'Complacency' hindering regulation? FSSAI questioned as 'illegal' keto diet pills pop up online
A Mumbai-based food technologist known only as Sharadha G had reportedly decided to find out more after a week of repeatedly seeing Facebook advertisements for a keto supplement sold on Amazon.
Subsequently, she tweeted that the product was "flouting all possible rules" of the FSSAI, as it contained "unapproved ingredients", had "no licence number", and had an "undeclared shelf life".
The product, made by a US-based firm called Simple Organics, carries claims of promoting weight loss, and even has a money-back guarantee should customers fail to see results.
Apart from substances such as sodium beta-hydroxybutyrate, calcium beta-hydroxybutyrate and potassium beta-hydroxybutyrate, the product’s Amazon listing — which has since been removed — did not state any other ingredients.
Its main selling point is beta-hydroxybutyric (BHB), a ketone produced from body fat during fasting or periods of glucose deficiency that may act as an alternative energy source. This is in line with the increasingly popular ketogenic or keto diet, a low-carbohydrate, high-protein and high-fat diet said to result in weight loss.
However, according to the Nutraceutical Regulations implemented by India's Health Ministry in 2016, BHB is not among the ingredients permitted for use in health supplements.
Despite the Amazon listing having been removed, Sharadha G later tweeted that she was still seeing "sponsored ads on Facebook and Instagram". She also told Indian media that while she was able to spot the red flags due to her position as a food technologist, a layperson might not have the same advantage.
Amazon responded by saying all sellers on its marketplace were "solely responsible for all necessary product compliance and are required to sell products which are legally allowed to be sold in India".
It added that it had contacted the seller when concerns were raised about the product, which eventually led to the listing being removed from the website.
Founder and director of India's Expert Nutraceutical Advocacy Council (ENAC), Sandeep Gupta, told NutraIngredients-Asia that consumers should look out for essential information when purchasing dietary supplements: the FSSAI license number and logo, brown non-vegetarian or green vegetarian / vegan logo, a list of all the ingredients along with the excipients used, the recommended dosage, and usage directions.
The product packaging should also include precautionary statements such as "do not exceed daily recommended dose", as well as directions for use in relation to various health conditions, and advice to take the product under clinical supervision if needed.
Complacency complicating matters?
An FSSAI official said in a media statement that it was aware of unlicensed products being sold online, and expected the e-commerce platform in question to "take action, delist the product, and inform us so we can take action against them".
However, a former FSSAI consultant — who chose to remain anonymous — claimed the regulator had become 'complacent' in taking said action, saying that there was a "significant backlog" of products awaiting approval in an increasingly crowded health and wellness market.
Furthermore, the consultant said there was a "lack of appropriate updates to (the) general public on ingredient approval status", and that some products already on the Indian market were not "licensed according to Indian norms, but are selling anyway".
Gupta disagreed, saying the FSSAI had already tightened import regulations and stipulated guidelines that required the suspension or cancellation of the licence of any importer that sold unsafe or prohibited food or supplement products in India; this includes not just not just sales, but also rechannelling and repacking.
He added that the FSSAI had already implemented regulations regarding approved ingredients and additives under various food and supplement categories that applied to all food business owners (FBOs) manufacturing, marketing, importing and / or distributing such products for consumption in India.
"I disagree that FSSAI is 'complacent', and caution FBOs to be proactive and comply with these regulations. The onus of self-regulation lies largely on FBOs, as well as e-commerce platforms.
"The FSSAI has directed 10 such e-commerce platforms to take action against unlicensed and unregistered food operators, and ensure compliance with food safety rules and regulations."
Gupta did, however, acknowledge that there was room for regulatory improvement, starting with the monitoring of the labelling of imported products purchased via e-commerce.
He said the FSSAI should require official declaration from FBOs on e-commerce platforms, especially since more consumers were now using such platforms as their main buying channel.
He added: "The FSSAI should carry out periodical supervision of e-commerce FBOs. On their part, FBOs should educate and create awareness of their products to help consumers make informed decisions.
"FBOs should be careful when making health claims and ensure they are approved by the FSSAI. The safety of the consumer is a shared responsibility of both the regulator and FBOs."
NutraIngredients-Asia contacted both Simple Organics and the FSSAI for comment, but did not receive a response from either party.