Over the past few years, I have been bombarded with different dietary and herbal supplements/products purporting a never-ending list of ‘benefits’. One that stands out way above the crowd, for all the wrong reasons, is Herbalife.
Why only look at Herbalife?
It is not difficult for me to imagine why Herbalife has been so successful; I was unfortunately conned into attending one of the Herbalife Distributor seminars last year. The presentation consisted of a few slides on the “scientific basis” of Herbalife products, a chart depicting astronomical growth of the company (missing some critical ‘bad’ year performances and brushing over the importance of the concurrent expansions into other countries), and then a launch into the business opportunity of becoming a distributor. The cult-like nature of the seminar reminded me of the fanatical religious US shows we see on TV. Each person would ‘randomly’ be picked from the audience to talk about their experience with Herbalife. Losses of 20+kilograms in ridiculously short time periods were reported, thanks given to Herbalife, and talk of significant money gained from becoming a distributor. Overseas trips and opportunities to make a lot of money waiting at your fingertip (or wallet)! There was a wide discrepancy between the incomes of distributors who had been with Herbalife for 10+years, compared to those who had only recently signed up; no one stood between these two extremes.
I came home really angry at some of the outrageous claims being made that night; it sounded like those ‘too good to be true’ schemes that government regulators warn you about, and decided to do research into Herbalife*, some of which I’ve posted here. I hope you find the research useful. If I’ve made any errors, please let me know.
*Just so you know, I have no interest or affiliation to declare in Herbalife or any other nutritional products.
#1 – Regulation, or lack thereof
While herbal medicines (also referred to as ‘complementary medicines’) have been around for thousands of years, the evidence to support their efficacy is still being scientifically scrutinised. The problem is that a lot of that scrutiny lies behind a myriad of pay-for-viewing journals and scientific jargon, making it extremely inaccessible to the general public. The regulation on such products also varies from one jurisdiction to another, so getting a straight answer over whether a dietary/herbal supplement is ‘good’ and ‘safe’ to use is really difficult.
United States of America
In America, dietary supplements are not regulated nearly as strictly as ‘conventional’ drugs. This is because the Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations. Under the Dietary Supplement Health and Education Act 1994 (DSHEA):
- These dietary supplements are classified as ‘foods’, rather than drugs, regardless of their historical uses. Specifically, “the DSHEA defines them as products ‘intended to supplement the diet’ that contain vitamins, minerals, herbs, or other botanicals, amino acids or a ‘concentrate, metabolite, constituent, extract, or combinations of these ingredients.’ The DSHEA eliminated the requirement that the FDA review efficacy and safety data for these products—providing that no claims are made to diagnose, treat, cure, or prevent disease. This legislation also eased marketing restrictions for dietary supplements…[T] he FDA’s attempt to hold health claims for dietary supplements even to the same scientific standard required for conventional foods was rejected in Pearson v. Shalala. The ruling in this court case stated that the FDA must allow such ‘qualified’ health claims in labeling even if they are based on equivocal scientific evidence. The FDA is therefore restricted from policing ‘truth-in-labeling’ for dietary supplements, and manufacturers are permitted to use vague terms to suggest therapeutic effects for nonspecific health problems, which consumers tend to interpret inaccurately as efficacy” Click here for source.
- The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.
- FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
This is why, with each Herbalife product benefit claim comes the mandatory disclaimer: “*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Bear that in mind when purchasing Herbalife products that claim to:
- Boost metabolism, build energy and promote weight loss.*
- Help replenish intestinal flora after antibiotic use*
- Support healthy cartilage to cushion joints and maintain joint flexibility*
- Help address PMS and menstrual challenges*
- Help reduce symptoms of menopause/perimenopause*
- Support prostate health and urinary function*
- Enhance blood flow to support the function of the heart, brain and other organs*
- Enhance sexual performance*
The list, alarmingly, goes on, highlighting just how important having good eyesight is! Ok more seriously, the FDA’s lack of regulatory ‘bite’ is concerning as it only takes a bit of creative writing, and some good lawyers, to get around the regulatory framework.
