Tuesday, 27 February 2018

US Regulation of Homeopathy #2 - Advertising of Homeopathic Drugs

US regulation of advertising is a patchwork of Federal and State legislation and regulation. It is highly dependent on the Courts in a way that other foreign jurisdictions are not. It does not have effective voluntary regulation in the way that the UK does with the Advertising Standards Authority (ASA) - a model that has been adopted in many countries.

This is not intended to be a totally comprehensive guide to legislation that affects advertising of homeopathic drugs. That would be huge. This is meant to be more illustrative.

Federal Trade Commission
The FTC has wide ranging responsibilities and powers. Part of its mission is consumer protection. This includes dealing with misleading advertising and marketing practises. In theory, there is a crossover between the FDA and FTC in terms of responsibilities but the convention is that the FDA deal with claims for prescription only (Rx) drugs and the FTC over the counter (OTC) drugs. As discussed in a previous post, how the FDA regards a homeopathic drug is not always straightforward.

It is worth pointing out that the FDA and FTC cooperate, especially on more serious cases. There is not the kind of turf war that can exist between government departments. The FTC has numerous formal and informal cooperation agreements with other bodies, both national and international.

One of the FTC's powers is to rulemaking. It can impose "trade rules" on particular industries. One commonly cited example is the Funeral Rule - which largely eliminated dubious trading practices in the funeral homes industry. But "trade rules" can be broader than a single industry - they can also be about a type of business behaviour. 

Whilst a full discussion of the FTC's history is beyond the scope of this blog, let alone this post, it is important to mention that US history has important lessons regarding what unfettered capitalism can result in. Anti-trust law came into being to prevent the worst excesses of increasingly powerful commercial interests.

Federal Trade Commission Act et al
The Federal Trade Commision Act (Act) dates back to 1912 and has been subject to a large number of amendements. One of its provision relates to the creation of the Federal Trade Commission.

Unfortunately, the Act is not always particularly helpful in itself. Some provisions are very broad. It is the interpretation of the Act by the FTC, its Commissioners and the Courts that matters. Fortunately, there are documents that help, including one that the FTC thinks highly significant...

The Address on THE ADMINISTRATION OF THE FEDERAL LAWS RELATINGTO FALSE AND MISLEADING ADVERTISINGBY THE FEDERAL TRADE COMMISSION (Address) was made in 1940 by Garland S Ferguson. Despite the age of the Address, many of the issues it raises about misleading advertising are still, unfortunately, relevant today. It is also a model of clarity. 
The original Federal Trade Commission Act, in Section 5, declared unlawful, and empowered and directed the Commission to prevent, unfair methods of competition In commerce. The Act did not define the term "unfair methods of competition" but left its meaning and Interpretation to the courts on review of the Commission's orders. 
During the twenty-five years of its existence hundreds of the Commission's orders have been reviewed by the United States Circuit Courts of Appeal and many by the Supreme Court of the United States. Many more have become effective because they have been accepted without appeal. The result is that now almost every conceivable competitive practice has been defined and legal determination made as to whether it amounts to an unfair method of competition within the meaning of the statute. Among such unfair trade practices are included the following: false and misleading advertising; mlsbranding, mislabeling and misrepresenting products as to composition, origin, quality or source; passing off one's goods as those of another; disparagement of competitors' business or merchandise; causing breach of contract between competitors and their customers or employees; sale of products by means of lottery devices; unfair use of patent rights; combination or conspiracy to maintain or control prices; combination or conspiracy between competitors to hamper or obstruct the business of rivals; combination or conspiracy to refuse to sell or refuse to buy where the effect is to suppress competition; combination or conspiracy to obstruct the source of supply of a competitor; commercial bribery; threats of litigation not in good faith; full line forcing; and white-listIng, black-listing, and other forms of concerted boycott.
Some of the terms may be unfamiliar. For example, "full line forcing" - which is the practice of a manufacturer forcing a distributor/retailer to carry the whole range of their products regardless of whether they will sell or not.

