Thursday, 1 March 2018

US Regulation of Homeopathy #3 - Recent Developments etc

There have been a number of developments over the past year or so that have significant implications for manufacturers and vendors of homeopathic drugs. It is suggested that readers may find this post difficult to follow without having read previous posts on the regulation and enforcement of laws relating of the manufacture and advertising of homeopathic drugs. 

FTC Enforcement Policy
The FTC published their Staff Report on the Homeopathic Medicine and Advertising towards the end of 2016. It is an astonishing document in several ways.

US consumer awareness of what homeopathic drugs are would appear to be poor. Anecdotally, looking at social media etc, it would seem that many US consumers are unable to distinguish between the homeopathic drugs and herbal products. There also seems to be a thread of thinking it is home-opathy - home remedies and tied up with ideas about folk medicine.
Ms. Candace Corlett, president of WSL Strategic Retail, which monitors changes in consumer thinking and behavior, described the results of an unpublished, mid-2013 survey that her company conducted of purchasers of homeopathic products. Of those surveyed, 37% learned about their homeopathic medication through some form of recommendation; 18% did their own online research; and 12% learned about it through traditional advertising. Over the course of a year, 52% purchased a homeopathic product from a drugstore, 48% bought from a mass merchant, about 30% purchased in a supermarket, 17% to 20% bought from a specialty food or vitamin store, and 14% made purchases on the Internet. There did not appear to be any geographic trends in terms of homeopathic usage. Thirty-eight percent of the homeopathic product purchasers surveyed felt that they clearly understood what “homeopathic” meant. The survey found that 60% to 73% of homeopathic product purchasers were satisfied with the performance of the homeopathic treatment they used and half of the people who used a homeopathic medication for one condition went on to use a homeopathic treatment for other conditions. Mr. Land said that such levels of satisfaction would not be explained by the placebo effect based on his assertion that the “placebo effect … is probably around 30%.”
38% of purchasers felt that they clearly understood what "homeopathic" meant? To put this into context, a footnote in the report states -
For comparison, 50% of the homeopathic product purchasers said they felt they had a clear understanding of what “natural” meant and 52% felt they had a clear understanding of “organic.” A panelist on a subsequent panel noted that the survey did not test whether consumers who thought they knew what “homeopathy” was actually did.
Of course that consumers feeling that they understand something does not mean that they do.

The FTC commissioned some consumer research of its own.
FTC staff worked with Shugoll Research to conduct focus groups exploring the extent to which consumers understand the differences between various non-prescription health-related products including conventional, herbal, and homeopathic products. Shugoll Research conducted two focus groups in Baltimore, Maryland in late 2010. One focus group included eight general adults while the other included eight parents of young children.
This research found that -
Focus group participants in both groups were likely to group or categorize products in a number of ways including conventional versus non-conventional. They tended to group all nonconventional products, including homeopathic products, into a single category, using the terms “natural,” “herbal,” and “homeopathic” interchangeably. Most adults and parents struggled when asked to distinguish between herbal and homeopathic products. They did not understand what “homeopathic” means. Most participants associated homeopathic products with natural or “non-chemical” products.
Even those who had purchased homeopathic products were unfamiliar with the principles underlying homeopathy. When those principles were explained to participants, they found them confusing; some parents were motivated by the relatively few side effects of homeopathic products, while the explanation of how homeopathy was supposed to work made other parents and adults question the effectiveness of homeopathic products. Furthermore, most adults and parents said they were more likely to continue to use the conventional non-prescription products with which they were familiar and unlikely to purchase homeopathic products without an express recommendation from a trusted source due to their skepticism about the effectiveness of such products. 
As the Report states, many consumers become confused when the serial dilution and agitation processes involved in the manufacture of homeopathic drugs is explained. However, the Report does not indicate whether the vitalistic nature of homeopathy was explained - that homeopathic drugs purportedly contain "dematerialised spiritual essences" rather than active ingredients. The nature of homeopathy was discussed here.

The idea that consumers are less likely to purchase homeopathic drugs if they understand the nature of the products poses all sorts of problems for the industry. To a degree, sales are dependent on consumer ignorance and consumer education could lead to a decrease in sales. This is likely to apply to the practice of homeopathy too.