The Therapeutic Goods Administration (TGA) is the federal department that regulates all medicines in Australia, including complementary medicines such as Herbalife products. Its regulatory approach depends on whether products are deemed ‘low risk’ or ‘high risk’. Low risk products have much less stringent conditions attached than the higher risk ‘Registered’ category, particularly as ‘low risk’ does not require clinical trials. Without clinical trials, “we can’t know for sure whether a complementary therapy actually works. The short and long-term risks of the treatment also remain unknown” (Source: Better Health Channel). Most importantly for our analysis, only complementary medicines that are deemed ‘high risk’ are assessed for efficacy.
Such a regulatory approach is common throughout Australian government departments, i.e. regulation commensurate with risk. Of course, adopting this type of regulatory approach relies heavily on a deep understanding of the risk profiles of the market you are dealing with; the sources of your information become increasingly critical as you identify the associated risks of each product. I did contact the TGA, and contrary to the popular notion of public servants, my email received a quick response to my questions:
Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in or exported from Australia. A therapeutic good can only appear on the ARTG if a sponsor (i.e. the individual or company intending to supply the goods) has lodged an application to the TGA. A sponsor must provide evidence to support the safety, quality and efficacy of the product.
You can search the ARTG with sponsor name, active ingredients or product name. Currently, a search with the term “Herbalife” returns several ARTG results. You will need to check the results to see if the description of the product matches the product you are enquiring about. If a product is on the ARTG it is currently approved by the TGA. Please note: the presence of a product in the ARTG does not always mean that the sponsor is currently supplying it in Australia.
If you believe that there is a therapeutic product that is being supplied that is not approved by the TGA, you can report this through the Reporting problems page on our website. The TGA relies on healthcare professionals, the public, and industry to report problems with therapeutic goods – this allows us to identify and respond to safety matters.
For your information you may also be interested in the Database of Adverse Event Notifications (DAEN). The DAEN provides information about adverse events related to medicines and vaccines in Australia.
A search through the ARTG for the term ‘Herbalife’ came up with 13 hits, all of which showed the products as ‘listed’; i.e. are categorised as ‘low risk’. The public summary attached to each product’s record comes with the disclaimer that the summary is not an ARTG Certificate, and that “[t]he onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.”
So again, at this stage, we are no closer to finding out whether Herbalife products really do improve our sex lives and PMS symptoms.
A search through DAEN for all Herbalife products yielded 17 results [note, this is higher than the number currently ‘listed’, possibly due to historical products], 12 of which had a ‘single medicine suspected of being related to the adverse event’ (i.e. the Herbalife product itself). While thankfully no deaths have been reported, a whole range of ‘adverse events’ were reported, the most serious of which included ‘Liver function test abnormal’ (3 cases), ‘Jaundice’ (3), Thrombocytopenia (1) and ‘renal impairment’ (1). Frustratingly, the DAEN has disclaimers stating:
- “[a]n adverse event report does not mean that the medicine is the cause of the adverse event”.
- The DAEN – medicines contains information from reports of adverse events that the TGA has received in relation to medicines including vaccines used in Australia
- The DAEN – medicines does not contain all known safety information about a particular medicine. Please do not make an assessment about the safety of a medicine based on the information in the DAEN – medicines.
So consumers are enlightened only so far as Herbalife products are suspected of having caused the adverse event, but not whether the products themselves in fact did cause it, or whether they are safe to consume following the publication of the summary on the ARTG.
Personally, I do not find the TGA’s reliance on the suppliers to provide ‘evidence’ to back up their claims and on the public/medical practitioners to inform the TGA of any wrong doing/adverse events all that reassuring. Certainly, this ‘light touch’ approach has been criticised in a major audit of TGA’s complementary medicine regulation regime. From the looks of things, the TGA still as quite a way to go in implementing all of the recommendations of this audit.
