Sandra Reis, Director of Regulatory Affairs03.21.11
During the past decade, a strong “green wave” has evolved out of steadily increasing consumer interest and demand for functional foods and natural health products. As a result, food companies have invested substantial resources in research and development of innovative food products aimed at filling this demand. As research in this area grows, new health claims are often being sought for inclusion on food product labeling.
To ensure consumers are appropriately informed about the use of these food products, and to protect public safety, regulators have recognized the need to revise existing regulations. In some jurisdictions, new legislation has been introduced to address these emerging trends in the food market. As regulations evolve, food companies should conduct regular reviews of their products’ labeling in the context of current legislation. The need for clinical trials to support regulatory clearance or substantiate desired claims for new and existing products should be assessed as the regulatory landscape changes.
The type of regulatory clearance required for a food product is dependent on a combination of the composition and characteristics of the product as well as on the product’s desired labeling claims. Sponsors who intend to market their food product with health claims often find identifying the appropriate regulatory pathway complex.
The regulations can be confusing, in particular when more than one set of regulations apply to a particular food product and claim. The challenge is accentuated for global food suppliers by the fact that regulations can vary substantially between jurisdictions.
One of the first steps in defining the appropriate regulatory pathway, and thereby determining the level of scientific evidence needed to support regulatory clearance of a food product bearing health claims, is to understand how the desired labeling claim will be classified. The following provides an introduction to the current regulatory landscape for food products bearing health claims in three major jurisdictions: Canada, Europe and U.S.
Food Product Health Claims in Canada
A health claim for food products is defined by Health Canada as “any representation in labeling or advertising that states, suggests or implies that a relationship exists between consumption of a food or an ingredient in the food and a person's health.” Health claims are classified into three categories: disease risk reduction and therapeutic claims, function claims and general health claims.
The regulatory pathway and level of scientific evidence need to support the regulatory clearance of food with health claims varies depending upon the type of health claim being made. Some claims may be made without approval provided they are truthful and not misleading. In other cases a pre-market assessment of the health claim, supported by scientific evidence, is mandatory. Health Canada has published a guidance entitled “Preparing a Submission for Food Health Claims” to outline the standards of evidence used as the basis for reviewing health claims.
Disease Risk Reduction and Therapeutic Claims
A disease risk reduction claim is a statement that links a food or a food constituent to the reduction of risk of developing a diet-related disease or condition in the context of the total diet. Therapeutic claims are claims about the treatment or mitigation of a disease or condition. These drug-like claims can include wording that discuss the treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms, and can also include labeling which describes an effect on the body that is beyond that which is normally associated with a food such as restoring, correcting or modifying organic functions in the body.
Disease risk reduction claims and therapeutic claims are allowed on food products only where specifically permitted by the Canadian Food and Drug Regulations (FDR). Currently, while no therapeutic claims have been approved for food in Canada, several disease risk reduction claims are permitted on food. These are:
· a healthy diet low in sodium and high in potassium and reduced risk of high blood pressure;
· a healthy diet with adequate calcium and vitamin D and reduced risk of osteoporosis;
· a healthy diet low in saturated and trans fat and reduced risk of heart disease;
· a healthy diet rich in vegetables and fruit and reduced risk of some types of cancers; and
· non-fermentable carbohydrates in gums and hard candies and the non-promotion of dental caries (cavities).
Making these disease risk reduction claims on food product labeling has been made possible through specific regulatory exemptions in the FDR. To enable new drug-like claims that are currently not listed in the FDR, an amendment to the FDR is required. Once a claim of this type is permitted by the Regulations, any food that meets the stated criteria may carry the claim.
Function Claims & General Health Claims
Function claims are used to describe “the specific beneficial physiological effects of foods and food constituents when consumed at levels consistent with normal dietary patterns, on normal functions of the body with on health or physical/mental performance.” A function claim cannot refer directly or indirectly to drug-like claims.
General health claims are broad claims that promote health through healthy eating or claims that provide dietary guidance. These claims do not refer to a specific or general health effect, disease, or health condition.
The use of most function and general health claims can be made without applying for a regulatory amendment to the FDR. Health Canada maintains a list of permitted function claims that have been deemed to be truthful and not misleading. While there are some guidelines that discuss general health claims, to date no specific criteria have been formalized for general health claims.
Natural Health Products
Natural Health Products (NHP) are defined as a subset of drugs in Canada and are regulated under the Natural Health Products Regulations (NHPR). Due to the broad definition for a NHP there is an overlap between regulatory frameworks and it is often not clear when a product should be regulated as a food or an NHP based on the claims and the types of ingredients present in a product.
