The analysis showed that nearly 70 percent of the 36 supplements had inaccurate protein information, with some brands offering only half of what they claimed. Also, around 14 percent of samples contained harmful fungal aflatoxins, while 8 percent showed traces of pesticide residue.
Also, noted the authors — clinical researchers associated with Rajagiri Hospital in Kerala and a technology entrepreneur from the US — “most Indian-made herbal protein-based supplements are poor quality and contain liver toxic botanicals”.
“We demonstrate that the protein-based herbal and dietary supplement industry requires stringent scrutiny, regulation, and basic safety studies before being marketed,” the authors said.
Dr Cyriac Abby Philips, hepatologist from Rajagiri Hospital in Aluva in Kerala, the principal investigator of the self-funded study, told ThePrint that though there is published data from various research groups and clinical units across the world on organ damage, especially liver injury due to herbal and dietary supplements, there has been no proactive and prospective analysis of widely utilised supplements — especially protein-based — in published literature.
“There are occasional published reports that look at the quality of whey protein and amino acids analysis in protein supplements to identify amino acid spiking or ‘doping’ to falsely elevate protein content,” he said.
Philips added that one study also looked at how marketed protein supplements adhered to regulations with respect to quality — but much of this was done on protein supplements sold in the US and there were no such studies done from the Asia Pacific region.
“Our work sheds light on regulatory flaccidity, importance of consumers rights in being privy to transparency regarding choosing safe food or supplement options and general apathy of the medical community towards educating the public regarding food and diet supplements that are potentially beneficial versus potentially harmful,” he said.
ThePrint reached G. Kamala Vardhana Rao, chief executive at the Food Safety and Standards Authority of India (FSSAI), over calls, for comments on the findings in the paper but had received no response by the time of publication. This report will be updated if and when a response is received.
In response to a question in the Lok Sabha in August last year, Union Health Minister Mansukh Mandaviya had informed the Lower House that in 2022-23, as many as 38,053 civil cases and 4,817 criminal cases were lodged by the FSSAI for non-conforming food samples including protein powders and dietary supplements.
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The study and the findings
The 36 protein powders analysed were either blended, pure plant-based, and pure whey-based formulations (protein from whey, the watery portion of milk that separates from the curds when making cheese).
The blends included either different blends of proteins or those with herbal extracts.
Of the 14 blended formulations, seven contained herbal extracts, and the rest included various types of protein sources, such as pea, soy, egg, milk (whole, whey, or casein), and peanuts.
Four products were purely plant-based in nature, and 18 powders were purely whey-based and whey-blended (concentrate, hydrolysate, and isolate).
Twenty products were made in India, and the rest were manufactured by multinational companies.
Of the 36 products, nine had less than 40 percent detected protein content, while the rest had above 60 percent. Overall, 25 protein supplements (69.4 percent) were mislabeled about protein content; that is, the protein content per 100 g detected in analysis was less than what was advertised on the product, featuring less than 10 percent to more than 50 percent deficit.
Two products from one manufacturer had 62 percent and 50.4 percent lower protein content while a commonly prescribed protein from a well reputed company also mislabelled protein content of approximately 30 percent deficit than advertised.
Also, according to the authors, certain protein brands were found to contain more than the labelled protein content in the quantification analysis.
Higher protein content could suggest either good quality protein sources used in manufacturing or it could also be part of “protein or amino spiking” where supplement manufacturers intentionally add cheaper protein components such as cheaply available amino acids glycine and taurine to deceptively showcase higher protein content, noted the researchers.
On fungal toxin analysis, five of 36 (13.9 percent) samples were found to be contaminated with aflatoxins — toxins from certain fungi — and in some samples, the aflatoxin content was above 10 μg/kg. In pesticide residue analysis, three samples (8.3 percent) were found to be contaminated by trace amounts.
Based on these results, Philips said on social media that the protein powder by BigMuscles was the “worst brand”, the one by Amway was the “worst plant-based”, and Protinex, Ensure and B-Protin were the “worst brands advertised as the best”.
He also said that brands that need extreme caution include Elements and Nutrilite by Amway as they contain fungal toxins.
Hello, I have a fantastic Saturday morning read for you. In fact, you’ll be engrossed in this the whole day.
As promised, we have published our disruptive project – the unique public-health project funded by @paraschopra to analyze common/well-known protein supplements sold in… pic.twitter.com/xzb7Gh0G3Q
— TheLiverDoc (@theliverdr) April 6, 2024
ThePrint reached the makers of these powders (Big Muscles Nutrition, Amway, Nestle, Abbott, Danone India and British Biologicals) over email for their comments on the findings but had not received a response from any of them by the time of publication. This report will be updated if and when a response is received.
Based on the findings, Philips said, the “best” whey brand in the Indian market was One Science Nutrition, and the protein supplement by Nutrabox was the “best medium range” whey. The protein powder by Origin, according to the analysis, was the “best vegan” protein.
Huge implications
The study highlights that similar to the United States Food and Drug Administration, the FSSAI does not approve herbal and dietary supplements but regulates good manufacturing practices.
The safety of contents in protein-based herbal and dietary supplements must be assured by the manufacturer, while the content and labelling are scrutinised by the FSSAI, based on test results submitted by the manufacturer that are not made public and remain non-transparent, according to the study’s authors.
“The implications of our study are important,” said Philips. “One, we need regulatory bodies to come clean and be transparent about food and dietary supplements because these are not tested for efficacy or safety as we do with drugs and medications.”
The only driving factor that makes such products “ready for the market” are good manufacturing practices, the hepatologist and medical researcher explained, adding that the manufacturers cannot be trusted because they are not forthcoming with respect to realistic quality and will do anything to make a profit and enhance promotion.
For example, he said that the new analysis has shown that labelled protein content and identified content were dissimilar in many brands and there were suggestions of “protein spiking or amino acid doping” in some of the brands tested.
“In the absence of regulatory oversight in such situations, it then becomes an ‘every person for themselves’ sort of situation when it comes to choosing a food supplement from a public perspective. This is unfair and dangerous,” he stressed.
Dr Sabine Kapasi, adviser, public health and healthcare services strategist with the United Nations Covid-19 task force who is not directly associated with the study, too, agreed that it underscored the urgent need for stricter regulations and quality control in manufacturing and labelling of protein supplements.
“It stresses the importance of transparent and accurate product information, enabling consumers to make informed decisions about their health,” she said.
Kapase added that the Supreme Court issuing a contempt notice to ayurvedic conglomerate Patanjali for continued dissemination of misleading advertisements further emphasised the necessity for stringent accountability in the health supplement sector.
“These observations reflect a growing worry about misleading information, lack of transparency, and potential health risks posed by such products. As consumers, it’s vital to be aware of these issues and exercise caution when choosing protein supplements,” she said.
According to Kapase, while protein supplements can offer benefits when used correctly, the study’s findings highlight the urgent need for increased scrutiny and regulation in the industry.
(Edited by Nida Fatima Siddiqui)
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