A Comparative Study of Registration Process of Nutraceuticals in different countries

 

Hiteksha J. Dobariya*, Urvi J. Chotaliya

B. K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dam, Rajkot - 360003 Gujarat, India.

*Corresponding Author E-mail: hiteksha134@gmail.com, urvi_jc@yahoo.com

 

Abstract:

Nutraceuticals, which are defined as any food or component of food that has health benefits, such as the ability to prevent or treat disease, have become essential for consumers in both developed and developing nations. Functional elements like vitamins, minerals, and other nutrients are becoming more important due to the changing lifestyle. This category now includes things like probiotics, amino acids, and fatty acids, among others. In light of the fact that these items are intended for human consumption, regulatory bodies worldwide are concentrating on the Product Quality and Safety. This paper looks into the nutraceutical registration processes in different countries. The India have developed the Food for special dietary use registration process whereas the USA have put into place Dietary supplement registration process and the Japan have developed registration process for Foods for specified dietary use (FOSHU) whereas the China have developed registration process for Health foods. It also includes the marketed formulation of nutraceuticals. The aim of this paper is to compare the regulation processes between the different countries.

 

KEYWORDS: Nutraceuticals, Registration process, Regulation of nutraceuticals, Health claims, Food.

 

 

INTRODUCTION:

A word that combines the words "nutrient" and "pharmaceuticals" is called a nutraceutical. The term "nutrient" refers to a feed component that will help, sustain a person or animal's existence, whereas the term "nutraceutical" refers to any non-toxic food component that prevents or treats diseases, according to AAFCO (The Association of American Feed Control Officials), 1996.1-3

 

Dr. Stephen L. DeFelice, Chairman of the Foundation of Innovation Medicine (FIM), defined the word "nutraceutical" (New Jersey, USA).4

 

This phrase has been defined differently by several international organisations, but generally, it refers to a substance that is separated or purified from food and converted into a pharmaceutical dosage form for use in treating a variety of chronic conditions.5-6

 

Nutraceutical categories:

Dietary supplements: Vitamins, minerals, ashwagandha, shilajit, and other nutrients.

 

Functional foods:

Omega-3 milk for heart disease prevention, canola oil with lowered triglycerides for cholesterol reduction, stanols (Benecol) for reduction of cholesterol adsorption, table salt fortified with iodine, and others. Oats, bran, psyllium, and lignins for heart disease and colon cancer. Prebiotics like oligofructose for control of intestinal flora.7

The two categories of functional foods are processed food and fermented foods.8

Medicinal foods:

Others include health bars with additional pharmaceuticals, slowly absorbed carbohydrates for diabetic mellitus, lactoferrin for immune system support, transgenic plants for oral immunization against infectious diseases, and others.9-10

 

In most cases, nutraceuticals are not patented. Although both pharmaceutical and nutraceutical chemicals have the regulatory approval, only pharmaceutical compounds can be utilized to treat or prevent diseases.11-14

 

Hippocrates accurately emphasized "Let food be your medicine and medicine be your food" almost 2000 years ago. Since it is now widely acknowledged that "Nutraceuticals" have a significant role in improving health, there has been an increase in interest on a global scale.15

 

The term "dietary supplement" has many definitions and names around the world, including "natural health product" in Canada, "dietary supplement" in the USA, "food for special health use" (FOSHU) in Japan, "biologically active food supplements" in Russia, "complementary medicine" in Australia, "food supplements" in the EU, and "foods for special dietary use" in India.16-17

 

India:

In India, nutritional supplements are referred to as "foods for special dietary uses." Foods that are specially processed or formulated to satisfy specific dietary requirements that exist as a result of a particular physical or physiological condition, or specific diseases and disorders, are referred to as "foods for special dietary uses or functional foods, nutraceuticals, or health supplements" by the Food Safety and Standards Authority (FSSA).18-19

 

Concept of Nutraceuticals:

In order to verify the therapeutic effects of supplements, clinical test data derived from research and testing on animals are necessary as part of the pharmaceutical development process.20 However, there was no historical means of verifying the efficacy of foods in nutraceuticals for avoiding disease. However, as the link between lifestyle-related diseases and food composition has been established scientifically, it has recently become a social issue. The health benefits of the nutraceutical goods are well known and include lowering the risk of heart disease and cancer as well as preventing or treating hypertension and excessive cholesterol as well as many other diseases. One strategy for preventing such situations is the idea of nutraceuticals, which has begun to gain recognition.21-28 The concept of nutraceuticals is shown in figure 1.

