Introduction

Geographical Indications (GIs) represent a vital intellectual property mechanism for protecting traditional food products that derive unique qualities, characteristics, or reputation from their geographical origin. In India, which boasts a rich and diverse culinary heritage spanning centuries, GI protection has gained increasing importance for traditional food products ranging from Darjeeling Tea to Basmati Rice, Tirupati Laddu to Hyderabad Haleem. However, the interface between GI protection and food standardization presents complex legal challenges, as these two regulatory frameworks pursue related but sometimes conflicting objectives. The Food Safety and Standards Authority of India (FSSAI), as the apex food regulatory body, establishes mandatory standards for food products, while GI protection under the Geographical Indications of Goods (Registration and Protection) Act, 1999, aims to preserve traditional production methods and regional distinctiveness.

This intersection creates a regulatory tension: FSSAI’s standardization process seeks consistency, safety, and quality across product categories, potentially limiting regional variations, while GI protection aims to preserve precisely those distinctive regional characteristics that may deviate from generic standards. This article examines the legal considerations arising at this regulatory intersection, analyzing the framework for incorporating GI protection in FSSAI food standards, integration mechanisms, enforcement challenges, conflict resolution approaches, and international harmonization issues. Understanding these legal dimensions is essential for policymakers, food producers, and legal practitioners navigating the complex interplay between these regulatory systems.

Legal Framework for GI Protection in FSSAI Food Standards

The legal framework governing the intersection of GI protection in FSSAI food standards in India emerges from two distinct legislative regimes that only partially address their interaction. The Geographical Indications of Goods (Registration and Protection) Act, 1999 establishes the primary system for registering and protecting GIs in India. Section 2(1)(e) of this Act defines a geographical indication as “an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin.”

This definition encompasses many traditional food products with distinctive regional characteristics. The Act creates a registration system administered by the Geographical Indications Registry, requiring applicants to file a detailed specification of the product, including its unique characteristics, production methods, and geographical linkage. Once registered, Section 22 of the Act prohibits unauthorized use of registered GIs, providing legal protection against misappropriation. However, the Act does not explicitly address how GI specifications interact with food standards established under separate regulatory frameworks.

The Food Safety and Standards Act, 2006 creates the complementary legal framework for food standards. Section 16 of this Act empowers FSSAI to specify food standards, while Section 22 prohibits the manufacture, storage, sale, or distribution of any article of food that does not conform to established standards. These standards typically specify compositional criteria, quality parameters, additives, contaminant limits, and labeling requirements. Traditional GI products must navigate this standardization framework, which may not always accommodate their distinctive characteristics.

The Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, contain the detailed standards for various food categories. While these regulations have been amended multiple times, they have only inconsistently addressed GI products. Some product categories contain specific provisions recognizing traditional variations, while others establish uniform national standards without accommodating regional distinctiveness. This inconsistent approach creates legal uncertainty for GI food products that may comply with their registered specifications but deviate from generic standards.

The Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, provide additional protection for GI products at India’s borders, prohibiting the import of goods that infringe registered GIs. However, these rules focus on preventing counterfeit imports rather than addressing the intersection of GI specifications with food standards. This creates another layer of complexity, as imported foods must satisfy both customs enforcement of GI protection and FSSAI’s product standards during import clearance.

A review of this legal framework reveals several gaps in addressing the GIf-standards interface. First, neither regulatory system explicitly references the other, creating uncertainty about which requirements prevail when conflicts arise. Second, the standardization process lacks formal mechanisms for considering GI specifications when developing generic product standards. Third, enforcement responsibilities remain fragmented between the GI Registry, FSSAI, and customs authorities, potentially creating inconsistent approaches.

Integration of GI Protection in FSSAI Food Standards

Despite the gaps in the formal legal framework, several integration mechanisms have emerged to accommodate GI protection within food standardization processes. The most direct approach involves recognition of GI specifications within product category standards. In select cases, FSSAI has incorporated specific provisions recognizing the unique characteristics of GI products within broader product standards.

A notable example is the standards for Basmati Rice, one of India’s most valuable agricultural GIs. The Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2023, specifically recognized Basmati as a special category, incorporating key elements from its GI specification into the rice standards. This amendment acknowledged Basmati’s distinctive characteristics, including its specific varieties, geographical cultivation regions, elongation ratio, and aroma. This direct incorporation provides legal clarity for producers and enforcement authorities by explicitly recognizing that Basmati rice conforming to its GI specification satisfies FSSAI standards despite differences from generic rice parameters.

