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health claims

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poonam singh

on 7 December 2012

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Transcript of health claims

Health claims
Submitted by:-
Lakhdeep Kaur
Neetu Singh
Harit Galgat
Prabhu deep
Sunil babu
Mayank patel
Bhargav Daru
Rakesh chandra A health claim is any representation in labeling or advertising
on food product

Stating a relationship exists between consumption of a food, or an ingredient in the food, and health.

All health claims must be truthful and not misleading, and substantiated with scientific evidence before they appear on food product labels What Are Health Claims? Types of health claims. Disease risk reduction claims
 highlight a specific relationship between a food and reduced risk of developing a diet-related disease or condition.
Five such claims have been authorized in Canada through an amendment to the Food and Drug Regulations in 2003.
Therapeutic claims
 highlight the therapeutic effect of a food including restoring, correcting, or modifying body functions.
A list of claims reviewed by Health Canada for scientific validity is published on the Health Claim Assessments Web page.
Function claims 
statements based on the specific beneficial effects that the consumption of a food or a food constituent has on the normal functions or biological activities of the body.
To be eligible to display a function claim, a product must meet the specific conditions for its use.  Nutrient function claims 
function claims that describe the well-established roles of energy or known nutrients that are essential for the maintenance of good health or for normal growth and development.
General health claims 
claims that promote health through healthy eating or that provide dietary guidance.
These claims can be made on any product provided no linkage is made to a specific product or to a health effect, disease or health condition. "A healthy diet rich in a variety of vegetables, fruit and whole grain products may reduce the risk of heart disease.""A healthy diet rich in a variety of vegetables and fruit may reduce the risk of heart disease.""A healthy diet rich in a variety of vegetables and fruit may reduce the risk of heart disease and some types of cancer."  In the case of a vegetable or fruit: "A healthy diet rich in a variety of vegetables, fruit and whole grain products may reduce the risk of heart disease. (Naming the food) contains (naming the percentage) whole grain(s) / (Naming the food) contains (naming the percentage) whole (naming the grain(s))."

"A healthy diet rich in whole grain products may reduce the risk of heart disease. (Naming the food) contains (naming the percentage) whole grain(s) / (Naming the food) contains (naming the percentage) whole (naming the grain(s))." In the case of a whole grain product: The whole grain foods must meet the definition for "low in saturated fatty acids" contained in B.01.513 and contain not more than 100 mg cholesterol per 100 g, not more than 0.5% alcohol and not more than 480 mg sodium per reference amount and per serving of stated size and per 50 g if the reference amount is 30 g or 30 ml or less, or 960 mg or less of sodium per serving of stated size.
hese criteria are not applied to fruit and vegetables because the evidence related to the consumption of fruit and vegetables and their juices per se which are already free of cholesterol and low in saturated and trans fatty acids. Conditions for the Claim: On any part of the available display surface 6:
"Women consuming healthy diets with adequate folate and taking a daily multivitamin supplement containing 0.4 mg folic acid starting at least three months before becoming pregnant may reduce their risk of having a baby with a birth defect of the brain or spinal cord. (Naming the food) is an excellent source of folate Health Claim for Folate and Neural Tube Defects On the principal display panel (PDP):"
A diet rich in folate along with a daily folic acid supplement may reduce a woman's risk of having a baby with a birth defect of the brain or spinal cord. (Naming the food) is an excellent source of folate.",accompanied by the following message, in letters of at least the same size and prominence as the claim on the PDP, on any other part of the available display surface;"
Women consuming healthy diets with adequate folate and taking a daily multivitamin supplement containing 0.4 mg folic acid starting at least three months before becoming pregnant may reduce their risk of having a baby with a birth defect of the brain or spinal cord. (Naming the food) is an excellent source of folate." Claim for Dietary Lipids and Cancer Several large prospective cohort studies have examined the relationship between dietary fat and risk of breast, prostate and colon cancer in particular.
For the nine cohort studies focussing on breast cancer risk, only one found a relationship with both total fat and saturated fat intake, one identified an association with saturated fat only.
two identified an inverse association with monounsaturated fatty acids (MUFA) while one found a positive association with MUFA. Canadian Regulation of Functional Food Claims natural health products (NHPs), governed by the Natural Health Product Regulations, or food, governed by the Food and Drug Regulations
The Canadian Food Inspection Agency’s Guide to Food Labelling and Advertising states that claims must be clear, must be supported by acceptable scientific evidence and should include the specified ingredients in amounts equal to at least the established recommended nutrient intake.