Examples of products found in the overlap may include beverages and nutrition bars that carry health claims and certain substances such as vitamins, minerals and herbs. Health Canada has published a guidance documented, entitled “Classification of Products at the Food-Natural Health Product Interface,” which outlines the criteria used in determining the appropriate classification of a product that has characteristics of both a food and an NHP.
Food Product Health Claims in the European Union
In December 2006, the European Parliament adopted Regulation No. 1924/2006, which outlines the requirements for the use of health or nutritional claims on foods. In addition to nutritional claims, the Regulation defines two types of health claims for foods: a function claim and a reduction of disease risk claim.
The European Food Safety Authority (EFSA) is responsible for verifying the scientific evidence available to support food claims, some of which are currently in use, and some of which have been proposed and are currently under review.
Article 13 Function Claims
A health claim is defined in the European Union (EU) as “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.” One type of health claim is referred to as “Article 13” or “function” claims. Specifically, these claims are defined as (a) the role of a nutrient or other substance in growth, development and the functions of the body; or (b) psychological and behavioural functions; or (c) slimming or weight control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet.
Article 13 claims are further subdivided into Article 13(1) or “general function” claims and Article 13(5) or “new function” claims, with each type of claim having its own procedure for evaluation and authorization.
The European Commission (EC) in conjunction with EFSA is compiling a list of permitted function health claims (referred to as the Article 13 List), consisting of “well established health claims relating to the growth, development and functions of the body.” This “Community List” is initially to be based on national lists provided by European Member States. A list of permitted claims is currently available, however is not yet complete. The EFSA is still sifting through the 44,000 plus submitted claims and have a target date of end of 2011 to complete evaluation of the general function health claims.
Claims based on newly developed scientific evidence and/or which include a request for theprotection of proprietary data are referred to as Article 13(5) claims and are subject to the scientificevaluation by EFSAprior to their addition to the list of permitted health claims. These claims are evaluated on a case-by-case basis. The opinions that are published by EFSA after its review of the scientific evidence to support each claims will then serve as a basis for the EC and Member states to determine whether to authorize a specific claim.
Article 14 Reduction of Disease Risk Claims
A reduction of disease risk claim, also are referred to as an “Article 14” claim, means any health claim that “states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.” In addition, Article 14 covers claims referring to children’s development and health. As with Article 13(5) claims, applications for authorization of Article 14 claims are subject to scientific evaluation by EFSA. Article 14 applications submitted to EFSA are included in the “Register of Questions” outlining the indication of the food substance and claimed effect.
As with other jurisdictions, it is not always clear as to which regulation a food product is subject; some function and reduction of disease risk claims can be difficult to classify. To address this, a document entitled “The Implementation of Regulation No. 1924/2006 on Nutrition and Health Claims Made on Foods—Conclusions of the Standing Committee on the Food Chain and Animal Health” has been made available to provide guidance in the determination of the appropriate product classification.
Food Product Health Claims in the U.S.
In the U.S., claims permitted on food and dietary supplement labels fall into three categories: health claims, nutrient content claims and structure/function claims. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. As defined by FDA, a health claim has two essential components: a substance (whether a food, food component, or dietary ingredient) and a disease or health-related condition.
There are three types of health claims that are permitted for foods: a) the 1990 Nutrition Labeling and Education Act (NLEA) Authorized Health Claims; b) The Food and Drug Administration Modernization Act of 1997 (FDAMA) Health Claims based on Authoritative Statements and c) Qualified Health Claims. All health claims require that a petition be submitted to FDA.
NLEA Authorized Health Claims
Authorized Health Claims are those claims that characterize a relationship between a food, food component, dietary ingredient, or dietary supplement and risk of a disease. These health claims are authorized by FDA based on a review of the scientific literature; this review is usually triggered by the submission of a health claim petition. FDA uses the significant scientific agreement (SSA) standard to evaluate if the nutrient/disease relationship is well established. Under the provisions of NLEA, FDA has approved 12 specific health claims.
FDAMA Health Claims Based on Authoritative Statements
Prior FDAMA, the only method authorizing health claims on food labeling was to publish a new regulation allowing such a claim (i.e., NLEA claims). Given the length of time it takes to adopt a new regulation, FDAMA offered the ability to make health claims "about the relationship between a nutrient and a disease or health-related condition" based on current, published authoritative statements from "a scientific body of the United States with official responsibility for public health protection or research directly related to human nutrition . . . or the National Academy of Sciences (NAS) or any of its subdivisions," such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). While the adoption of a new regulation is not needed for a FDAMA health claim petition, the SSA standard is still used as a basis for evaluating the scientific evidence presented.
