Partner, Vaish Associates Advocates, New Delhi, India, vpdalmia@vaishlaw.com
One of the potential threats for manufacturing and sale of food/health supplements such as "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements", is its categorization in the category of "Food" or "Drugs", as there is a very thin line between "drugs/ medicines" and "nutritional supplements". Practically all ingredients of a nutritional supplement, known through different nomenclatures, include the ingredients which may fall into the category of drugs as well as food supplements.
Present Indian law for foods is contained in the (Indian) FOOD SAFETY AND STANDARDS ACT, 2006, (FSS Act ) under which an embargo has been placed under Section 22 of the FSS Act stating that no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify, except in accordance with FSS Act or rules made there under. Prior to the FSS Act, a manufacturer had to comply with the Prevention of Food Adulteration Act,1954 (PFAA) and Rules framed there under.
The determination of the categorization of "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements" becomes important to identify whether a particular manufacturer or seller of the said products would become eligible for mandatory regularization under the FSS Act, as the new Rules, i.e.1 FOOD SAFETY AND STANDARDS (LICENSING AND REGISTRATION OF FOOD BUSINESSES) REGULATIONS, 2011 ( FSS Regulations) formulated under the FSS Act also mandate for compulsory registration by any food business operator with the Foods Safety and Standards Authority of India (FSSAI), since the FSSAI has been created for laying down scientific standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.
It is significant to note that various products, claiming to contain high amounts of vitamins and minerals, are being sold in the Indian market as health/food supplements. At the same time, multivitamin tablets and products containing other nutrients are being sold as drugs, with requisite licensing from the Drug authorities. This confusion, or if it can be said that the liberty taken by the manufacturers in the garb of food safety laws to avoid rigours of drug laws acquire importance, as the manufacturers and traders of food supplements may be running the risk of prosecution in case of incorrect categorization. There is a thin line of distinction between food/health supplement and drugs, particularly in a case where the contents and quantum of nutritional value and vitamins are specifically mentioned for various commercial reasons, making the categorisation highly subjective. There is also no judicial unanimity in this regard. There is no specific statutory or judicial yardstick available for being decisive on this aspect. Accordingly, the categorization of health and nutritional supplements as "food supplement" or "drug" would depend on the analysis of the ingredients/composition of the particular supplement as well as subjectivity of the authorities.
A dietary supplement may be defined as a product taken by mouth that contains a dietary ingredient and / or a new dietary ingredient intended to supplement the diet. The dietary ingredients in these products may include: vitamins minerals herbs or other botanicals amino acids and substances such as enzymes organ tissues glandular and metabolites.
However, despite the legislative mandate, no rules under Section 22 of the FSS Act have been notified till date. The explanation of Section 22 of the FSS Act defines "foods for special dietary uses or functional foods or neutraceuticals or health supplements" in the following terms:
(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:-
(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake; and
(b)
(i) a product that is labelled as a "Food for special dietary uses or functional foods or neutraceuticals or health supplements or similar such foods" which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made there under;
(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;
(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made there under and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;
From the above it is clear that under the present Indian law, no person can manufacture, distribute, sell or import any foods for special dietary uses or functional foods or neutraceuticals or health supplements, unless in accordance with the provisions of the FSS Act or FSS Regulations made there under.
It is pertinent to point out that the draft regulations in this regard have been prepared by the Ministry of Health and Family Welfare in exercise of power conferred under Section 22 and 92 of the FSS Act. These draft regulations have elaborately defined the word "health supplements" as under:
'Health Supplements' can be explained as foods which are intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, metals or their compounds, amino acids or enzymes, other dietary substances, plants or botanicals , substances from animal origin or other similar substances with known and established nutritional or physiological effect, and which are presented as such, wherein the composition of these foodstuffs differ significantly from the composition of ordinary foods of comparable nature, and are offered alone or in combination, but are not drugs as per the Drugs and Cosmetics Act 1940 and Rules made there under.
The said regulations providing the standards for novel food, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food have yet not been notified. Therefore, under the FSS Act, the position of nutrition and supplements products is still vague and ambiguous.
