complaint to tga: brauer (homeopathic) products · complaint to tga: brauer (homeopathic) products...
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Complaint to TGA: Brauer (Homeopathic) Products
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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
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
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/products/baby-child-reflux-100ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://brauer.com.au/condition/baby-child-immunity
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/collections/all-products/products/baby-child-sleep-100ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/collections/all-products/products/baby-child-teething-100ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/collections/all-products/products/baby-child-teething-gel-20g
Complaint to TGA: Brauer (Homeopathic) Products
Page 8 of 26
https://shop.brauer.com.au/products/baby-child-runny-nose-relief-100ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/products/baby-child-cough-100ml
Complaint to TGA: Brauer (Homeopathic) Products
Page 10 of 26
https://shop.brauer.com.au/products/baby-child-cold-flu-100ml
Complaint to TGA: Brauer (Homeopathic) Products
Page 11 of 26
https://shop.brauer.com.au/products/baby-child-pain-fever-relief-50ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/products/baby-child-calm-100ml
Complaint to TGA: Brauer (Homeopathic) Products
Page 13 of 26
https://shop.brauer.com.au/products/baby-child-sleep-100ml
Complaint to TGA: Brauer (Homeopathic) Products
Page 14 of 26
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
Complaint to TGA: Brauer (Homeopathic) Products
Page 15 of 26
https://shop.brauer.com.au/collections/kids-manuka-honey/products/brauer-kids-manuka-honey-cold-flu
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
Complaint to TGA: Brauer (Homeopathic) Products
Page 17 of 26
https://shop.brauer.com.au/products/sleep-500ml
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/products/sleep-o-s-20ml
https://shop.brauer.com.au/collections/all-products/products/sleep-tablets-60-vial
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/products/snore-eze-o-s-20ml
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
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
Complaint to TGA: Brauer (Homeopathic) Products
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https://shop.brauer.com.au/collections/lifestyle/products/brauer-elimitona-20-day-200ml
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
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
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
Complaint to TGA: Brauer (Homeopathic) Products
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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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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
Page 6 of 10
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;
Page 7 of 10
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
Page 8 of 10
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
Page 9 of 10
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.
Page 10 of 10
Appendix B: Excerpt of the Advertisement
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.
2
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.
3
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.
4
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
5
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.
6
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
7
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
8
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
9
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
10
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
11
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/
12
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
13
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
14
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.
15
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.
16
17
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.
18
19
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
20
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
21
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