Removing health advisory for those with sickle cell anemia and thalassemia consuming iron-fortified food is a matter of concern

To:

Chief Executive Officer
Food Safety and Standards Authority of India, 
FDA Bhawan, Kotla Road, 
New Delhi- 110002 /

[email protected]
October 13, 2024 

Dear Sir, 

We write to you as concerned citizens of India to express our concern regarding the initial “Direction” dated July 19th 2024, and the draft notification published for amendment to the Food Safety and Standards (Fortification of Foods) Regulations, 2018. Many of us belong to the medical fraternity. Specifically, we are troubled by the removal of the health advisory for patients with Sickle Cell Anemia and Thalassemia through the omission of sub-regulation (4) of regulation 7, namely, “People with Thalassemia may take under medical supervision and persons with Sickle Cell Anaemia are advised not to consume iron fortified food products”. This amendment being proposed to the 2018 regulations is surprising given that the mandatory advisory was included into the statutory regulations of 2018 in the first instance after scientific discussions in statutory bodies of FSSAI Act 2006, whereas the current omission is at the initiative of another Ministry which has no mandate of food safety. We are also concerned about the way fortification is being promoted as an effective solution to tackling malnutrition problems.

Iron fortified rice unnecessary and ineffective to tackle anaemia: We have been questioning the very need and efficacy for this iron-fortified rice as a near-universal solution for all citizens who are dependent on public food schemes. To begin with, anaemia is only partly caused by iron deficiency[1]. It has a multifactorial etiology, including nutritional deficiencies (iron, folate, vitamin B12), infections, and other factors. Moreover, the most credible scientific reviews such as a Cochrane review have shown that fortified rice is not an effective solution to tackle anemia, showing that evidence on benefits of mass fortification are uncertain and unequivocal.[2] ICMR’s study among children noted that “iron fortified rice has a similar effect as mid-day meal on improvement in anaemia,” thus questioning the rationale behind this expensive program.[3] 

Safety concerns: On the other hand, there are also concerns of risks from consumption of iron-fortified foods, especially in some contra-indicated medical conditions, as well as causing non-communicable diseases like diabetes that increase with higher serum ferritin levels in children,[4] including risks of gut microbial dysbiosis from unabsorbed iron[5]. The impact of iron fortification in a population like India with high levels of malnutrition and dietary insufficiency have also not been sufficiently studied. We also have large scale iron supplementation programmes impacting, for instance, pregnant and lactating women, children and adolescent girls.

Thus, the situation of the dosage in fortified rice is such that it is either ineffective, or unsafe, and cannot be both effective and safe for consumption at a population level.

Extra iron to thalassemia, sickle cell anaemia patients risks liver cirrhosis, cardiomyopathy, heart failure, hypothyroidism, hypogonadism, diabetes, delayed puberty.[6] A study for MoFPD, Govt of India suggested how “sometimes, fortification of food with iron can lead to iron overload in persons with hemochromatosis. Monitoring of additional intake of iron of nontargeted groups must be an integral part of any fortification program.”[7] Another study from 2024 published in European Study of Nutrition found that sickle cell anemia patients consuming iron fortified food “may be at risk of developing primary iron overload” and calling for further studies to help establish a safe nutrition approach.[8] There are also concerns of risks from consumption of iron-fortified foods, especially in some contra-indicated medical conditions, as well as causing non-communicable diseases like diabetes that increase with higher serum ferritin levels in children,[9] including risks of gut microbial dysbiosis from unabsorbed iron.[10]

Serious lacunae in quality control: Simultaneously, a NITI Aayog report[11] into iron fortified rice raised several concerns about Quality Assurance and Quality Checks with regard to such fortification. It found samples were not being collected at all suggested points (rice mills, fair price shops, anganwadis/schools etc.) as prescribed by guidelines of DoFPD. Same samples are noted to have given different test results from different labs and some samples had higher concentrations of iron fortified kernals due to blending that was not uniformly done, increasing the risk of higher dosage due to poor quality control.[12] In fact this reality contradicts of the key recommendations of the Rajiv Bahl committee that was set up by the MoHFW to review FSSAI’s health advisory on Thalassemia and SCD was that “there is a need for ensuring appropriate blending for uniform distribution of fortified rice kernals in rice.”

The Niti Aayog report also pointed out that instead of sample testing, reliance was being placed on Certificate of Analysis supplied by FRK manufacturers, whereas guidelines specify at least quarterly tests of micronutrient analysis by state/district officials. It further recorded that Blending Efficiency Tests (BET) or iron spot checks are not being conducted at all rice mills. There were also variations found in the frequency of collection of samples with no standardised protocol in many districts. The NITI Aayog report also notes inadequate number of NABL-accredited labs approved for testing of rice fortificants. There is also a concentration of such labs in only some regions, which then entails high cost for sample transportation and time delays, leading to long delays in receipt of sample test results. FSSAI officials right now have not been given any special mandate with regard to quality checks.