 

Figure 1: Concept of nutraceuticals

 

Regulation of Nutraceuticals in India:

In India, "Foods for special dietary uses" is how nutraceuticals are referred to. "Foods for particular dietary applications or health supplements or nutraceuticals or functional food," according to the Food Safety and Standards Authority (FSSA).29

 

The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards Act, 2006 in India. Various Acts like Prevention of Food Adulteration Act, 1954, Fruit Products Order, 1955, Meat Food Products Order, 1973, Vegetable Oil Products (Control) Order, 1947, Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order, 1967, Edible Oils Packaging (Regulation) Order 1988, Milk and Milk Products Order, 1992 etc. have been repealed after commencement of FSS Act, 2006.30

Health Claim31

A relationship between a food or a component of that food and health is referred to as a "health claim."

Health claims can be categorized as follows:

Nutrient content claim

Reduction of disease claim

Structure/Function claim

 

Regulatory Requirements in India:

1.     Product Evaluation

2.     Licenses

3.     Health and label claims

 

Registration Process in India32

Registration process of nutraceuticals in India shows in Figure 2.

 

Figure 2: Registration Process of India

 

Regulation in United State:

Nutraceuticals are categorized as dietary supplements by the USFDA, and the rules took effect in 1994. Dietary supplements and ingredients are governed by a different set of rules by the FDA under the DSHEA, or the Dietary Supplement Health and Education Act.33

 

It is against the law for producers and distributors of dietary supplements and components to advertise contaminated or falsely labelled goods. This implies that before putting their products on the market, these companies must assess the safety and labelling of their products to make sure they comply with all DSHEA and FDA rules.

 

After a dietary supplement product enters the market, the FDA is responsible for taking action against any adulterated or misbranded versions of the product.

 

Health Claims in USA34

Health Claims can be of three types:

Health claims

Nutrient content claims

Structure/function claim.

 

Nutraceuticals Registration Process in USA35

Registration process of nutraceuticals in USA shows in Figure 3.

 

Figure 3: Registration Process of USA

 

Nutraceuticals Regulation in Japan:

Foods with functional elements that modify the structure or function of the body are classified as Foods for Specified Health Uses (FOSHU). The major purpose of these foods is to maintain or control a certain health condition.36

 

FOSHU are categorized into four classes based on the strength of the supporting evidence. Depending on the quality of the supporting evidence, as is outlined in Table 1, there are many levels of claims, ranging from A to C.37

 

Regular and reducing disease risk FOSHU demands A-grade data that has been scientifically validated in both nutrition and medicine. Evidence that is confirmed at the level previously necessary for the approval of existing FOSHU is required for categorized FOSHU and must be graded B. C level evidence is acceptable for Qualified FOSHU when the efficacy is only suggested rather than proven.38

Table 1: Japanese FOSHU Categories

Regular FOSHU

Foods approved by the MHLW as “regular” FOSHU are those whose safety and effectiveness with relation to health claims have been established via a number of clinical trials and safety/stability assessments (Ministry of Health, Labour and Welfare).

Reduction of Disease Risk FOSHU

This category permits claims on the product label that indicate the efficacy in reducing illness risk if the efficacy has been demonstrated medically and nutritionally.

Standardized FOSHU

The Standardized FOSHU stands for foods that include active substances that have been shown to meet the criteria for a certain health claim, ingredient, or quality standard. Foods that have amassed a body of scientific evidence (more than 100 prior approvals as FOSHU) may be approved as Standardized FOSHUs after only being subjected to MHLW’s evaluation and without the necessity for a separate examination by the examination council.

Qualified FOSHU

Refers to foods that have some effectiveness but whose scientific evidence is not as strong as that needed to meet the current FOSHU level. The application procedure is less complicated and strict. ‘This product comprises (name of substance), which may be appropriate for (health claim), however the grounds for this effectiveness have not necessarily been established,’ can be found on the labels of Qualified FOSHU products.

 

Applicants from abroad submit their applications directly to the MHLW. There are four quarters in the calendar. Applications are accepted three times per year (usually March, June, September and December).39-40 Each piece of information must be submitted in Japanese. Japanese participants in clinical trials and at least a portion of the clinical data must originate from Japan. Additionally necessary is the publication of data in a scientific journal published in Japan.41

 

Japanese FOSHU Registration Process

Registration process of nutraceuticals in Japan shows in Figure 4.