This type of functional food claim specifies the type or quantity of a particular nutrient within the product and advertises the nutrient’s well-established role in the maintenance or support of specific bodily functions. Recently in Canada Health Canada publications that assist in classifying functional foods and guiding health claims on probiotic foods.
Canadian functional food manufacturers might soon experience warnings similar to those seen in the United States if labelling guidelines are violated.
for example, “Contains 100 percent of an individual’s daily vitamin C intake” or “Calcium aids in the formation and maintenance of bones and teeth.” U.S. Regulation of Functional Food Claims the U.S. Food and Drug Administration (FDA) has initiated enforcement practices against companies that use functional food claims to overstate the benefits of their food products
These FDA warning letters represent a recent wave of enforcement against deceptive functional food claims in the United States.
Although not legally binding, these letters are significant because the FDA can commence legal action against companies that ignore the warnings Example of Food Claim In USA Dannon, the makers of Activia and DanActive yogurt, to pay consumers $45 million in damages under the terms of a class action settlement.
The action was based on false claims that the product was “clinically” and “scientifically” proven to regulate digestion and boost immune systems.
The court-approved agreement called for Dannon to replace the word “immunity” in its health claims with the phrase.
“helps strengthen your body’s defenses” or “helps support the immune system. Role of health claims Commissioned literature reviews that followed the process outlined in the Health Canada guidance document on health claim submissions to assess the weight of scientific evidence available for seven food-health relationships .
Examining marketplace and consumer trends, Canadian sector capacity, and the level of supporting scientific evidence, to help focus the sector's investment of time and resources, including additional research needed to validate health benefits as required for a health claim submission to Health Canada.
To illustrate how to present the findings of a systematic scientific literature review according to Health Canada's specifications.
To help the agri-food sector understand and navigate Canada's science-based regulatory system for foods with health benefits. Contd.... “Whole grains" have included intakes of dark bread, popcorn, oatmeal, wheat germ, brown rice, bran, bulghur wheat, kasha (buckwheat), couscous (semolina), and those breakfast cereals with >25% whole grain or bran content.
Based on the Nova Scotia and Québec provincial surveys, the whole grain and dietary fibre intakes of these Canadian adults are estimated at 2 servings/d and 13 to 15 g /d, respectively. 
Brans are not included in the health claim because the health benefits of brans may be affected by food processing, e. g ., depending on the type of bran, milling, grinding, extruding or cooking may change its nature and its effects on health. Health Canada Scientific Summary on the U. S. Health Claim on Fibre-Containing Grain Products, Fruits and Vegetables and Cancer U. S. health claim pertaining to a diet rich in fibre-containing grain products, fruits, and vegetables was accepted in 1993, a considerable amount of research has been published examining the relationship between cancer and consumption of dietary fibre and cereal foods.
A Medline search was conducted for the period 1993-2000 that included the terms "dietary fiber AND (grains OR cereals OR legumes) AND neoplasms NOT (fruit OR citrus OR vegetables)".
A further Medline search was conducted for the period January 1996 to April 2000 using the following key words: cereals, whole grains, neoplasms, and human. The search was expanded to Medline, CAB, Food Science and Technology Abstracts and EMBase for the terms "whole grain OR wheat OR oat OR rye OR barley OR rice OR corn OR cereals" and "cancer OR tumour OR neoplasm OR neoplasms". Health Canada's Scientific Summary on the U. S. Health Claim for Fruit, Vegetables, and Grain Products Containing Fibre, Particularly Soluble Fibre, and Heart Diseases Role of health claims Commissioned literature reviews that followed the process outlined in the Health Canada guidance document on health claim submissions to assess the weight of scientific evidence available for seven food-health relationships .
Examining marketplace and consumer trends, Canadian sector capacity, and the level of supporting scientific evidence, to help focus the sector's investment of time and resources, including additional research needed to validate health benefits as required for a health claim submission to Health Canada.
To illustrate how to present the findings of a systematic scientific literature review according to Health Canada's specifications.
To help the agri-food sector understand and navigate Canada's science-based regulatory system for foods with health benefits. A search was conducted for papers published between 1991 and 2000 using Medline, EMBase and Food Science and Technology Abstracts
For Medline the following key words were used: dietary fibre, dietary fiber, cereals, fruit, vegetables, nuts and intersected with the terms cardiovascular disease and hyperlipidemia. 
 For EMBase and Food Science and Technology Abstracts, key words used included cardiovascular diseases, hyperlipidemia, hyperlipaemia, hypertension, hypercholesterol, hyperlipid, cardio, arteri, athero, heart, vascular, vein, venous, artery, cerebrovascular, stroke, cardiac, coronary, and were intersected with fruit, fruits, vegetable, vegetables, nuts, seed, seeds, cereal, cereals, legume, dietary fiber and dietary fibre. Continued Continued “Whole grains" have included intakes of dark bread, popcorn, oatmeal, wheat germ, brown rice, bran, bulghur wheat, kasha (buckwheat), couscous (semolina), and those breakfast cereals with >25% whole grain or bran content.