The focus groups also revealed that -
Many adults and parents did not readily differentiate between different product types in terms of the evidentiary requirements for product claims or regulatory oversight. While they generally believed that manufacturers of conventional non-prescription products were required to support their claims with scientific evidence, they had varying opinions regarding the evidentiary requirements and federal oversight for herbal and homeopathic products. Some participants indicated there were no requirements, others insisted there must be some governmental oversight, and still others were unsure but hopeful that there were requirements.
The FTC also commissioned a "copy test". 
Dr. Manoj Hastak, a professor of marketing at the Kogod School of Business at American University and a consultant for the FTC, designed a research study to investigate consumer understanding of claims made on homeopathic product packages. The study tested three different homeopathic products: a Similasan product that claimed to relieve cold-related symptoms in children, a Boiron product called Oscillococcinum that claimed to relieve flu symptoms, and a Hylands product called Arnica that claimed to relieve pain. The study was conducted via an online panel.
Consumer understanding of efficacy claims will be discussed shortly but -
The copy test results revealed that many consumers mistakenly believed the FDA had approved the homeopathic products for efficacy. After controlling for “yea saying,” the copy test showed that between 10% and 29% of respondents exposed to the original product packaging for the three products indicated that they believed that a government agency like the FDA had approved the products for efficacy. Although making the word “homeopathic” more prominent on the Similasan label significantly reduced the belief that the product was FDA approved (down to 11%), it did not have a similar effect for either the Oscillococcinum or Arnica products. Likewise, at least one of the two disclaimers used in this study significantly reduced the misperception of FDA approval for each product. However, after controlling for “yea saying,” the copy test showed that 19% of respondents exposed to the Similasan product packaging with the disclaimer still believed that a government agency like the FDA had approved the product for efficacy, as did 7% to 8% of respondents exposed to the other two tested products. As noted in FTC staff’s comment to the FDA, it is possible that different or more prominent disclaimers could further reduce the percentage of consumers with the misperception that homeopathic products are FDA approved. This research suggests the persistence of mistaken consumer beliefs about government approval for homeopathic products.
 Some vendors do imply FDA approval of products. Some products are marketing with claims such as "FDA approved manufacturer" and use the FDA logo. Manufacturers are registered, not approved. The FDA takes a dim view of this. Meaningless faux symbols of "approval" are also sometimes used - the Non GMO Project logo is one example. "Physician approved" or "Pharmacist recommended" are other example - these statements could well be true and they are couched in terms of the singular - but are designed to mislead, especially when the physician involved turns out to be a naturopath. In many States, naturopaths would not be recognised as physicians.

The Copy Test also revealed that -
The copy test results also showed that consumers mistakenly believed that the manufacturers of homeopathic products had tested their products on people in order to show their effectiveness. After controlling for “yea saying,” the copy test results showed that from 23% to 34% of respondents exposed to the original product packaging indicated that they believed the manufacturers had tested the product on people to show its effectiveness. The disclaimers used in this study did not significantly reduce the misperception of human testing. After controlling for “yea saying,” the copy test showed that from 23% to 26% of respondents exposed to product packaging with the statement, “This product has not been shown to relieve … symptoms” still indicated that they believed that the products had been tested on people in order to show their effectiveness, as did 26% of respondents exposed to the packaging with the statement, “The ingredients in this product have not been tested for effectiveness.” Again, it is possible that different or more prominent disclaimers could further reduce the percentage of consumers with the misperception of efficacy established by human testing.
The misperception of human testing is problematic. It could be as with FDA approval consumers are making the assumption that what is true for OTC non-homeopathic drugs is also true for homeopathic drugs.

