Professor, MVN University Palwal, Haryana |
Former State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India |
Email: narendervivek16@gmail.com
- Need for Regulatory Reforms to improve contraceptive access and workforce participation - October 6, 2024
- Pharma Printers must come under the ambit of Drugs Act - March 27, 2024
- How to stop Fake Medicine Business - March 20, 2024
Last Updated on October 20, 2024 by The Health Master
Smokeless Tobacco products and the food articles containing tobacco or scented tobacco, chewing tobacco, gutkha, zarda, khaini and other processed tobacco products should be banned being injurious to the health. Because the Ministry of Health & Family Welfare, Government of India has on the direction of the Hon`ble Supreme Court in the SLP No. 16308 of 2007, submitted a health report that states that there are 3095 chemical components in smokeless tobacco products, of which 28 are proven carcinogens (cancer causing substances). The major and most abundant group of carcinogens is the tobacco-specific N-nitrosamines (TSNA). The Report indicates a strong association between smokeless tobacco usage and incidence of oral, esophageal, stomach, pancreatic, throat (pharynx and larynx) and renal cancers. The use of smokeless tobacco is associated with high prevalence of oral cancer in India, with almost 90% of such cases being linked to smokeless tobacco use.
The Global Adult Tobacco Survey India (GATS India), conducted in the year 2009-10 by the International Institute for Population Sciences (IIPS) Mumbai, more than one-third (35%) of adults in India used tobacco in some form or the other. Among them, 21 % adults used only smokeless tobacco, 9 % only smoke, and 5 % smoke as well as use smokeless tobacco. Based on these, the estimated number of tobacco users in India was 274.9 million, with 163.7 million users of only smokeless tobacco, 68.9 million only smokers, and 42.3 million users of both smoking and smokeless tobacco.
Study titled “Economic Burden of Tobacco Related Diseases in India” (2014) commissioned by Ministry of Health & Family Welfare the total economic costs attributable to tobacco use from all diseases in India in the year 2011 for persons aged 35-69 years amounted to Rs. 1,04,500 crores. This estimated cost was 1.16 % of the GDP and was 12 % more than the combined state and central government expenditures on health in 2011-12 and revenue generated from tobacco tax.
Word “food” is defined in the Food Safety and Standards Act, 2006 and the PFA Act, 1954 as any substance, which is used and/or is intended for human consumption, and covers products like Gutka, Chewing Tobacco such as Zarda and Khaini. Hon’ble Supreme Court in the State of Tamil Nadu v R. Krishnamurthy, (1980)1 SCC 167, held that all that is required to classify a product as food is that it be commonly used for human consumption or in preparing human food. Hon’ble Allahabad High Court in Manohar Lal v State of U.P., Criminal Revision No. 318 of 1982 and in Khedan Lal and Sons vs State Of U.P. And Ors., 1980 CriLJ 1346, relying upon the judgment of State of Tamil Nadu v R. Krishnamurthy, (1980)1 SCC 167, has held chewing tobacco as an article of food. Hon`ble Supreme Court in the Godawat Pan Masala Products I.P. Ltd. v Union of India (2004) 7 SCC 68, held gutka, pan masala and supari as food articles.Because under the Food Safety and Standards (Contaminants, toxins, and Residues), Regulation 2011 of the FSS Act, 2006, chewing tobacco is listed in the category of food items.
Chewing Tobacco was always considered as a food item for it was listed in the category of food at entry 34 in the Prevention of Food and Adulteration Rules, 1955 and labeled under 42(ZZZ) of Prevent of Food Adulteration Rules, 1955 with the warning: “Chewing of tobacco is injurious to health”. [The FSS Act, 2006 repealed the PFA Act from 5th, August, 2011, vide Notification F.No. 2-15025/41/2011]
The guiding principle under section 18(1)(a) of the FSS Act,2006 entrusts the State Government to take endeavours to achieve an appropriate level of protection of human life and health. Under Section 26(2)(i) of the FSS Act, there is a prohibition on the food business operator to manufacture, store, sell or distribute any article of food which is unsafe.
Section 89 of the Food Safety and Standards Act, 2006, entails that the FSS Act, has overriding effect on all other legislations:-
Section 89: Overriding effect of this Act over all other food related laws.
The Food Safety and Standards (Prohibition and Restrictions on Sales) Regulation, 2011 notified on 1st August, 2011, Clause 2.3.4 mandates that a food product shall not contain any substance which may be injurious to health and tobacco and nicotine shall not be used as ingredients in any food product. Further, the FSS Act, 2006 defines the word “ingredient” as any substance, including a food additive used in the manufacture or preparation of food and present in the final product. Hence, Clause 2.3.4 of the said Regulations 2011 extends to all products where tobacco and nicotine is added as ingredient to areca-nut or food ingredients/additives such as gutka or where flavoring agents are added to tobacco to make it edible such as zarda, khaini (processed) and where tobacco and nicotine is present in the final food product.
It is clear that chewing tobacco comes under the definition of food and is liable to banned for being injurious to health and in the interest of public health. The schedule of COTPA merely defines the word tobacco products and will not preclude the product from being banned. The schedule of COTPA, 2003, mentions “tooth powder containing tobacco” as a tobacco product, while the Central Government has vide notification G.S.R. No. 443(E) and 444(E) dated 30th April, 1992, under the Drugs and cosmetics Act, 1940, banned the use of tobacco in tooth-pastes/tooth-powders in public interest. The said notification was upheld by the Hon`ble Supreme Court in the case of Laxmikant vs UOI & Ors. 1997(4) SCC 739, with the observation that the imposition of total ban is in the public interest. This does not mean that COTPA, 2003 has removed the ban and legitimized the use of tooth powder containing tobacco, in contravention of the objective of the Act to discourage the use or consumption of tobacco products and improve public health.
Because the FSS Act, 2006 is later then COTPA, 2003 and therefore takes precedence over COTPA. Further as per the mandate of section 89 of the FSS Act, 2006, the said Act has overriding effect on all other legislations including COTPA, 2003.
The Hon’ble Supreme Court in various cases has already establish the following Rules later Act will prevail over the earlier Act. If there is a provision in one of the Acts giving overriding effect then that Act will prevail. A later Act, even if it is a general Act, can prevail over an earlier special Act, in the case of a repugnancy if there is no express provision to the contrary in the earlier special Act.
Therefore, from the provisions discussed above it is appropriate to put a blanket ban on smokeless tobacco products and the food articles containing tobacco or scented tobacco, chewing tobacco, gutkha, zarda, khaini and other processed tobacco products should be banned being injurious to the health and should not be allowed to be manufactured and used under the garb of COTPA.
Disclaimer:This is the personal opinion of the writer and anyone may have a different opinion about these products and will not attract any legal implication.
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