Initially, the Act dealt with misleading advertising in terms of unfair competition but this lead to certain problems,
We were confronted with serious problems, such as the appearance on the market of a new nostrum or device, the manufacturer advertising that it would "cure" almost all the ills of the human race. As an instance, I want you to note the advertising claims which, prior to the Commission's cease and desist order, were used by a concern known as the Gravitonic Life Ray Corporation. This company was claiming that its device -  
"Is a cure or remedy for sinus trouble and infections, sleeping sickness, tuberculosis, stomach and gall bladder troubles, diseases of the kidneys, arthritis, gland disorders, diabetes, tumor, prostate trouble, colds, dizziness, anemia, cancer, chronic indigestion, acute appendicitis, colitis, dyspepsia, nervousness, spinal trouble, high blood pressure, tonsilitls, catarrh, mastold and ear trouble."  
In such cases the Commission, of course, had great difficulty in proving the existence of actual competition. However, in 1938 Congiress passed the Wheeler-Lea Act which amended our original Act declaring unlawful, not only unfair methods of competition, but also "unfair and deceptive acts and practices" in commerce.
The Gravitonic Life Ray machine was the invention of one Frederick Finch Strong who was apparently a follower of Albert Abrams.
The amended Act, which was approved on March 21, 1938, is designed specifically to protect the public by making unlawful the dissemination of false advertisements of food, drugs, devices and cosmetics: "When such dissemination is by the United States mails, or in commerce by any means, for the purpose of inducing, or which is likely to Induce, the purchase of such commodities;  
Also, when such dissemination Is by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase In commerce of those commodities." 
By virtue of this amendment, the necessity of establishing an unfair method of competition and showing Injury to competition was dispensed with, and the dissemination or the causing of the dissemination of the false advertising has become an "unfair or deceptive act or practice", and as such is unlawful. 
The text of the Wheeler Lea Act can be found here in its orginal form. Section 52 - Dissemention of false advertisements - doesn't add anything to the Address.
The amended Act has armed the Commission with four forms of corrective procedure against offenders. These are as follows:  
(1) Order to cease and desist; 
(2) Civil penalties of not more than $5,000 for each violation of a cease and desist order after It has become final; 
(3) Enjoining the dissemination of any false advertisement of a food, drug, device, or cosmetic where the Commission has reason to believe that it would be in the Interest of the public to enjoin such dissemination, pending the issuance and until final disposition is made of its complaint under Section 5; 
(4) Criminal penalties or fines as high as $10,000 or imprisonment up to one year, or both, (a) when the false or misleading advertisement is with reference to a food, drug, device or cosmetic which may be injurious to health when used under the conditions prescribed In such advertisement, or under customary and usual conditions; or (b) when the advertisement is disseminated with the intent to defraud or mislead, regardless of whether the product Is or Is not Injurious to health.
Section 53 - False advertisements; injunctions and restraining orders gives the FTC to seek Court orders to prevent advertising - which does include the internet. Section 54 - False advertisements; penalties is self explanatory. The fines have not changed - which is surprising. It also exempts broadcasters, publishers, etc from prosecution. It is the manufacturer/vendor that is held liable, not the medium. To quote -
No publisher, radio-broadcast licensee, or agency or medium for the dissemination of advertising, except the manufacturer, packer, distributor, or seller of the commodity to which the false advertisement relates, shall be liable under this section by reason of the dissemination by him of any false advertisement, unless he has refused, on the request of the Commission, to furnish the Commission the name and post-office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the United States, who caused him to disseminate such advertisement. No advertising agency shall be liable under this section by reason of the causing by it of the dissemination of any false advertisement, unless it has refused, on the request of the Commission, to furnish the Commission the name and post-office address of the manufacturer, packer, distributor, or seller, residing in the United States, who caused it to cause the dissemination of such advertisement.
There are some grey areas - products that are "fulfilled by Amazon" for example.

