Complaint to TGA: Weleda Arnica 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, the most recent being (2017/12/001) Weleda Arnica 6x Drops.

See: http://tgacrp.com.au/complaint-register/?_search=homeopathic (9) and http://tgacrp.com.au/complaint-register/?_search=Homoeopathic (6).

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.

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.

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

“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”.

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

Complaint to TGA: Weleda Arnica Homeopathic Products

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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. Meanwhile, in Australia, misleading and deceptive advertising continues.

The CRP (2017/12/001) determination (appended) concluded that the promotion of Weleda Arnica 6x Drops by the Weleda Australia Pty Ltd and other advertisers breached the Therapeutic Goods Advertising Code, 2017, sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) and (in some cases) 6(3)(d). The sponsor was requested to withdraw the offending advertisements and representations and also advise 3rd party advertisers that the representation(s) should be withdrawn.

Regardless, misleading and deceptive advertisements and representations for this and related products continue.

I submit that this complaint is "high priority" because the sponsor is recalcitrant, this class of products have had numerous upheld complaints and the sponsor (and others) continue to make claims (documented below) that the CRP determined breached the Therapeutic Goods Advertising Code 2017. This clearly impacts on the consumers ability to appropriately use these goods.

The Weleda products involved are (none are listed on the ARTG):

• Arnica 30c Oral Liquid • Arnica 6x Oral Spray, 30ml • Arnica 30c - 100 Tablets • Arnica Pilules, 30g

Screen shots of misleading and deceptive advertising claims taken today (10/07/2018) follow.

https://naturalhealthchoices.com.au/shop/first-aid/arnica-30c-liquid-30ml/

Complaint to TGA: Weleda Arnica Homeopathic Products

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Arnica 6x Oral Spray, 30ml Description

Supports the body's natural healing response to bruising, pain and swelling of strained and sprained tissue and muscles after injury or surgery. Improves recovery after sport. Boost recovery with Weleda Arnica Cream for external use. Ingredients

Contains 1mL/1mL: Arnica montana, fresh whole plant juice 6x in water/ethanol base (30ml, approx. 250 sprays). Free from synthetic preservatives. Directions Adults/Children: In acute cases take 2 sprays every 15 minutes. After 6 doses take every hour. Reduce the number of doses, as relief is obtained, to 3 times daily at least 15 minutes before meals, or as directed by your health care professional. Always read the label. Use only as directed. If symptoms persist see your healthcare professional Keep all medicines out of reach of children. Store below 30° C, away from direct sunlight and strong smelling substances.

http://weleda.com.au/arnica-6x-oral-spray-30ml_1003857/

Complaint to TGA: Weleda Arnica Homeopathic Products

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https://birthpartner.com.au/product/arnica-30c-100-tablets/

Complaint to TGA: Weleda Arnica Homeopathic Products

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Arnica Pilules, 30g

Description Relieves and helps heal bruising, pain and swelling of strained and sprained tissue and muscles after injury or surgery. Improves recovery after sport. Boost healing and recovery with Weleda Arnica Cream for external use Ingredients Each 1g contains: (approx. 120 pilules) sucrose pilules contains: Arnica montana, fresh whole plant 4x, 10mg. Free from synthetic preservatives. Directions In acute cases let 5 pilules (child under 7 years) or 15 pilules (7 years to adult) dissolve under the tongue every 15 minutes. After 6 doses take every hour. Reduce the number of doses, as relief is obtained, to 3 times daily at least 15 minutes before meal. Or as directed by your health care professional. Always read the label. Use only as directed. If symptoms persist see your healthcare professional. Keep all medicines out of reach of children. Store below 30°C, away from direct sunlight and strong smelling substances..

http://weleda.com.au/arnica-pilules-30g_1003857/

Similar claims can be found at:

• https://zenorganichealth.com.au/shop/weleda-arnica-6x-drops-30ml/ • https://nutrientavenue.com.au/products/weleda-arnica-6x-drops-30ml • https://ballarathealthfoods.com.au/products/weleda-arnica-6x-drops-30ml • https://vitaminsonly.com.au/products/weleda-arnica-30c-30ml • https://welcomeorganics.com.au/arnica-6x-drops-30ml.html • https://mrvitamins.com.au/weleda-arnica-6x-drops-30ml • https://naturalhealthorganics.com.au/weleda-arnica-6x-drops-30ml.html • https://healthdelivery.com.au/weleda-arnica-6x-drops-30ml.html • https://birthpartner.com.au/product/weleda-arnica-6x-drops-30ml/ • https://goodness.com.au/arnica-30c-100-tablets • https://nourishedlife.com.au/natural-medicines/58032/weleda-arnica-30c.html • https://sproutmarket.com.au/arnica-30c-100-tablets-weleda.html • https://naturalhealthchoices.com.au/shop/first-aid/arnica-30c-100-tablets/

