Table of Contents  
REVIEW ARTICLE
Year : 2016  |  Volume : 9  |  Issue : 6  |  Page : 680-683  

Regulatory framework for "gluten-free" foods in India: Magic bullet for celiac disease patients


Department of Community Medicine, AFMC, Pune, Maharashtra, India

Date of Web Publication16-Nov-2016

Correspondence Address:
Puja Dudeja
Department of Community Medicine, AFMC, Pune, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-2870.194181

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  Abstract 

Coeliac disease (CD) remains largely unrecognized and actual burden is much more than reported or diagnosed. The treatment essentially remains 'gluten free' foods. Adulteration of these foods with gluten can occur anywhere in the chain from farm to fork. The current Food Safety and Standards Regulations (FSSR) 2011 brought a ray of hope for CD patients by including prevention of contamination of food with gluten and labeling of gluten-free items under regulatory framework. The definition of "gluten-free" includes food items containing <20 ppm of gluten. These guidelines are at par with those given in USA and Canada. These regulations provide a reference point for manufacturers, physicians, and CD patients and ensure easy availability, accessibility, and identification of "gluten-free" food items. This step forward by Government of India constitutes the first comprehensive step taken toward management of the disease.

Keywords: Coeliac disease, Food Safety and Standards Authority of India, gluten, labeling


How to cite this article:
Dudeja P, Dudeja A, Singh G, Mukherji S. Regulatory framework for "gluten-free" foods in India: Magic bullet for celiac disease patients. Med J DY Patil Univ 2016;9:680-3

How to cite this URL:
Dudeja P, Dudeja A, Singh G, Mukherji S. Regulatory framework for "gluten-free" foods in India: Magic bullet for celiac disease patients. Med J DY Patil Univ [serial online] 2016 [cited 2024 Mar 28];9:680-3. Available from: https://journals.lww.com/mjdy/pages/default.aspx/text.asp?2016/9/6/680/194181


  Introduction Top


Celiac disease (CD), also known as "nontropical sprue" or "celiac sprue," is a "gluten-induced enteropathy." Earlier, it was considered that CD is largely a disease of European descent. However, prevalence studies carried out recently have documented its worldwide distribution. Burden of CD is progressively rising in India, and now it is being considered as a disease of public health importance. [1]

The quote "let food be your medicine and medicine be your food" applies truly to the management of CD cases where the keystone of treatment is to consume gluten-free diet. [2],[3] Despite this, gluten labeling on food items in India was nonexistent and posed a huge challenge for physicians as well as patients in the identification of gluten-free food products. [4],[5]

The felt need for nutrition labeling for packaged food items in India was addressed with promulgation of Food Safety and Standards Regulations (FSSR), 2011. Gazette notifications on "food products standards and food additives" as well as "packaging and labeling" of Government of India published in January 2015 showed progress toward acceptance of need for gluten-free label and start of regulatory process. Further, recent notifications by Ministry of Health and Family Welfare (MoHFW) on May 3, 2016, have brought a new ray of hope for the management of CD by giving regulations on gluten-free food items. The present review was carried out to study FSSR regulations related to "gluten" in food products and to compare them with already existing regulations worldwide.


  Celiac Disease Burden in India: An Emerging Public Health Issue Top


The prevalence pool of CD is estimated to be 6-8 million in the country. A study conducted by Makharia et al. in national capital region reported prevalence of CD and positive anti-transglutaminase antibodies to be 1.04% (1 in 96) and 1.44% (1 in 69), respectively. [6] Further, extremes of age have been found to have a high prevalence, but no age is immune to the disease.

Various studies have documented the higher burden of CD in Northern parts of the country. In fact, on the basis of place distribution, term "celiac belt" has been introduced in the country. [7] The disease has commonly been reported from states of Punjab, Haryana, New Delhi, Rajasthan, Uttar Pradesh, Bihar, and Madhya Pradesh. This has been attributed to high prevalence of required haplotypes in genetic composition of population residing in these areas and wheat as staple diet.

