In a Napa County Superior Court this month, actor Gwyneth Paltrow’s lifestyle brand, Goop, accepted civil penalties in the amount of $145,000 for unsubstantiated health claims regarding some products sold on the company’s website. The online ‘wellness empire’ was found guilty of misbranding and false advertisement in a suit brought by the California Food, Drug, and Medical Device (FDMD) Task Force, following notification by the group Truth in Advertising Inc., an independent non-profit with a mandate to protect consumers from false advertising and deceptive marketing practices. And what has brought us to this point? A curious admixture of belief in fringe medicine, slick marketing, and a tendency to tolerate fruitloopery. Perplexed? Read on!
In other words, fruitloopery occurs when writers wish to bamboozle, obfuscate, or otherwise bewilder a reader sufficiently that scrutiny of claims does not occur.
In Physics World, the online portal dedicated to the ‘latest breakthroughs in physics and interdisciplinary science,’ a reference is made to a term beloved of readers of the British science publication, New Scientist.(1) Fruitloopery – the ‘pretentious and erroneous use of scientific words’ – is the in-house notation for the use of scientific terms ‘wildly out of context or in a completely unverifiable way.’(2) In other words, fruitloopery occurs when writers wish to bamboozle, obfuscate, or otherwise bewilder a reader sufficiently that scrutiny of claims does not occur. And while this can be entertaining and amusing – as is almost always the case in the New Scientist articles dedicated to exposing fruitloopery – it can be damaging, dangerous, or even potentially life-threatening when used outside of the realm of theory. This could happen in the sales and marketing of items intended for use within the human body, for instance.
Way back in January of last year we incorporated the idea of fruitloopery in our analysis of supplements targeted at specific areas of men’s health. In that piece, Supplement Mislabeling – More Bang for your Buck or a Clear and Present Danger to Health?, we explored how the, a-hem, ‘rise’ of erectile dysfunction diagnoses had precipitated a corresponding uptick in nutritional supplements, and also examined the role of the FDA in defining and regulating supplements and medical devices. And much as this was all very interesting to our male readership we also received mail from our female readership. Functional foods, nutritional supplementation, and the ‘fun’ of sexual dysfunction are not limited solely to men after all.
And because of a recent West Coast lawsuit we’re going to expand our focus beyond the traditional supplement industry and look at, of all things, vaginal eggs.
In accepting their point, it’s now time for us to redress the balance. And because of a recent West Coast lawsuit we’re going to expand our focus beyond the traditional supplement industry and look at, of all things, vaginal eggs. Yes, we said it: vaginal eggs. What exactly are these? According to Goop, they are a ‘must-have’ for any sexually active woman requiring a stronger connection between her ‘heart chakra and yoni.’ As long, that is, as she has $66 to spare. Confused already? We empathize and will do our best to elucidate…
Headquartered in Los Angeles, California, Goop was launched by Hollywood celebrity entrepreneur Paltrow in 2008. Initially conceived as a newsletter in which the actor shared personal insights and discoveries, Goop was incorporated within three years as a ‘lifestyle brand with its roots in content across six key pillars.’(3) Including wellness and beauty as two of the ‘pillars,’ Goop markets and sells a variety of devices and supplements that have, increasingly, tended towards the outer fringes of science. Officially, Goop positions itself as incorporating the best of Western and Eastern health and wellness modalities while approaching conditions such as anxiety/depression, infertility, cancer, autoimmune disease, and trauma ‘from a place of unbiased and open-minded curiosity.’(4) In actuality, depending upon your perspective, the company offers tools and devices on the cutting edge of human health and wellness, or snake oil backed solely by clever-sounding but nonetheless entirely dubious pseudo-medical junk science. Let’s take the aforementioned eggs as an example…
Moreover, an explanation of the science behind how it works is, at least on the website, woefully absent.