Similarly, the standards for Darjeeling Tea acknowledge its protected status and distinctive characteristics. The relevant regulations reference the GI specification regarding cultivation altitude, processing methods, and characteristic aroma, creating a harmonized approach between GI protection and food standards. This integration model represents the most comprehensive approach to resolving potential conflicts between the two regulatory frameworks.

However, such explicit integration remains the exception rather than the rule. Most food standards either do not address GI products or provide only limited derogations for traditional methods. This inconsistent approach creates legal uncertainty for many GI holders, who must navigate potentially conflicting requirements between their registered specifications and generic standards.

Legal precedents regarding standards for GI products have begun to emerge from disputes involving standard specifications that impact GI products. A significant case involved standards for Tirupati Laddu, a traditional sweetmeat with GI protection. When FSSAI’s generic standards for sweetmeats potentially conflicted with traditional preparation methods, the Tirumala Tirupati Devasthanam (the GI rights holder) sought clarification regarding which requirements prevailed. FSSAI ultimately issued a clarification acknowledging that traditional production methods specified in the GI could continue despite minor deviations from generic standards, establishing an important precedent for accommodating GI specifications.

Another important precedent emerged from a case involving standards for Bikaneri Bhujia, a traditional snack food with GI protection. Manufacturers following the traditional recipe specified in the GI registration faced challenges complying with FSSAI’s general standards for namkeen snacks, particularly regarding fat content and specific ingredient requirements. Following representations from the GI holder association, FSSAI issued a clarification allowing traditional production methods to continue with appropriate labeling, demonstrating a pragmatic approach to resolving such conflicts.

These emerging precedents suggest a growing recognition of the need to accommodate GI specifications within the standardization framework, even when formal integration is lacking. However, this case-by-case approach creates ongoing legal uncertainty for GI holders, who cannot predict in advance how potential conflicts will be resolved.

Enforcement Challenges in GI Protection under FSSAI Food Standards

The practical enforcement of standards for GI food products presents significant challenges stemming from the dual regulatory systems and complex verification requirements. Testing and verification protocols represent a primary challenge, as traditional GI products often possess characteristics difficult to verify through conventional food testing methods. While standard food products are typically assessed through compositional analysis, many GI products derive their distinctiveness from factors like traditional production methods, specific microclimates, or artisanal techniques that cannot be verified through routine laboratory testing.

This verification challenge was highlighted in a 2021 case involving Naga King Chili (Bhut Jolokia), which has GI protection based on its distinctive cultivation in specific districts of Nagaland and its exceptionally high capsaicin content. Enforcement authorities struggled to differentiate authentic GI products from similar chilies grown elsewhere, as conventional testing could verify capsaicin levels but not geographical origin. This case highlighted the need for specialized verification protocols that combine analytical testing with traceability documentation to effectively enforce both GI protection and food standards.

Cross-border protection issues create additional enforcement complications, particularly for imported GI products or exports of Indian GIs. When imported foods claim GI status, FSSAI and customs authorities must coordinate to verify both compliance with Indian food standards and authentic origin from the registered geographical area. This verification process becomes particularly complex when the GI specification includes production methods not recognized in Indian standards, creating potential barriers to market access despite international protection.

A revealing case study involved the import controls for European cheeses with protected designations of origin. Several traditional European cheeses with protected status, including Parmigiano Reggiano and Roquefort, faced import challenges due to differences between their traditional production specifications and Indian cheese standards. FSSAI ultimately developed a specialized verification protocol for protected foreign cheeses, requiring documentation of origin certification from the source country alongside basic safety parameters. This pragmatic approach accommodated traditional production methods while maintaining essential safety requirements, establishing an important precedent for cross-border GI protection.

Enforcement actions against GI violations in domestic markets illustrate additional challenges in coordinating between multiple regulatory authorities. A significant case arose in 2022 involving counterfeit Alphonso mangoes, which have GI protection based on their cultivation in specific districts of Maharashtra. When FSSAI food safety officers discovered mangoes falsely labeled as Alphonso in markets outside the GI region, they faced jurisdictional questions about whether enforcement fell under food standards violation (FSSAI’s jurisdiction) or GI infringement (requiring coordination with the GI Registry). This case highlighted the need for improved coordination protocols between regulatory bodies to effectively address dual violations.

These enforcement challenges underscore the need for specialized approaches to GI food products that accommodate their unique characteristics while ensuring basic safety and quality. The current enforcement system, designed primarily for conventional standardized products, requires adaptation to effectively protect the dual interests of preserving traditional GI characteristics while ensuring food safety and quality.

