Diet, Supplements, & Athletic Performance
Diet, Supplements, & Athletic Performance KIN 380
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Does the Evidence Support the Claim Harry Rice PhD Senior Scientist Regulatory amp Scienti c Affairs Cargill Minneapolis MN As FDA ramps up enforcement in food and dietary supplements companies need to know what claims can be made for their products based on their level of substantiation 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 ifadequate 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 Claims Categories In the US 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 structurefunction 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 healthrelated 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 quali ed health claims NLEA Authorized Health Claims are based on the totality of the publicly available scienti c evidence using the signi cant scienti c agreement standard Guidance for Industry Signi cant Scienti c 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 08 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 signi cant amount of scienti c 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 noti cation to FDA of a health claim based on an authoritative statement from a scienti c body of the Us Government or the National Academies of Science Guidance for Industry Noti cation of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scienti c Body June 11 1998 If FDA does not act to prohibit or modify such a claim within 120 days of receipt of the noti cation 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 Quali ed Health Claims are similar to NLEA Authorized Health Claims but there exists less scienti c agreement among experts therefore this type of claim requires language that quali es the extent of the available science Guidance for Industry and FDA Interim Procedures for Quali ed Health Claims GuidanceInterim Procedures for Quali ed Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 10 2003 AND Guidance for Industry EvidenceBased Review System for the Scienti c Evaluation of Health Claims July 2007 AND Guidance for Industry FDA s Implementation of Quali ed Health Claims Questions and Answers May 12 2006 The genesis of quali ed 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 speci c substancedisease relationships in the labeling of dietary supplements Although the district court ruled for FDA 14 F Supp 2d 10 DDC 1998 the US Court of Appeals for the DC Circuit reversed the lower court s decision 164 F3d 650 DC 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 structurefunction in humans characterize how a nutrient or dietary ingredient acts to maintain structurefunction describe the general wellbeing resulting from consumption of a nutrient or dietary ingredient and describe a bene t along with prevalence related to a nutrient de ciency disease Structurefunction 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 scienti c or lay terminology on one or more signs or symptoms that are recognizable to healthcare professionals or consumers as being characteristic of a speci c disease or of a number of diseases Structurefunction claims are not preapproved 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 structurefunction claims on labels or in labeling must submit a noti cation to FDA no later than 30 days after marketing the dietary supplement Because structurefunction claims are not preapproved and lack a rigorous noti cation 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 scienti cally 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 indepth understanding of the science associated with the proposed effect of the dietary ingredient on the specific structure andor 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 exhaustive the following list of resources will prove valuable to ensure a claim is supported by adequate substantiation In July of 2007 the FDA published a draft guidance document detailing its evidencebased 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 Evidencebase Ranking System for Scientific Data July 2003 the differences are irrelevant While neither document is specific to substantiating structurefunction 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 4036 of the Federal Food Drug and Cosmetic Act 2004 describes the amount type and quality of evidence FDA recommends manufacturers have to substantiate a claim The Agency for Healthcare Research 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 evidencebased 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 andor 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 amp 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 9527424627 Email harryiricecargillcom 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 wwwcfsanfdagovdmshclaimshtml 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 wwwcfsanfdagovdmshclmgui3html 3 Guidance for Industry A Dietary Supplement Labeling Guide April 2005 wwwcfsanfdagovdmsdslgtochtml 4 Guidance for Industry EvidenceBased Review System for the Scientific Evaluation of Health Claims July 2007 wwwcfsanfdagovdmshclmgui5html 5 Guidance for Industry FDA s Implementation of Qualified Health Claims Questions and Answers May 12 2006 wwwcfsanfdagovdmsqucqaguihtml 6 Guidance for Industry Interim Evidencebased Ranking System for Scientific Data July 10 2003 wwwcfsanfdagovdmshclmgui4html 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 wwwcfsanfdagov7Edmshclmguidhtml 8 Guidance for Industry Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements December 22 1999 wwwcfsanfdagovdmsssaguidehtml 9 Guidance for Industry Structure Function Claims Small Entity Compliance Guide January 9 2002 wwwcfsanfdagovdmssclmguidhtml 10 Guidance For Industry Substantiation for Dietary Supplement Claims Made Under Section 403r6 of the Federal Food Drug and Cosmetic Act November 2004 wwwcfsanfdagovdmsdsclmguihtml 11 Institute of Medicine 2002 Evolution of Evidence for Selected Nutrient Disease Relationships National Academy Press Washington DC 12 West S King V Carey TS Lohr KN McKoy N Sutton SF and Lu L Systems to Rate the Strength of Scientific Evidence Evidence Report Technology Assessment No 47 Prepared by the Research Triangle InstituteUniversity of North Carolina Evidencebased Practice Center under Contract No 290970011 AHRQ Publication No 02E016 Rockville MD Agency for Healthcare Research and Quality April 2002wwwncbinlmnihgovbooksbvfcgiindexedgoogleampridhstatlchapter70996