Qualified Health Claims
Where sufficiently robust scientific evidence does not exist to meet the SSA standard required for FDA to issue an authorizing regulation, FDA's 2003 Consumer Health Information for Better Nutrition Initiative provides for the use of an interim solution through qualified health claims when “there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition,” as long as the claims do not mislead consumers.
Qualifying language is included as part of the claim to indicate that the evidence supporting the claim is limited. While conventional foods are permitted to make qualified health claims, as of yet, dietary supplements are not.
Conclusion
Food regulations are complex, can vary substantially between jurisdictions, and are ever evolving. To ensure appropriate commercialization of existing food products and to minimize delays in reaching commercialization for new food products, it is critical that sponsors take the time to ensure their product is on the appropriate regulatory pathway. Understanding the various overlapping layers of food regulations is vital in determining the appropriate product classification. This in turn dictates the level of scientific substantiation needed to support a particular health claim for a food product and ultimately the type of regulatory clearance required to bring a food product to market.
About the author: Sandra Reis, B.Sc., RAQC, is Director of Regulatory Affairs for Clinical Development Solutions.
References
1. Canadian Food Inspection Agency. Guide to Food Labeling and Advertising.
2. Natural Health Products Directorate and Food Directorate. Classification of Products at the Food-Natural Health Product Interface: Products in Food Format. June 2010.
3. Bureau Nutritional Sciences, Food Directorate, Health Products and Food Branch. Guidance Document for Preparing a Submission for Food Health Claims. March 2009.
4. European Commission. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(OJ L 404, 30.12.2006)
5. European Commission. Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council.
6. European Commission. Commission Regulation (EC) No 1169/2009 of 30 November 2009 amending Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council.
7. European Commission. Guidance on the implementation of Regulation No 1924/2006 on nutrition and health claims made on foods - conclusions of the standing committee on the food chain and animal health.Dec 2007.
8. European Food Safety Authority. “General function” health claims under Article 13.
9. European Food Safety Authority. “New function” health claims under Article 13.5.
10. European Food Safety Authority. Claims on disease risk reduction and child development or health under Article 14.
11. US Food and Drug Administration. Claims that can be made for conventional foods and dietary supplements. Sept 2003.
12. US Food and Drug Administration. Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. June 1998.
To ensure consumers are appropriately informed about the use of these food products, and to protect public safety, regulators have recognized the need to revise existing regulations. In some jurisdictions, new legislation has been introduced to address these emerging trends in the food market. As regulations evolve, food companies should conduct regular reviews of their products’ labeling in the context of current legislation. The need for clinical trials to support regulatory clearance or substantiate desired claims for new and existing products should be assessed as the regulatory landscape changes.
The type of regulatory clearance required for a food product is dependent on a combination of the composition and characteristics of the product as well as on the product’s desired labeling claims. Sponsors who intend to market their food product with health claims often find identifying the appropriate regulatory pathway complex.
The regulations can be confusing, in particular when more than one set of regulations apply to a particular food product and claim. The challenge is accentuated for global food suppliers by the fact that regulations can vary substantially between jurisdictions.
One of the first steps in defining the appropriate regulatory pathway, and thereby determining the level of scientific evidence needed to support regulatory clearance of a food product bearing health claims, is to understand how the desired labeling claim will be classified. The following provides an introduction to the current regulatory landscape for food products bearing health claims in three major jurisdictions: Canada, Europe and U.S.
Food Product Health Claims in Canada
A health claim for food products is defined by Health Canada as “any representation in labeling or advertising that states, suggests or implies that a relationship exists between consumption of a food or an ingredient in the food and a person's health.” Health claims are classified into three categories: disease risk reduction and therapeutic claims, function claims and general health claims.
The regulatory pathway and level of scientific evidence need to support the regulatory clearance of food with health claims varies depending upon the type of health claim being made. Some claims may be made without approval provided they are truthful and not misleading. In other cases a pre-market assessment of the health claim, supported by scientific evidence, is mandatory. Health Canada has published a guidance entitled “Preparing a Submission for Food Health Claims” to outline the standards of evidence used as the basis for reviewing health claims.
Disease Risk Reduction and Therapeutic Claims
A disease risk reduction claim is a statement that links a food or a food constituent to the reduction of risk of developing a diet-related disease or condition in the context of the total diet. Therapeutic claims are claims about the treatment or mitigation of a disease or condition. These drug-like claims can include wording that discuss the treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms, and can also include labeling which describes an effect on the body that is beyond that which is normally associated with a food such as restoring, correcting or modifying organic functions in the body.
