Harry Rice, PhD10.01.07
Claims have proven controversial and difficult to regulate. Regulators must balance the potential to achieve public health objectives with the risk of deceiving or misleading consumers. Even with the best intentions, the context and words of a claim may confuse consumers. This article is meant to serve as a primer on claims and to provide resources to determine if adequate substantiation exists for a claim. The claim you want to make will determine the level of research you need to carry out on your product and vice versa.
In the U.S., there are three categories of claims associated with the labeling of conventional foods and dietary supplements (hereafter, dietary ingredients), including: 1) health claims 2) nutrient content claims and 3) structure/function claims. The following provides a brief description of each category and subcategories, if applicable.
Health Claims characterize the relationship of a substance to a disease or health-related condition. Within this category, there are three subcategories, including: a) NLEA (Nutrition Labeling and Education Act of 1990) authorized health claims, b) health claims based on authoritative statements, and c) qualified health claims.
NLEA Authorized Health Claims are based on the totality of the publicly available scientific evidence using the significant scientific agreement standard (Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, December 22, 1999). An example of this type of health claim is "Diets low in saturated fat and cholesterol that include two servings of foods providing a total of 0.8 grams of phytosterols in two meals may reduce the risk of heart disease." These are the strongest claims that can be made; they also require a significant amount of scientific support.
Health Claims Based on Authoritative Statements are permitted as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA permits making certain health claims as a result of a successful notification to FDA of a health claim based on an authoritative statement from a scientific body of the U.S. Government or the National Academies of Science (Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, June 11, 1998). If FDA does not act to prohibit or modify such a claim within 120 days of receipt of the notification, the claim may be used. An example of this type of claim includes: "Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers." NOTE: FDAMA does not include dietary supplements in the provisions for such health claims.
Qualified Health Claims are similar to NLEA Authorized Health Claims, but there exists less scientific agreement among experts; therefore, this type of claim requires language that qualifies the extent of the available science (Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims Guidance-Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, July 10, 2003 AND Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, July 2007 AND Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers, May 12, 2006).
The genesis of qualified health claims was the court of appeals decision in Pearson v. Shalala (Pearson). In that case, the plaintiffs challenged FDA's decision not to authorize health claims for four specific substance-disease relationships in the labeling of dietary supplements. Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998), the U.S. Court of Appeals for the D.C. Circuit reversed the lower court's decision (164 F.3d 650 (D.C. Cir.1999)). The appeals court held that the First Amendment does not permit FDA to reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that a disclaimer would not eliminate the potential deception.
Nutrient Content Claims (Claims that Can Be Made for Conventional Foods and Dietary Supplements, September 2003) describe the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced and lite. An accurate quantitative statement (e.g. 200 mg of long chain omega 3 fatty acids) that does not "characterize" the nutrient level may be used to describe any amount of a nutrient present.
Structure/Function Claims (Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide, January 9, 2002) describe the role of a nutrient or dietary ingredient intended to affect normal structure/function in humans; characterize how a nutrient or dietary ingredient acts to maintain structure/function; describe the general well-being resulting from consumption of a nutrient or dietary ingredient; and describe a benefit (along with prevalence) related to a nutrient deficiency disease.
Structure/function claims SHOULD NOT imply disease treatment or prevention. The claim would be considered a disease claim if it explicitly or implicitly claimed an effect (using scientific or lay terminology) on one or more signs or symptoms that are recognizable to healthcare professionals or consumers as being characteristic of a specific disease or of a number of diseases.
Structure/function claims are not pre-approved by the FDA. Rather, the manufacturer is responsible for ensuring the accuracy and truthfulness of these claims. If a dietary supplement label, but not a conventional food label, includes such a claim, it must state in a disclaimer that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease." Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement.
Because structure/function claims are not pre-approved and lack a rigorous notification process, it is this type of claim that most commonly lacks proper substantiation.
Claims used in the labeling or marketing of dietary ingredients are widespread, but are they scientifically substantiated? While consumer safety should be a company's number one priority, there still exists a moral and ethical responsibility to market effective products. Determining whether or not there is sufficient scientific evidence to substantiate a claim is a difficult exercise, requiring knowledge of the regulations, not to mention an in-depth understanding of the science associated with the proposed "effect" of the dietary ingredient on the specific structure and/or function in the human body.