The American Association of Homeopathic Pharmacists (AAHP - a trade organisation that represents some manufacturers) also conducted consumer research.
The purpose of the first AAHP study was to determine consumers’ perceptions of the FDA approval status of labeling claims for a variety of product categories, including homeopathic products. The survey population was a nationwide sample of adults. Respondents were asked a closed-ended question about their understanding of whether the FDA approves labeling claims for each of the product categories.
This study revealed that -
A total of 159 respondents completed the first AAHP study. As reported, 78% of the respondents had previously purchased a homeopathic product and another 11% did not know or were not sure if they had done so. The vast majority of consumers surveyed (85%) believed the FDA approves prescription drug claims, while 76% of respondents believed the FDA approves claims for over-the-counter medicines. Less than a quarter of respondents (24%) believed the FDA approves claims made for homeopathic products, which is lower than the percentage of consumers who believe the FDA approves claims for every other product category, including pet foods (39%), cosmetics (40%), dietary supplements (48%), and grocery foods (64%).
That 78% of respondents had previously purchased a homeopathic product means that the study is unlikely to be representative of consumers as a whole. It is generally known that the market for homeopathic drugs is small compared to the markets for OTC drugs and supplements. Indeed, the AAHP themselves cited an NIH stufy that suggests that only 2.2% of consumers used homeopathic drugs in 2012.
According to Dr. Maronick, these results indicate that consumers have a better understanding of the FDA approval status of claims made for homeopathic drugs than the FDA approval status of claims for other product categories that are not approved, such as grocery foods, dietary supplements, cosmetics, and pet foods. According to the AAHP comment, the study suggested that most consumers can differentiate between allopathic OTC products and homeopathic OTC products.
The FTC commented that -
Contrary to the AAHP’s assertion, nothing in the first AAHP survey suggests that consumers can differentiate between allopathic and homeopathic OTC products on the store shelf or in advertising. Furthermore, whether or not consumers think that homeopathic product claims are approved by the FDA is not dispositive as to whether consumers are misled about the support for homeopathic claims.
The second piece of research commissioned by the AAHP examined the effect of different disclaimers on consumer perception of a ficitious homeopathic drug.
The survey population was a nationwide sample of adults who had purchased a product to relieve heartburn over the prior year. Approximately 450 respondents completed the study, with approximately 150 exposed to each of the three different disclaimer statements.
The study is flawed in a number of ways. Most significantly, the scenario of directing consumers to view an enlarged version of packing is highly artificial and ignores the questions of whether in real life disclaimers are read and if so, whether they affect purchasing decisions. The FTC believed that many of the questions were confusing to consumers. The FTC noted that certain questions were not asked - it did not ask about consumer beliefs about the product and homeopathic drugs.

The FTC stated -
The second AAHP study does not demonstrate that the tested disclaimers would be effective without forced exposure, and does not demonstrate that even with forced exposure they stop consumers from expecting a product’s efficacy claims to be supported by scientific or other reliable evidence. To the contrary, the results suggest that at least a significant proportion of consumers would be deceived despite directed exposure to the disclaimers. 
The Staff Report also contains what can be best described as attempts by the AAHP et al to reconcile their desire to make marketing claims and yet not mislead consumers. The lack of effectiveness of disclaimers makes this an impossible balancing act.