Disease risk reduction claims and therapeutic claims are allowed on food products only where specifically permitted by the Canadian Food and Drug Regulations (FDR). Currently, while no therapeutic claims have been approved for food in Canada, several disease risk reduction claims are permitted on food. These are:
· a healthy diet low in sodium and high in potassium and reduced risk of high blood pressure;
· a healthy diet with adequate calcium and vitamin D and reduced risk of osteoporosis;
· a healthy diet low in saturated and trans fat and reduced risk of heart disease;
· a healthy diet rich in vegetables and fruit and reduced risk of some types of cancers; and
· non-fermentable carbohydrates in gums and hard candies and the non-promotion of dental caries (cavities).
Making these disease risk reduction claims on food product labeling has been made possible through specific regulatory exemptions in the FDR. To enable new drug-like claims that are currently not listed in the FDR, an amendment to the FDR is required. Once a claim of this type is permitted by the Regulations, any food that meets the stated criteria may carry the claim.
Function Claims & General Health Claims
Function claims are used to describe “the specific beneficial physiological effects of foods and food constituents when consumed at levels consistent with normal dietary patterns, on normal functions of the body with on health or physical/mental performance.” A function claim cannot refer directly or indirectly to drug-like claims.
General health claims are broad claims that promote health through healthy eating or claims that provide dietary guidance. These claims do not refer to a specific or general health effect, disease, or health condition.
The use of most function and general health claims can be made without applying for a regulatory amendment to the FDR. Health Canada maintains a list of permitted function claims that have been deemed to be truthful and not misleading. While there are some guidelines that discuss general health claims, to date no specific criteria have been formalized for general health claims.
Natural Health Products
Natural Health Products (NHP) are defined as a subset of drugs in Canada and are regulated under the Natural Health Products Regulations (NHPR). Due to the broad definition for a NHP there is an overlap between regulatory frameworks and it is often not clear when a product should be regulated as a food or an NHP based on the claims and the types of ingredients present in a product.
Examples of products found in the overlap may include beverages and nutrition bars that carry health claims and certain substances such as vitamins, minerals and herbs. Health Canada has published a guidance documented, entitled “Classification of Products at the Food-Natural Health Product Interface,” which outlines the criteria used in determining the appropriate classification of a product that has characteristics of both a food and an NHP.
Food Product Health Claims in the European Union
In December 2006, the European Parliament adopted Regulation No. 1924/2006, which outlines the requirements for the use of health or nutritional claims on foods. In addition to nutritional claims, the Regulation defines two types of health claims for foods: a function claim and a reduction of disease risk claim.
The European Food Safety Authority (EFSA) is responsible for verifying the scientific evidence available to support food claims, some of which are currently in use, and some of which have been proposed and are currently under review.
Article 13 Function Claims
A health claim is defined in the European Union (EU) as “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.” One type of health claim is referred to as “Article 13” or “function” claims. Specifically, these claims are defined as (a) the role of a nutrient or other substance in growth, development and the functions of the body; or (b) psychological and behavioural functions; or (c) slimming or weight control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet.
Article 13 claims are further subdivided into Article 13(1) or “general function” claims and Article 13(5) or “new function” claims, with each type of claim having its own procedure for evaluation and authorization.
The European Commission (EC) in conjunction with EFSA is compiling a list of permitted function health claims (referred to as the Article 13 List), consisting of “well established health claims relating to the growth, development and functions of the body.” This “Community List” is initially to be based on national lists provided by European Member States. A list of permitted claims is currently available, however is not yet complete. The EFSA is still sifting through the 44,000 plus submitted claims and have a target date of end of 2011 to complete evaluation of the general function health claims.
Claims based on newly developed scientific evidence and/or which include a request for theprotection of proprietary data are referred to as Article 13(5) claims and are subject to the scientificevaluation by EFSAprior to their addition to the list of permitted health claims. These claims are evaluated on a case-by-case basis. The opinions that are published by EFSA after its review of the scientific evidence to support each claims will then serve as a basis for the EC and Member states to determine whether to authorize a specific claim.
Article 14 Reduction of Disease Risk Claims
A reduction of disease risk claim, also are referred to as an “Article 14” claim, means any health claim that “states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.” In addition, Article 14 covers claims referring to children’s development and health. As with Article 13(5) claims, applications for authorization of Article 14 claims are subject to scientific evaluation by EFSA. Article 14 applications submitted to EFSA are included in the “Register of Questions” outlining the indication of the food substance and claimed effect.