Section 55 - Additional definitions provides some additional useful information.
(1) The term "false advertisement" means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual. No advertisement of a drug shall be deemed to be false if it is disseminated only to members of the medical profession, contains no false representation of a material fact, and includes, or is accompanied in each instance by truthful disclosure of, the formula showing quantitatively each ingredient of such drug.
This provision makes clear that the omission of information can be misleading. In the case of homeopathic drugs, this could be interpretated as indicating the need for disclamiers - advertisements must explain that there is no evidence of efficacy to avoid being misleading. It exempts advertising of drugs aimed at medical professionals which is purely factual. As which professions are classed as "medical" can vary by State, there is scope for confusion. However, advertising to medical professionals is generally restricted to direct mail and specialist trade publications and their electronic counterparts.

Returning to the address - 
Another Important amendment to the original Act was the limitation of the time for appeal from an order to cease and desist. In the original Act there was no limitation, but the Wheeler-Lea Act provides that our orders shall become final, unless an appeal is taken within sixty days. Under the original Act there was no penalty for failure to comply with an order of the Commission. If the Commission discovered that Its order to cease and desist was being violated, a petition for enforcement was filed in the Circuit Court of Appeals within the circuit In which the respondent was domiciled, or in the Circuit Court of Appeals within any circuit where the violation occurred. If the Court held that the Commission's order should be affirmed, and so ordered, and the respondent continued the unlawful practices, such respondent could be fined or imprisoned for failure to obey - not the order of the Commission, but the order of the Court. Since approval of the Wheeler-Lea Amendment, we have been able to detect a very marked improvement in advertising. Unscrupulous vendors who formerly had the temerity to resist the Commission's orders are now faced with the possible assessment of civil penalties up to $5,000 for each violation.  
Section 56 - Commencement, defense, intervention and supervision of litigation and appeal by Commission or Attorney General is where the 60 day limit to appeals is implemented. This section also outlines the processes of litigation. It also empowers the FTC to litigate in foreign Courts although whether local laws allow this is another matter. Some attempt to evade the FTC by basing themselves outside of the US even though their primary market are US consumers.

FTC Enforcement Actions
The FTC has rarely acted against vendors/manufacturers of homeopathic drugs. When it does, it is generally part of broad initiatives. 

As mentioned in the previous post, the FDA and FTC did cooperate in issuing joint Warning Letters as part of the homeopathic hCG initiative but it also fitted with the FTC's long running inititiatives against bogus weightloss products. This is best understood by looking at the case of HCG Platinum/Right Way Nutrition. 

The initial Warning Letter was issued in November 2011. It mentions the violations of the FDCA and then goes onto say -
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well‐controlled human clinical studies, substantiating that the claims are true at the time they are made.
And -
More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.
It goes on to instruct Platinum HCG to respond in 15 working days to explain what steps they have taken to remedy the violations. It clearly states -
FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or an Administrative Cease and Desist Order. An order also may require that you pay back money to consumers.
It is unknown what, if any, response Platinum HCG made. As will be seen, Platinum HCG carried on selling the product. 

What is known is that FTC started proceedings. A timeline of the case and its links reveal the size and scope of the fraud. To say it is instructive is a gross understatement. The time the legal process took may come as a surprise.

The FTC issued a press release.

The intial Application for Permanent Injuction and other Equitable Relief tells us a great deal. It contains the evidence that the FTC presented to the Arizona District Court for one thing. Many things in the application are interesting, but legal details aside, Platinum HCG made $13 million dollars in sales over a period of 2-3 years. The product was sold not just online through the HCG Platinum website but also by major retailers such as GNC and Rite Aid among others. It may seem astonishing that such retailers would even stock such products but as this press release reveals, many dubious products can be end up in OTC drug and/or supplement supply chains. The application also revealed somewhat complicated corporate arrangements with monies moving between different companies. It also showed Carmen Electra on some of the packaging.

