Functional Foods Policy and Regulatory Developments

Global Policy and Regulatory Functional Foods Developments

Joint Food and Agriculture Organization (FAO)/WHO Evaluation of the Work of the Codex Alimentarius Commission 

  • Discussed at its 28th sessions in 2005 the findings from Codex Alimentarius Workshop on Functional Foods in 2004 and next steps.
  • FAO/WHO Functional Foods:  Safety and Regulatory Aspects Workshop was held in collaboration with the Korea Food and Drug Administration, ILSI, and the Korean Society of Food Science and Technology on September 6, 2004 in Jeju-do, Republic of Korea
  • Director-General emphasized in 2003 the importance of functional foods as consumer demands and technology advances to create products that deliver enhanced health benefits.

Codex Alimentarius 

National Policy and Regulatory Functional Foods Developments

Besides food labeling issues, patent law often pertains to new functional foods being introduced across the world.

Australia and New Zealand

  • Only permits a health claim for folate and neutral tube defects on food.
  • Prohibits the use of certain words like slimming or health food. 
Brunei Canada
  • Agriculture and Agri-Food Canada provides assistance through its Food Regulatory Issues Division for industry members interested in going to market in Canada with a functional food.  Their functional foods and nutraceuticals web-based resources also provide consumers and product developments information regarding the science and health benefits around these foods and beverages.
China
  • The Ministry of Health China established the regulation of the Control of Health Food in 1996 and recognized foods with health benefits.   
European Union
  • The European Food Safety Authority evaluates health claim petitions and issues opinions.  The EFSA site includes:
    • Resolution and amendments that harmonized the use of nutrition and health claims through EU-wide rules.
    • Scientific advice by the EFSA 
    • Guidance for applicants on health claims
    • The European Commission approved a list of 222 health claims to help provide clarity to food manufacturers and reduce the administrative burden
    • The European Food Safety Authority Panel on Dietetic Products, Nutrition, and Allergies (NDA) published guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health.
    • The European Food Safety Authority Panel on Dietetic Products, Nutrition, and Allergies (NDA) issued a scientific opinion concluding that the consumption of glucosamine has not been associated with significant improvements in maintenance of normal joint cartilage.
    • National reports and projects provide some guidance and perspective on how EU defines functional foods and regulates these foods and health claims
    Japan
    • The development of its special seal on foods for specified health use is credited for the original concept of naming and promoting functional foods.
    • The Ministry supported a project focused on the research and development of functional foods and this project helped define functional foods for the first time in 1984 as foods that have physiological functions, including regulation of biorhytms, the nervous system, the immune system, and bodily defense beyond nutrient functions.
    Indonesia
    • Allows limited health claims on food label.
    Ireland Malaysia
    • The Ministry of Health regulates health claims made on foods and beverages through authority vested in the Food Act of 1983 and the Food Regulations of 1985. 
    Netherlands
    • A Code of Practice was established in 1998.
    • Voluntarily stakeholders came together to establish a Code of Practice for assessing the scientific evidence for health benefits stated in health claims on food and drink products.
    • Established the Netherlands Nutrition Centre.
    Philippines
    • Allows limited health claims on food label.
    Singapore Sweden
    • Article explains how the Swedish Nutrition Foundation worked to standardize generic claims related to eight well-established diet and health relationships in 1996 with their Swedish Code of Practice “Health Claims in the Labeling and Marketing of Food Products.”
    Thailand United Kingdom
    • In 1998 and 2002, the United Kingdom’s Joint Health Claims Initiative was established voluntarily by a variety of stakeholders and set forth a code of practice for health claims but the endeavor ended as UK joined broader EU initiatives.
    United States
    In the United States, functional foods can be regulated as conventional food, a dietary supplement, a food for special dietary use, a medical food, or a drug and often these distinctions are made by the food manufacturer depending on how they would like to market a product and what claims the manufacturer would like to put on the product. 

    The First Amendment to the US Constitution, part of the country’s Bill of Rights, prohibits any law from abridging the freedom of speech including commercial speech, while the Supreme Court has upheld some exceptions to this law.     

    United States Congress

    Federal Trade Commission Act of 1914, 15 USC §41

    • Prohibits “unfair or deceptive acts or practices.”
    • Prohibits false advertisement that is “misleading in a material respect.”
    • Empowers FTC to evaluate the claims of health benefits in advertising and compel scientific information a company uses to substantiate its claims. 

