US Regulation of Homeopathy #4 - "Outliers" etc

It was clear from a previous post that there are homeopathic drugs that are considered of concern or are a source of content. Some individual products have been mentioned in discussion of FDA/FTC enforcement and class actions but it is worth having a slightly different discussion, partly because of the unethical practices of some businesses.

Somaderm
The issue of homeopathic hCG products was discussed in post on Manufacturing. But these products are not isolated. There are also other products based on homeopathic Human Growth Hormone, Insulin-like Growth Factor and even Testosterone which make extraordinary claims. Homeopathic drugs that purport to contain hormones or synthetic versions thereof. Testosterone may appear appear in the Homeopathic Pharmacopeia of the United States, but the others do not and thus can not be marketed as an OTC homeopathic drug. The FDA would treat such products as a "new drug". 

Something that seems to have appeared in the past few months is a product- a gel - that purports to contain Human Growth Hormone (HGH) that is using a Multi-Level Marketing model. Affiliates are turning up on social media selling the product and some are very aggressive in their marketing.

The American Association of Homeopathic Pharmacists (AAHP) issued a position statement back in 2014 which clearly spells out the illegality of these products. It is a felony under Sections 303 and 505 of the Food, Drug and Cosmetics Act to manufacture, distribute or sell these products. It is also a felony under the Controlled Substances Act which is the remit of the Drug Enforcement Agency.  In addition, the FDA have made rules that require topically products containing hormones to go through the New Drug Application process.

The FDA have acted against similar products in the past as this FDA warning letter to Libido Edge Labs shows (FDA don't always archive warning letters). Worse was yet to come as the products were subject to a recall by the manufacturer Apotheca Inc in 2011 due to bacterial contamination. Yes, Libido Edge Labs are still going but none of their products contain HGH or any other hormone now.

This product represents a triple deception. Firstly, the claims made for HGH itself in terms of rejuvenation are simply not backed up by evidence. Secondly - the principle of "like cures like" suggests that homeopathic HGH would be used to treat symptoms similar to those caused by an excess of HGH - very different from the claims made for Somaderm. Thirdly, that homeopathy has any effect that is not consistent with placebo, regression to the mean, etc.

This product does not represent the same risks of medical harm that homeopathic hCG does (no dangerous diet associated with it) but the MLM model poses a great risk of financial loss to consumers. This article on the scam is highly recommended. The numerous comments make for interesting reading. It is sad to read affiliates who persist in their belief in the product even when it is pointed out selling it is a felony (and once this is pointed out, ignorance of the law is no longer considered a mitigating factor in a court of law). The MLM aspect falls under FTC jurisdiction.

The product and the MLM scam have been reported to both the FDA and the FTC multiple times. Neither of them is known to have acted yet but it is likely they will. 

Products containing actual and "Inactive" ingredients. There are also products like Zicam (again discussed in the post on Manufacturing) that actually do contain active products and are "homeopathic" by virtue of a 1 in 10 dilution.The reasons for doing so are unclear. Possibly the manufacturers believe they can evade certain aspects of regulation. It's worth pointing out that even a 1 in 10 dilution of a herbal extract can result in far higher concentrations of active ingredients than, say, a capsule of dried herbs.

Valerin is good examples. It contain valerian root (1X), passiflora (1X) and magnesium carbonate (1X) - which are often ingredients in dietary supplements. 1X is a 1 in 10 dilution of an extract. Because of the way that the product is labelled, it is difficult to determine how much of each is in each tablet. The label says that it has a distinctive smell - which would be consistent with high concentrations of herbal extracts. But magnesium carbonate is insoluble and will react with acids. These may actually be made of dried herbs and the magnesium carbonate is used as a binder. It's not really homeopathic in the generally accepted sense of the word.

In the EU, the product would be permitted Traditional Herbal Registration. It would be allowed indications of a limited kind. But US regulation doesn't have such category. Products are either homeopathic drugs, drugs (medicines) or dietary supplements and the latter are only permitted very limited indications (although this widely ignored). This probably explains why Valerin is labelled as homeopathic when it very likely isn't.