It may be noted that Section 98 of the FSS Act relates to transitory provisions for food standards and states as under:
"Notwithstanding the repeal of the enactment and Orders specified in the Second Schedule, the standards, safety requirements and other provisions of the Act and the rules and regulations made there under and Orders listed in that Schedule shall continue to be in force and operate till new standards are specified under this Act or rules and regulations made there under......."
It can be argued that due to Section 98 of the FSS Act, and in absence of notified regulations, Rule 37A of The Prevention of Food Adulteration Rules, 1955 (hereinafter referred as "PFA Rules"), though repealed by the FSS Act, would remain in force and be applicable on manufacture of health supplements food since clause 1 of Rule 37A defines "Proprietary food" as a food which has not been standardized under the PFA Rules, as in the case of health and nutritional supplements which are not defined under the Prevention of Food Adulteration Act, 1954.
Rule 37A of the PFA Rules provides as under:
"37A MANUFACTURE OF PROPRIETARY FOODS:
(1) Proprietary food means a food which has not been standardized under the Prevention of Food Adulteration Rules, 1955.
(2) In addition to the provisions including labeling requirements as prescribed under these rules, all proprietary foods shall also conform to the following requirements:-
(a) the manufacturer of proprietary products shall obtain separate licence for manufacture of each proprietary food products;
Provided that Halwais manufacturing traditional foods like Indian traditional snacks and sweets shall obtain a composite licence;
(b) the name of the food and/or category under which it falls in these rules shall be mentioned on the label;
(c) tobacco and nicotine shall not be used as ingredients in the manufacture of proprietary food products;
(d) where any food contains any allergenic and / or hypersensitive ingredients as identified under the rules, or any ingredient originating from an allergenic and / or hypersensitive ingredients does not specify the allergenic ingredients / hypersensitive ingredients, such food shall the label declaration as provided under clause (24) of subrule (zzz) of rule 42.
(e) the proprietary food product shall not contain food additives except as provided in the rules for that food and / or category of food.".
From the perusal of above Rule 37A, it is clear that any person manufacturing a product as proprietary food under the PFA Rules has to mandatorily comply with the above requirements.
In the case of Glaxo India Ltd. Vs. State Of Assam And Ors2, the Gauhati High Court held that wherein after considering the composition and ingredients for preparation of both GLUCON-C and GLUCON-D, it was held that these products as such, cannot at all be called an article of 'food under a misbranded name' and without any hesitation one can come to the conclusion to call these products as 'proprietary food'. It was also held that:
"Since 'proprietary food' cannot be the subject-matter of standards laid down in Appendix 'B', the question of non-conformity of the product 'GLUCON-C and GLUCON-D with standards prescribed under Appendix 'B' under Rule 37A, cannot be considered at all for declaring this articles of food as misbranded."
In the case of Hindustan Lever v. Food Inspector3, the Supreme Court of India has held that the instant dairy whitener is an article for which no standards has been laid and hence the standard for skimmed milk powder cannot be applied to instant dairy whitener as it contained only partly skimmed milk powder with other ingredients. Therefore the standards of such supplements would be determined based on the facts and circumstances of each case.
In the case of State of Maharashtra vs Pravin Krishnadas Shah4 it was held that the said supplements cannot be considered as drugs as:
"It is common knowledge that proteins are a body building substance - a nutrition, while a medicine is a therapeutic substance - essentially connected with healing. In absence of evidence on all aspects it will be difficult to term proteins as a 'medicine'."
The definition of "Drugs" has been elaborated under clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (hereinafter referred as "the DCA, 1940") and rules made there under.
Section 3 (b) of the DCA, 1940 provides that "drug" includes:
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;
From the bare perusal of above section, it is clear that health or nutritional supplements may be categorized as drugs, because of the very wide definition of drug as provided in the DCA, 1940. Any "foods for special dietary uses or functional foods or neutraceuticals or health supplements" which falls within the definition of "drugs" under the DCA, 1940, has to be excluded from the applicability of the FSS Act.