Complaint to TGA: Weleda Arnica Homeopathic Products

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• https://glutenfreegrocer.com.au/household/natural-remedy/arnica-30c-oral-liquid-weleda-30ml.html

• https://glutenfreegrocer.com.au/household/natural-remedy/arnica-pilules-weleda-30g.html • https://rchnaturalproducts.com.au/product/weleda-arnica-6x-drops-30ml/ • https://megavitamins.com.au/en/supplements/1703-weleda-arnica-30c-100-tablets.html • Etc.

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: kenneth.harvey@monash.edu WWW: www.medreach.com.au 10 July 2018

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COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2017-12-001 Weleda Arnica 6x Drops

Meeting held 15 February 2018

Complaint summary^

Complainant Dr Ken Harvey

Advertisers Weleda Australia Pty Ltd

Rudolf Steiner Book Centre

Echolife Australia Pty Ltd

Natural Chemist

Subject matter of complaint Internet advertisements

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)(c), 4(2)(d), 6(3)(d)

Sections of the Code,

Regulations or Act found not

to have been breached*

Code section 6(3)(c)

Sanctions

Withdrawal of advertisement

Withdrawal of representations

* 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 internet advertisements published at the websites www.weleda.com.au,

www.rudolfsteinerbookcentre.com.au, www.echolife.com.au and www.naturalchemist.com.au,

viewed by the complainant in December 2017.

2. The advertisement at www.weleda.com.au included representations such as “relieves and helps heal

bruising, pain and swelling of strained and sprained tissue and muscles after injury or surgery”,

“improves recovery after sport”, and other claims.

3. The advertisement at www.rudolfsteinerbookcentre.com.au included representations such as

“internal medicine to assist tissue healing after accidents, sports injuries, falls and knocks”, “use

before and after exercise to minimise tissue damage”, “use after surgery to assist with tissue

healing and speed recovery”, “helps to calm the nerves after accidents and trauma”, “Contains

1ml/1ml: Arnica montana, fresh whole plant juice 6x in water/ethanol base”, “in acute cases take 5

drops (child under 7 years), 10 drops (7 to 14 years) or 15 drops (adults) every 15 minutes. After 6

doses take every hour. Reduce the number of doses, as relief is obtained, to 3 times daily at least 15

minutes before meals, or as directed by your health practitioner”, “Biodynamic Bruising Healing

Medical Care Medicine Organic Remedies Shock Sprains Therapeutic Trauma START Natural

Health Care”, and other claims.

4. The advertisement at www.echolife.com.au included the representations “Weleda Arnica 6x Drops

harness the plant’s naturally anti-inflammatory and pain-relieving properties” and “the drops

support the body’s healing response and recovery to a range of tissue ailments.”

5. The advertisement at www.naturalchemist.com.au included representations such as “relieves and

helps heal bruising, pain and swelling of strained and sprained tissue and muscles after injury or

surgery”, “improves recovery after sport”, “in acute cases take 5 drops (child under 7 years), 10

drops (7 to 14 years) or 15 drops (adults) every 15 minutes. After 6 doses take every hour. Reduce

the number of doses, as relief is obtained, to 3 times daily at least 15 minutes before meals, or as

directed by your healthcare professional”, “Ingredients - Contains 1mL/1mL: Arnica montana,

fresh whole plant juice 6x in water/ethanol base.”

6. Excerpts of the advertisements can be viewed in the relevant Appendix to this determination.

The product(s)

7. The advertisement promoted the product Weleda Arnica 6x Drops.

The advertiser(s)

8. The advertisers were Weleda Australia Pty Ltd (the sponsor of the product) in relation to all of the

advertisements, Rudolf Steiner Book Centre in relation to the advertisement published at

www.rudolfsteinerbookcentre.com.au, Echolife Australia Pty Ltd in relation to the advertisement

published at www.echolife.com.au and Natural Chemist in relation to the advertisement published

at www.naturalchemist.com.au.