Global scenario of labelling requirement and high number of undiagnosed individuals in India:  According to the committee that was set up to review FSSAI’s health advisory on Thalassemia and SCD by the MoHFW headed by Dr Rajiv Bahl of the ICMR, other countries as well as the WHO don’t have warning labels, but do ask for ‘proper labelling’ so that patients on iron restricted diets can make informed choices. Moreover they also cite the United States Food and Drug Administration’s (FDA) position on this- which is that while labelling is clearly required, no health warning is needed because “individuals with illnesses where iron intake is contraindicated, would have been advised by their healthcare providers.” This assumes that such individuals in India are in contact with healthcare providers and have been diagnosed- which is not the case. Access to healthcare is particularly low in tribal areas where such contraindicated diseases are high. Despite the fact that India has one of the highest prevalences of sickle cell disease (SCD) globally, with over a million people affected,[13] the majority of individuals living with such conditions remain undiagnosed.[14] Moreover, given that fortified rice is being provided in loose form, such individuals will not be able to see the labels, and their ability to make informed choices is being taken away.

Current decision to omit warning labels questionable against the above backdrop: This decision to omit a warning label, that was originally imposed after scientific assessment of the matter poses a risk to the health and well-being of individuals living with these genetic blood disorders, especially given the lack of quality control on the ground.

Moreover, processes adopted for omission of warning label suspicious: The process by which this health advisory was removed is suspect and shows that the warning was removed due to inconveniences caused, rather than any clear basis in science. The Scientific Committee of the FSSAI had in fact strengthened this warning in 2021 announced via a Gazette notification[15], to include Sickle Cell Anemia in the warning, as previously, the warning only applied to Thalassemia. However, after a petition was filed in the Supreme Court challenging the lack of protection for patients of such haemoglobinopathies under the government’s iron fortified rice distribution programs, the government sprung into action to remove the advisory entirely. The timeline of developments and process by which this was done, as given in the annexure, strengthens this suspicion. Several reports by government linked bodies such as the NIN ICMR whitepaper,[10]  the New report by the Economic Advisory Council to the Prime Minister’s report,[16] a report by the Niti Aayog[17], and concerns raised by the Director General of the Indian Council for Medical Research (ICMR),[18] all advise great caution and question iron fortification as the approach to combat anaemia. Yet all such reports have been sidelined. FSSAI itself has categorized fortified rice as “high risk“[19], requiring mandatory safety checks. However, a confidential evaluation by the NITI Aayog in May 2022 exposed various lacunae as pointed out earlier in this letter. Still such fortified rice, despite no quality control, is being widely distributed. We believe that using a blanket approach of iron fortification is counterproductive, both in terms of lack of efficacy and lack of safety.

We strongly believe that this omission of the caution label is not advisable, for the above stated reasons. We therefore urge the FSSAI to reconsider this decision, and reinstate the advisory in the regulations immediately. More importantly, the policy decision to supply iron-fortified rice in such a large scale manner (with distinct potential for risk) without any scientific proof of its need and effectiveness, should be revisited.

We look forward to your prompt action on this critical matter and request a timely response outlining the steps FSSAI intends to take, to rectify this situation. Full letter with sign-ons attached here too.

Sincerely,

ENDNOTES

[1] https://www.mdpi.com/2072-6643/16/11/1673 

[2] https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009902.pub2/full 

[3] https://www.greenpeace.org/india/en/press/13001/no-substantive-evidence-on-fortification-as-a-solution-to-nutritional-security-reveals-rtis/ 

[4] https://www.researchsquare.com/article/rs-1136688/v1 

[5] https://www.nin.res.in/downloads/whitepaper.pdf 

[6] https://www.ncbi.nlm.nih.gov/books/NBK562146/ 

[7] https://www.sciencedirect.com/science/article/abs/pii/S0924224419307290 

[8] https://pubmed.ncbi.nlm.nih.gov/38722385/ 

[9] https://www.researchsquare.com/article/rs-1136688/v1 

[10] https://www.nin.res.in/downloads/whitepaper.pdf 

[11] https://drive.google.com/file/d/1mFv6mr6u8Ez49cXutA9gphW-07yviu2W/view 

[12] “Mishra of Sun-Tech laboratory said that the results of micronutrients in the fortified rice varied also because of lack of uniform blending by those who sold the fortified kernels, which includes a range of suppliers from big industry to smaller players.” In: https://thewire.in/rights/fortified-rice-kernel-experiment-testing 

[13] https://www.thehindu.com/opinion/lead/indias-sickle-cell-challenge/article68630935.ece 