Unfortunately, actual burden of CD is much more than reported or diagnosed. In clinical settings, it remains largely unrecognized, and age-old adage of iceberg phenomenon applies aptly to CD. Routinely, only those patients with typical signs and symptoms undergo screening. [8] Another predicament to screening is a lack of standardized kits for Indian population. At present, no public service units are manufacturing screening kits in India. Thus, the predictive values of imported test kits remain questionable. [9]


  Gluten-Free Food Products: Issues from Farm to Fork Top


Gluten is a versatile protein increasingly being used not only in manufacture of processed food items such as ice creams, sweets, confectionery, soups, and sauces but also in lipsticks and postage stamps. [10]

Under routine circumstances "gluten-free" food adulteration with gluten occur during milling, processing, and preparation of commercial food products, at retail outlets and in households. Gluten-free food product adulteration has been found to be of common occurrence in mills where grinding of gluten-containing and gluten-free grains is carried out in same equipment's and more so when done without proper cleaning. During processing of raw products in factories, presence of a common production line is implicated in majority of instances of adulteration. Further, during preparation of commercial food products, especially packaged items, gluten is added as fillers, stabilizing agents, or processing aids. At retail outlets such as grocery stores, use of the same spatula to pick gluten-containing and gluten-free grains/flours is common. Furthermore, while eating out, thickeners or fillers/binders are added which contain gluten. At household level, use of common utensils for storage, cooking, and handling (rolling pin, surface griddle, dusters, and oil for frying) are the attributable risk factors for contamination and adulteration.

At the beneficiary level among CD patients, lack of compliance to "gluten-free" diet has been attributed to cultural factors such as the presence of wheat as a staple, lack of awareness about disease, increase in consumption of processed food items, and eating out culture in contemporary Indian Society.


  Nutrition Labeling for Gluten-Free Products: Global Scenario Top


Codex Alimentarius Commission of the World Health Organization (WHO) and Food and Agricultural Organization (FAO) for the first time adopted the term "gluten-free" for food labels in 1976. These were later reviewed and amended in 1983 and 1990. According to these regulations, gluten-free products were those food items including processed food products having gluten level <20 mg/kg and "consisting of" or "made only from" ingredients which do not contain wheat (i.e., all Triticum species such as durum wheat, spelt, and kamut), rye, barley, oats, or their crossbred varieties.

Later, in 2007, Food and Drug Administration (FDA) included "gluten-free item" under its regulations. According to FDA, it was defined as one which does not contain wheat, rye, barley, or their crossbred hybrids. Compared to earlier definition of the WHO/FAO, FDA did not include oats in their definition considering the fact that oats can be tolerated by most patients who are intolerant to gluten.

European countries accepted the definition of "gluten-free" as was designed by Codex Alimentarius and included food items containing <20 ppm of gluten. [11] In addition, "very low gluten" term was formalized for food items with gluten levels between 20 and 100 mg/kg, which encompassed items such as breads manufactured using cereals, specially processed to remove most of gluten contents. This was the distinguishing feature from Canadian and FDA guidelines.


  Nutrition Labeling for Gluten-Free Products: Indian Scenario Top


In India, MoHFW enacted the Prevention of Food Adulteration Act in 1954 to regulate food safety standards. However, guidelines for labeling of "gluten-free" items were nonexistent in the act. Disclosure of nutritional information was largely voluntary.

A new era of food safety began in the country with the launch of evidence-based comprehensive Food Safety and Standards Act 2006. Regulations for nutrition labeling were made more stringent under FSSR, 2011. The main intent of this endeavor was to ensure availability of safe and wholesome food for human consumption. The current law brought a ray of hope for CD patients by including prevention of contamination of food with gluten and labeling of gluten-free items under regulatory framework. FSSA 2006 adopted "farm to fork" approach to deal with vast gamut of issues in food safety.

The second step forward has been the introduction of regulations for "gluten-free" food in India according to recent notification by MoHFW in May 2016. Box 1 and 2 depicts definitions laid out for gluten-free products in India.






