This article is the second in a series of articles describing similarities and differences between claim regulation in the U.S. and in Europe. Whereas the first article in this series addressed all types of claims for food ingredients in both regions, this article will focus on Health Claims (U.S.) and Regulation (EC) No 1924/2006 Article 14.1.a Claims (Europe).
Health claims in the U.S. characterize the relationship between a food, food component, or dietary supplement ingredient, and the reduction of risk of a disease or health-related condition. Health claims are authorized by the Food and Drug Administration (FDA) through publication of a new regulation (21 CFR §101.14) or by an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences (NAS). The latter are permitted by the Food and Drug Administration Modernization Act of 1997 and are referred to as FDAMA claims.[1] In the U.S., per 21 CFR §101.14, the standard by which health claims are evaluated is “significant scientific agreement” (SSA) among qualified experts. The qualified experts have been defined by the FDA as a government scientific body or the NAS.
Claims for disease “risk factor” reduction (article 14.1.a.) are permitted in Europe by Regulation 1924/2006 and must be authorized by the European Commission. While qualified health claims (QHC) may be authorized in the U.S. based on emerging evidence (per the Nutrition Labeling and Education act of 1990), claims that are worded like QHC cannot be authorized in Europe due to the EC No. 1924/2006 requirement that “heath claims should only be authorized… after a scientific assessment of the highest possible standard”.
In both Europe and in the U.S., any claim that a substance is intended for use in “the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” makes that substance a drug. In the U.S., according to 21 U.S.C. 343(r)(6), a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition. Therefore, claims for use of vitamin C to prevent scurvy or niacin to prevent pellagra are permitted. In Europe, claims for “disease reduction” or “symptom reduction” cannot be authorized because they are forbidden by Regulation 1924/2006. These claims are only dedicated to drugs and are included under Pharmaceutical Affairs Law.
Implied disease claims that do not mention the name of a specific disease but refer to identifiable characteristics of a disease from which the disease itself may be inferred are also considered drug claims by the FDA. These claims describe an effect (using scientific or lay terminology) on one or more recognizable signs or symptoms as being characteristic of a specific disease (including pictorial representations). Claims using the terms “support”, “maintain” or “promote” are permitted only if they do not suggest disease prevention or treatment or use for a serious health condition that is “beyond the ability of the consumer to evaluate”.[2] Examples of implied claims (and corresponding diseases) include “relieves crushing chest pain” (angina or heart attack), “prevents irregular heartbeat” (arrhythmia) or “prevents bone fragility in postmenopausal women (osteoporosis).[3]
Claims that are permitted in the U.S. and in Europe for the same substances are shown in Table 1. Whereas FDA evaluates health claims based on reduction of risk of disease, EFSA evaluates (Article 14.1.a) claims based on reduction of “risk factors” of disease. More health claims are permitted in the U.S. than Article 14.1.a claims in Europe. Reasons mentioned for the low rate of approval in Europe include the regulatory requirements (Article 14.1.) claims must: (1) focus on risk factors of disease (2) only be authorized… after a scientific assessment of the highest possible standard” (the US requires SSA) and; (4) cannot refer to a “general, non-specific benefit” unless the other requirements of the claim are also met. Therefore, studies that do not show an effect of the substance on a recognized risk factor of the particular disease (but may show an effect on clinical endpoints or the incidence of the disease itself) would not support an Article 14.1.a. claim. For example, the claim “diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors” (21 CFR §101.74) would not be permitted in Europe because the claim does not mention a risk factor.
An example of FDA thinking into how it evaluates health claims is embodied in a letter from the FDA regarding rejection of a health claim petition for consumption of glucosamine and/or chondroitin sulfate and reduced risk of osteoarthritis and osteoarthritis-related joint pain, tenderness, swelling and degeneration and cartilage. In determining whether a condition is a “health-related condition”, and also in evaluating evidence supplied to demonstrate that a substance reduces the risk of a disease, FDA “considers the modifiable risk factors for the disease in question.” The term “modifiable risk factor” means a measurement of a variable related to a disease that may serve as an indicator or predictor of that disease and that can be altered by a change in behavior, e.g., changes in diet or activity level. Modifiable risk factors are a type of biomarker. Biomarkers (intermediate or surrogate endpoints) are parameters from which risk of a disease can be inferred, rather than being a measure of the disease itself.[4] An example of a modifiable risk factor cited by FDA is serum LDL cholesterol, for risk of coronary heart disease. As shown in Table 1, EFSA also considers cholesterol to be a risk factor for coronary heart disease.
By evaluating health claims based on “modifiable risk factors”, the FDA appears to be adopting the European Article 14.1.a. regulation in practice, rather than 21 CFR §101.14. So, it would seem to reason that health claims based on “modifiable risk factors” could be accepted in both the U.S. and Europe. The difficulty with this picture is that very few “modifiable risk factors” are universally accepted and by regulation, U.S. health claims must pertain to the health condition, which is often multifactorial in nature. Unless the FDA amends 21 CFR §101.14 to permit health claims for disease “risk factor” reduction and EFSA accepts the SSA standard, obtaining authorization for the same health claim in both regions will continue to be a daunting task. To increase the probability of success in both regions, manufacturers must focus on obtaining irrefutable evidence that their substance modifies a risk factor that is unequivocally involved in the mechanism of disease development. Because few risk factors have been validated, it may be more prudent to develop claims that could be considered structure/function claims in the U.S. and Article 13.1 (general function) claims in Europe. Contact Burdock Group for assistance with claims and keep tuned for additional information about claims in our next newsletter.
Table 1. Authorized Health Claims (U.S.)/ Article 14.1.a Claims (Europe)
References
[1] FDA (1998). Guidance for Industry; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm056975.htm
[2] Commission on Dietary Supplement Labels (1997). The report of the commission on dietary supplement labels, available at http://www.health.gov/dietsupp/final.pdf, p. 38.
[3] FDA (2000). Final Rule. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Jan 6, 2000 Docket No. 98N-0044.
[4] FDA (2004). Letter from William K. Hubbard to Jonathan W. Emord, Esq, Available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073400.htm.