Based on the Nova Scotia and Québec provincial surveys, the whole grain and dietary fibre intakes of these Canadian adults are estimated at 2 servings/d and 13 to 15 g /d, respectively. 
Brans are not included in the health claim because the health benefits of brans may be affected by food processing, e. g ., depending on the type of bran, milling, grinding, extruding or cooking may change its nature and its effects on health. Health Canada Scientific Summary on the U. S. Health Claim on Fibre-Containing Grain Products, Fruits and Vegetables and Cancer U. S. health claim pertaining to a diet rich in fibre-containing grain products, fruits, and vegetables was accepted in 1993, a considerable amount of research has been published examining the relationship between cancer and consumption of dietary fibre and cereal foods.
A Medline search was conducted for the period 1993-2000 that included the terms "dietary fiber AND (grains OR cereals OR legumes) AND neoplasms NOT (fruit OR citrus OR vegetables)".
A further Medline search was conducted for the period January 1996 to April 2000 using the following key words: cereals, whole grains, neoplasms, and human. The search was expanded to Medline, CAB, Food Science and Technology Abstracts and EMBase for the terms "whole grain OR wheat OR oat OR rye OR barley OR rice OR corn OR cereals" and "cancer OR tumour OR neoplasm OR neoplasms". The fundamental question addressed by this report is whether increasing consumption of diets high in fibre and of cereal foods can have a significant effect on lowering the risk of cancer. Health Claim stating that diets high in fruit and vegetable may lower the risk of some cancers.
Evidence presented-not support.
Three different expert panel-different conclusions .
For colorectal cancer, four randomized intervention trials -failed to demonstrate .
In addition, most prospective cohort studies found no effect of grain consumption on cancer risk and data also fail to support.
Methodological. Different methods -measure the dietary fibre content of foods in nutritional databases. In addition, cereal intake and cancer -influenced by methods of processing of the cereals, a factor which has not been assessed consistently or extensively in the literature.
Plausible biologic mechanisms and by four case-control studies that examined the link between refined grain intake and risk of colon cancer, all of which found a statistically significant higher risk of colon cancer with increasing refined grain intake.
The lack of consensus from expert panels and the literature, indicate that premature ,to support a Health Claim that indicates a link exists between cancer risk and consumption of dietary fibre or cereal foods. fruits, vegetables, whole grain products are independent of dietary fat content Do not require a low fat diet for the claimed benefit
The claim should only be permitted for foods that meet the "low in saturated fatty acids" content claim (containing equal to or less than 2 g saturated and trans fatty acids combined) and contain less than 480 mg sodium per reference amount to avoid a health claim for foods that may contribute to diets associated with potentially adverse health effects due to fat composition or sodium content The proposed claim wording is:
"A healthy diet rich in a variety of vegetables, fruits and whole grain products may reduce the risk of heart disease." As STATED IN ANNEX 1 HEALTH CANADA Health Canada Scientific Summary on the U. S. Health Claim Regarding Dietary Fat and Cancer Annex 4 The U. S. health claim pertaining to dietary fat and cancer was accepted in the U. S. in 1993.
 To update included Medline from 1993 to December 2003 inclusive, Food Science and Technology Abstracts for the period 1997 to 2002 and Current Contents from 1998 to 2002.
In addition six expert committee reports (Food and Agriculture Organisation of the United Nations / the World Health Organisation (FAO/WHO), 1994; The World Cancer Research Fund / the American Institute for Cancer Research (WCR/AICR), 1997; The Committee on Medical Aspects of Food and Nutrition Policy (COMA), UK, 1998 (Gurr, 1998); WHO, 1999 (Scheppach et al.,1999); the Institute of Medicine(IOM), 2002 and FAO/WHO, 2003) have been published during this period as well as several systematic reviews. Annex 4 FAO/WHO report Diet, Nutrition and the Prevention of Chronic Diseases (2003) concluded that the evidence does not support a relationship between dietary fat intake and the increased risk of breast, prostate, colorectal and other cancers.
The IOM (2002) recommended an acceptable macronutrient distribution range (AMDR) for fat to be 20 to 35 percent of energy for adults. Repercussions of Annex 4 Overall the scientific evidence of an association between dietary fat intake and incidence of breast, prostate and colon cancer has weakened over the past ten years.
The evidence indicating no relationship between total fat intake and different types of cancers greatly outweighs the evidence for the claim and thus it is recommended that Canada does not accept a health claim for an association between dietary fat and cancer. THANKS
AND
HAPPY NEW YEAR Conditions for the Claims: It is proposed that inclusion/exclusion criteria for vegetables and fruit be the same as those for the claim linking vegetable and fruit consumption with reduced risk of some cancers
The food is one of the following vegetables, fruit, or juice, and may contain only sweetening agents, food additives as permitted by these Regulations, salt, herbs, spices, seasonings or water:
a fresh, frozen, canned or dried vegetable,
a fresh, frozen, canned or dried fruit,
a vegetable or fruit juice, or
a combination of the foods set out in subparagraphs (I) to (iii);
is not one of the following:
potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices,
vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,
jams or jam-type spreads, marmalades, preserves and jellies,
olives, or
powdered vegetables or fruit  Background Information In November 1998, Health Canada announced certain policies regarding the health claims for foods in the policy paper on Nutra-chemicals/ Functional foods, and certain health claims on foods.