    The Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act), Pub. L. 75-717, 52 US Stat. 1040, codified 21 USC §301 et seq.

    • Establishes FDA’s authority to regulate food while making no explicit mention of a functional food category; therefore, functional foods are often regulated under this law like conventional foods.
    • Establishes the FDA will inspect food plants.
    • Set forth the process for evaluating new ingredients as either deemed to be GRAS or must go through FDA’s review and approval process as a food additive.
    • Prohibits the misbranding of food and using labels on the food product that are false or misleading. 

    Nutrition Labeling and Education Act of 1990 (NLEA), Pub. L. No 101-535, 104 Stat. 2353 and subsequent legislation

    • Aims to make nutrition information available to assist consumers in selecting foods that could lead to healthier diets, eliminate consumer confusion, and encourage industry innovation in health communications and product reformulations.
    • Requires health claims for food labels be authorized by FDA following a determination by FDA that “significant scientific agreement” exists among qualified experts that the totality of publicly available scientific evidence supports the claims. 
    • Permits petitions to FDA for review of health claims; only a few have been approved through this path such as sugar alcohols and dental caries or plant sterol/stanol esters and coronary heart disease. 
    • Mandated FDA to review 10 diet-disease relationships for health claims and 8 of these 10 were approved:  calcium and osteoporosis; sodium and hypertension; dietary fat and cancer; dietary saturated fat and cholesterol and coronary heart disease; fiber containing grain products, fruits and vegetables, and cancer; fruits, vegetables, and grain products that contain fiber, particularly soluble fiber and coronary heart disease; fruits and vegetables and cancer; and folate and neural tube birth defects.

    FDA Modernization Act of 1997 (FDAMA), Pub. L. 105-115

    • Streamlines FDA’s preapproval process by approving “authoritative statements” on food labels as health claims.  Authoritative statements must be published by certain US federal governmental bodies such as NIH, CDC, and the National Academies of Sciences. 
    • Requires food manufacturers to notify the FDA at least 120 days before marketing product using an authoritative statement. 

    Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. 103-417

    • Regulates dietary supplements as foods rather than as food additives.
    • Defines dietary supplements as “vitamins, minerals, herbs, or other botanicals, amino acids, or other dietary substances for use by man to supplement the diet by increasing the total dietary intake, including concentrates, metabolites, constituents, extracts, or any combination of the above.” 
    • Permits the use of “structure/function” claims without FDA premarket approval that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans; characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; describes the general well-being from consumption of a nutrient or dietary ingredient; or claims a benefit related to a classical nutrient deficiency disease and the prevalence of such disease in the United States. 
    • Requires dietary supplement manufacturers to notify the FDA within 30 d of marketing a product displaying a structure/function claim.
    • Mandates this disclaimer on any dietary supplements using structure/function claims:  “This statement has not been evaluated by the FDA.  This product is not intended to diagnose, treat, cure, or prevent any disease.”    
    • Functional foods making the same structure/function claim for the same ingredients as a dietary supplement do not have to include this disclaimer.
    • Puts burden of proof for safety and efficacy on the FDA.

    FDA Food Safety Modernization Act of 2011, Pub. L. 111-353

    • Authorizes FDA to order mandatory recalls if there is reasonable probability an article of food is adulterated or misbranded that is a major food allergen or may cause serious adverse health consequences or death in humans or animals.
    • Considered regulatory differences between conventional foods and dietary supplements.
    • Congress has used its legal authority and appropriations over the years to direct the Government Accountability Office to examine functional food issues:

    Food Labeling:  FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims.  GAO-11-102.  Directed by Congress to examine issues regarding FDA’s implementation of qualified health claims on food (Pub. L. No. 110-161 §4, 121 Stat. 1844, 1846 (2007)) and felt FDA was hindered in bearing the burden of proof that a company has the scientific support for a structure/function claim without legal authority to compel a company to provide FDA with its scientific support, which FTC has.  FDA guidance was also found lacking on the level of scientific evidence needed for making structure/function claims and to avoid providing false or misleading information.  

