A nutrient claim on a package trigg

A nutrient claim on a package triggers the requirement for nutrient information, which otherwise is voluntary [6]. Hence all product which a claim of “low fat” or “fat-free” must present the nutrient content information.
As indicated above, nutrient content claims can indicate to the consumer that the product has a particular level of a nutrient, but they cannot relate that to any health issue; in other words, they cannot tell the consumer why they should care about this level of the nutrient. Consumer have to know why they would buy a product with “low fat” or “high fiber” on it.
3.1.4 Structure-Function Claims
Many nutrients are known to affect particular physiological or biochemical processes in the body. A “structure-function claim” is a claim on a package, which indicates that a nutrients plays a role in a particular biological process. These can also be described as “biological role claims”[6]. Examples of such claims would be to say that “high fiber promotes regularity” or that “iron is important for the funtioning of red blood cell to carry oxygen” or that “calcium aids in the growth and maintenance of bones.” None of this assosiation indicates a disease antity, and generally such claims cannot directly or indirectly refer to the treatment, mitigation or prevention of any desease, disorder, or abnormal physical state. One could infer from these claims that oversupply of a nutrient or a deficient intake could leat to a malfuntion of the biological process described, but this is not stated in a “structure-function” claim. Many countries that at present do not allow “health”claims. (i.e., where health or a desease entity is mentioned) do, however, allow “structure-function” claims. Generally, if a product contains astructure-function claim, this triggers the declaration of nutrient content information.
3.1.5 Health Claims
Health claims are statements that relate a nutrient, series of nutrients, food component or food product to the prevention or treatment of desease. The definition of health claim in the United States, as part of the Nutrition Labelling and Education Act (NLEA), is: “a health claim is any claim made on the label that either expressly through implication (through the use of endorsements, written statements, symbols or vignettes), characterizes the relationship between any substance to a desease or health related condition”[7].
Claims relating to essential nutrient diseases are not included in this definition and are not considered health claims[7]. Health claims can related to components of foods them selves, and for purposes of clarification, it is useful to separate them into three types: (1) generic, (2) commodity, and (3) product-spesific.
3.1.5.1 Generic Health Claims
Generic health claims are those that relate a nutrient, in the context of a total diet, to a particular disease or condition. Examples of generic health claims are those permitted in the United states under the NLEA such as: “diets low in saturated fat and cholesterol and rich in fruits, vgetables and grain products that contain some types of fiber, particulary soluble fiber, may reduce the risk of heart disease, a disease associated with many factors”[8]
Generic claims do not apply to a spesific product or food and thus the product on which they are placed cannot be said to be protective, only the nutrients in them. The basis for the claim to be permitted is the weight of scientific evidence demonstrating the benefica effect of the nutrient in the prevention or treatment of the condition stated[7]
3.1.5.2. Commodity/Ingredient Helath Claims
Commodity or ingredient claims describe claims for commodities or ingredients, like the statements recently permitte in the United States for oatmeal and oat bran: “’diets high in oat bran/oatmeal and low in saturated fat and cholesterol m ay reduce the risk of heart disease”[9]
Similiar statements for psyllium are now being considered favourably by the food and drug administration (FDA)[10]. Again, such claims are not product-spesific, although it may be indicated that the commodity is present in the product [11]. However, it does not indicate in the claim that the product on which the claim is placed is protective [11]. Like the generic claims, the basis for allowing such claims isthe weight of scientific evidence in support of the beneficial effect of the commodity or ingredients in the prevention or treatment of a condition.
3.1.5.3 Product-Spesific Claims
A product-spesific claim would be a claim that states the product on which the claim is placed has a protective effect againts a disese, that it either reduces teh risk of the disease occuring or is useful in treating or reducing the symptoms of a pre-existing condition. Such claims can be made for food productd in some nutrients, but it most cases in order to do so, the product must be evaluated under the guedelines for efficacy and toxicity specified for drugs [3]. For this type of claim, the product itself, rather than simply the ingredient or nutrients in it, have to be shown to have benefit.