Substantiation Standard. Unfortunately, the Federal Food Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the legislative history accompanying DSHEA do not define substantiation. Despite the absence of a definition for substantiation, all claims must be "truthful and not misleading," not to mention substantiated by "competent and reliable scientific evidence." While not considered exhaustive, the following list of resources will prove invaluable in the quest to ensure a claim is supported by adequate substantiation.
In July of this year, the FDA published a draft guidance document detailing its evidence-based review system for the scientific evaluation of health claims (Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, July 2007). While this document contains information similar to that found in FDA's 2003 document (Guidance for Industry: Interim Evidence-base Ranking System for Scientific Data, July 10, 2003), the differences are irrelevant. While neither document is specific to substantiating structure/function claims, the process described in either document provides a foundation upon which to evaluate such claims.
In addition, FDA's Guidance For Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(6) of the Federal Food, Drug, and Cosmetic Act (November 2004) describes the amount, type and quality of evidence FDA recommends manufacturers have to substantiate a claim.
The Agency for Healthcare Re-search and Quality also published a report titled, Systems to Rate the Strength of Scientific Evidence (West et al., 2002). This report examines systematic approaches to assessing the strength of scientific evidence, allowing evaluation of either individual articles or entire bodies of research on a particular subject. While the intent was to provide a tool to use in making evidence-based healthcare decisions, the information provided in this report provides concepts that can be generalized to the evaluation of science for the purpose of determining adequate substantiation for claims.
And believe it or not, warning letters are good sources of information. They provide insight into the current thinking of FDA.
The challenge of the claims game is to communicate compelling benefits within scientific and regulatory boundaries. Claims must be substantiated such that they are truthful and not misleading. A lack of enforcement should not be viewed as an opportunity to ignore the applicable regulations. In addition, the FDA never meant for the disclaimer associated with dietary supplement structure/
function claims to be used as qualifying language to replace proper substantiation. So, regardless of enforcement discretion and/or the presence of a disclaimer, there still exists a moral and ethical responsibility to market effective products.
About the author: Harry Rice, PhD, is senior scientist, Regulatory & Scientific Affairs at Cargill, Minneapolis, MN. He specializes in regulatory and trade issues as they pertain to food and dietary supplements. He can be reached at 952-742-4627; E-mail: harry_rice@cargill.com.
Resources
1. Claims that Can Be Made for Conventional Foods and Dietary Supplements. September 2003. www.cfsan.fda.gov/~dms/hclaims.html.
2. Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. July 10, 2003. www.cfsan.fda.gov/~dms/hclmgui3.html.
3. Guidance for Industry: A Dietary Supplement Labeling Guide. April 2005. www.cfsan.fda.gov/~dms/dslg-toc.html.
4. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. July 2007. www.cfsan.fda.gov/~dms/hclmgui5.html.
5. Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers. May 12, 2006. www.cfsan.fda.gov/~dms/qucqagui.html.
6. Guidance for Industry: Interim Evidence-based Ranking System for Scientific Data. July 10, 2003. www.cfsan.fda.gov/~dms/hclmgui4.html.
7. Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. June 11, 1998. www.cfsan.fda.gov/%7Edms/hclmguid.html.
8. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. December 22, 1999. www.cfsan.fda.gov/~dms/ssaguide.html.
9. Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide. January 9, 2002. www.cfsan.fda.gov/~dms/sclmguid.html.
10. Guidance For Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. November 2004. www.cfsan.fda.gov/~dms/dsclmgui.html.
11. Institute of Medicine (2002) Evolution of Evidence for Selected Nutrient Disease Relationships. National Academy Press, Washington, D.C.
12. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF and Lux L. Systems to Rate the Strength of Scientific Evidence. Evidence Report/Technology Assessment No. 47 (Prepared by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center under Contract No. 290-97-0011). AHRQ Publication No. 02-E016. Rockville, MD: Agency for Healthcare Research and Quality. April 2002.www.ncbi.nlm.nih.gov/books/bv.fcgi?indexed=google&rid=hstat1.chapter.70996.