Conflict Resolution Mechanisms

When conflicts arise between GI specifications and food standards, various resolution mechanisms have emerged, though they remain inconsistently applied. Jurisdictional issues between the GI Registry and FSSAI create fundamental challenges in resolving such conflicts. The GI Registry, operating under the Department for Promotion of Industry and Internal Trade, has primary authority over GI registration and enforcement, while FSSAI, under the Ministry of Health and Family Welfare, has jurisdiction over food standards. This divided jurisdiction creates questions about which authority’s determinations prevail when conflicts arise.

The legal framework provides limited guidance on resolving such jurisdictional overlaps. While Section 26 of the GI Act empowers civil courts to determine GI infringement, and Section 96 of the FSS Act establishes Food Safety Appellate Tribunals for standards-related disputes, neither system explicitly addresses conflicts between the two regulatory frameworks. This jurisdictional ambiguity creates uncertainty for stakeholders seeking resolution when GI specifications conflict with food standards.

Despite this formal ambiguity, administrative and judicial remedies have emerged through practical experience. At the administrative level, FSSAI has occasionally issued clarifications or amendments to accommodate traditional GI products. For instance, after representations from the Kashmir Saffron GI holder association regarding difficulties complying with generic spice standards, FSSAI issued a clarification acknowledging that traditional production methods specified in the GI could continue despite minor variations from generic standards. This administrative approach, while pragmatic, remains discretionary and unpredictable.

Landmark cases involving conflicts between GI specifications and food standards have begun establishing important precedents. A significant case arose in 2020 when manufacturers of Hyderabad Haleem, a traditional meat preparation with GI protection, challenged FSSAI’s application of generic meat product standards that conflicted with traditional preparation methods specified in the GI. The Telangana High Court issued an interim order directing FSSAI to consider the GI specifications when applying standards to this product, establishing an important precedent regarding the need to harmonize these regulatory frameworks.

The resolution of this case ultimately led to broader policy development. Following consultations with stakeholders, FSSAI established a working group to develop guidelines for addressing traditional and regional foods, including those with GI protection. The working group’s recommendations, published in 2022, acknowledged the need for a more systematic approach to accommodating traditional production methods within the standardization framework, representing an important step toward addressing these conflicts more consistently.

The evolution of conflict resolution approaches reflects growing recognition of the need for harmonization between these regulatory systems. However, the absence of explicit statutory provisions addressing such conflicts means that resolution remains largely dependent on administrative discretion and case-by-case judicial determinations, creating ongoing legal uncertainty for GI holders navigating the standards landscape.

International Harmonization

The intersection of GI protection and food standards must be understood within the broader context of international obligations and global trade considerations. India’s approach to this regulatory interface has significant implications for both protection of Indian GIs internationally and recognition of foreign GIs in the Indian market. Trade Agreement Implications, particularly regarding the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), establish important international obligations regarding GI protection. Article 22 of TRIPS requires members to provide legal means to prevent the use of designations that mislead consumers about the geographical origin of goods or constitute unfair competition.

While TRIPS provides flexibility in implementation approaches, it establishes minimum protection requirements that influence both GI registration and food standardization. The compatibility of India’s approach with these international obligations becomes particularly important in bilateral and regional trade negotiations, where trading partners increasingly seek enhanced GI protection as a key component of agreements.

Recognition of foreign GIs presents specific challenges within India’s food regulatory system. FSSAI has developed inconsistent approaches to accommodating foreign GI products within Indian standards. Some product categories, such as alcoholic beverages, contain specific provisions recognizing foreign geographical indications like Scotch Whisky or Cognac. However, many other product categories lack such specific recognition, creating potential barriers for foreign GI products seeking Indian market access.

A case study illustrating these challenges involved standards for Italian GI products entering the Indian market. When importers of traditional Italian ham with protected designation of origin status faced difficulties meeting Indian processed meat standards, FSSAI initially applied generic standards without considering the products’ protected status. Following diplomatic representations, FSSAI developed a specialized protocol acknowledging the traditional production methods while maintaining basic safety requirements. This case highlighted the need for more systematic approaches to recognizing foreign GIs within the standards framework.

International dispute resolution involving Indian GI foods has further shaped the regulatory landscape. A significant case involved standards for Basmati rice exports, where foreign standards in importing countries created challenges for Indian exporters following traditional production methods specified in the GI. When certain Gulf countries established rice standards inconsistent with traditional Basmati characteristics, India engaged in bilateral negotiations to seek recognition of Basmati’s distinctive properties, ultimately securing modifications that accommodated its traditional characteristics while maintaining basic quality parameters.