The complaint^

9. The complainant was Dr Ken Harvey.

10. The complainant alleged that the advertisements breached sections 4(1)(b), 4(2)(a), 4(2)(c) and

4(2)(d) of the Code “because there is no mention that the claims relate to the homeopathic

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tradition” (also stating that he could find “no good scientific evidence to support them”), and “the

‘6X’ dilution, unexplained, exploits the lack of knowledge of consumers about homeopathic

principles”. The complainant also cited the following claims in his complaint:

a) “relieves and helps heal bruising, pain and swelling of strained and sprained tissue and muscles

after injury or surgery”;

b) “use after surgery to assist with tissue healing and speed recovery”;

c) “improves recovery after sport”;

d) “use before and after exercise to minimise tissue damage”;

e) “Weleda Arnica 6x Drops harness the plant’s naturally anti-inflammatory and pain-relieving

properties”;

f) “the drops support the body’s healing response and recovery to a range of tissue ailments”;

g) “helps to calm the nerves after accidents and trauma”; and,

h) “in acute cases take 5 drops (child under 7 years), 10 drops (7 to 14 years) or 15 drops (adult)

every 15 minutes. After 6 doses take every hour. Reduce the number of doses, as relief is

obtained, to 3 times daily at least 15 minutes before meals, or as directed by your health care

professional.”

11. The complainant referred to evidence in relation to the representations, arguing that:

a) a 1998 systematic review (Ernst and Pitter) concluded that “controlled trials do not prove that

homeopathic arnica works better than placebo”;

b) a 2007 systematic review (Kouzi and Nuzum) concluded that “the majority of randomized

clinical trials suggest that homeopathic arnica is no better than placebo in treating bruising,

swelling and pain”;

c) the 2015 NHMRC Statement on Homeopathy noted: “There was no reliable evidence from

research in humans that homeopathy was effective for treating the range of health conditions

considered: no good-quality, well-designed studies with enough participants for a meaningful

result reported either that homeopathy caused greater health improvements than placebo, or

caused health improvements equal to those of another treatment.

“For some health conditions, studies reported that homeopathy was not more effective than

placebo. For other health conditions, there were poor-quality studies that reported homeopathy

was more effective than placebo, or as effective as another treatment. However, based on their

limitations, those studies were not reliable for making conclusions about whether homeopathy

was effective. For the remaining health conditions, it was not possible to make any conclusion

about whether homeopathy was effective or not, because there was not enough evidence.”

Additional matters raised by the Panel

12. 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 sections 6(3)(c) and 6(3)(d) of the Code because the advertisements

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may lack certain mandatory information including the statements “always read the label”, “use

only as directed” and “if symptoms persist see your healthcare professional”.

The advertisers’ response to the complaint^

Weleda

13. The product sponsor, Weleda Australia Pty Ltd, responded as follows.

14. Weleda stated that it had had “no intent” to contravene the Act or the Code.

15. Weleda stated that it “acknowledge[d] that it is important to provide the context of traditional use

for product claims, in this case traditional use in the homeopathic medicine paradigm” and that it

had “taken steps to correct the advertisement on our website by the addition of the words

‘Traditionally used in homeopathic medicine.’” Weleda provided screenshots of its amended

advertisement.

16. Weleda argued that “scientific evidence is not required to support claims for homeopathic

products”, but rather that “the evidence required is that based on long-term use and experience in

the homoeopathic traditional paradigm”.

17. In relation to the term “6X”, Weleda argued that this would be explained once the words

“traditionally used in homeopathic medicine” were included in advertising, and argued that “there

is no requirement under the current TGA provisions to provide an explanation for homeopathic

potencies.”

18. Weleda otherwise argued that the complaint had been addressed by amendments to its website. In

relation to the warning “always read the label”, Weleda argued that it had complied with the

requirements of section 6(3)(c) of the Code because it had included a “pack shot showing the

product name which is also the active ingredient”, and because it had included under an

“ingredients tab” the words “contains 1mL/1mL: Arnica montana, fresh whole plant juice 6X in

water/ethanol base.”

19. Weleda also provided a range of evidence material. The evidence material was directed largely at

demonstrating that the Arnica 6X ingredient was traditionally used in homeopathic medicine for

the uses described in the advertisements.

Echolife

20. Echolife responded in some detail, in essentially the same terms as Weleda (see above).

Natural Chemist

21. Natural Chemist responded by acknowledging receipt of the complaint materials and stating “we

will provide a response by the due date… please note also that we have removed the product listing

in question from our website until the matter is resolved.”

22. Natural Chemist subsequently responded in some detail, in essentially the same terms as Weleda

(see above).