As with other jurisdictions, it is not always clear as to which regulation a food product is subject; some function and reduction of disease risk claims can be difficult to classify. To address this, a document entitled “The Implementation of Regulation No. 1924/2006 on Nutrition and Health Claims Made on Foods—Conclusions of the Standing Committee on the Food Chain and Animal Health” has been made available to provide guidance in the determination of the appropriate product classification.
Food Product Health Claims in the U.S.
In the U.S., claims permitted on food and dietary supplement labels fall into three categories: health claims, nutrient content claims and structure/function claims. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. As defined by FDA, a health claim has two essential components: a substance (whether a food, food component, or dietary ingredient) and a disease or health-related condition.
There are three types of health claims that are permitted for foods: a) the 1990 Nutrition Labeling and Education Act (NLEA) Authorized Health Claims; b) The Food and Drug Administration Modernization Act of 1997 (FDAMA) Health Claims based on Authoritative Statements and c) Qualified Health Claims. All health claims require that a petition be submitted to FDA.
NLEA Authorized Health Claims
Authorized Health Claims are those claims that characterize a relationship between a food, food component, dietary ingredient, or dietary supplement and risk of a disease. These health claims are authorized by FDA based on a review of the scientific literature; this review is usually triggered by the submission of a health claim petition. FDA uses the significant scientific agreement (SSA) standard to evaluate if the nutrient/disease relationship is well established. Under the provisions of NLEA, FDA has approved 12 specific health claims.
FDAMA Health Claims Based on Authoritative Statements
Prior FDAMA, the only method authorizing health claims on food labeling was to publish a new regulation allowing such a claim (i.e., NLEA claims). Given the length of time it takes to adopt a new regulation, FDAMA offered the ability to make health claims "about the relationship between a nutrient and a disease or health-related condition" based on current, published authoritative statements from "a scientific body of the United States with official responsibility for public health protection or research directly related to human nutrition . . . or the National Academy of Sciences (NAS) or any of its subdivisions," such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). While the adoption of a new regulation is not needed for a FDAMA health claim petition, the SSA standard is still used as a basis for evaluating the scientific evidence presented.
Qualified Health Claims
Where sufficiently robust scientific evidence does not exist to meet the SSA standard required for FDA to issue an authorizing regulation, FDA's 2003 Consumer Health Information for Better Nutrition Initiative provides for the use of an interim solution through qualified health claims when “there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition,” as long as the claims do not mislead consumers.
Qualifying language is included as part of the claim to indicate that the evidence supporting the claim is limited. While conventional foods are permitted to make qualified health claims, as of yet, dietary supplements are not.
Conclusion
Food regulations are complex, can vary substantially between jurisdictions, and are ever evolving. To ensure appropriate commercialization of existing food products and to minimize delays in reaching commercialization for new food products, it is critical that sponsors take the time to ensure their product is on the appropriate regulatory pathway. Understanding the various overlapping layers of food regulations is vital in determining the appropriate product classification. This in turn dictates the level of scientific substantiation needed to support a particular health claim for a food product and ultimately the type of regulatory clearance required to bring a food product to market.
About the author: Sandra Reis, B.Sc., RAQC, is Director of Regulatory Affairs for Clinical Development Solutions.
References
1. Canadian Food Inspection Agency. Guide to Food Labeling and Advertising.
2. Natural Health Products Directorate and Food Directorate. Classification of Products at the Food-Natural Health Product Interface: Products in Food Format. June 2010.
3. Bureau Nutritional Sciences, Food Directorate, Health Products and Food Branch. Guidance Document for Preparing a Submission for Food Health Claims. March 2009.
4. European Commission. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(OJ L 404, 30.12.2006)
5. European Commission. Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council.
6. European Commission. Commission Regulation (EC) No 1169/2009 of 30 November 2009 amending Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council.
7. European Commission. Guidance on the implementation of Regulation No 1924/2006 on nutrition and health claims made on foods - conclusions of the standing committee on the food chain and animal health.Dec 2007.
8. European Food Safety Authority. “General function” health claims under Article 13.
9. European Food Safety Authority. “New function” health claims under Article 13.5.
10. European Food Safety Authority. Claims on disease risk reduction and child development or health under Article 14.
11. US Food and Drug Administration. Claims that can be made for conventional foods and dietary supplements. Sept 2003.
12. US Food and Drug Administration. Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. June 1998.