An application was made to move the case from Arizona to Utah. In itself, this is purely a procedural matter but it does reveal that Kevin Wright was made bankrupt in 2002. Whilst the details of this are unknown, Wright and his wife attempted to appeal elements of the decision. It would appear that the bankruptcy stems from an industrial injury claim made by an employee of Wright and Wright not having workers' compensation insurance which is mandatory in Arizona (with a few exceptions).

A statement from then Chairwoman Edith Ramirez and Commissioner Julie Brill of the FTC reveals something interesting in that the FTC have a two positive randomised controlled trial standard for marketing claim substantiation. However a statement from Commissioner Joshua Wright argues against a rigid definition. This is moot given that Platinum HGC offering no substantiating scientific evidence for claims.

The Judgement of the Utah District Court was delivered on 8th December 2014 - more than three years after the initial Warning Letter was issued. The Court imposed a $1 million settlement (potentially to increase to $10 million). It also placed prohibitions on Wright et al on making weight loss claims, not just specific claims either. It also ordered cooperation with the FTC, the turning over of customer information and for the next 20 years inform the FTC of changes to personal and corporate contact details.

Unfortunately, the Platinum HCG website would appear to still be making the same claims although the shopping element no longer functions. Wright may find himself back in Court.

Wright was represented by Leonard L Gordon of Venable LLC. His CV makes for interesting reading - although not strictly relating to homeopathic drugs, the Daniel Chapter One case makes for extraordinary reading. Also, Venable LLC will be mentioned in a future post.

But the FTC action is not the whole of the story. Wright et al became involved in various legal actions involving parties such GNC and Preferred Product Placement Corporation. It would appear that Platinum HCG is/was only part of his business. Supplements under the Right Way Nutrition brand form a substantial part of the business.

This is not unique. There do seem a number of supplement vendors/manufacturers that supply non-compliant homeopathic drugs with ingredients that do not appear in HPUS and make incredible claims whereas long established vendors/manufacturers supply products with ingredients that do appear in HPUS and make misleading claims to treat self limiting conditions. This will be explored in a further post.

State Bodies and Laws
The structure of State governments and their departments varies. Consumer protection departments fall under States' Department of Justice.

Whilst State laws vary, many States have adopted the Uniform Deceptive Trade Practices Act (UDTPA). Those that haven't, have something very similar generally only varying in wording rather than meaning.The National Consumer Consumer Law Centre (NCLC) published a report back in 2009 that is informative. Some things may have changed but it paints a picture of highly variable levels of consumer protection and redress. It also describes varying barriers to obtaining justice - in terms of not being able to recover attorney fees, exempting whole industries and placing burdens of proof on the plantiff rather than the defendant. 

This guide to the deceptive practices laws in Georgia is helpful. Georgia has implemented the UDTPA but according to the NCLC Report Georgia makes it difficult for consumers to seek redress.

§ 10-1-372. When trade practices are deceptive; common-law and other remedies unaffected resembles the FTC Act in that it doesn't spell out what deceptive trade practices are in terms of advertising. That comes later on. Mention of common law is important but implications are are too complex to explain in a blog. Case law is important, hence why cases are discussed.  § 10-1-373. Enjoining deceptive trade practices; costs and attorney's fees; relief cumulative allows injured parties to seek injunction against deceptive trade practices. It does require proof of damages or intent. 

 § 10-1-421. False or fraudulent statements in advertising prohibited; broadcaster or publisher acting in good faith excepted; penalties states -
  • (a)  No person, firm, corporation, or association or any employee thereof, with intent directly or indirectly to dispose of real or personal property or to perform services, professional or otherwise, or to do anything of any nature whatsoever to induce the public to enter into any obligation relating thereto, shall make or disseminate or cause to be made or disseminated before the public in this state, in any newspaper or other publication, radio, television, or advertising device or by public outcry or proclamation or any other manner or means whatever, any statement concerning such real or personal property or services, professional or otherwise, or concerning any circumstances or matter of fact connected with the proposed performance or disposition thereof which is untrue or fraudulent and which is known or which by the exercise of reasonable care should be known to be untrue or fraudulent.
  • (b)  Nothing in this Code section shall apply to any visual or sound broadcasting station or to any publisher or printer of a newspaper, magazine, or other form of printed advertising who broadcasts, telecasts, publishes, or prints such advertisement in good faith without knowledge of its false or fraudulent character.
  • (c)  Whoever violates this Code section shall be fined not less than $200.00 nor more than $1,000.00 or imprisoned not more than 20 days, or both.
Compared to the interpretation of the FTC Act, there is no discussion of omission. Also note the lesser penalties compared to the FTC Act.