Claims Categories
In the U.S., there are three categories of claims associated with the labeling of conventional foods and dietary supplements (hereafter, dietary ingredients), including: 1) health claims 2) nutrient content claims and 3) structure/function claims. The following provides a brief description of each category and subcategories, if applicable.
Health Claims characterize the relationship of a substance to a disease or health-related condition. Within this category, there are three subcategories, including: a) NLEA (Nutrition Labeling and Education Act of 1990) authorized health claims, b) health claims based on authoritative statements, and c) qualified health claims.
NLEA Authorized Health Claims are based on the totality of the publicly available scientific evidence using the significant scientific agreement standard (Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, December 22, 1999). An example of this type of health claim is "Diets low in saturated fat and cholesterol that include two servings of foods providing a total of 0.8 grams of phytosterols in two meals may reduce the risk of heart disease." These are the strongest claims that can be made; they also require a significant amount of scientific support.
Health Claims Based on Authoritative Statements are permitted as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA permits making certain health claims as a result of a successful notification to FDA of a health claim based on an authoritative statement from a scientific body of the U.S. Government or the National Academies of Science (Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, June 11, 1998). If FDA does not act to prohibit or modify such a claim within 120 days of receipt of the notification, the claim may be used. An example of this type of claim includes: "Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers." NOTE: FDAMA does not include dietary supplements in the provisions for such health claims.
Qualified Health Claims are similar to NLEA Authorized Health Claims, but there exists less scientific agreement among experts; therefore, this type of claim requires language that qualifies the extent of the available science (Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims Guidance-Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, July 10, 2003 AND Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, July 2007 AND Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers, May 12, 2006).
The genesis of qualified health claims was the court of appeals decision in Pearson v. Shalala (Pearson). In that case, the plaintiffs challenged FDA's decision not to authorize health claims for four specific substance-disease relationships in the labeling of dietary supplements. Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998), the U.S. Court of Appeals for the D.C. Circuit reversed the lower court's decision (164 F.3d 650 (D.C. Cir.1999)). The appeals court held that the First Amendment does not permit FDA to reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that a disclaimer would not eliminate the potential deception.
Nutrient Content Claims (Claims that Can Be Made for Conventional Foods and Dietary Supplements, September 2003) describe the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced and lite. An accurate quantitative statement (e.g. 200 mg of long chain omega 3 fatty acids) that does not "characterize" the nutrient level may be used to describe any amount of a nutrient present.
Structure/Function Claims (Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide, January 9, 2002) describe the role of a nutrient or dietary ingredient intended to affect normal structure/function in humans; characterize how a nutrient or dietary ingredient acts to maintain structure/function; describe the general well-being resulting from consumption of a nutrient or dietary ingredient; and describe a benefit (along with prevalence) related to a nutrient deficiency disease.
Structure/function claims SHOULD NOT imply disease treatment or prevention. The claim would be considered a disease claim if it explicitly or implicitly claimed an effect (using scientific or lay terminology) on one or more signs or symptoms that are recognizable to healthcare professionals or consumers as being characteristic of a specific disease or of a number of diseases.
Structure/function claims are not pre-approved by the FDA. Rather, the manufacturer is responsible for ensuring the accuracy and truthfulness of these claims. If a dietary supplement label, but not a conventional food label, includes such a claim, it must state in a disclaimer that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease." Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement.
Because structure/function claims are not pre-approved and lack a rigorous notification process, it is this type of claim that most commonly lacks proper substantiation.
The Level of Substantiation Required
Claims used in the labeling or marketing of dietary ingredients are widespread, but are they scientifically substantiated? While consumer safety should be a company's number one priority, there still exists a moral and ethical responsibility to market effective products. Determining whether or not there is sufficient scientific evidence to substantiate a claim is a difficult exercise, requiring knowledge of the regulations, not to mention an in-depth understanding of the science associated with the proposed "effect" of the dietary ingredient on the specific structure and/or function in the human body.