According to Goop’s Q&A with ‘beauty guru/healer/inspiration/friend’ Shiva Rose, the eggs are a ‘closely guarded secret of Chinese royalty [with a] power to cleanse and clear [making] them ideal for spiritual detox.’(5) Precisely sculpted from either rose quartz (‘brings in more love energy’) or nephrite jade (‘a great stone for taking away negative energy’), the eggs are 1.57 inches in length and 1.18 inches in width – when it comes to product dimension information, precision is clearly important to Goop. More so, in fact, than information on how to actually use the product. Moreover, an explanation of the science behind how it works is, at least on the website, woefully absent. Goop markets the item to be used ‘by women to increase sexual energy and pleasure [and help] connect the second chakra (the heart) and yoni for optimal self-love and well being,’ so there’s no real clue as to the mechanisms of use or how to get results. And since we have to use our eminently fertile imaginations, we have come to think of these items as vital equipment in the perhaps emerging sport of vaginal weightlifting.
But there’s an all-too obvious problem with this need to use imagination in place of data. According to a group of prosecutors across California (where the company is headquartered), Goop’s claims that the eggs can help balance hormones, increase bladder control, prevent uterine prolapse, and regulate menstrual cycles are simply not based in fact. In the suit brought this month by the California Food, Drug, and Medical Device (FDMD) Task Force in Napa County Superior Court, claims relating to health benefits of the eggs ‘were not supported by competent and reliable science.’(6) This finding also related to a specific oral supplement/bath additive, Inner Judge Flowers Essence Blend, which the company had promoted as a preventative against depression. And a host of perhaps dubious nutraceutical products is very much in evidence on Goop’s website. Brain Dust, for instance, is one of a line of products ‘alchemized’ to enhance and support the female consumer. Just 1 teaspoon of the product ingested with 8oz of liquid (hot or cold will work equally well) will facilitate an alignment with ‘the mighty cosmic flow for great achievement.’ Sister product, Power Dust, ‘supports success and harmony in accomplishing physical or entrepreneurial feats.’ And let’s not forget Spirit Dust, ‘a divine edible formula alchemized to help you unwind, expand peaceful awareness and align with bliss,’ which lists its ingredients as extracts of goji berry, reishi mushroom, ashwagandha, astragalus, silk tree bark, longan berry, red rooted sage, and stevia leaf.(7)
Fruitloopery perhaps, but given that these ingredients are all natural components, the end product must be fine, right? Wrong. According to the FDA, dietary supplements which include vitamins, herbs, amino acids, whey proteins, and creatine are not subject to approval prior to sale and the regulatory body relies upon consumer and/or industry complaints to initiate safeguards. What’s more, safeguards can be absolutely necessary given the ‘adverse events’ these ingredients can precipitate in susceptible consumers. Issues such as chest pain, anaphylaxis, nausea/vomiting, abnormal bleeding, cognitive/mood changes, joint/muscle pain, low blood pressure, and heart dysrhythmia are all listed by the FDA as potential effects of consuming some herbs, vitamins etc.(8) And this is why supplements like Brain Dust are considered ‘food products’ under the Dietary Supplement Health and Education Act (DSHEA) of 1994. As we outlined in our earlier examination of the regulation of the supplement industry, DSHEA ‘establishes specific labeling requirements, provides a regulatory framework, and authorizes the FDA to establish current Good Manufacturing Practices (cGMP) regulations for dietary supplements.’(9) But the problem is that, by its own admission, the ‘FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for […] products only cover a small fraction of […] products on the market.’(10)
Which leaves us with the uncomfortable reality that it is only through consumer complaint, industry self-regulation, and honesty in retail that consumer safety will be protected. Returning to Goop for a moment, as a result of the lawsuit, the company agreed to the $145,000 fine and must also refund the purchase price to any dissatisfied egg customers. But what is more interesting is that it must also abide by an injunction regarding ‘any claims regarding the efficacy or effects of any of its products without possessing competent and reliable scientific evidence that substantiates the claims.’(11)
The second reason for concern is that jade is porous, which has obvious dangers when it comes to the question of bacterial contamination.