§ 10-1-422. Degree to be designated in advertisements using "Doctor" or "Dr."; penalty for violation whilst not relevant to the advertising of homeopathic drugs may be relevant to advertising of services by those that use homeopathic drugs. This will be discussed in a future post. § 10-1-423. Enjoining prohibited advertising empowers a superior court to forbid advertising. Different terms for "superior court" are used in other States.

One key thing is about State consumer protection laws as opposed to the FTC Act is that can they allow persons other that Attonery Generals to mount a case. This is seen in the form of class actions - although note that some States prohibit class actions on certain consumer protection matters.

Class Actions
There have been a number of class actions against vendors/manufacturers on the grounds of misleading advertising. 

Perhaps the clearest and easiest to follow is Forcellati et al v. Hyland's Inc - part of the settlement was that a website was set up that detailed the settlement and allowed consumers to file claims for damages. This is likely to increasingly form part of future settlements. Note that the case is heard in California. Whilst Californian consumer protection has its deficiencies, it is among the better States. Also, Hyland's is based in California.

The initial complaint is worth reading in its entirity but in short the class action relates to misleading claims for the following Hyland's products -

  • Cold ’n Cough 4 Kids
  • Cough Syrup with 100% Natural Honey 4 Kids
  • Sniffles ‘n Sneezes 4 Kids
  • Cold Relief Strips 4 Kids with Zinc
  • Complete Flu Care 4 Kids
  • Nighttime Cold ‘n Cough 4 Kids
The claims challenged where that the products were -
  • “Fast acting”
  • “Safe & Effective”
  • Offered  “Multi-symptom” relief from cold and flu symptoms, including -
  • Runny noses
  • Sore throats
  • Coughs
  • Headaches
  • Body aches
  • Flu
  • Congestion
Plaintiffs alledge that they bought these products on the basis of misleading advertising and that they turned out to be neither fast acting or effective. The advertising took many forms and made many additional claims. Some elements of the Hyland's marketing tactics were questionable. To quote from the Complaint -
F. Hyland’s Markets Its Cold And Flu Remedies By Creating Fear And Distrust Of Conventional OTC Medicines  
57. To profit from FDA warnings concerning conventional OTC cold and flu medicines and the near flu hysteria which began in 2009, Hyland’s promoted its Cold and Flu Remedies through false and misleading print advertisements, television advertisements, Internet advertisements and press releases. Not only does each of these advertisements falsely claim that Hyland’s products are fast acting and effective for the treatment of cold and flu symptoms, but many such advertisements also attempt to stoke parents’ fears of competing products that may actually be effective. 
58. For instance, an edition of Hyland’s online newsletter raises questions about each medically accepted treatment for cold and flu symptoms, including conventional non-homeopathic OTC drugs, antibiotics and even flu shots, which the United States Center for Disease Control (the “CDC”) recommends to everyone older than 6 months of age (the “Newsletter”). The Newsletter states: 
"Over-the-counter (OTC) medications for cold and flu may include a pain and fever reducer, such as acetaminophen or ibuprofen, antihistamines, decongestants and/or cough suppressants. Potential side effects of OTC cold and flu medications include: allergic reactions; liver damage; easy or unusual bleeding or bruising; drowsiness; dizziness; fainting; dry eyes, nose, and mouth; blurred vision; difficulty urinating; or excitation in children. Considering the side effects and possible drug interactions, OTC medications should be used with caution. Antibiotics continue to be overused, but they are not effective treatment against colds and the flu. Antibiotics fight off bacteria, but colds and flu are caused by viruses. Tamiflu is one antiviral that has been recommended by the Centers for Disease Control. However, one of the side effects, particularly in children, may be at increased risk for selfinjury and delirium. The FDA's safety information and adverse event reporting program has sent alerts to physicians advising them to closely monitor their patients for signs of abnormal behavior. One other option is a flu shot. But an article in the October 28, 2006 issue of British Medical Journal questions the evidence of safety and effectiveness of the flu shot. Some of the known possible adverse effects of flu shots include fever, malaise, muscle aches, irritability, insomnia and allergic reactions (e.g., hives, swelling, asthma and anaphylaxis). 
59. The Newsletter goes on to laud the safety and efficacy of Hyland’s homeopathic products over the dangerous products recommended by the CDC, noting: Some of the products that appear to be particularly helpful for colds are Hyland’s Cold Plus C Tablets and Hyland’s Cold ‘n Cough 4 Kids. These products contain a group of homeopathic medicines that help relieve symptoms of the common cold. In addition, Hyland’s Cough Syrup with 100% Natural Honey 4 Kids is safe for children over 2 years old. For flu, Hyland’s Complete Flu Care and Hyland’s Complete Flu Care 4 Kids include some of the top remedies for flu symptoms. For example, some of the medicines in Complete Flu Care 4 Kids specifically help relieve body aches associated with fevers. Other ingredients help with weakness, sleepiness and chills and relieving inflamed and eyes and runny noses. 
There is more but the above is sufficient to demonstrate scare-mongering. Hyland's issued press releases, a brochure that all promoted that the ideas that conventional OTC drugs were dangerous and Hyland's products were safe and effective.