  Comparative Statement Top


[Table 1] describes comparison of gluten-free claims in Canada, the USA, and India. Limits for Gluten content according to the Food Safety and Standards Authority of India in India are in concordance with regulations given earlier by the WHO/FAO, FDA, and European and Canadian Food Standards Code.
Table 1: Gluten - free claims omparison between Canada, USA, and India


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However, in the country, there is a lack of strategies laid under regulations to be carried out when adulterated food products are found in the market. Although we have a provision of recall for any unsafe food item in FSSA 2006, there is no specific mention under the gluten-free labeling in the gazette. In comparison, FDA has laid additional risk management strategies under regulations. In case, gluten levels are equal to or >20 and <100, product withdrawal is requested along with a review of procedures and/or labeling and investigation of the cause of adulteration. In extreme cases with gluten levels of more than 100 ppm, product recall is done immediately. In some western countries, gluten content of 20 ppm is being adhered as indicated in Codex Alimentarius standards. These measures have been effective since January 2012 in the European Union. Indian standards also need to take a step forward to effectively tackle such implementation issues.

Further, In India where majority of patients cannot read labels in English, development of symbols or logos for gluten-free products is a necessity. This needs to be developed and disseminated to beneficiaries on lines of regulations for vegetarian and nonvegetarian food items (green and red dots).


  Conclusion Top


Food Safety authorities have taken a step forward by issue of labeling guidelines to deal CD. However, this magic bullet of regulatory framework will involve successful implementation at manufacturing, retail, and storage levels by stakeholders. These regulations provide a reference point for manufacturers, physicians, and CD patients and ensure easy availability, accessibility, and identification of "gluten-free" food items. This will not only generate awareness about the disease in the public but also will constitute the first comprehensive step taken toward management of the disease.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Deora NS, Deswal A, Dwivedi M, Mishra HN. Prevalence of coeliac disease in India: A mini review. Int J Latest Res Sci Technol 2014;3:58-60.  Back to cited text no. 1
    
2.
Zarkadas M, Cranney A, Case S, Molloy M, Switzer C, Graham ID, et al. The impact of a gluten-free diet on adults with coeliac disease: Results of a national survey. J Hum Nutr Diet 2006;19:41-9.  Back to cited text no. 2
    
3.
Murray JA, Rubio-Tapia A, Van Dyke CT, Brogan DL, Knipschield MA, Lahr B, et al. Mucosal atrophy in celiac disease: Extent of involvement, correlation with clinical presentation, and response to treatment. Clin Gastroenterol Hepatol 2008;6:186-93.  Back to cited text no. 3
    
4.
Hall NJ, Rubin G, Charnock A. Systematic review: Adherence to a gluten-free diet in adult patients with coeliac disease. Aliment Pharmacol Ther 2009;30:315-30.  Back to cited text no. 4
    
5.
Haines ML, Anderson RP, Gibson PR. Systematic review: The evidence base for long-term management of coeliac disease. Aliment Pharmacol Ther 2008;28:1042-66.  Back to cited text no. 5
    
6.
Makharia GK, Verma AK, Amarchand R, Bhatnagar S, Das P, Goswami A, et al. Prevalence of celiac disease in the northern part of India: A community based study. J Gastroenterol Hepatol 2011;26:894-900.  Back to cited text no. 6
    
7.
Ramakrishna BS. Celiac disease: Can we avert the impending epidemic in India? Indian J Med Res 2011;133:5-8.  Back to cited text no. 7
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8.
Leffler D, Vanga R, Mukherjee R. Mild enteropathy celiac disease: A wolf in sheep's clothing? Clin Gastroenterol Hepatol 2013;11:259-61.  Back to cited text no. 8
    
9.
Rajpoot P, Makharia GK. Problems and challenges to adaptation of gluten free diet by Indian patients with celiac disease. Nutrients 2013;5:4869-79.  Back to cited text no. 9
    
10.
García-Manzanares A, Lucendo AJ. Nutritional and dietary aspects of celiac disease. Nutr Clin Pract 2011;26:163-73.  Back to cited text no. 10
    
11.
Codex Alimentarius Commission. Draft revised codex standard for foods for special dietary use for persons intolerant to gluten Joint FAO/WHO Food Standards Programme. Geneva, Switzerland: WHO; 2007.  Back to cited text no. 11
    



 
 
    Tables

  [Table 1]


This article has been cited by
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[Pubmed] | [DOI]
2 All that a physician should know about gluten-free diet
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Introduction
Celiac Disease B...
Gluten-Free Food...
Nutrition Labeli...
Nutrition Labeli...
Comparative Stat...
Conclusion
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