 

Figure 4: Registration Process of Japan

 

The approval process necessitates a minimum of six months. The MHLW receives the application as the first step. However, this time frame does not take into account the additional time needed to answer to the numerous questions from the committee, the Council, and the MHLW office. The standard minimum duration is 12 months. The necessary efficacy and safety tests, which might take between 4 and 12 months, are not part of this process. So, the registration process takes between one and two years to complete.42

 

Nutraceuticals Regulation in China:

According to the Chinese regulatory system, "health foods" are primarily defined as foods that have certain health benefits, are suitable for consumption by particular demographic groups, and have the ability to regulate bodily functions. The company's representative office or authorized agent in China must submit the application.43

 

The following paperwork must be received before submission from Beijing's Chinese Center for Disease Control's INFS (Institute of Nutrition and Food Safety).44

·       Report of toxicology safety assessment

·       Report of functionality evaluation

·       Analytical report of active ingredient

·       Report of product stability study

·       Report of sanitary inspection

 

Figure 6 shows the registration procedure for healthy foods in China. The application should contain information about the product's name, ingredients, active ingredients, dose, and usage, as well as its specifications, expiration date, recommended storage conditions, and safety measures. There should be 13 photocopies and one original copy of each document. With the exception of the manufacturer's address, all other elements submitted in a foreign language must be accompanied by comparable translations in Chinese.45

 

Chinese Health Food Registration Process:

Registration process of nutraceuticals in China shows in Figure 5.

 

Figure 5: Registration Process of China

Marketed Product of Nutraceuticals:

There are many nutraceutical products which are available in market and use for different purpose and manufacture by different company in different countries. Commercial products are mentioned in Table 2.46-47

 

Table 2: Marketed Nutraceutical Product

Product

Category

Company

Country

Probiotic Wraps and Hummus

Support immune function and promote digestive health

Cedar’s Mediterranean Foods

USA

Phenorex 

Burn fat

Gaspari Nutrition

USA

Calcium Plus Milk

Lower risk of osteoporosis

Shamrock Farms

USA

Calcirol D-3

Calcium supplement

Cadilla healthcare limited

India

Proteinex®

Protein supplement

Pfizer Ltd.

India

GRD

Nutritional supplement

Zydus Cadila Ltd.

India

 

A Comparative Study:

Comparative study of regulatory requirements for nutraceuticals in different countries given in Table 3.

 

Table 3: A comparative study between different countries

Country

India

USA

Japan

China

Definition

Foods for special dietary uses

Dietary supplement

Food for Special Health Use

Health foods

Rules/ Regulations for licensing and registration

The Food Safety and Standards Regulations

United States Food, and Drug Administration (USFDA)

The Food Sanitation Act (FSA)

Food Safety Law

Act/ Regulatory

authority for registration of nutraceuticals

Food Safety and Standard Authority of India (FSSAI)

Dietary Safety and Health Education Act

Ministry of Health, Labour and Welfare

State Food and Drug Administration

Regulations came into force

2011

1994

1938

2003

Registration process

Comparatively easy

Comparatively easy

Strict process

Strict process

Registration authority

In FSSAI

In USFDA

In MHLW

In SFDA

Form number

Form A, B. and C

Form 3537

-

-

 

CONCLUSION:

A comparison of the nutraceutical registration processes in India, USA, Japan and China reveals a number of similarities and differences. In India registration process is comparatively easy as compared to other countries. There are strict regulation and registration process implementation required in India to get the nutritive product with proper label claim. In USA registration is approved after the inspection of the manufacturing site. In Japan clinical trials and sample testing is required before the registration of product whereas in China applicant submit sample to the specific authority to carry out safety, toxicology and stability tests before the registration of product. In Japan and China registration process is comparatively strict. There should be common and uniform registration process of nutraceuticals in worldwide to get better nutritive product to all individuals globally. By applying same procedure of registration, import and export of product become easier because all registration of all products in all countries is possible by using same procedure. It will give benefit to health of all individuals globally ands people get nutritive product with proper label claim.

 

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Received on 25.11.2022       Modified on 14.12.2022

Accepted on 29.12.2022      ©A&V Publications All right reserved

Research J. Science and Tech. 2023; 15(2):73-80.

DOI: 10.52711/2349-2988.2023.00013