The Complaint includes a great deal of evidence of the lack of efficacy of homeopathic drugs. It cites numerous studies and official investigations.

Whilst interesting in revealing how the US and California legal systems work - ie slowly and with a great deal of complexity and cost - many of the documents will be of little interest to the casual reading. What they do reveal is that Settlement was reached "on the eve of trial". It is important to note that jury trials are expensive and time consuming. If a jury found Hyland's guilty, costs would have been awarded against them.

The Settlement imposed the following on Hyland's
  • The payment of monies corresponding to upto two items to class members without proof of purchase
  • The payment of monies corresponding to all items to class members with proof of purchase
  • Money-back guarantee on website
  • Payment of costs to the Settlement administrator (ie the company that would deal with claims by class members, etc)
  • Payments of $5,000 to the class representives (ie the named plantiffs) in recognition of their time and efforts
  • Payments not to excede $2.9 million to pay Class Counsel fees (ie the lay firms that represented the plantiffs)
Hyland's at no point admitted liability. Essentially, that matter is unresolved and there is nothing to prevent further Complaints being raised that could eventually result in jury trial and finding of liability.

However, the case of Allen v. Hyland's paints a very different picture as explained in this article published by Jurimetrics. In short, a previous class action went to jury trial and Hyland's were found not guilty of misleading consumers. This is a perverse finding. There are multiple problems with the case and the trial. One of the key ones is that Court allowed submission of "expert" statements and testimony without any critical evaluation - contrary to Federal Rules Of Evidence - in particularly the Daubert standard. It gave equal, if not greater standing to anecdotal evidence. Plantiff's application to disregard was denied. Secondly, the Court instructed the jury that to find in favour of the Plantiff, they would have to decide that homeopathic drugs can not work - which is a harder test (in combination with allowing anecdotal evidence from unreliable "expert" witnesses) than, say, having an effect that is consistent with and no greater than placebo. This may not the end of the matter.