4. FOOD VERSUS DRUGS
In most countries, an act of goverment regulates the sale and promotion of food and drugs. For some countries, the act is for both food and drugs, as in the food and drugs act and regulation in Canada or the Federal food drugs, and Cosmetic Act in The Uniited States. In othe coutries there are separate acts for food and for drugs. For example, Sweden has a Food Act and an act on Medicinal Product [12]. In the past, food and drugs were dealt with separately by different divisions or departments, sometimes within the same agency, branch or administrative unit of goverments as in Canada (Helath Protection Branch, Health Canada), the United States (ood and Drug Administration), or iin separate agencies as in the United Kingdom, where foods are regulated by the Ministry of Agriculture, fisheries an food (MAFF), often in conjuction with the department of Health (DH), while drugs are regulated by the Medicines Control Agency (MCA). There was little apparent overlap, mainly because the definitions of food and drug were distinct when the acts of goverment were written and foods were not promoted on helth grounds. The definitions of food and drug were distinct as in Canada:
Food : any article manufactured, sold or rpresented for use as food or drink for man, chewing gum and any ingrdient that may be mixed with food for any purpose whatsoever.
Drug : any substance manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of disease or (b) restoring correcting or modifying organic funtions in man or animal [3].
These remain the definitions in Canada ; hence there is no statement within the definition of a food that it can confer health benefits. If a company wants to indicate a health benefit, then the food must undergo evaluation as a drug, generally referred to as pursuing “the drug route” [3,12].
In recent years, with the growth of interest in foods and components of foods, natural product, herbal products, botanicals, and dietary supplements to promote health and reduce the risk or treat disease, the existing definitions of food and drug are being questioned. Many countries are dealing with this issue, and some have introduced separate categories for such products or indicated clearly under which department of goverment certain types of products must be regulated.
4.1 DIETARY SUPPLEMENTS
Definition of the term dietary supplements vary. In many countries, these are throught of as purified nutrient preparations to “supplement” the diet,providing vitamins and minerals in amounts to ensure sufficients intake to prevent deficiency. However, what is now included under the term supplement has broadened in some countries, so that compounds other than vitamins and minerals are also included.
With the passing of the Dietary Supplement Health And Education Act (DSHEA) in the United State in1994, the term dietary supplements is now defined as :
• Containing one or more nutrients, herbs, botanicals, or a concentrate, metabolite or consituent extract from the ingredients previously mentioned
• In the form of a supplements 9meaning tablet, capsule or powder)
• Is not represented as a food or sole item of a meal of the diet
• Includes a similiar new drug or biologic approved under previous legislation and not currently being investigated [13]
The DSHEA distinguishes dietary supplements from both foods and drugs and provides separate regulation for these preparation. Unlike the health claims now permitted for nutrient, which are strictly worded and where compliance with wording is mandatory, regulations for supplements are less rigid in terms of wording but can have no relationship with disease.
Inlike the U.S,. most other countries have not created a special category for dietary supplments, And there are considerable dofferences in the way these product are regulated. In many countries, they continue to be regulated as foods; however, if a claim of medicinal purpose is assigned to a product, it is then regulated as a drug. There are many concerns worldwide about concentrated formulations where dosages above amounts recommended are easily achieved, and considerable discussion is presently occurring in how to regulate these products.
5. MEDICAL FOODS/FOODS FOR SPECIAL DIETARY USE
Many countries have separate regulations for foods spesifically designed to be used for nutrition-related disorders. These come under two terms medical foods and foods for special dietary use. In the United States, medical foods are defined as “foods formulated to be consumed or administared under the supervision of a physician and which are intended for teh spesific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientifc principle, are established by medical evaluation” [14]

Hasil (Bahasa Indonesia) 1:

Klaim gizi pada paket memicu kebutuhan nutrisi informasi, yang jika tidak bersifat sukarela [6]. Maka semua produk yang klaim "rendah lemak" atau "bebas lemak" harus menunjukkan konten informasi nutrisi.Sebagaimana ditunjukkan di atas, potensi hasil klaim dapat menunjukkan kepada konsumen bahwa produk memiliki tingkat tertentu dari nutrisi, tetapi mereka tidak berhubungan bahwa untuk masalah kesehatan; dengan kata lain, mereka tidak memberitahu konsumen mengapa mereka harus peduli tentang tingkat nutrisi. Konsumen harus tahu mengapa mereka akan membeli produk dengan "rendah lemak" atau "serat tinggi" di atasnya.3.1.4 struktur-fungsi klaim Banyak nutrisi yang dikenal untuk mempengaruhi proses fisiologis dan biokimia yang buruk yang tertentu dalam tubuh. "Struktur-fungsi klaim" adalah klaim pada paket, yang menunjukkan bahwa nutrisi memainkan peran dalam proses biologis. Ini dapat juga digambarkan sebagai "peranan biologis klaim" [6]. Contoh klaim tersebut akan mengatakan bahwa "serat tinggi mempromosikan keteraturan" atau bahwa "besi penting untuk funtioning sel darah merah untuk membawa oksigen" atau bahwa "kalsium membantu dalam pertumbuhan dan pemeliharaan tulang." Tak satu pun dari Asosiasi ini menunjukkan antity penyakit, dan umumnya klaim seperti itu tidak langsung atau tidak langsung merujuk kepada pengobatan, mitigasi atau pencegahan penyakit, gangguan, atau kondisi fisik yang abnormal. Satu bisa menyimpulkan dari klaim-klaim ini bahwa pasokan nutrisi atau asupan yang kurang bisa leat untuk malfuntion proses biologis yang dijelaskan, tetapi ini tidak dinyatakan dalam klaim "struktur-fungsi". Banyak negara yang saat ini tidak mengizinkan klaim "kesehatan". (yaitu, mana kesehatan atau entitas penyakit yang disebutkan), bagaimanapun, memungkinkan "struktur-fungsi" klaim. Umumnya, jika produk yang mengandung klaim astructure-fungsi, ini memicu Deklarasi gizi konten informasi.3.1.5 klaim kesehatanHealth claims are statements that relate a nutrient, series of nutrients, food component or food product to the prevention or treatment of desease. The definition of health claim in the United States, as part of the Nutrition Labelling and Education Act (NLEA), is: “a health claim is any claim made on the label that either expressly through implication (through the use of endorsements, written statements, symbols or vignettes), characterizes the relationship between any substance to a desease or health related condition”[7].Claims relating to essential nutrient diseases are not included in this definition and are not considered health claims[7]. Health claims can related to components of foods them selves, and for purposes of clarification, it is useful to separate them into three types: (1) generic, (2) commodity, and (3) product-spesific.3.1.5.1 Generic Health ClaimsGeneric health claims are those that relate a nutrient, in the context of a total diet, to a particular disease or condition. Examples of generic health claims are those permitted in the United states under the NLEA such as: “diets low in saturated fat and cholesterol and rich in fruits, vgetables and grain products that contain some types of fiber, particulary soluble fiber, may reduce the risk of heart disease, a disease associated with many factors”[8]Generik klaim tidak berlaku untuk produk spesifik atau makanan dan dengan demikian produk yang mereka ditempatkan tidak bisa dikatakan menjadi pelindung, hanya nutrisi dalam mereka. Dasar untuk klaim untuk diizinkan adalah berat bukti ilmiah menunjukkan efek benefica nutrisi dalam pencegahan atau perawatan kondisi menyatakan [7]3.1.5.2 komoditi/bahan Helath klaimKlaim komoditas atau bahan menggambarkan klaim untuk komoditas atau bahan-bahan, seperti pernyataan baru-baru ini permitte di Amerika Serikat dedak oatmeal dan oat: "' Diet tinggi dalam bran oat/oatmeal dan rendah lemak jenuh dan kolesterol m ay mengurangi risiko penyakit jantung" [9]Pernyataan serupa psyllium kini sedang dipertimbangkan menguntungkan oleh administrasi makanan dan obat (FDA) [10]. Sekali lagi, klaim tersebut yang tidak produk-spesifikasi, meskipun itu dapat ditunjukkan bahwa komoditi yang ada dalam Produk [11]. Namun, itu tidak menunjukkan di klaim bahwa produk yang klaim ditempatkan pelindung [11]. Seperti klaim generik, dasar untuk memungkinkan klaim seperti itu adalah berat bukti ilmiah untuk mendukung efek menguntungkan dari komoditas atau bahan dalam pencegahan atau perawatan kondisi.3.1.5.3 produk-spesifikasi klaimProduk-spesifikasi klaim akan klaim yang menyatakan produk yang klaim ditempatkan memiliki efek perlindungan terhadap disese, bahwa itu mengurangi risiko penyakit terjadi atau berguna dalam mengobati atau mengurangi gejala dari kondisi yang sudah ada. Klaim seperti itu dapat dibuat untuk makanan productd beberapa nutrisi, tetapi kebanyakan kasus untuk melakukannya, produk harus dievaluasi di bawah guedelines untuk efektivitas dan toksisitas yang ditentukan untuk obat-obatan [3]. Untuk jenis klaim, produk