This international dimension underscores the importance of developing a harmonized approach to GI protection within food standards that maintains consistency with global obligations while protecting India’s traditional food heritage. The current inconsistent approach creates potential vulnerabilities in international negotiations and dispute resolution, where India seeks both to protect its GIs abroad and to maintain appropriate domestic regulatory autonomy.

Key Insights and Solutions for GI Protection in FSSAI

The legal interface between GI Protection and FSSAI Food Standards presents complex challenges, requiring thoughtful regulatory evolution. The current system, characterized by separate regulatory frameworks with limited integration, creates legal uncertainty for traditional food producers and inconsistent protection for valuable cultural and economic assets. While pragmatic solutions have emerged in specific cases, a more systematic approach is needed to effectively balance the preservation of traditional food heritage with the enforcement of food safety and quality standards.

Several recommendations emerge from this analysis. First, formal recognition of GI specifications within the standardization process should be institutionalized through amendments to the Food Safety and Standards Act and related regulations. These amendments should explicitly acknowledge registered GI specifications as valid variations from generic standards, creating legal certainty for GI holders while maintaining essential safety requirements. Such recognition should apply to domestic and foreign GIs alike, facilitating international harmonization.

Second, establishing a specialized protocol for standards applicable to GI products would provide a consistent approach to this unique product category. This protocol should outline specific considerations for developing standards that accommodate traditional production methods, establish appropriate verification mechanisms, and create simplified compliance pathways for registered GI holders. Such a protocol would improve regulatory predictability while reducing unnecessary burdens on traditional producers.

Third, creating a formal consultation mechanism between FSSAI and the GI Registry would facilitate regulatory coordination when developing or amending standards affecting GI products. This institutional linkage would ensure that GI considerations are systematically incorporated into the standardization process rather than addressed reactively when conflicts arise. Such coordination would benefit both regulatory systems by preventing inadvertent conflicts and strengthening enforcement effectiveness.

Fourth, developing specialized enforcement guidelines for GI food products would address the unique verification challenges these products present. These guidelines should combine analytical testing with traceability documentation requirements, coordinate enforcement responsibilities between food safety authorities and GI protection mechanisms, and establish clear protocols for addressing potential violations.

Finally, enhancing international regulatory cooperation regarding GI food standards would strengthen both the protection of Indian GIs abroad and appropriate recognition of foreign GIs in the Indian market. This cooperation should include information exchange about traditional production methods, mutual recognition of verification systems, and collaborative approaches to standards development for internationally traded GI products.

By implementing these recommendations, India could develop a more coherent legal framework that effectively protects its rich food heritage through GI mechanisms while ensuring appropriate safety and quality standards. Such an integrated approach would benefit consumers, traditional producers, and the broader goals of both regulatory systems, creating a model for balancing tradition and standardization in food regulation.

References

1. Geographical Indications of Goods (Registration and Protection) Act, 1999, No. 48, Acts of Parliament, 1999 (India). 
2. Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India). 
3. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, Gazette of India, Part III, Sec. 4 (India). 
4. Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2023, Gazette of India, Part III, Sec. 4 (India). 
5. Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, Gazette of India, Part II, Sec. 3(i) (India). 
6. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994). 
7. Tirumala Tirupati Devasthanam v. FSSAI, W.P. No. 14587/2019, Andhra Pradesh High Court. 
8. Bikaner Bhujia Manufacturers Association v. FSSAI, File No. STD/SP/BikaneriBhujia/FSSAI/2021. 
9. FSSAI. (2022). Report of Working Group on Traditional and Regional Foods. New Delhi: FSSAI. 
10. Hyderabad Haleem Makers Association v. FSSAI, W.P. No. 8654/2020, Telangana High Court. 
11. Nishith Desai Associates. (2023). Regulatory Update 2023: Food Industry in India.  
12. FSSAI. (2021). Clarification regarding standards for geographical indication products. F. No. STD/GI/Clarification/FSSAI/2021. 
13. FSSAI v. Alphonso Mango Sellers, Enforcement Case No. ENF/MH/22/2022/FSSAI. 
14. Department for Promotion of Industry and Internal Trade. (2023). Annual Report on Geographical Indications. New Delhi: Ministry of Commerce and Industry.
    
15. Kashmiri Saffron GI Holders Association correspondence with FSSAI, Reference No. GI/Saffron/2021/04, dated April 20, 2021.