The Staff Report also contains information from submission from individuals/organisations not present at the workshop. Most of it is uninteresting. The United States Homeopathic Regulatory Commission (USHRC) is an organisation that appears to have no internet presence but it would appear to be linked to the American College of Medical Homeopathy (AMCH).
Among other things, the USHRC critiqued the FTC’s homeopathic consumer research and argued that homeopathic purchasers have much greater understanding of homeopathic products than suggested by the research. It argued that because the focus groups commissioned by the FTC were five years old, conducted in just one city and involved just 16 individuals, they are not sufficiently representative of homeopathic product purchasers for their results to be the basis of policy decisions. With respect to the larger Hastak study, the comment noted the data was over three years old and that the survey did not inquire about the participants’ prior experience with homeopathic products or their knowledge of homeopathy.
Suggesting that consumer understanding can rapidly change?
The USHRC asserted, based upon a 2014 survey conducted by the American Medical College of Homeopathy’s Department of Research (AMCH) of over 1,000 homeopathic product users, that consumers who purchase homeopathic products are knowledgeable about what they are purchasing and highly educated.40 Seventy-eight percent of survey respondents said that they had an “extremely high” or “high” understanding of the homeopathic treatments they were taking. Of those surveyed, 36% had a master’s or doctoral degree, 33% had a bachelor’s degree, and 23% worked as health care providers. FTC staff notes, however, that the AMCH survey was distributed to homeopathic practitioners who were then asked to send the survey to their patients. Therefore, not only was the survey not random, it is not representative of users of OTC homeopathic products who are not patients of homeopathic practitioners. Only 8% of those who completed the survey said that they did not use a homeopathic practitioner. FTC staff also notes the large discrepancy between the AMCH survey showing 78% of respondents having a high or very high understanding of homeopathic treatments and the 38% of homeopathic product purchasers in the WSL Strategic Retail survey who said that they felt that they clearly understood what “homeopathic” meant. Furthermore, it is not known whether the homeopathic product purchasers in either survey were correct in their understanding of homeopathy.
In addition, there are questions about the nature of the "health care providers". Are they MDs who practice homeopathy consulting other practitioners? Are they medically unqualified practitioners in some other field?
The USHRC asserted that there have been studies showing that homeopathy can be beneficial for the treatment of certain conditions and that many countries around the world recognize homeopathy as a therapeutic option that is both safe and cost efficient. The USHRC believes that homeopathic products should not be held to the same proof of efficacy standards applied to allopathic OTC drugs because the homeopathic industry would not be able to afford to test thousands of homeopathic ingredients and an entire class of products would be forced off the market. It argued that such a result would be contrary to the intent of Congress, which expressly included homeopathic drugs in the “drug” definition at the time that the FDCA was passed. The USHRC would support the use of a homeopathic disclaimer such as “These statements have not been reviewed by the Food and Drug Administration.”
The intentions of Congress or those who framed the FDCA at the time of passing are not clear - there is a lack of historical records to support any particular assertion. The canard of cost of testing is common. To quote from earlier on in the Staff Report -
According to Mr. Land, the homeopathic industry is a small industry compared to the OTC drug, prescription drug, and dietary supplement industries in terms of revenues, advertising, and the number of marketed products. Although more than 7,000 homeopathic medicines are registered with the FDA, only about 1,000 are marketed on a routine basis, and fewer than 100 are marketed in mass distribution channels.
The cost of testing is irrelevant as no homeopathic drug could meet efficacy standards.

Although present at the workshop, the AAHP also provided a submission. Some of it was discussed at the workshop but -
The American Association of Homeopathic Pharmacists submitted a comment that recognized that consumers not familiar with homeopathy might not realize that homeopathic drugs do not undergo the same regulatory review process as allopathic OTC drugs. It believes that this concern can be addressed by disclaimers. AAHP’s advertising guidelines provide that consumer advertising for OTC homeopathic drugs should disclose, “These statements have not been reviewed by the Food and Drug Administration.” The guidelines also allow for an additional disclosure explaining the homeopathic nature of the advertised product claim.
The compliance with AAHP guidelines by members is moot.
The AAHP comment recognized that an advertiser needs to have a “reasonable basis” for a product claim and noted that the determination of the necessary level of support for a claim requires an analysis of a number of factors including the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts in the field believe is reasonable (the Pfizer factors).
Which raises a question - if the cost of substantiating a claim is too high from an economic perspective, then should that claim be made? Claims do not come out of nowhere.
The AAHP sought to apply the Pfizer factors to claims for OTC homeopathic products. The comment asserted that because OTC homeopathic products are not claimed to treat lifethreatening conditions, RCTs should not be required. With respect to the type of product, the comment claimed that homeopathic products have an unsurpassed safety profile. It said that the only consequences of a false claim for an OTC homeopathic product are minor discomfort and wasted money, and that the benefits of a truthful claim are relief from a condition while avoiding possible side effects. The AAHP said that the cost of Phase III clinical studies, which the comment said would cost almost $2 trillion for testing 100 active ingredients, was greater than the homeopathic industry could bear. The AAHP also argued that there are a significant number of qualified physicians who believe in the practice of homeopathy. The AAHP believes that the Pfizer factors support the conclusion that the traditional homeopathic literature provides adequate substantiation for appropriately qualified homeopathic advertising claims.
The cases of Zicam and Hylands et al suggest that the safety profile of homeopathic drugs isn't perfect. It is not clear where the $2 trillion cost figure comes from - and again, costs are irrelevant as no homeopathic drug could pass clinical studies unless they were of low dilution but if they were, they might as well be treated as non-homeopathic drugs.
The AAHP comment pointed to an FTC staff guidance document, Dietary Supplements: An Advertising Guide for Industry, which states that claims based on historical or traditional use should either be substantiated by scientific evidence or should be presented in such a way that consumers understand that the sole basis for the claim is a history of use of a product for a particular purpose. The AAHP asked the FTC to apply the same principle to OTC homeopathic products and asserted that the AAHP disclaimer about the absence of FDA review, together with a statement that the claims are based upon traditional homeopathic practice, should be sufficient. Nevertheless, the AAHP said that OTC homeopathic medications should never be marketed so that they “could lead consumers to forego other treatments that have been validated by scientific evidence.”
This is the principle that is behind EU regulations that allow (certain) homeopathic and herbal medicines to carry indications. Putting aside whether any such claims should be permitted at all, it places a dependence on homeopathic literature - most likely HPUS. The problem with any homeopathic pharmacopoiea is that indications are often couched in very specific terms and not necessarily mention any condition. Indeed, the homeopathic concept of "dis-ease" can be very different from the common sense understanding.