itu sendiri, bukan hanya bahan atau nutrisi di dalamnya, harus terbukti memiliki manfaat.4. MAKANAN VERSUS OBATIn most countries, an act of goverment regulates the sale and promotion of food and drugs. For some countries, the act is for both food and drugs, as in the food and drugs act and regulation in Canada or the Federal food drugs, and Cosmetic Act in The Uniited States. In othe coutries there are separate acts for food and for drugs. For example, Sweden has a Food Act and an act on Medicinal Product [12]. In the past, food and drugs were dealt with separately by different divisions or departments, sometimes within the same agency, branch or administrative unit of goverments as in Canada (Helath Protection Branch, Health Canada), the United States (ood and Drug Administration), or iin separate agencies as in the United Kingdom, where foods are regulated by the Ministry of Agriculture, fisheries an food (MAFF), often in conjuction with the department of Health (DH), while drugs are regulated by the Medicines Control Agency (MCA). There was little apparent overlap, mainly because the definitions of food and drug were distinct when the acts of goverment were written and foods were not promoted on helth grounds. The definitions of food and drug were distinct as in Canada:Food : any article manufactured, sold or rpresented for use as food or drink for man, chewing gum and any ingrdient that may be mixed with food for any purpose whatsoever.Drug : any substance manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of disease or (b) restoring correcting or modifying organic funtions in man or animal [3].Ini tetap definisi di Kanada; oleh karena itu, ada tidak ada pernyataan dalam definisi makanan bahwa itu dapat memberikan manfaat kesehatan. Jika sebuah perusahaan ingin menunjukkan manfaat kesehatan, makanan harus menjalani evaluasi sebagai obat, umumnya disebut sebagai mengejar "obat rute" [3,12].Dalam beberapa tahun terakhir, dengan pertumbuhan minat dalam makanan dan komponen makanan, produk alami, produk-produk herbal, tumbuhan, dan suplemen makanan untuk meningkatkan kesehatan dan mengurangi risiko atau mengobati penyakit, definisi yang ada dari makanan dan obat-obatan yang sedang dipertanyakan. Banyak negara yang berurusan dengan masalah ini, dan beberapa telah memperkenalkan kategori terpisah untuk produk tersebut atau ditunjukkan dengan jelas di bawah Departemen yang pemerintah jenis produk tertentu harus diatur.4.1 SUPLEMENDefinisi istilah suplemen makanan bervariasi. Di banyak negara, ini adalah berpikir dari sebagai murni hara persiapan untuk "suplemen" diet, menyediakan vitamin dan mineral dalam jumlah untuk memastikan asupan sufficients untuk mencegah kekurangan. Namun, apa yang sekarang termasuk di bawah istilah suplemen telah memperluas di beberapa negara, sehingga senyawa selain vitamin dan mineral juga disertakan.Dengan berlalunya dari makanan suplemen kesehatan dan pendidikan Act (DSHEA) di Amerika negara in1994, istilah suplemen makanan sekarang didefinisikan sebagai:• Mengandung satu atau lebih nutrisi, herba, tumbuhan, atau konsentrat, metabolit atau consituent ekstrak dari bahan-bahan yang disebutkan sebelumnya • In the form of a supplements 9meaning tablet, capsule or powder)• Is not represented as a food or sole item of a meal of the diet • Includes a similiar new drug or biologic approved under previous legislation and not currently being investigated [13]The DSHEA distinguishes dietary supplements from both foods and drugs and provides separate regulation for these preparation. Unlike the health claims now permitted for nutrient, which are strictly worded and where compliance with wording is mandatory, regulations for supplements are less rigid in terms of wording but can have no relationship with disease.Inlike the U.S,. most other countries have not created a special category for dietary supplments, And there are considerable dofferences in the way these product are regulated. In many countries, they continue to be regulated as foods; however, if a claim of medicinal purpose is assigned to a product, it is then regulated as a drug. There are many concerns worldwide about concentrated formulations where dosages above amounts recommended are easily achieved, and considerable discussion is presently occurring in how to regulate these products.5. MEDICAL FOODS/FOODS FOR SPECIAL DIETARY USEMany countries have separate regulations for foods spesifically designed to be used for nutrition-related disorders. These come under two terms medical foods and foods for special dietary use. In the United States, medical foods are defined as “foods formulated to be consumed or administared under the supervision of a physician and which are intended for teh spesific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientifc principle, are established by medical evaluation” [14]