Rudolf Steiner Book Centre

23. Rudolf Steiner Book Centre responded in some detail, in essentially the same terms as Weleda (see

above).

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Findings of the Panel

responsibility for the advertisements

24. Under regulation 42ZCAA of the Regulations, the person apparently responsible for an

advertisement is the person who, based on the particulars of a complaint and the assessment of the

Panel, appears to be responsible for requesting the publication of the advertisement.

25. On review of the material, including the submissions of the advertisers, the Panel was satisfied that

apparent responsibility for the advertisements was as follows:

a) Weleda Australia Pty Ltd in relation to all of the advertisements;

b) Rudolf Steiner Book Centre in relation to the advertisement published at

www.rudolfsteinerbookcentre.com.au;

c) Echolife Australia Pty Ltd in relation to the advertisement published at www.echolife.com.au;

and,

d) Natural Chemist in relation to the advertisement published at www.naturalchemist.com.au.

the evidence material

26. The Panel reviewed the evidence material before it.

27. It appeared to the Panel that it was quite clear, and apparently undisputed, that:

a) there was good evidence that Arnica (also expressed as “Arnica montana” or “Arn.”), as a

homeopathic ingredient, did have a tradition of use in homeopathic medicine in relation to

injuries from falls and similar concerns;

b) there was no good or persuasive evidence that homeopathic Arnica would have any therapeutic

effects.

28. The Panel noted that evidence that a product or ingredient has traditionally been used for a

therapeutic purpose is not in itself evidence that the product or ingredient will in fact be effective

for that therapeutic purpose.

the advertisements in context

29. 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.

30. In assessing the advertisements, the Panel was mindful not only of the particular words cited by the

complainant, but of the entire context of each advertisement and its likely impact on a reasonable

consumer.

31. The Panel was satisfied that:

a) there were no elements in any of the advertisements that would cause a reasonable consumer to

understand that the advertised product was homeopathic in nature;

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b) there were no elements in any of the advertisements that would cause a reasonable consumer to

understand that the amount of Arnica montana in the advertised product was at an extreme

dilution (1:1,000,000);

c) the reference to “6x” was not likely to be understood by the ordinary and reasonable consumer

to mean that the amount of Arnica montana in the advertised product was at an extreme

dilution (1:1,000,000);

d) references to “Arnica 6x”, “contains 1mL/1mL: Arnica montana, fresh whole plant juice 6x in

water/ethanol base”, “Arnica 6x drops, 30ml”, “Weleda Arnica 6x Drops harness the plant’s

naturally anti-inflammatory and pain-relieving properties”, and similar references, were likely

to cause the ordinary and reasonable consumer to believe that the advertised product contained

a measurable amount of Arnica montana herb, or herbal extract, or juice, or contained an

amount of ingredient that was biochemically active in the same manner as conventional

medicines or herbal medicines;

e) representations such as “contains 1mL/1mL: Arnica montana, fresh whole plant juice 6x in

water/ethanol base”, “Weleda Arnica 6x Drops harness the plant’s naturally anti-inflammatory

and pain-relieving properties”, and similar references, would cause the ordinary and reasonable

consumer to believe that the advertised product contained a herbal medicinal ingredient in a

conventional sense, rather than an ingredient at a homeopathic dilution;

f) representations such as “in acute cases take 5 drops (child under 7 years), 10 drops (7 to 14

years) or 15 drops (adult) every 15 minutes. After 6 doses take every hour. Reduce the number

of doses, as relief is obtained, to 3 times daily at least 15 minutes before meals” would tend to

support the view formed by the consumer noted above, that the product was a herbal medicinal

product containing a conventional dose of a herbal medicinal ingredient, and conveyed that the

advertised product would cause a response that was related to dosage in the manner of a

conventional medicine or herbal medicine;

g) the representations about therapeutic benefits in the advertisement would convey to the

ordinary and reasonable consumer that the advertised product would have the claimed

therapeutic benefits;

h) the representations about therapeutic benefits in the advertisement would be taken by the

ordinary and reasonable consumer that the advertised product to have been made on the basis

of evidence of actual effectiveness, and not merely on the basis of a history of use.

the alleged breaches

32. 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”. Section 4(2)(c) of the Code prohibits representations that “mislead

directly or by implication or through emphasis, comparisons, contrasts or omissions”. Section

4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack of

knowledge of consumers or contain language which could bring about fear or distress.”