It would also make it very difficult to place new products on the market that have little or nothing in the way of historical usuage.
The AAHP argued that the use of appropriate disclaimers that qualify and explain the therapeutic claim made by an OTC homeopathic product is an adequate means of providing consumers with truthful and non-misleading information and that to reject such an approach would offend the First Amendment. It also argued that if the FTC adopted a significantly different position from the FDA’s and prevented consumers from receiving information about homeopathic products, it would create a significant disharmony in federal regulation.
Invoking the First Amendment and free speech protections do not fully apply in the context of marketing of homeopathic drugs. The principle of commercial speech and the restrictions upon such speech are well established in US case law. Commercial speech was also discussed in this UK focussed post. At the time submissions were invited and the Workshop took place, the FDA was in the process of reconsidering guidance and enforcement policies.

FDA Enforcement Policy
The FDA began to re-examine its policies on homeopathic drugs back in 2015. Irritatingly, the FDA seems to have deleted a lot of content from its website for reasons unknown. What is known is that comments were solicited and a public hearing Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century held where various interested parties spoke. 

However this captures all the supporting documents and comments. The transcript of the first day of the hearing is here and the second here. Concerns were raised but they will be summarised rather than quoted.

  • Adverse homeopathic drug reactions reported to Poison Control are, unlike other products, many in the under 6 age group
  • Some products on the market are of low dilution and contain active ingredients
  • Some products on the market are marketed as "homeopathic", contain high dilutions but yet contain "inactive ingredients" that are not homeopathic yet are in sufficient concentrations to be active
  • Linked to the above some products are in effect supplements (which claims are restricted for) yet inclusion of homeopathic ingredients allows them make OTC drug type claims
  • Homeopathic drugs containing multiple homeopathic ingredients are an issue - for example, they are not "proved" as combination whereas individual ingredients have been
  • Homeopathic drugs containing prescription drugs are an issue - for various reasons
  • Concerns about products marketed for asthma- which is potentially life-threatening
One thing that was clear from manufacturers et al was that they believed that CPG 400.400 was effective and that the FDA was adequately dealing with "outliers"- products that fell outside of the guidance. Homeopathy practitioners generally were concerned about combination products, some practitioners about low dilution. Manufacturers and practitioners seem to believe that consumers were reasonably well informed as the nature of products and unlikely to be mislead by labelling. However, critics and more neutral parties did not agree. They also shared the concerns about "outlier" products.

The transcripts tell us that no representative of "Big Pharma" was present. The FDA staff's questioning did not seem to be hostile.

Whilst it took some time, in December 2017 the FDA issued its draft enforcement strategy for homeopathic drugs, which it is currently seeking comment on. It is risk based.
  • Products with reported safety concerns.
  • Products that contain or purport to contain ingredients associated with potentially significant safety concerns.
  • Products for routes of administration other than oral and topical.
  • Products intended to be used for the prevention or treatment of serious and/or life threatening diseases and conditions.
  • Products for vulnerable populations.
  • Products deemed adulterated under section 501 of the FD&C Act.

