Case Note & Summary
A writ petition under Article 226 of the Constitution of India was filed by Vital Nutraceuticals Private Limited and the Indian Drug Manufacturers’ Association challenging the validity of advisories issued by the Food Safety and Standards Authority of India, particularly the advisory dated 11-05-2013, which superseded earlier advisories. Petitioner No.1, a manufacturer of nutraceuticals and health supplements, held licenses under the repealed Prevention of Food Adulteration Act, 1954, which were converted under the Food Safety and Standards Act, 2006. Petitioner No.2 is an association of drug manufacturers. The petitioners alleged that the advisory effectively amended the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, and was ultra vires the authority’s powers. The primary ground was that the advisory was not issued under section 92 of the Act, which provides the sole mechanism for framing regulations, and it was not in conformity with sections 16(2) and 18(2)(d) of the Act. The respondent authority contended that it had the power to issue advisories under sections 16(1), 16(5), 18, and 22 of the Act, read with the Chief Executive Officer’s functions under section 10, and that the advisory was consistent with Regulations 2.1.2 and 2.1.7 of the 2011 Regulations. The court heard arguments from both sides, examined the scheme of the Act, the Statement of Objects and Reasons, and the framework of authorities and their functions. The judgment was reserved on 22-01-2014 and pronounced on 28-01-2014, but the available extract does not include the final decision or operative part.
Headnote
A) Food Law - Delegated Legislation - Advisories vs. Regulations - Sections 16(1), 16(5), 18, 22, 92 Food Safety and Standards Act, 2006 - The petition challenges an advisory dated 11-05-2013 issued by the Food Safety and Standards Authority of India on the ground that it effectively amends the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, without following the rule-making procedure under section 92; the court analyzes the statutory scheme, highlighting the objects of the Act to consolidate food laws and establish science-based standards, and examines the functions of the Authority, noting the arguments that the advisory falls within the general powers under sections 16, 18, and 22 (Paras 3, 9-11).
Issue of Consideration
Whether Respondent No.2 has the power to issue advisories that have the effect of amending the Regulations framed under section 92 of the Food Safety and Standards Act, 2006, and whether the advisory dated 11/05/2013 is illegal and without statutory force.
Law Points
- Validity of advisories under FSS Act
- 2006
- Scope of Food Authority’s power under sections 16(1)
- 16(5)
- 18
- 22
- Requirement that regulations be framed only under section 92
- Advisories cannot override statutory regulations
- Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations
- 2011
Case Details
2014 LawText (BOM) (01) 38
Writ Petition No. 2746 of 2013
V. M. Kanade, Girish S. Kulkarni
Mr. I. M. Chagla, Senior Counsel with Mr. Riyaz Chagla and Mr. Rajeev Talasikar for the Petitioners; Dr. G.R. Sharma with Mr. G. Hariharan and Mr. S.D. Bhosale for Respondent No.1; Mr. Mehmood Pracha with Mr. I.A. Khan for Respondent No.2
Vital Nutraceuticals Private Limited, Indian Drug Manufacturers' Association
Union of India through Secretary Ministry of Health and Family Welfare, Food Safety and Standards Authority of India
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Nature of Litigation
Petition under Article 226 of the Constitution of India challenging the validity of an advisory issued by the Food Safety and Standards Authority of India, contending it amends regulations without statutory authority.
Remedy Sought
Petitioners sought a writ, order or direction to strike down or declare null and void the advisory dated 11/05/2013 issued by Respondent No.2, and to restrain the respondents from acting on it.
Filing Reason
The advisory allegedly imposed restrictions or conditions on the manufacture and sale of nutraceuticals, health supplements, and functional foods, which the petitioners claimed were contrary to the existing regulations framed under the FSS Act, 2006, thus affecting their businesses.
Issues
Whether Respondent No.2 has the power to issue advisories that amend or modify the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, without following the procedure under Section 92 of the Food Safety and Standards Act, 2006.
Whether the advisory dated 11/05/2013 is in consonance with Sections 16(2) and 18(2)(d) of the Act.
Submissions/Arguments
Petitioners contended that Respondent No.2 does not have power or authority to issue advisories that have the effect of amending regulations framed under section 92 of the Act; the advisories are illegal and without statutory force, not having been issued under section 92 nor in consonance with sections 16(2) and 18(2)(d) of the Act.
Respondent No.2 argued that it has power and authority to issue advisories under sections 16(1) and 16(5), 18, and 22 of the Act; the advisory was issued in exercise of the Chief Executive Officer’s functions under section 10 and is in consonance with Regulations 2.1.2 and 2.1.7 of the 2011 Regulations.
Judgment Excerpts
Rule. Rule is made returnable forthwith. Respondents waive service. By consent of parties, matter is taken up for final hearing.
By this Petition which is filed under Article 226 of the Constitution of India, Petitioners, inter alia, are seeking an appropriate writ, order or direction for striking down or declaring as null and void all the advisories which have been issued by Respondent No.2 and more particularly an advisory dated 11/05/2013 primarily on the ground that Respondent No.2 does not have power or authority to issue these advisories which have an effect of amending Regulations which have been framed under section 92 of the Food Safety and Standards Act, 2006 and that they are illegal and without any statutory force; they being issued neither under section 92 of the Act nor having been in consonance with section 16(2) and 18(2)(d) of the Act.
it is contended by the learned Counsel appearing on behalf of Respondent No.2 that Respondent No.2 – Food Safety and Standards Authority of India has a power and authority to issue these Advisories by exercising power vested in it under sections 16(1) and 16(5) and under sections 18 and 22 of the Act and that they have been issued while exercising functions of the Chief Executive Officer under section 10 of the said Act.
Multiplicity of food laws, standard setting and enforcement agencies pervades different sectors of food, which creates confusion in the minds of consumers, traders, manufacturers and investors.
Procedural History
The writ petition was filed under Article 226. On the date of hearing, the court issued Rule, made it returnable forthwith, and with consent of parties, took up the matter for final hearing. Counter affidavits were filed by the respondents. The court reserved judgment on 22-01-2014 and pronounced judgment on 28-01-2014.
Acts & Sections
- Food Safety and Standards Act, 2006: 4, 10, 16(1), 16(2), 16(5), 18, 18(2)(d), 22, 27, 28, 30, 31, 92
- Prevention of Food Adulteration Act, 1954:
- Essential Commodities Act, 1955:
- Companies Act, 1956:
- Societies Registration Act, 1860:
- Constitution of India: 226
- Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011: 2.1.2, 2.1.7