33. The complainant alleged that the advertisements breached these provisions “because there is no

mention that the claims relate to the homeopathic tradition” (also stating that he could find “no

good scientific evidence to support them”), and “the ‘6X’ dilution, unexplained, exploits the lack

of knowledge of consumers about homeopathic principles”. The complainant also cited the

following claims in his complaint:

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a) “relieves and helps heal bruising, pain and swelling of strained and sprained tissue and muscles

after injury or surgery”;

b) “use after surgery to assist with tissue healing and speed recovery”;

c) “improves recovery after sport”;

d) “use before and after exercise to minimise tissue damage”;

e) “Weleda Arnica 6x Drops harness the plant’s naturally anti-inflammatory and pain-relieving

properties”;

f) “the drops support the body’s healing response and recovery to a range of tissue ailments”;

g) “helps to calm the nerves after accidents and trauma”; and,

h) “in acute cases take 5 drops (child under 7 years), 10 drops (7 to 14 years) or 15 drops (adult)

every 15 minutes. After 6 doses take every hour. Reduce the number of doses, as relief is

obtained, to 3 times daily at least 15 minutes before meals, or as directed by your health care

professional.”

34. The advertisers stated that they would amend their advertising to include the words “traditionally

used in homeopathic medicine.”

35. They also argued that “scientific evidence is not required to support claims for homeopathic

products”, and that “the evidence required is that based on long-term use and experience in the

homoeopathic traditional paradigm”.

36. As noted above, the Panel was satisfied that the advertisements conveyed that the advertised

product would have the claimed therapeutic effects. The claims in the advertisements were not

confined to claims that Arnica 6x had traditionally or historically been used for particular

therapeutic effects, and amounted to claims of actual efficacy. No evidence before the Panel,

however, supported a view that the advertised product would be of actual efficacy for any of the

therapeutic purposes claimed.

37. On this basis, the Panel was satisfied that the each of the advertisements breached sections 4(1)(b),

4(2)(a), 4(2)(c) and 4(2)(d) of the Code in the manner alleged by the complainant.

38. In particular, the Panel noted that in addition to being misleading, the advertisements abused the

trust and exploited the lack of knowledge of consumers, by presenting a homeopathic product in a

manner that would make it likely that consumers would believe the product to be a conventional or

herbal medicine.

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

40. In relation to the term “6x”, the advertisers argued that this would be explained once the words

“traditionally used in homeopathic medicine” were included in advertising, and argued that “there

is no requirement under the current TGA provisions to provide an explanation for homeopathic

potencies.”

41. The Panel noted, without making any formal finding, that even in a context where the words

“traditionally used in homeopathic medicine” were included in advertising, the notation “6x”

would be likely to be taken by consumers to mean that the advertised product contained a non-

negligible quantity of a conventionally active ingredient, such as the juice or an extract of the herb

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Arnica montana, in the absence of words that clearly communicated that the advertised product in

fact did not work in the manner of a conventional medicine and did not contain quantities of active

ingredient in the manner of a conventional medicine.

minimum requirements

42. The advertisements ought to have included the words “use only as directed” and “if symptoms

persist see your doctor/healthcare professional” (section 6(3)(d) of the Code). The advertisement

did not include these mandatory statements.

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

44. The Panel found, however, that the advertisements, by including the words “Arnica 6x”, did not

breach section 6(3)(c) of the Code, which requires the inclusion of a list of ingredients or the words

“always read the label.”

45. The Panel found, therefore, that this aspect of the complaint was not justified.

Sanctions

46. The Panel requests Weleda Australia Pty Ltd, Rudolf Steiner Book Centre, Echolife Australia Pty

Ltd and Natural Chemist, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods

Regulations 1990:

a) to withdraw their respective advertisements from further publication;

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

advertised product or its ingredients offer benefits in relation to:

i) relief or healing of bruises, pain, or swelling of strained or sprained tissue or muscles after

injury or surgery;

ii) tissue healing and recovery after surgery;

iii) recovery after sport;

iv) tissue damage from exercise;

v) healing and recovery in cases of “tissue ailments”;

vi) calming after accidents and trauma; and,

vii) anti-inflammatory and pain-relieving effects;

together with any claims conveying or implying that:

viii) the advertised product has therapeutic effects;

ix) the advertised product contains a non-negligible amount of an active ingredient that works

in the manner of a conventional medicine or herbal medicine;

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

advertisement*;

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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 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.

47. The advertisers’ 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 18 May 2018

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: Excerpts of the Advertisements

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.

)

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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.

22

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.

23

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/

24

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