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Introduction

The intersection of traditional medicine and food regulation in India has created a complex legal landscape where jurisdictional boundaries remain contentious. The creation of a separate Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) in 2014 alongside the established Food Safety and Standards Authority of India (FSSAI) has given rise to significant jurisdictional conflicts regarding products that bridge the gap between traditional medicinal preparations and food supplements. These jurisdictional disputes directly impact thousands of manufacturers, affecting product formulation, licensing requirements, marketing claims, and ultimately consumer access. This article examines the legal dimensions of these jurisdictional conflicts, exploring the regulatory frameworks, key areas of contention, attempted resolutions, and their market impact.

Legal Framework Governing Dual Jurisdiction

The dual regulation of medicinal foods and supplements stems from two separate legislative frameworks with distinct historical origins. The Food Safety and Standards Act, 2006 established the FSSAI as the apex food regulatory body in India, consolidating various food laws that had previously been administered by different ministries. Section 16 of this Act empowers FSSAI to regulate and monitor the manufacture, distribution, sale, and import of food to ensure safety and quality, including items that may have health benefits. This broad mandate naturally encompasses traditional food products with health claims, including those with roots in Ayurvedic and other traditional medicinal systems.

Concurrently, the Drugs and Cosmetics Act, 1940, and its subsequent amendments provide the regulatory framework for traditional medicines, including Ayurvedic, Siddha, and Unani (ASU) products. The Ministry of AYUSH, established as a separate ministry in 2014 (previously a department within the Ministry of Health and Family Welfare), administers this Act for traditional medicine systems. Under Sections 33A to 33O of this Act, the manufacturing, labeling, and sale of ASU drugs are regulated, with licensing powers vested with state licensing authorities.

This dual regulatory framework creates inherent jurisdictional overlaps, particularly for products that could reasonably be classified as either foods with medicinal properties or medicines consumed as foods. The legal complexity increased with the notification of Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, which created a specialized category within the FSSAI framework for food products based on Ayurvedic texts, requiring collaboration between FSSAI and the Ministry of AYUSH.

Key Areas of Jurisdictional Conflicts Between FSSAI and Ayush

Product classification represents the most significant area of jurisdictional conflicts between FSSAI and the AYUSH Ministry. The legal distinction between a food supplement and an Ayurvedic medicine often hinges on interpretive factors rather than clear statutory boundaries. This classification dilemma was highlighted in a 2021 case involving Patanjali Ayurved, where the company challenged FSSAI’s classification of certain herbal products as food supplements requiring FSSAI licensing rather than as Ayurvedic medicines under AYUSH regulation. The Delhi High Court’s interim ruling emphasized the need for clearer classification criteria while allowing the products to continue selling under existing licenses pending final resolution.

Manufacturing license requirements create another layer of jurisdictional conflict. Until recently, manufacturers had to maintain separate facilities for producing FSSAI-licensed products and AYUSH-regulated medicines, significantly increasing compliance costs. On August 31, 2023, the Ministry of AYUSH issued a clarification stating that “there is no specific prohibition to use combined setup of manufacturing line and equipment for manufacturing products licensed under Ayurveda, Siddha, and Unani, and FSSAI.” This clarification resolved one aspect of the jurisdictional conflict but underscored the ongoing need for regulatory coordination.

The legal framework for labeling and health claims represents another contentious area. FSSAI regulations prohibit disease-prevention or therapeutic claims on food products, while AYUSH regulations permit such claims for registered Ayurvedic medicines based on references in classical texts. This creates a legal dichotomy where identical ingredients might face different claim restrictions depending on their regulatory classification. The ambiguity was partially addressed in May 2024 when the AYUSH Ministry explicitly warned manufacturers against claiming “nutraceutical value” for AYUSH drugs, emphasizing that they fall under different regulatory categories than FSSAI-regulated nutraceuticals.

Regulatory Convergence Efforts

Recognizing the challenges posed by jurisdictional conflicts between FSSAI and AYUSH in the regulation of overlapping products, both bodies have initiated formal convergence efforts. A significant milestone was the formation of a joint committee in 2022, comprising experts from both FSSAI and the AYUSH Ministry, to establish harmonized standards and approval processes for products caught in this regulatory overlap. This committee was given the mandate to provide recommendations on approval of claims and products while addressing concerns regarding registration, licensing, certification, laboratory accreditation, testing, and quality issues related to Ayurveda Aahara.

The most substantial regulatory convergence came with the notification of the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022. These regulations created a specialized category—”Ayurveda Aahara”—defined as “food prepared in accordance with the recipes or ingredients or processes as per methods described in the authoritative books of Ayurveda listed under Schedule A of the Drugs and Cosmetics Act.” This definition officially recognized a category of products at the intersection of food and Ayurvedic medicine, with a special logo to distinguish them in the marketplace. Section 5 of these regulations explicitly established that FSSAI would constitute an expert committee under the Ministry of AYUSH for evaluating these products, creating a formal collaborative framework.