[14] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10466490/ 

[15] https://egazette.gov.in/(S(dgccbmk3vlx3qn50zyajyebg))/ViewPDF.aspx 

[16] https://eacpm.gov.in/wp-content/uploads/2024/09/Comprehensive-Nutrition-Report-Final-1.pdf 

[17] https://drive.google.com/file/d/1mFv6mr6u8Ez49cXutA9gphW-07yviu2W/view 

[18] https://www.reporters-collective.in/trc/despite-internal-red-flags-and-uncertain-science-modi-govt-serves-fortified-rice-to-indias-poor

[19] https://www.fssai.gov.in/upload/advisories/2022/05/626fad52101b0Order_RBIS_02_05_2022.pdf

ANNEXURE: 

Process by which the decision to remove the warning label was taken

12th May 2023: DFPD (Dept of Food and Public Distribution in the Ministry for Consumer Affairs, Food and Public Distribution, GoI) claims that it has received two reports, one from the National Institute of Nutrition (NIN) that advises to retain the advisory, and another report by its own Working Group. Based on which, it writes to the FSSAI, to initiate a process to review the advisory. The DFPD’s mandate is procurement and distribution. That the DFPD initiates the removal of the health advisory that came about through statutory scientific processes, by creating a Working Group to question and review scientific advisories established via statutory protocols of the FSSAI is problematic. The DoFPD’s Working Group (WG-2) was to “examine the safety of iron-fortified rice for normal population as well as patients with hemoglobinopathies and SCD”. This Committee’s main reasoning was that globally, no country has mandated a warning label. This reasoning ignores the fact that India’s conditions related to contra-indications, poverty, and malnutrition could be unique.

The 22nd meeting of the FSSAI’s Scientific Panel records that they will review the advisory after they get the DFPD Working Group report. Once again, the DFPD’s own Working Group is the catalyst behind the review by FSSAI’s Scientific Panel, even though their own 2-year long process had led to the establishment of the warning and further strengthening in the first place.

6th July 2023: Scientific Panel (SP-18, in its 23rd meeting) invites experts. And they recommend omission of the advisory on the grounds that patients receiving blood transfusions are always under a doctor’s care.

22nd July 2023: Scientific Committee of FSSAI, in its 46th meeting, endorses this recommendation.

30th May 2023 and 19th September 2023: An unusual 2-session 42nd Food Authority meeting (where the two sessions are 3.5 months apart) discusses change in regulations with regard to warning labels for iron fortified foods. The Authority did not want to omit the advisory fully in its 42nd meeting, as per the 44th meeting minutes. “It was decided to continue with the precautionary statement on iron-fortified food packages albeit with suitable modification of the statement till the time more conclusive evidence is available in this context for an informed decision”, and the change proposed in the regulation by the 42nd meeting was: “Every package of food, fortified with iron, shall carry a statement – ‘People with Thalassemia and Sickle Cell Anaemia may consume iron fortified food products after medical advice’”. 

25th October 2023: Committee of Secretaries under the Chairmanship of Cabinet Secretary discusses the above-mentioned advisory as per the 42nd Food Authority meeting. They recommend to review the advisory.

1st November 2023: IMC meeting under Chairpersonship of Secretary, DoFPD deliberates the matter. They ask for a Committee constituted under chairpersonship of Additional Secretary of DoFPD to review the matter as the issue is technical in nature and requires close scrutiny. 

30th November 2023: Rajiv Bahl (DG, ICMR) Committee gets constituted by the MOHFW, tasked with a review of the advisory. Committee co-opts a member who represents conflict of interest, even though the Committee Constitution Order does not allow inclusion of any more members, but only allows for inviting independent experts, whenever necessary, for deliberation on specific matters. 

16th January 2024: Committee comes up with its report and recommends the removal of the warning label.

1st February 2024: Letter to CEO FSSAI from MoH&FW asks for the advisory to be removed, based on Rajiv Bahl Committee report. It also informs that the Health Minister has approved the report recommending the omission.

19th June 2024: 44th Food Authority Meeting endorses the omission recommendation.

19th July 2024: FSSAI issues a “Direction” omitting the cautionary label, using an urgency provision in the Food Safety and Standards Act 2006, which is technically valid for only a 6-month period.

18th September 2024: Draft Gazette Notification for amendments that propose omission of the warning label are published, giving public 60 days’ time for feedback. 

Copy to : Shri JP Nadda, Union Minister for Health & Family Welfare and Secretary, Union Minister for Health & Family Welfare–

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Alliance for Sustainable & Holistic Agriculture (ASHA-Kisan Swaraj)

FOOD – FARMERS – FREEDOM

www.kisanswaraj.in

www.indiaforsafefood.in