    Food Labeling:  FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods.  GAO-08-597.  Examined FDA’s efforts to ensure that domestic and imported food comply with food labeling requirements, including those prohibiting false or misleading labeling; the challenges FDA faces in its efforts to administer and enforce food labeling requirements; and the actions stakeholders from health, medical, and consumer organizations believe are needed to mitigate the effects of food labeling practices they consider misleading and to help consumers identify healthy food.  GAO found FDA had limited assurance that domestic and imported food comply with food labeling requirements. 

    High-Risk Series:  An Update.  GAO-07-310.  Added food safety to their High-Risk Series. 

    Food Safety:  USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food.  GAO-05-51.  Identified gaps in USDA and FDA regulatory approaches to food recalls.

    Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods”.  GAO/RCED-00-156.  Examined the extent to which FDA, USDA, and FTC efforts and federal laws ensure the (1) safety of functional foods and dietary supplements and (2) accuracy of health-related claims on product labels and in advertising.  Concluded FDA’s inability to review safety evidence for functional foods without a pre-market safety notification was a regulatory gap, as well as their inability to track and analyze instances of adverse effects.  Also, GAO determined the distinction between functional foods and dietary supplement was often difficult for clear and consistent regulatory action.  Recommended Congress amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of functional foods to notify the FDA regarding the use of structure/function claims and to use disclaimers of FDA approval on product labels containing structure/function claims.       

    United States Department of Health and Human Services Food and Administration

    Selected Functional Foods FDA Guidance & Activities:

    • Working Agreement between FTC and FDA, 4 Trade Reg. Rep. (CCH) ¶ 9,850.01 (1971).  Memorandum of Understanding establishes how FTC and FDA will delegate primary responsibilities in areas of overlapping jurisdiction to regulate advertising, labeling, and promotion of foods, over-the-counter drugs, cosmetics, and medical devices.
    • FDA sets forth a 10 year implementation plan for DSHEA.  69 Fed. Reg. 64957, November 11, 2004.

    Food Label

    Health Claims

    Case Law Developments:

    • An administrative Law Judge of the Federal Trade Commission issues an initial decision in May 2012 upholding FTC charges that the company made deceptive health claims in some advertisements but the Judge found that requested FDA pre-approval requirement "would constitute unneccessary overreaching"
    • Alliance for Natural Health US, et al. vs. Sebelius, et al., 714 F. Supp. 2d 48 (D.D.C. 2010).  This later case discusses the issues presented in a very similar case brought first involving the same parties.  This case focuses on the plaintiffs’ challenge of the FDA’s authority to deny certain qualified health claims regarding dietary supplements containing vitamin C and E.  The court remanded vitamin C-gastric cancer and vitamin E-bladder cancer claims to the FDA for further action and reaffirmed the role of the First Amendment in FDA’s evaluation of health claims.
    • Nutraceutical Corp. v. Von Eschenbach, 459 F. 3d. 1033 (10th Cir. 2006), reversed Nutrilabe, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983).  FDA appropriately analyzed the risk-benefit ratio of ephedrine-alkaloid dietary supplements in determining its ruling on proposed health claim.
    • Pearson v. Shalala:
      • 141 F. Supp. 2d 105 (D.C. Cir. 2001).  FDA’s motion for reconsideration was denied and the case was later dismissed after FDA reached an agreement with plaintiffs. 
      • 130 F. Supp. 2d 105 (D.C. Cir. 2001).  The court determined FDA violated the First Amendment rights of plaintiff’s when the Agency continued after the initial ruling to authorize the plaintiffs’ folic acid claim. 
      • 164 F. 3d 650 (D.C. Cir. 1999), reh’g en banc den., 172 F. 3d 72 (D.C. Cir. 1999).  The court held that the First Amendment does not permit FDA to prohibit a potentially misleading health claim on a dietary supplement label unless FDA considers whether qualifying language on the label could negate the potentially misleading nature of the claim.
    • Whitaker v. Thompson:
      • 248 F. Supp. 2d 1 (D.C. Cir. 2002).  The court found the FDA should permit a health claim on a dietary supplement because it was not inherently misleading when read with the disclaimer and the weight of the evidence was not against the claim. 
      • No. 00-0123-PLF, Docket No. 28 (D. C. Cir. 2001).  The court dismissed the complaint challenging FDA's decision on health claims and subsequently the FDA and plaintiffs reached an agreement about the use of the health claim and accompanying disclaimer.