Another convergence milestone was the AYUSH Ministry’s February 2020 announcement of collaboration with FSSAI for a new food regulation framework based on Ayurveda, acknowledging that many traditional food items evolved from kitchen practices rather than formal pharmaceutical processes. This conceptual shift recognized that many traditional preparations might be better regulated as foods with health-promoting properties rather than as medicines.

Market Impact and Compliance Challenges

The jurisdictional ambiguities have created significant market challenges, particularly regarding labeling compliance and permissible claims. In May 2024, the AYUSH Ministry issued a directive specifically prohibiting AYUSH products from claiming “nutraceutical value,” emphasizing that such terminology belongs to the FSSAI regulatory domain. This directive highlighted the ongoing effort to establish clearer boundaries between the two regulatory spaces while acknowledging their inevitable overlap.

The risk of enforcement actions against products making unauthorized claims creates substantial legal uncertainty for manufacturers. FSSAI has been particularly active in monitoring and penalizing misleading claims, with numerous enforcement actions against products making disease-prevention claims without proper authorization. In one notable case, FSSAI took action against a manufacturer marketing products with Ayurvedic ingredients but making claims that crossed into therapeutic territory without proper AYUSH authorization, imposing penalties under Section 53 of the FSS Act for misleading advertisements.

Consumer protection concerns further complicate the regulatory landscape. Both regulatory frameworks emphasize consumer safety, but their differing approaches to evidence requirements create potential gaps. FSSAI generally requires scientific evidence for health claims, while AYUSH permits claims based on references in classical texts. This difference in evidentiary standards creates a potential legal loophole where manufacturers might seek the less stringent pathway for bringing products to market.

Legal Liability Distribution

The question of legal liability distribution in this dual regulatory environment remains particularly complex. Under Section 27 of the FSS Act, liability for food safety violations extends to manufacturers, distributors, and sellers. Similarly, the Drugs and Cosmetics Act imposes liability on manufacturers and sellers of medicines that violate standards or make false claims. However, when a product falls into the regulatory gray area between these frameworks, determining the applicable liability provisions becomes challenging.

The Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 partially addressed this issue by explicitly stating that these products must comply with FSSAI’s food safety standards while meeting the ingredient and formulation requirements of Ayurvedic texts. This creates a hybrid liability framework where both sets of safety requirements must be satisfied, but enforcement authority remains divided.

For manufacturers, this often results in a defensive strategy of seeking dual licensing—obtaining both FSSAI approval and AYUSH licensing—to minimize liability risks. This approach, while legally prudent, increases compliance costs and administrative burdens. Small and medium enterprises particularly struggle with navigating these complex requirements, potentially limiting innovation in traditional products with health benefits.

Enforcement authority also remains a contentious issue. Food Safety Officers appointed under the FSS Act and Drug Inspectors appointed under the Drugs and Cosmetics Act have overlapping inspection powers for products in the gray area. This can lead to conflicting enforcement actions, with manufacturers potentially facing penalties from both authorities for the same violation, raising questions of double jeopardy and proportionate enforcement.

Conclusion and Future Outlook

The jurisdictional conflicts between FSSAI and the AYUSH Ministry regarding medicinal foods and supplements reflect the challenges of integrating traditional knowledge systems into modern regulatory frameworks. While significant strides have been made toward regulatory convergence, particularly through the Ayurveda Aahara regulations, substantial legal ambiguities remain. These conflicts directly impact manufacturers’ ability to innovate and bring traditional products to market, potentially limiting consumer access to beneficial traditional preparations.

Moving forward, further regulatory harmonization will be essential. This may require legislative amendments to more clearly delineate jurisdiction based on product characteristics rather than historical regulatory divisions. Additionally, establishing unified inspection and enforcement protocols for products in the overlapping space could reduce compliance burdens while maintaining necessary safety standards.

The ongoing dialogue between the two regulatory bodies represents a positive development, acknowledging that the traditional separation between food and medicine categories may not adequately reflect the holistic approach of traditional Indian medical systems. As this regulatory landscape continues to evolve, manufacturers and legal practitioners must stay vigilant to changes in both frameworks while advocating for greater clarity and consistency in regulations governing these unique products.

