The concept of functional foods dates back to the time of Hippocrates, the father of medicine, who said, “Let food be thy medicine and medicine be thy food.”
In 1994, the Institute of Medicine (IOM) defined functional foods as any food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains. To date, the Food and Drug Administration (FDA) does not have a definition for functional foods. After all, functional food is food, and as such the same laws covering the safety of conventional foods govern functional foods.
However, when talking about functional foods, most of us think primarily of their claimed efficacy. A health claim has two essential components: a substance (food, or food component, or dietary ingredient) and a disease[i] or health related condition. Therefore, claimed efficacy can be made for dietary ingredients or food ingredients used in dietary supplements[ii] or functional foods. As with dietary supplements, claims about the health benefits of functional foods must be based on scientific data. Claims can also be made for specific segments of the population, in which case the scientific data necessary for claim substantiation need to be appropriate. Consequently, claims made for functional foods can target women, which according to the Census Bureau 2000 report account for just over one-half of the U.S. population. Women are identified as one of the most important consumer groups for functional foods, because they have more specific health and nutrition needs than men, such as during pregnancy, post-partum period, menstruation and menopause. Therefore, it is generally recognized that maintaining optimal health varies greatly between genders.
In the United States, health conscious “baby boomers” have shown great interest in functional foods and their claimed benefits, as demonstrated by more than half of U.S. consumers. The reason is that this generation wants to control their own health and well being, as well as to have more control over their medical treatment and increasing cost of prescription medications.
Until recently, the medical community addressed women’s health by mainly focusing on the reproductive system. The assumption used to be that men and women reacted comparably to medical conditions and, therefore, drug treatment. However, with the emergence of gender-specific medicine[iii] over the last decade, that thought process is shifting. Clinical experience and research show that the diagnosis and treatment of certain medical conditions are different between genders. This realization comes after many women have been misdiagnosed and under treated because they did not present to their doctors with the “classical, textbook” symptoms—symptoms that after all were recorded from observations in men. Below are some interesting findings.
Women frequently do not have chest pain during a heart attack and complain of more vague, flu-like symptoms. (Women are 11 times more likely to die from a heart attack than from breast cancer).
Aspirin does not protect women against heart attacks in the same way it does men.
Women who don’t smoke appear to be more susceptible to lung cancer than non-smoking men. Women also tend to get lung cancer at younger ages than men.
Women metabolize nicotine faster than men do—especially women who are taking oral contraceptives.
Women are less likely than men to get oral cancer.
Women are twice as likely to develop gall bladder problems.
Women are more prone to autoimmune diseases, including lupus, rheumatoid arthritis, and multiple sclerosis.
Research is being conducted in the fields of digestive disorders, general medicine, autoimmune diseases, bariatrics, and heart disease—which are all recognized as either presenting differently or more frequently, or having different outcomes in women than in men. Malignancies are another concern for women of all ages. Cancers unique to women are ovarian, uterine, and cervical. Although breast cancers are predominantly seen in women, the disease can also afflict a very small percentage of men. Cancer is intimately linked to non-genetic factors. Diet, lifestyle, and the environment contribute to approximately three-quarters of all cancer cases.
Interestingly, some conditions, like premenstrual syndrome, pregnancy, lactation, and menopause, are purely stages in a woman’s life where she has special nutritional needs that can be met with specific nutrients. Claims cannot be made for these conditions, because as discussed earlier, a claim has to have two key components—a substance and a disease. Pregnancy and menopause, although physiologically complex, are not disease states.
North American women are at risk for certain major nutrition-related diseases and conditions, including diabetes mellitus, cardiovascular disease, several cancers, and osteoporosis, conditions that might benefit from specifically targeted functional foods. Development of gender-based medicine and the growing concerns of women with health issues have led to an increased demand for functional foods as reflected by heightened sales from over $50 billion in 2004 to an anticipated $70 billion by 2009. The marketing of products with a gender in mind is not a novel approach; the “for women only” and “formulated for women’s health” segments are reached over $4 billion in retail sales in 2004, up approximately 11 percent from the year before.
Functional foods represent an area that will likely remain of interest to consumers contemplating life-long, beneficial effects from day-to-day nutrition. It is anticipated that in the future, functional foods will be designed for people with special needs, such as those of adolescents, women of childbearing age, athletes, military personnel, the elderly, and people with chronic conditions. The selection process for consumers making choices concerning diet and supplements is complex, which should alert industry and regulators to focus on two key areas: the importance of using sound science when substantiating claims for functional foods, and educating the public to facilitate their decision making.
[i] Disease is defined in 21 CFR Part 101.14(a)(5) as damage to an organ, structure, or system of the body such that it does not function properly (e.g., CHD), or a state of health leading to dysfunction (e.g., hypertension).
[ii] Dietary supplements were defined as foods by DSHEA of 1994.
[iii] Gender-specific medicine is the field of medicine that studies the biological and physiological differences between the human sexes and how that affects differences in disease.