Something somewhat similar happened in the case of Rosendez v Green Pharmaceuticals although the case does include a forceful dismissal of the testimony of Dana Ullman -
The Defendant presented the testimony of Gegory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman's testimony to be not credible. Mr. Ullman's bias in favor of homeopathy and against conventiona medicine was readily apparent from this testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted. 
Mr. Ullman's credibility was undermined by his adission that he advocated the use of a radionics machine, whereby a physician puts a picture of his patients on on side, and a few medicines on the other side, and then sees which o the medicines the needle points toward. He relied on his personal experience with a radionics machine. 
Mr. Ullman's testimony wa unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.
A class action had been brought against Green Pharmaceutical and their SnoreStop product on the basis of misleading advertising. The bench trial resulted a ruling that stated that the Plantiff had not met the treshhold of proving the advertising misleading despite the Court expressing skepticism as to the efficacy of SnoreStop.

The case was appealed and the judgement overturned. Again, it makes for very interesting reading for the legally inclined reader. The Court stated that the Plantiff had satisfied the necessary burden of proof and in particular that they provided a witness who gave "uncontradicted and unimpeached expert testimony". This case is a rich source of other cases -

Hammock v. Nutramarks, Inc. et al

Something that crops up in National Council Against Health Fraud, Inc. v. King Bio Pharmaceuticals, Inc. and elsewhere is the concept that that the FDCA allows homeopathic drugs that are listed in HPUS some immunity from claims that advertising is misleading. This is not the case but the idea does seem to have a hold over some. This will be mentioned in a future post. 

Voluntary Regulation etc
To readers in jurisdictions that do have have voluntary regulation of advertising that is generally abided by and unambiguous status of homeopathic drugs, all this business of class actions and courts will seem incredibly alien.

There is some voluntary regulation of advertising in the US and also the possibility of alternative dispute resolution without recource to courts. The Better Business Bureau is a voluntary organisation that accredits paying members. It is strangely structured in that is, in fact, a number (106 at time of writing) of local organisations that cover the US and Canada that operate under the umbrella of the Council of Better Business Bureaus (CBBB), which sets the rules for accreditation. There are some questions regarding the utility of accreditation and the ratings provided by the BBB but they do offer alternative dispute resolution services to consumers. The businesses involved do not have to be BBB accredited but there is no obligation on them to participate.

The National Advertising Division (NAD) of the CBBB does routinely monitor advertising in national media. It also accepts complaints from consumers and competitors regarding individual advertisers. Whilst it claims to "enforce" certain standards of advertising, compliance with its findings is voluntary. It is unclear what levels of voluntary compliance are acheived. However, the NAD will refer to the FTC when voluntary compliance does not occur.

It is also the case that the BBB does provide some consumer education resources and also advertising regulation compliance guidance for members.

Whilst not offering voluntary regulation themselves, there are a number of consumer groups that campaign on, amongst other things, misleading advertising. Mostly, their impact is in terms of investigation, reporting on finding and bad publicity for advertisers that results, especially if the story is picked up by national media. The impact of unfavourable reporting varies but in addition to causing consumers to avoid products, it can also spur regulators into action. Some consumer groups will also mount legal actions in the same manner as class actions. Most do provide consumer education materials and some also lobby Federal/State Government and legislators. 

One of the most relevant groups is Truth in Advertising (TINA). TINA engages in a number of activities such as sending letters to business advising them of problems with their advertising and advising them that they will refer the matter onwards to the FTC and/or relevant State Attorney General if they do not comply. TINA conducts investigations and issues press releases - some of which do get picked up by national media. TINA also monitor advertisers post settlements in FTC cases/class actions/etc and if the breach the terms of settlement, report them to FTC/and or relevant State Attorney General. TINA has challenged proposed settlements to class actions in the role of amicus curiae.

TINA also reports on some news stories relating to regulatory and legal issues. It also has a class action tracker that is potentially useful. A search on their site using "homeopathy" as a term returns some interesting results.

Certainly, some of issues that have come to light during research may well be suited to TINA's self-declared remit.

1 comment:

  1. Homeopathy and Homeopaths are under pressure to comply with advertising standards. The latest ASA rulings mean that they must have rigorous evidence for any claims made.

    Thank you for keeping an eye on this industry and for going to so much trouble to keep us all informed.