#2 – History of Herbalife
At this point, you may be thinking: “Well, everything you’ve highlighted above applies to all complementary medicines, not just Herbalife”, and you’d be perfectly right. I think it’s important though to understand just how this dark and fuzzy regulatory environment has enabled Herbalife to get away with many unverified claims about not only the efficacy and veracity of the science behind its products, but also the viability and legitimacy of its chosen business model.
Herbalife constantly touts itself as offering ‘scientifically advanced’ nutritional alternatives to modern day medicine. Even in 2013, the promoters of Herbalife point to a Nobel Laurete, Louis Ignarro, as having endorsed their dietary supplements. What they fail to mention is the huge conflict of interest of this endorsement as Ignarro had done this in exchange “for royalties and then touted the ingredients in a scientific journal [as far back as 2004], without disclosing his financial interest to the publication.” Worse yet, Ignarro chairs the so-called ‘independent’ scientific advisory board that, as advertised in a recent company brochure, will “plan and execute new research to establish the scientific basis for new cutting-edge products” for Herbalife! It is extremely difficult for me to accept that someone who has received such massive kickbacks can be capable of making an objective decision on the efficacy and safety of Herbalife products, irrespective of whether they are a Nobel Laurete.1
You will never find Herbalife products at pharmacies and supermarkets. Why? From what I understand, Herbalife products are sold only through registered Herbalife distributors, who have to pay a commission to the distributor up the line who sold it to them, and so on and so forth… Naturally, the higher up the chain you are, the bigger the cut you get. What is interesting in all this is the ridiculously high prices of these products (one friend told me she’d spent $400 in a month on these products!) – if you are wondering why it is difficult to obtain any online pricing on Herbalife products, it is because one of the (many) Herbalife rules is that you need to register first before being able to obtain this pricing. I have yet to hear of a Herbalife product that does not have a pre-existing competitor, so it absolutely makes no sense, marketing wise, how these over-priced products would successfully be retailed to everyday consumers in a highly saturated market. That’s the point though, isn’t it? It seems like Herbalife deliberately goes out of its way to target its products to those keen to develop a ‘business opportunity’ with the company.2
Nothing I raised above is new; all these are questions that have led to persistent accusations of Herbalife deliberately and systematically targeting vulnerable people from low socio-economic backgrounds; the internet is a graveyard of ‘Herbalife is a scam’ stories.
Herbalife has also repeatedly been accused of operating a pyramid scheme, which is, of course, illegal. The company has been taken to court on this point in several jurisdictions, notably the US and Belgium, with the Canadian Competition Bureau reportedly launching its own formal investigation into the pyramid scheme business model complaints against the company. Interestingly, the recent Belgian court case seems quite specific in stating that Herbalife was a ‘legitimate’ business model that was compliant with Belgian law; this does not mean necessarily that it is compliant with other jurisdictions’ definitions of what constitutes a pyramid scheme.
Amid the claims and counterclaims, and counterclaims to the counterclaims (!), there are many people with vested interests steering the discussion, with some of the world’s biggest investing titans laying bets either way as to whether the company is a pyramid scheme.
I do not have a legal background to judge whether, despite there being a range of Herbalife products, the business model chosen by Herbalife (i.e. revenue through sales to distributors) would still render it a pyramid scheme. What I do know is that what gets lost in the middle of all the dollar signs and legal technicalities, is any ability to independently verify the truth about the ethics and scientific basis of Herbalife and its products.
At the end of the day, the online discussion about Herbalife has moved so far beyond what Herbalife is purportedly selling: ‘nutritional’ supplements.
One thing that has come out in all my research is that the only shortcut key in life that exists are the ones on your keyboard. The FDA/TGA do not know your medical history and circumstances to tell you what you should or shouldn’t do. At best, they offer you warning flags to swim between; it is up to you to decide what’s best for you.
If you’re concerned about your health, consult your doctor. Better yet, get more than one medical opinion. It’s not okay to be pressured into buying products that cost a ridiculous amount. It should not cost you so much to be healthy.
Whatever you do choose to do, you and your body will have to live with your decision, so please make it an informed one!
Until next time!