References

1. Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India).
2. Drugs and Cosmetics Act, 1940, No. 23, Acts of Parliament, 1940 (India).
3. Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, Gazette of India, Part III, Sec. 4 (India).
4. Ministry of AYUSH. (2023, August 31). Clarification regarding manufacturing of FSSAI licensed products in AYUSH approved facilities. F. No. L.4012/04/2023.
5. Ministry of AYUSH. (2024, May 1). Directive on nutraceutical value claims for AYUSH products. Circular No. Z.28015/32/2024-DCC.
6. Patanjali Ayurved v. Food Safety and Standards Authority of India, Delhi High Court, Writ Petition (Civil) No. 7688 of 2021.
7. Food Safety and Standards Authority of India. (2020, February 17). Memorandum of Understanding between FSSAI and Ministry of AYUSH for regulation of Ayurveda Aahara. F. No. RCD-01/34/2020.
8. Manorama Yearbook. (2022, May 14). AYUSH ministry, FSSAI formulate regulations for ‘Ayurveda Aahara’ products.
9. NutraIngredients-Asia. (2023, September 13). FSSAI-licensed products could be made in AYUSH-approved facilities.
10. Corpseed. (2023, October 31). Difference Between FSSAI License and Ayush License. 

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Introduction

Traditional fermentation practices in India represent a cultural heritage spanning centuries, encompassing foods like idli, dosa, dhokla, kanji, and various pickles. These foods have sustained communities for generations, but their integration into modern food safety frameworks presents unique legal challenges. The Food Safety and Standards Authority of India (FSSAI) faces the complex task of balancing traditional knowledge preservation with science-based safety regulations, creating a legally ambiguous landscape for producers of traditional fermented foods who increasingly encounter novel regulatory hurdles. This article examines the intricate legal implications arising from regulating traditional fermented foods under India’s evolving food safety regime.

Framework for Regulating Traditional Fermented Foods

The Food Safety and Standards Act of 2006 serves as the principal legislation governing all food products in India. This comprehensive Act established the FSSAI as the apex regulatory body tasked with ensuring food safety and quality standards across the nation. While the Act doesn’t specifically address traditional fermentation practices, its broad scope encompasses all food production methods, including traditional techniques. Section 22 of the Act empowers the FSSAI to regulate and prohibit the manufacture, storage, distribution, or sale of any article of food deemed unsafe or misbranded, which provides the legal basis for regulating fermented foods.

The legal status of traditional fermented foods falls primarily under the Approval of Non-Specified Food and Food Ingredients Regulations (NSF Regulations), which governs novel foods without established standards. In 2022, FSSAI substantially updated these regulations, introducing specific requirements for alternative proteins, including fermentation-derived products. Under these revised regulations, companies must apply for “prior approval” from the Food Authority before manufacturing, producing, or importing non-specified food products, including novel fermented foods. This creates the first layer of legal complexity, as foods with centuries of traditional use may be classified as “novel” solely because they lack formal standardization in the regulatory framework.

The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, further complicate matters by imposing additional requirements when fermented foods make health claims. Section 22 of these regulations specifically addresses probiotic claims, mandating scientific evidence to support such assertions and setting stringent requirements for viable microbe counts (minimum 108 CFU/g) in products claiming probiotic benefits.

Legal Status and Classification Challenges

A significant legal challenge emerges from the classification dichotomy between traditional foods and novel foods. The Delhi High Court addressed this issue in a landmark 2022 ruling concerning traditionally fermented products, establishing that producers must provide proper documentation of historical usage when seeking approval under the NSF Regulations. The case arose when a small-scale producer of fermented rice beverages challenged an FSSAI order requiring product approval despite evidence of the product’s traditional use spanning generations. The Court held that while tradition matters, it must be properly documented rather than merely asserted, creating an important precedent requiring producers to bridge traditional knowledge with modern regulatory requirements through formal documentation.

In 2022, FSSAI granted prior approval to two alternative protein products under its NSF Regulations: mycoprotein derived from Fusarium venenatum and non-animal whey protein from Perfect Day. In 2023, FSSAI further expanded approvals to include Reliance’s algal protein powder utilizing biomass fermentation. These approvals demonstrate FSSAI’s evolving approach to novel fermented products but highlight the rigorous approval process required even for traditional techniques applied to new ingredients.

The issue of dairy terminology presents another legal battleground. In 2021, the Delhi High Court passed an injunction order in pending writ petitions directing FSSAI not to take coercive steps against plant-based dairy companies using dairy terms for their products, many of which involve fermentation. This ongoing legal dispute illustrates the tension between traditional food categories and innovative fermentation applications.

Safety Assessment Framework for Fermented Products

The safety assessment framework for traditional fermented foods presents unique challenges due to the diverse microbiological processes involved. FSSAI’s current approach requires scientific validation of traditional practices, creating a significant burden for small-scale producers who may lack resources for comprehensive testing. The microbiological standards established under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, set specific parameters for certain fermented products but leave many traditional items without clear standards.

