Big pHat lies? Can you trust the health supplement industry?

Freely available online and lining the shelves of big-name pharmaceutical retailers, some of these health brands claim their products cure diseases such as diabetes and heart disease.

What irks Dr Harris Steinman, a long-time public opponent of health supplement scams, is that this industry is only getting bigger, and the actions of its operators more nefarious.

Steinman, who edits quackery debunking website CAMCheck, raised the alarm on a brand that has repeatedly found itself on his website, its supplements supposedly being the key to warding off such ailments as arthritis.

Supplement brand Immunadue has bumped heads with the Advertising Standards Authority (ASA) which in 2016 ruled against a radio advertisement in which it made bold statements about health science and its products.

The multivitamin maker is one of the more successful of hundreds of South African companies who jumped on the “optimal body pH level” bandwagon of the decade. It told its audience in the 2016 commercial that the optimal PH for the human body was 7.2 and that its pills would assist in achieving this state. It also claimed a lower or higher pH left people vulnerable to diseases such as cancer, arthritis and diabetes.

The complainant, Dr Arial Eyal, contended that Immunadue made false claims in the advert, including that the product would normalise the body’s pH levels.

He said the company incorrectly quoted the optimal pH level and mentioned that the product was clinically proven, all of which was untrue and contradicted by prestigious medical journals, according to Eyal.

The ASA ruled that the claims made in the advertisement were “currently unsubstantiated” and upheld the complaint.

But the founder and director of Immunadue, Schalk Mulder, insists his product is no snake oil, and swears his customers would attest to the numerous and rather miscellaneous health benefits of his supplements.

“If you have got clinical trials on the raw material of your product, saying that it can help with diabetes, stress and so forth — and there are a lot of products which are extracted from the same active ingredient patented by all of these firms to help with diabetes and so forth — then according to me, it’s not a false claim,” said Mulder.

“We have clinical studies that say it does work and we have been on the market for 18 years. We have so many testimonials of satisfied clients who say using our product does work.”

Steinman, a lauded consumer rights activist in the health industry, said companies claiming their products treat multiple illnesses are largely unscrupulous and misleading in their wording.

After perusing Immunadue’s claims on their website, Steinman concluded that none of the claims made about this product’s health benefits could be true and added that the pills could even be dangerous.

“They appear to making the claims based on the ingredients being ‘herbal’ and some having ‘traditional use’, but there is no robust evidence that any of these ingredients together have any of the claimed effects,” he says.

“There is some preliminary evidence for or against some of the ingredients, but based on cell cultures and not proven in humans. Of course, one has to prove that the combination of ingredients work and that the dosages are correct. Also, that they are safe.

“For example, African wild potato products have been associated with decreased production of blood cells and irregular heartbeat. It may interfere with the effectiveness of other drugs or supplements, such as antiretrovirals.”

A big pHat lie?

Scientific literature dating back to 2009 has seen claims about PH balance in the body used by the alternative medicine industry debunked, but the trend continues to dominate the industry.

Studies into the importance of pH homeostasis in metabolic health and diseases have been used by multivitamin pushers to give credence to their claims that their health products could normalise the body’s PH, meaning their product could prevent, treat or even cure diseases.

Responding to earlier claims that certain “health” products could change the PH in one’s blood stream, sports medicine doctor Gabe Mirkin wrote that while certain foods could change the acidity of urine, this was the only bodily fluid whose PH could be changed by diet.

He said this was irrelevant to pH homeostasis, since urine was contained in the bladder and did not affect the pH of any other part of the body.

This means that it really isn’t possible to change the body’s pH level, since the lungs and kidneys regulate this, and even changes of just a few decimals in either direction would lead to death, debunking the claims of companies such as Immunadue.

A quack run through history

In 2017, health supplements were added as a second category of Complementary medicines to the Medicines and Related Substances Act (1965):

Currently, all complementary medicines, as defined, are permitted continued rights of sale, provided that:

– An application is submitted for their registration by the prescribed deadlines of any applicable call-up notice;

– They are manufactured, imported, exported, wholesaled or distributed by a holder of a relevant licence contemplated in section 22C(1)(b) of the Medicines Act at the end of the timeframe specified by the SAHPRA;

– They are specifically compliant with the requirements of section 20 and regulations 10, 11, 12 and 42 as prescribed, and are compliant with any other relevant provisions of the Medicines Act and its regulations; and

– They are indicated based on LOW RISK, which includes:

i. General health enhancement without any reference to specific diseases;

ii. Health maintenance; or

iii. Relief of minor symptoms (not related to a disease or disorder).

The registration and availability of these medicines will take into account quality, safety and efficacy of their production and sale in line with their relative risk which are prescribed according to the developed guidelines issued by the SAHPRA.

According to SAHPRA spokesperson Yuven Gounden, there has been a significant shift in compliance with labelling and low-risk indications since the publication and implementation of the regulations.

This was despite the fact that discipline-specific medicines and health supplements were yet to be called up for registration.

“The new roadmap and associated regulatory framework provide for products found to be making disease-specific medicinal claims to be called up immediately. The registration and availability of these medicines will consider their quality, safety and efficacy as per section 1(2) of the Medicines Act and in line with their relative risk. We encourage members of the public to report any adverse effects to SAHPRA.”

A big business

According to Eben Esterhuizen, general manager of the Pharma Group, one of the trends changing the status quo in the pharmaceuticals industry is the rise of preventative healthcare products rather than reactive medicine, which can be seen in the increase in sales in vitamin products, health foods, immune boosters and sporting tonics, among others.

Clicks is a leader in the South African retail healthcare market, and South Africa’s largest pharmacy chain with a 23.3% share of the retail pharmacy market.

According to the group’s integrated annual report for the period ended 31 August 2018, Clicks’ turnover increased by 9.1% from R26.8 billion in 2017 to R29.2 billion in 2018.

The global multivitamin market was worth US$132.8 billion (about R1.99 trillion) in 2016 and is projected to grow at a compound annual growth rate (CAGR) of 8.8% up to 2022.

This is according to Insight Survey’s South African Vitamins and Supplements Landscape Report 2018. The report says the increase in the prevalence of lifestyle diseases and the rise of the active lifestyle trend significantly drove sales of vitamins and supplements.

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