Indian supplement industry 'surprised' by regulator's restrictive ingredients notice: IDMA expert
According to an industry source, this notification (issued on June 29) came as a surprise, and may cause "unnecessary concern" among consumers.
Sandeep Gupta, vice chairman of the Indian Drug Manufacturers' Association's (IDMA) nutraceutical subcommittee, told NutraIngredients-Asia: "Today, there is a lot of transparency and consultation between the FSSAI and the industry. We both place consumers as the top priority before arriving at any decision — we even have a meeting every month.
"This notification was a surprise. On the surface (at least), this has created some cause for concern in the industry. We should diligently screen and evaluate ingredients and come to conclusions, rather than receive such notifications."
The latest notification came half a year after the list of 33 ingredients was released, among which were Succinc acid, Inosine, Paramino benzoic acid (PABA), Vanadium, Prenolit, Ipriflavone, Polypodium leucotomos, selenium dioxide, D-ribose, artichoke, kale powder, Salvia hispanica, cashew fruit, passionfruit, kiwifruit extract, broccoli, and the enzymes Pectinase and Xylanase.
These ingredients were placed on the list as they had not been recommended by the FSSAI's scientific panel for inclusion in the nutraceutical regulations due to a lack of data. The new notification was then issued following a review of the ingredients based on additional information provided by health food and supplement business owners.
It states that companies can continue including S-acetyl glutathione and alpha cyclodextrin in their supplements, but are to discontinue the use of Succinc acid, Ipriflavone, Polypodium leucotomos, Inosine and D-ribose immediately, with no further manufacturing of the products containing these ingredients permitted.
However, products containing the abovementioned ingredients that have already been manufactured or imported are allowed to continue being sold until September 30, 2018.
D-ribose, on the other hand, can still be used in Foods for Special Medical Purposes (FSMP), so long as the FSSAI gives its prior approval.
Due to "safety concerns", even stricter directions apply to PABA, Vanadium, Prenolit, and selenium dioxide: not only must companies discontinue their usage, products containing these ingredients that have already been manufactured or imported are to be immediately withdrawn from the market.
Artichoke, kale powder, Salvia hispanica, cashew fruit, passionfruit, kiwifruit extract, broccoli, and the enzymes Pectinase and Xylanase are still permitted for use in health supplements, but only as general ingredients.
Manufacturers are no longer allowed to make health claims surrounding these ingredients, though products containing them and carrying such claims are allowed to continue being sold until September 30.
To ban or not to ban?
Gupta, however, is adamant that this does not constitute a ban on the listed ingredients.
"This is not a ban, this is (concern over) the inadequacy of information. The FSSAI is seeking more information from stakeholders, but it hasn't communicated what specific information is required to justify the inclusion of these ingredients."
He said that after a preliminary screening of the ingredients by the FSSAI's scientific panel, the regulator requested more information, which was duly submitted by the IDMA despite the former's lack of specificity.
He added: "Ingredients like PABA, saw palmetto, tea tree oil, artichoke, D-ribose and kale powder have all been consumed for a number of years in India, and there have been no major safety concerns.
"The industry has suggested to the FSSAI that the protocol and procedure for any product to be discontinued should be based on its last manufactured batch. This means that if the official notification was issued on June 29, records of anything manufactured before and up to June 29 should be maintained by food business owners (for evaluation)."
This way, he believes, it will be easier to determine if there is a genuine safety concern, whereupon it would be reasonable to withdraw affected products immediately.
But if the FSSAI merely requires additional information, companies should be given sufficient time to procure it, and there should be transparency on both sides so a justified decision can be made, he said.
Transparency necessitates clarity
According to Gupta, the notification was unexpected, considering the purported "transparency" between the authorities and the industry — the FSSAI is responsible for the preliminary screening of ingredients, while the IDMA procures relevant information from companies.
He said, "All stakeholders are happy to provide the relevant information and fill in the gaps if required. These regulations were released with the understanding that these ingredients would be screened and evaluated in due time.
"These ingredients and the products they are found in have not been reported as 'unsafe'. Their abrupt withdrawal or discontinuation would be very unfair and would cause unnecessary concern.
"The FSSAI must clarify exactly what concerns it has and what information it seeks, so we can better address its concerns. Rather than disallowing or discontinuing such ingredients, the industry should be given the opportunity and time to come up with more information."
In January this year, we reported on the FSSAI seeking scientific data on 34 ingredients, though the latest notification is based on a list published in December last year, which contained 33 ingredients.
While the industry was initially open to the regulatory clarity they felt the FSSAI's proposals would provide, it began to raise concerns regarding permitted ingredient use, leading the regulator to assure companies it would address their concerns accordingly.