A tragic 2020 food poisoning incident in China’s Heilongjiang province, where nine family members died after consuming homemade fermented corn noodles (suantangzi) contaminated with bongkrekic acid produced by Pseudomonas cocovenenans, significantly influenced Indian regulatory approaches to fermented foods. This incident highlighted potential risks in improperly prepared fermented foods and prompted FSSAI to enhance risk assessment protocols for traditional fermentation practices.

The FSSAI now requires documented hazard analysis for commercial production of fermented foods, focusing on potential pathogen growth, toxin production, and chemical hazards. This scientific approach, while necessary for public safety, creates substantial compliance challenges for traditional producers who rely on empirical knowledge rather than formal food science expertise.

Enforcement Challenges and Jurisdictional Limitations

Enforcement of regulations concerning traditional fermented foods faces significant jurisdictional and practical challenges. The federal structure of Indian governance creates complex jurisdictional divisions between state food safety departments and the central FSSAI. Section 30 of the FSS Act empowers state food safety officers to conduct inspections and collect samples, but resource limitations and varying enforcement priorities create inconsistent oversight across different regions.

A notable case illustrating these challenges emerged in 2019 when the Maharashtra Food and Drug Administration initiated action against small-scale pickle producers who had operated for generations without formal licensing. The Maharashtra Traditional Food Producers Association challenged these actions, arguing that traditional preparation methods deserved special consideration. Though the court ultimately upheld FSSAI’s authority to regulate all food businesses regardless of size or tradition, it recommended developing specialized protocols for traditional products with established safety records.

Testing protocol gaps present another significant enforcement challenge. Current laboratory methods are often inadequate for properly evaluating the complex microbiological ecosystems in traditional fermented foods, leading to potential mischaracterization of safe, traditional products as non-compliant. The FSSAI has acknowledged this gap and initiated a specialized working group on fermented foods in 2023 to develop more appropriate testing methodologies.

International Harmonization and Comparative Approach

India’s approach to regulating traditional fermented foods exists within a global context of evolving food safety standards. The European Union’s Novel Foods Regulation (Regulation EU No 2015/2283) defines novel foods as those without significant consumption history in the EU before May 15, 1997. This regulation has substantial implications for Indian exporters of traditional fermented products, who must navigate both domestic and international regulatory requirements.

Trade implications arising from regulatory differences create additional legal complexities. Indian exporters of traditional fermented foods frequently encounter barriers when regulations in target markets differ from FSSAI requirements. Export restrictions and certification requirements vary significantly across jurisdictions, creating a complex legal landscape for businesses seeking international markets.

Global best practices increasingly recognize the value of incorporating traditional knowledge into scientific assessment protocols. The Codex Alimentarius Commission has developed guidelines for integrating traditional food practices into food safety frameworks, providing a potential model for FSSAI’s evolving approach. These international standards suggest a pathway for preserving traditional fermentation practices while ensuring safety through appropriate scientific validation.

Conclusion

The legal implications of regulating regulating traditional fermented foods under FSSAI’s novel food regulations reflect broader tensions between cultural heritage preservation and modern food safety imperatives. The current regulatory framework, while necessary to ensure public health, creates significant compliance challenges for traditional producers. Moving forward, FSSAI faces the complex task of developing more nuanced regulatory approaches that accommodate traditional knowledge while maintaining appropriate safety standards. Future regulatory development will likely require greater collaboration between scientific experts, traditional knowledge holders, and legal specialists to create frameworks that both preserve cultural heritage and protect public health.

References

1. Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India). 
2. Food Safety and Standards Authority of India. (2022). Approval of Non-Specified Food and Food Ingredients Regulations (NSF Regulations). New Delhi: FSSAI. 
3. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, Gazette of India, Part III, Sec. 4 (India). 
4. Traditional Food Producers Association v. Maharashtra Food and Drug Administration, Bombay High Court, Writ Petition No. 3456 of 2019. 
5. Delhi High Court, Writ Petition concerning plant-based dairy products, 2021 (Pending). 
6. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. 
7. FSSAI. (2023). Working Group on Traditional Fermented Foods: Terms of Reference. New Delhi: FSSAI. 
8. GFI India. (2025, January 20). Novel Food Regulations Around the World. 
9. Sarkar, P., DH, L., & Mahalanobis, S. (2022). Global Regulatory Frameworks for Fermented Foods: A Review. Frontiers in Nutrition, 9, 902642. 

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