Substantiation Standard. Unfortunately, the Federal Food Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the legislative history accompanying DSHEA do not define substantiation. Despite the absence of a definition for substantiation, all claims must be "truthful and not misleading," not to mention substantiated by "competent and reliable scientific evidence." While not considered exhaustive, the following list of resources will prove invaluable in the quest to ensure a claim is supported by adequate substantiation.
In July of this year, the FDA published a draft guidance document detailing its evidence-based review system for the scientific evaluation of health claims (Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, July 2007). While this document contains information similar to that found in FDA's 2003 document (Guidance for Industry: Interim Evidence-base Ranking System for Scientific Data, July 10, 2003), the differences are irrelevant. While neither document is specific to substantiating structure/function claims, the process described in either document provides a foundation upon which to evaluate such claims.
In addition, FDA's Guidance For Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(6) of the Federal Food, Drug, and Cosmetic Act (November 2004) describes the amount, type and quality of evidence FDA recommends manufacturers have to substantiate a claim.
The Agency for Healthcare Re-search and Quality also published a report titled, Systems to Rate the Strength of Scientific Evidence (West et al., 2002). This report examines systematic approaches to assessing the strength of scientific evidence, allowing evaluation of either individual articles or entire bodies of research on a particular subject. While the intent was to provide a tool to use in making evidence-based healthcare decisions, the information provided in this report provides concepts that can be generalized to the evaluation of science for the purpose of determining adequate substantiation for claims.
And believe it or not, warning letters are good sources of information. They provide insight into the current thinking of FDA.
Conclusion
The challenge of the claims game is to communicate compelling benefits within scientific and regulatory boundaries. Claims must be substantiated such that they are truthful and not misleading. A lack of enforcement should not be viewed as an opportunity to ignore the applicable regulations. In addition, the FDA never meant for the disclaimer associated with dietary supplement structure/
function claims to be used as qualifying language to replace proper substantiation. So, regardless of enforcement discretion and/or the presence of a disclaimer, there still exists a moral and ethical responsibility to market effective products.
About the author: Harry Rice, PhD, is senior scientist, Regulatory & Scientific Affairs at Cargill, Minneapolis, MN. He specializes in regulatory and trade issues as they pertain to food and dietary supplements. He can be reached at 952-742-4627; E-mail: harry_rice@cargill.com.
Disclaimer: The opinions expressed in this article are those of the author and do not represent the opinions or advice from Cargill.
Resources
1. Claims that Can Be Made for Conventional Foods and Dietary Supplements. September 2003. www.cfsan.fda.gov/~dms/hclaims.html.
2. Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. July 10, 2003. www.cfsan.fda.gov/~dms/hclmgui3.html.
3. Guidance for Industry: A Dietary Supplement Labeling Guide. April 2005. www.cfsan.fda.gov/~dms/dslg-toc.html.
4. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. July 2007. www.cfsan.fda.gov/~dms/hclmgui5.html.
5. Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers. May 12, 2006. www.cfsan.fda.gov/~dms/qucqagui.html.
6. Guidance for Industry: Interim Evidence-based Ranking System for Scientific Data. July 10, 2003. www.cfsan.fda.gov/~dms/hclmgui4.html.
7. Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. June 11, 1998. www.cfsan.fda.gov/%7Edms/hclmguid.html.
8. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. December 22, 1999. www.cfsan.fda.gov/~dms/ssaguide.html.
9. Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide. January 9, 2002. www.cfsan.fda.gov/~dms/sclmguid.html.
10. Guidance For Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. November 2004. www.cfsan.fda.gov/~dms/dsclmgui.html.
11. Institute of Medicine (2002) Evolution of Evidence for Selected Nutrient Disease Relationships. National Academy Press, Washington, D.C.
12. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF and Lux L. Systems to Rate the Strength of Scientific Evidence. Evidence Report/Technology Assessment No. 47 (Prepared by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center under Contract No. 290-97-0011). AHRQ Publication No. 02-E016. Rockville, MD: Agency for Healthcare Research and Quality. April 2002.www.ncbi.nlm.nih.gov/books/bv.fcgi?indexed=google&rid=hstat1.chapter.70996.
