged against the

Defendants on behalf of the General Public of the District of Columbia pursuant to District of

Columbia Code § 28-3905(k)(1)(A)-(D).

122. Each Defendant is a “person” within the meaning of D.C. Official Code § 28-

3901(a)(1), and provides “goods” within the meaning of § 28-3901(a)(7).

123. Plaintiff is a “non-profit organization” within the meaning of § 28-3901(a)(14)

and a “public interest organization” within the meaning of § 28-3901(a)(15).

124. D.C. Code § 28-3904 makes it an “unlawful trade practice … whether or not any

consumer is in fact misled, deceived or damaged thereby,” to, among other things:

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(a) Represent that goods or services have a source, sponsorship, approval,

certification, accessories, characteristics, ingredients, uses, benefits, or

quantities that they do not have:

(b) Represent that goods or services are of particular standard, quality, grade,

style, or model, if in fact they are of another;

(e) Misrepresent as to a material fact which has a tendency to mislead;

(f) Fail to state a material fact if such failure tends to mislead;

(f-l) Use innuendo or ambiguity as to a material fact, which has a tendency to

mislead; and

(u) Represent that the subject of a transaction has been supplied in accordance

with a previous representation when it has not.

125. Defendants violated these provisions by, inter alia, intentionally representing

homoeopathic products, including those listed supra, as medicines that can treat and improve

specific diseases and symptoms by displaying them in sections labelled for those diseases and

symptoms.

126. Defendants violated these provisions by deliberately and intentionally placing

homeopathic products in the same sections as science-based medicines, thereby implying to

customers there is no difference between them.

127. Defendants knew or should have known that its placement of homeopathic

products beside science-based medicines and under labels referring to specific diseases and

symptoms would result in consumers considering the products to be equivalents.

128. Defendants knew or should have known that no scientific evidence exists to show

homeopathic remedies have any effect on specific diseases or symptoms other than those of a

placebo.

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129. Defendants knew or should have known that consumers would be led to believe

by its product placement and shelf labelling that homeopathic products were effective in the

treatment of specific diseases and symptoms.

130. Defendants knew or should have known of the likelihood of confusion created by

its product placement and labeling between homeopathic products and science-based medicines.

131. Defendants knew or should have known that the organization of its internet site

would create the same effects as listed supra, creating confusion among customers between

homeopathic and science-based medications and creating a false impression that homeopathic

products are efficacious in the treatment of specific diseases and remedies.

132. Although reliance is not required by the CPPA, customers in the District of

Columbia have nevertheless reasonably relied on Defendants’ misrepresentations and omissions

when purchasing healthcare products from Defendants.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff requests that this Court grants judgment against the

Defendants, and in favor of the Plaintiff and the District of Columbia General Public, and grant

the following relief:

a. Declaring that Defendants’ conduct is in violation of the D.C. Consumer

Protection Procedures Act;

b. Enjoining Defendants’ conduct found to be in violation of the D.C.

Consumer Protection Procedures Act and ordering corrective advertising, marketing, labeling

and product placement;.

c. Granting Plaintiff and the General Public of the District of Columbia

restitution, treble damages or statutory damages in the amount of $1,500 per violation, whichever

is greater;

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d. Granting Plaintiff its costs of prosecuting this action, including attorneys’

fees, experts’ fees and costs together with interest; and

e. Granting such other relief as this Court may deem just and proper.

JURY TRIAL DEMANDED

Plaintiff hereby demands a trial by jury on all issues so triable.

Respectfully submitted this 29th day of June, 2018.

s/Nicholas J Little

Nicholas J. Little, Esq. (Bar No. 979725)

Center for Inquiry

1012 14th St. N.W.

Suite 205

Washington, D.C. 20005

ATTORNEY FOR PLAINTIFFS