There are two key steps that were undertaken to implement this policy
an evaluation of the diet-disease relationships that formed the basis for the ten health claims that were authorized at that time in the U.S. under the Nutrition Labeling and Education Act of 1990.

This process involved contracting with Canadian experts to prepare reports updating the science related to the ten health claims; Background Information ctd…. The first was the development of the standards of the evidence foods with health claims,

Resulted in publication of the Interim Guidance Document on preparing a submission for foods for health claims incorporating the standard of evidence.

The second step in implementing this policy Background Information ctd…. Health Canada in 1999 began,
the other five remaining claims, but the outcome was different.
In one case the expert reviewers agreed that the updated science did not continue to support the claim that is fat and cancer.

for the other three they have disagreed about certain aspects of the claim that includes the strength of the evidence behind the claim fiber-containing grain products and cancer Background Information ctd…. Background Information ctd…. The reports were peer-reviewed.
The review process has supported five of the ten claims with modifications, which includes
Sodium
potassium and hypertension
calcium,
vitamin D and osteoporosis
saturated and trans fat and heart disease;
vegetables and fruit and cancer;
carbohydrates that do not promote dental caries. Background Information ctd….. The reports were peer-reviewed.
The review process has supported five of the ten claims with modifications, which includes
Sodium
potassium and hypertension
calcium,
vitamin D and osteoporosis
saturated and trans fat and heart disease;
vegetables and fruit and cancer;
carbohydrates that do not promote dental caries. Background Information ctd…. the other five remaining claims, but the outcome was different.
In one case the expert reviewers agreed that the updated science did not continue to support the claim that is fat and cancer.

for the other three they have disagreed about certain aspects of the claim that includes the strength of the evidence behind the claim fiber-containing grain products and cancer Background Information ctd….
oats and psyllium,

Folate and neural tube defects, the reviewers did not address the issue of supplement recommendations versus food sources in the Canadian context.
Health Canada scientists undertook systematic reviews in four cases to resolve the outstanding issues.

But, in the case of the claim pertaining to soluble fiber from oats and psyllium, there were no review considered because this was considered as a "product-specific" claim. Background Information ctd…. Based on the consistent evidence of a
causal relationship between folic acid and NTD
dose-response relationships for both folate and folic acid on folate status

the association of NTDs with vitamin B12 status, relatively high prevalence of genetic predisposition to NTDs,
Health Canada's Scientific Summary on Health Claim for Folate and Neural Tube Defects (Annex 2) These findings led to a reconsideration of a claim linking dietary folate to reduced risk of NTDs.

Following subsequent consumer focus testing the claim was changed as follows:

"Women consuming healthy diets with adequate folate and taking a daily multivitamin supplement containing 0.4 mg folic acid starting at least three months before becoming pregnant may reduce their risk of having a baby with a birth defect of the brain or spinal cord. (Naming the food) is an excellent source of folate."
Health Canada's Scientific Summary on Health Claim for Folate and Neural Tube Defects (Annex 2) Submitted to
Annie Wilkie
HEALTH CLAIMS
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