Valerin makes various claims to be a pain reliever, to treat muscle spasms, relieve stress etc. Most worryingly -

An All-Natural Homeopathic Alternative to NSAIDs and Opioid Pain Relief Prescriptions

Valerian and passiflora may have mild sedative effects. They are not an alternative to prescription only analgesics - if Valerin works for you, you'd never have needed a prescription analgesic.

A further variation on this products that contain highly diluted homeopathic ingredients but also "inactive" ingredients which may have an actual effect. Curoxen is an example and one with very strange marketing claims. Here is the back of the packaging



It lists Olive Extract 2X and Calendula 3X as "Active Homeopathic Ingredients". It listed "oxgenated olive oil" and lavender oil as inactive ingredients yet the marketing focuses on the supposed antibacterial properties -

95% of CUROXEN’s formula is comprised of ultra-pure, certified organic olive oil. The olive oil undergoes an oxygenation process (yep, it’s infused with good old O2, necessary for cell repair) that creates a highly antimicrobial substrate that heals quickly and effectively.

Oxygenated olive oil is rancid olive oil. Probably not harmful. It's a permitted inactive ingredient - a "carrier" for active compounds but no claims can be made for it. No OTC monograph exists of olive oil based antiseptics. If the manufacturers wish to make such the kind of claims they do, they should really submit a New Drug Application. It is likely that the labelling of the product is merely an attempt to avoid this.


Combination Products
Many of the OTC homeopathic drugs available contain multiple ingredients. This may seem strange to anyone familiar with the tenets of homeopathy, especially classical homeopathy. They would appear to violate the Law of Simplex. However, combination remedies are not unusual in other variants of homeopathy such as homotoxicology - although it is questionable whether it is strictly speaking homeopathy but it would seem that the products do meet the legal definition of a homeopathic drug.

It is not clear whether homotoxicology has had a direct influence on US manufacturers. Certainly Dr Reckeweg has a North American importer but the products don't seem to carry indications and seem to be aimed at practitioners rather than the OTC market. It seems unlikely.

The initial complaint in Forcellati v.Hyland's does provide some useful information.

C. Background Of Hyland’s  

42. In 1903, Hyland’s was founded as a Los Angeles pharmacy when homeopathy was a standard medical practice in the United States. Countless conventional medicines, both prescription and OTC, were developed and began to dominate the pharmaceutical market in the middle of the 20th Century. In response, Hyland’s pharmacists began to develop “combination” homeopathic medicines, which they formulated by combining several single homeopathic remedies believed to be effective for a particular ailment into one tablet. 

43. In the 1970s, Hyland’s began marketing these combination homeopathic remedies in health food stores. By the late 1980s, Hyland’s used Hyland’s Teething Tablets to break into the chain drugstore market. Since 2000, the company has annually enjoyed double-digit growth, introduced many financially successful new products, put its medicines on the shelves of every major drug retailer and has engaged in aggressive marketing to take advantage of the increasing demand for medicines that are perceived as effective without carrying negative side effects.

Whether Hyland's were the first to do this is unknown. It is not known what proportion of the market combination products make up but likely to be considerable if Amazon is anything to go by. Single ingredient homeopathic drugs appear less common than in EU markets.

Some practitioners of classical homeopathy are dismissive of these products. In general, these practitioners select single remedies by comparing patient symptoms (which can be incredibly bizarre and specific) to a list of remedies and the symptoms they are purported to treat. They select the remedy that is the best match to those symptoms. What these combination remedies contain are remedies that have been selected on the basis notional, pretty non-specific symptoms. Some practitioners would say they are unlikely to work.

Another objection is that combination remedies, in theory, could regarded as a new remedy rather than a collection of remedies in one pill. They may behave very differently. It is also the case that homeopaths believe some remedies "antidote" others. But that assumes that homeopathic remedies have any efficacy.