In the past, it has been tempting to dismiss the significance of some – shall we say ‘fringe’ – health claims as frivolous. But, as outlined above and our earlier article on male sexual dysfunction, some supplements and ‘medical devices’ can create actual harm, a point noted in a recent Business Insider analysis with regard to the eggs which can ‘lead people to engage in risky behavior.’(12) Let’s articulate this clearly: inserting a piece of jade into the vagina is problematic for a couple of reasons. The first reason, of course, is that the pelvic floor muscles are not designed to contract for extended periods of time and over-use can lead to pain, especially during intercourse. The second reason for concern is that jade is porous, which has obvious dangers when it comes to the question of bacterial contamination.
Despite the admonition to sterilize the egg before each use – ‘Boil it for a few minutes to clean it…place it on a beautiful piece of fabric…light a candle…burn some sage…become one with your egg’ – the risk of infection represents a clear and present danger.(13) And because of the possibility of contracting bacterial vaginosis or developing toxic shock syndrome through the insertion of a porous stone where, arguably, no porous stone should reside, the device falls under the regulation of the Food and Drug Administration regulation of medical devices. Unsure why? Let’s take a look at the medical device definition as understood by the FDA:
‘an instrument […] intended for use in […] the cure, mitigation, treatment, or prevention of disease […] and which does not achieve any of it’s (sic) primary intended purposes through chemical action […] and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.’(14)
Goop’s eggs are marketed as balancing hormones, increasing bladder control, preventing uterine prolapse, regulating menstrual cycles, cultivating sexual energy, clearing chi pathways, intensifying femininity, invigorating life force, and – much like the science-based Kegel exercises – assisting in tightening pelvic floor muscles. And in this latter regard they would seem to conform, to a certain extent, to the definition of a medical device. And in falling under this regulation, the product must comply with current Good Manufacturing Practices (cGMPs) which define everything from device design to production and process controls to packaging and labeling, distribution, and complaint handling. Yet a search of the company’s website reveals nothing about the products taking cGMPs into account at any stage of the design, manufacture, or distribution. It is almost as though, in providing shoppers with the opportunity to ‘find suggestions […] from a trusted friend – not an anonymous, crowd-sourced recommendation engine’ Paltrow’s enterprise can sideline the importance of curating a collection of products whose safety and efficacy is based in actual, demonstrable, provable scientific fact.(15)
In 1998, the Annals of Internal medicine published an article, ‘The Persuasive Appeal of Alternative Medicine,’ in which it juxtaposed the fact that the ‘extent to which these practices have clinical efficacy according to biomedical criteria is a matter of ongoing research and debate’ with their popularity given an attraction ‘related to the power of its underlying shared beliefs and cultural assumptions.’(16) Authors Ted J. Kaptchuk and David M. Eisenberg tease out the themes of ‘advocacy of nature, vitalism, “science,” and spirituality’ noting that these ‘offer patients a participatory experience of empowerment, authenticity, and enlarged self-identity when illness threatens their sense of intactness and connection to the world.’(17) And, of course, this is where the danger of non-science mediated medicine lies. In offering arguably false hope and empowerment to a disenfranchised patient: the sufferer of depression who seeks relief in Goop’s Inner Judge Flowers Essence Blend; or the overstretched working mom who spends $90 on a multi-vitamin called ‘Why Am I So Effing Tired?’
Be that as it may, given the lucrative nature of the business, it has never been more incumbent upon the consumer to exercise a degree of common sense when appraising the value of celebrity-endorsed ‘medical devices.’ Although there is a legal Implied Warranty of merchantability in anything sold by a vendor to a consumer –now newly termed the doctrine of caveat venditor – never was the original maxim, caveat emptor – Let the buyer beware – more a propos. Especially when it comes to items as non-returnable – one hopes – as a vaginal egg.