Without going into great detail, it would appear to cover the "outlier" products that were discussed at the public meeting.
Despite being desribed as "new", it doesn't really represent any change over what the FDA has been doing for a number of years. It is a codification.

One thing that the draft says is that is that the FDA will withdraw CPG 400.400 when implemented. It is not clear if the FDA intends to replace it - arguably it does not have to.

The FDA information page on homeopathic drugs states that the FDA has no intention of banning them.

Reactions and Campaigns
Mainstream media reactions to both the FTC and FDA announcements were muted to say the least. Specialist media and those critical of homeopathy viewed the announcements in terms of a "triumph of common sense" - hyperbole given that the announcements did not really represent anything fundamentally new. 

Supporters of homeopathy generally did not react very much to the FTC announcement. This maybe because the FTC does engender the same paranoid hostility that the FDA seems to. Curbing marketing claims of efficacy doesn't carry the same perceived threat as "banning" products in some minds despite the substantial implications for OTC homeopathic sales.

Dana Ullman wrote a piece that appeared on the Huffington post reacting to the FTC announcement. Ullman is nothing if not predictable. "Extreme bias!" he proclaims seemingly oblivious to his own well known bias and lack of credibility. The article is not reading worth the effort of reading.

The Alliance for Natural Health - USA posted this story on its website. Before discussing the story, it is important to understand what the ANH-USA is. It is part of the US health freedom movement although that phrase dignifies what these groups generally are. Although they present themselves as consumer groups most of them are funded by supplement manufacturers and to a lesser degree law firms that represent supplement manufacturers. They campaign on issues supposedly related to "freedom" and "customer choice" but it is fair to say that mostly they want to sell useless or even dangerous products to customers and to be able to make any marketing claims they want without restriction. It can be argued that they have already been successful in this.

The ANH-USA story cites no sources for its claim that the FDA has declared all homeopathic drugs illegal. The FDA has always had the ability to class homeopathic drugs as "new drugs" and as the discussion of FDA enforcement actions in a previous post shows, they do so if a product makes claims incompatible with OTC status.

The Dr Mercola website carried a story that was widely cited and republished. Social media is full of links to it. "All Homeopathic Products Now Illegal?" asks the headline. Most citing the article forget the question mark. It is full of conspiracy theory nonsense as well as getting a lot of things wrong.

The story links to the ANH-USA story as well as Ullman's it also links to an article that appears on the Venable LLC website. Venable are a big DC law firm.

The Venable LLC article is rather odd to say the least...
In a single decision this week, the FDA withdrew the established conditions under which homeopathic drugs have been marketed for the last quarter of a century, instead replacing them with a document that states that “any product labeled as homeopathic that is being marketed illegally” (i.e., that is being marketed without FDA drug approval) “is subject to FDA enforcement action at any time.” It also sets forth the Agency’s risk-based approach to enforcement. The new enforcement policy classifies all homeopathic drugs as unapproved new drugs, requiring FDA premarket approval based on a showing of safety and effectiveness (e.g., via traditional allopathic clinical trials).
Well, the FDA have always had the power to do so. In reality, whilst the FDA could declare all homeopathic drugs as "new drugs", it simply does not have the resources to enforce such a decision or deal with thousands of applications.
This position misunderstands the fundamental nature of homeopathic drugs and ignores the FDA’s history of regulating such products. Under the previous CPG 400.400, the FDA required that homeopathic drugs meet the standards for strength, quality, and purity set forth in the HPUS. This is important because before an ingredient is included in the HPUS, it must be determined safe and effective by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Effectiveness is generally established through a proving, a clinical verification process consisting of a double-blinded or placebo-controlled trial where a sample population is exposed to an infratoxic level of the test substance, providing symptom notes that are then aggregated and analyzed by both qualitative and quantitative methods. Effectiveness can also be established through the submission of two adequately controlled double-blind clinical studies using the drug as the single intervention. Safety is established through a review of toxicology and safety data by two different committees, one comprising scientists and pharmacists, and another comprising clinicians. Once an ingredient passes both rounds of review and is granted inclusion in the HPUS, the HPUS standards set the safe level of use, indicating which dilutions are appropriate for OTC products. Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient’s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS. Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.
Really? The article continues in a smiliar vein but...
Furthermore, we have seen the FDA take issue with low-risk drugs exempt from enforcement when the Agency finds noncompliance with current Good Manufacturing Practices (cGMPs) upon inspection. Warning letters resulting from these inspections may now state that the company is marketing unapproved new drugs.
"may". Supposition and to suggest that the products in question were somehow exempt from regulation is a gross mistatement as cGMP is an integral part of regulation. To suggest that the FDA should have ignored reports of Adverse Drug Reactions and not act is irresponsible to say the least. The products were considered adultered.