    GRAS

    • Generally Recognized As Safe (GRAS) describes substances the United States government has determined are not harmful under its intended conditions of use.  The data used to provide evidence of safety for GRAS substances should be generally available and a consensus should exist among qualified experts about the safety of the substance for its intended use. 
    • FDA guidance on GRAS
    • 21 CFR 182.1 Substances Generally Recognized as Safe (General Provisions)
    • If a substance is not listed as a GRAS substance, a food manufacturer can petition the FDA with convincing evidence that the added ingredient meets the safety standard for food additives.  The petitioner must demonstrate to a reasonable certainty no harm will result from the intended use of the food additive.  FDA evaluates the amount of the additive consumers are likely to consume and the likelihood of short and long term health effects.  If FDA finds the food additive safe, the Agency issues a regulation specifying the conditions it can be used.  For example, FDA published a response letter to GRAS Notice No. GRN 000041, submitted on behalf of Martek Biosciences Corporation and focusing on docosahexaenoic acid-rich single-cell oil and arahidonic acid-rich single-celln oil.  FDA had no questions about Martek’s conclusions that these two substances are GRAS sources under the intended conditions of use. 

    Nutrient Content Claims

    Structure/Function Claims

    • Describes the role of, or characterizes the mechanism by which, a nutrient affects a body structure or function of the body or a person’s well-being.
    • FDA Guidance on Structure/Function Claims
    • FDA has not set forth evidentiary standards for structure/function claims except that these claims can’t be false or misleading.
    • FDA issued a letter to manufacturers in 2001 cautioning them that structure/function effects for foods must be achieved through nutritive value; otherwise, the product could be subject to regulation as a drug. 

    Surgeon General

    • United States Department of Health and Human Services.  Public Health Service.  The Surgeon General’s Report on Nutrition and Health.  Washington, DC:  US Government Printing Office, 1988.  PHS 88 50210.  Explains diet-disease relationships and emphasizes the role of nutrition in preventing and managing chronic diseases.

    United States Department of Agriculture

    • Regulates product label claims for functional foods containing more than 2% percent or more of cooked meat or poultry or 3% or more of raw meat or poultry.
    • Reviews health claims on a case-by-case basis. 
    • Requires food manufacturer to ask USDA specifically for permission to use a health claim on a product it regulates.

    United States Federal Trade Commission

    • FTC enforces consumer protection laws on advertising (e.g., tv, radio, Internet, and print media) for both functional foods and dietary supplements.
    • Advertising claims of health benefits are subject to the provision of the FTC Act that prohibits “unfair or deceptive acts or practices” and any false advertisement that is “misleading in a material respect.”
    • FTC reopened the complaint against Kellogg because of their immunity claims on Rice Krispies and Kellogg agreed to a revised settlement order.
    • FTC reached a settlement with Kellogg on their unsubstantiated claims that Frosted Mini-Wheats were clinically shown to improve kids' attentiveness by 20%.
    • FTC Director of the Bureau of Consumer Protection stated before the National Advertising Division Annual Conference in New York, NY on October 5, 2009, that the FTC is working with the FDA to examine health claims.
    • FTC Enforcement Policy Statement on Food Advertising.  May 1994.  Puts forth a legal framework for Commission Action on nutrient content claims and health claims. 
    • Working Agreement between FTC and FDA, 4 Trade Reg. Rep. (CCH) ¶ 9,850.01 (1971).  Memorandum of Understanding establishes how FTC and FDA will delegate primary responsibilities in areas of overlapping jurisdiction to regulate advertising, labeling, and promotion of foods, over-the-counter drugs, cosmetics, and medical devices.

    Non-Government Developments & Reports

    Center for Science in the Public Interest

    • Urged FDA in 2006 to increase its regulation of functional foods
    • Wrote a report on the regulatory gaps relevant to functional foods
    • Petitioned FDA to develop stronger regulations for functional foods.
    • Urged FDA to stop the sale of and promotion of functional foods.

    European Commission Concerted Action on Functional Food Science in Europe Project (FUFOSE) works to establish a science-based approach for concepts in functional food science.

    Pew Initiative on Food and BiotechnologyApplication of Biotechnology for Functional Foods.  2007.  Reviews research and regulatory implications of biotechnology for functional foods.