For understanding the issue, reliance can also be laid on the verdict of the Kerala High Court in Cadila Pharmaceuticals Ltd. vs. State Of Kerala And Ors.
The High Court in the above case held EC 350 (Vitamin E and Vitamin C capsules) and Cecure (Multi-Vitamin Capsules) manufactured by the petitioner and sold in the market through medical shops as "Dietary Supplements" to fall within the definition of "drug" requiring licence under the Drugs and Cosmetics Act, 1940.
It was also held in the above case that "the definition of 'drug' in the Act clearly specifies that all, substances intended to be used for mitigation or prevention of any disease or disorder in human beings is a drug and further all substances intended for use as components of a drug including empty gelatin capsules is a drug."
In the case of Dr. Reddy's Laboratories Limited vs State Of Kerala, the test for determining "whether a particular supplement should be treated as a medicine?" was laid down as under:
"The word medicine means, any substance/chemical which when used in a disease will lead to cure or improvement.
The dietary supplement means any substance (usually a food item/ingredient) which helps in maintenance of health.
The clear distinction between health and disease is not there. What is healthy for a particular person/sex/ethnic group is a disease for someone else (for example being slim is healthy for a model but is a sign of malnutrition for a pregnant woman or for doctors). Since the distinction between disease and health itself is not clear, dietary supplement versus medicine is also not clear in many circumstances. In some way, we need to draw a distinction for various reasons (for rigorous pre-clinical and post marketing testing and for taxation purpose).
If GLA-120 is used to treat diabetic neuropathy then it should be considered a medicine. If for some reason it is used in normal healthy people (which it is not supposed to) as a tonic to improve the general well being, then it is a dietary supplement. If GLA-120 is a medicine then question still remains whether it has undergone the same rigorous stage I (testing in healthy volunteers), stage II (testing in diseased people) and stage III (randomized trials) clinical trials and whether its entire side effect profile and harmful effects are known in large group of people. If it is a dietary supplement it may not require such rigorous clinical testing and it may be available over the counter without doctors' prescription."
In an important case of The State of Bihar vs. Alkem Laboratories Limited, wherein the question whether certain products, which were in the nature of health supplements, would fall into the category of 'food' or 'drug' came before the Hon'ble High Court of Patna. The Court held that:
"Having heard both the parties and on a perusal of the report submitted by Director General of Health Services, Govt. of India, we are of the opinion that in the expert opinion as with regard to labelling of the drugs no material is available before this Court with regard to effect of the composition of such ingredients on the human body. If they are consumed as a 'food'. Of course, it is the general parlance that the ingredients generally would be tested on some animals for its ill-effects on the human body before its release in the open market.
The perusal of the report indicates the opinion is formed by the experts only on seeing the 'labelling' on the products. But there is no indication in the report with regard to the effects such products would cause on the human body. In the absence of such indication, we are of the opinion that it would be difficult to arrive at a conclusion whether it can be classified as a 'food' or 'drug'. But, however, in view of the controversy that arose in this case the Director General of Health Services, Govt. of India would take a fresh look into the matter by directing the experts to analyze the ingredients or components of each drug to know the effect of such drugs on the human body. In absence of such analysis, any one cannot come to the conclusion that whether it is a 'drug' or a 'food'.
Under the above circumstances, we are of the opinion that the matter can be referred back to the expert committee of the Drug Technical Advisory Board as provided under the Drugs and Cosmetics Act, 1940 and also under the provisions of the Prevention of Food Adulteration Act,1954 for analyzing the component or ingredients of each products and its effect on the human body if consumed as a food and come to the conclusion whether the products would fall under the classification of the Drugs and Cosmetics Act, 1940 or under the Prevention of Food Adulteration Act as 'food'."
It is very important to note that all of the above mentioned cited cases were decided before the FSS Act came into force. The present position would be governed under the provisions of the FSS Act. The confusion continues.
Footnotes
1 http://www.fssai.gov.in/GazettedNotifications.aspx#regulations2011
2 (2003) 1 GLR 407
3 2003(16)CriminalCC970
4 MANU/MH/0060/1984
5 AIR 2002 Ker 357
6 LPA No.865 of 2009
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