It is difficult to know what to make of the article. One cynical interpretation is that is designed into scaring potential clients to seek Venable's services.

Larry Malerba is generally totally wrong about most things but strangely manages to get a few things right here. The quotes and links are more interesting than the article itself. Like Ullman, Malerba suffers from the delusion that there is compelling evidence for the efficacy of homeopathic drugs. While he quotes the AAHP stating the need for safety, he fails to grasp why the teething products fiasco was a safety problem. Melerba openly admits to be being a conspiracy theorist. However, he does correctly state that the supply of products to practitioners (assuming that they are legally recognised in their State) will be unaffected - they can obtain products from compunding pharmacies.

Americans for Homeopathy Choice  is strange. Their Facebook page also makes for strange reading. For what would, on the face of it, appear to be a single issue campaign group, it has a bizarre manifesto. Its meaning is unclear. It reads as very naive or, alternatively, cynically targeting the very naive. The group claims to be non-partisan but the language invokes many conservative tropes. Writing to the President misunderstands how laws are made in the US. The list of supporters include notorious anti-vaccinationists, "mommy blogs" and other oddities. It also provides a link to buy a Dana Ullman book.

The AAHP's response is considerably more measured but before discussing it the AAHP were already preparing to lobby etc before the FDA announcement. A press release states -
The American Association of Homeopathic Pharmacists (AAHP) shares the FDA’s commitment to protecting public health and applauds the Agency’s plan to take quick action against illegal or unsafe homeopathic medicines. In fact, the Association encouraged FDA to do just that in its comments at the regulatory body’s April 2015 workshop on the topic. The AAHP is confident that the current Compliance Policy Guide provides FDA with ample opportunity to take such action right now.
AAHP also notes that the draft guidance would not materially affect the vast majority of homeopathic drug products available in the United States, given these products’ wide margin of safety and manufacturing according to current Good Manufacturing Practices (cGMPs). The Association further underscores that the current Compliance Policy Guide 400.400 remains in effect.

No panic here. No conspiracy theories. Then this appeared on the the National Center for Homeopathy (NCH) website. It is interesting to note the the AAHP advised consumers not to write to the FDA at one point stating that doing so could be counter productive. Of course, the FDA are unlikely to pay heed to consumer comments that are largely irrelevant, that display zero understanding of regulation etc but the argument that they be counter productive may not be immediately apparent. For one thing, comments could draw FDA attention to non compliant vendors and products.

(As an aside this article appears on the NCH website - which again does not seem to grasp the issues with the teething products.)

What the AAHP have done is start a campaign to write to US legislators to ask them to ask the FDA to provide new, clearer guidance to replace CPG 400.400. It contains what the AAHP would like to be a definition of a homeopathic drug -

  • A product that contains active ingredients listed in the Homeopathic Pharmacopeia of the United States
  • A product that is supported by references that describe appropriate homeopathic uses
  • A product with documentation to support active ingredients that are not recognized in the HPUS as being homeopathic
  • And products that contain a combination of a homeopathic and non-homeopathic active ingredients are not considered homeopathic
The third point is impossible as the FDCA is dependent on HPUS. The fourth point skirts around the issue of labelling non-homeopathic ingredients as "inactive".

It is understandable that the AAHP and its members are nervous about the withdrawal of CPG 400.400 but it has to be remembered that enforcement actions against members have been on the basis on cGMP violations and adultered drugs. Class actions against members have been on the basis of misleading claims of efficacy. CPG 400.400 provides no protection against that.

It seems likely that vendors and manufacturers have more to fear from class actions than the FDA enforcement policy.

Next Post
The issues of "outlier" and "combination" homeopathic drugs will be examined in more detail.


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