| The United States functional foods market is | | | | Health claims are limited to statements of a |
| relatively immature compared to that of | | | | reduction in the risk of a disease and cannot claim |
| nutraceuticals. From an intellectual property | | | | that the product is a treatment for it, lest it be |
| standpoint, this may be because functional food | | | | considered a drug. However, the distinction |
| technology develops from within the food | | | | becomes blurred as the physiological benefits of |
| industry, while nutraceuticals may come as the | | | | various botanical substances are determined. |
| result of convergence between the food industry | | | | Qualified health claims must contain a statement |
| and industries with greater IP acumen. | | | | such as this: "Although the evidence is not |
| Historically, food technology is not an area of | | | | conclusive, eating [a specific substance] may |
| frequent patenting relative to other technologies | | | | reduce the risk of [a specific disease]." In |
| such as formulation science that impacts the | | | | structure/function claims, the wording of the claim |
| nutraceutical and functional food markets. While | | | | is important in determining whether the substance |
| patenting of food technologies has risen in recent | | | | is considered a food or a dietary supplement as |
| years, most of the filings are classified more like | | | | opposed to a drug. The claim must discuss the |
| medicines and usually cover processes such as | | | | effect of the substance on a structure or |
| extraction or purification rather than bare end | | | | function of the body rather than claiming a benefit |
| product-and that results in the FDA treating the | | | | with respect to a disease. |
| products as drugs. Interestingly, the FDA | | | | Legal Requirements |
| regulates nutraceuticals less stringently than foods | | | | Legally, health claims must meet the Significant |
| in terms of what health claims can be made. | | | | Scientific Agreement (SSA) standard, which |
| Functional foods impart health benefits above and | | | | imposes a burden of showing to the FDA's |
| beyond those naturally found in foods. The | | | | satisfaction that the claims are supported by |
| functionality comes from adding ingredients such | | | | published studies and opinions from qualified |
| as antioxidants and cholesterol-reducing | | | | professionals. Exceptions are made for a few |
| ingredients, or from the elimination of undesirable | | | | qualified health claims or for claims based on an |
| components such as sodium or saturated fat. | | | | authoritative statement by a U.S. scientific body |
| Substances that the FDA classifies generally | | | | as defined by Congress. |
| recognized as safe (GRAS) are highly utilized | | | | However, most health claims necessary to |
| because they do not require separate FDA | | | | distinguish functional foods from their counterparts |
| approval. | | | | on the grocery store shelves require the |
| Marketing Health Benefits | | | | manufacturer to generate supportive data. |
| From a regulatory standpoint, the only way to | | | | Moreover, manufacturers are required to |
| market the benefits of a product to consumers is | | | | generate supportive data without having the |
| by using the product label to promote those | | | | studies deemed clinical trials, which would thrust its |
| benefits, which is more difficult with functional | | | | functional food into classification as a drug and |
| foods than nutraceuticals. Thus, while patented | | | | require the costly submission of a New Drug |
| technologies may be employed to create | | | | Application for market approval. This can create a |
| improved functional foods, their makers may be | | | | difficult dilemma for getting functional foods to the |
| unable to create the level of consumer benefit | | | | market. |
| awareness required for successful marketing. | | | | The Lines Are Blurring |
| Moreover, many U.S. consumers would rather | | | | As we become more knowledgeable about the |
| supplement their diets with nutraceuticals than | | | | mechanisms of action of botanical substances and |
| change the way they eat. That is, they'd rather | | | | exploit their properties by using them in functional |
| swallow a pill than eat and drink their way to | | | | foods or supplements, the division between food |
| health. | | | | ingredients and drugs is increasingly blurred. Food |
| The FDA position on food labeling is that food | | | | crops have always been bred for more desirable |
| content or health claims must be supported by | | | | traits. Now genetic modification is improving this |
| data, and the results of randomized, double-blind | | | | process, producing foods with increased nutritional |
| clinical studies are the best supporting data. | | | | value. |
| However, the FDA may consider a substance a | | | | Moreover, ingredient extraction technologies have |
| drug if it has been the subject of published clinical | | | | enabled product manufacturers to add functional |
| trials. In fact, the FDA will block foods containing | | | | ingredients from one food into another. In the |
| approved drugs or biologics from the food | | | | event that a producer is successful at |
| market. Thus, while tests must be conducted to | | | | developing-and preferably patenting-sound |
| support health claims, if those tests are in clinical | | | | functional food technology, the ultimate challenge |
| trials, they may cause the ingredients to be | | | | remains to sell enough of the product to make it |
| categorized as drugs and subject to more | | | | profitable. |
| onerous safety regulations. | | | | One may intuit that with patents granted and |
| The Four Food Label Claims | | | | health claims approved for labeling, functional |
| The FDA defines the four basic classifications of | | | | foods should succeed if the prices are reasonable. |
| food label claims as nutrient content, health, | | | | Not quite. Although ingredients may be available in |
| qualified health, and structure/function claims. | | | | functional foods at only a modest cost increase, |
| Nutrient content claims may describe reductions | | | | many people may rather get them from a |
| or increases of quantities of specific substances | | | | capsule than pay extra for functional food |
| from the list of allowed substances, or compare a | | | | products, even if the end cost of using functional |
| product to a reference food. Health claims are | | | | foods in lieu of nutraceuticals is less. As illogical as |
| statements that characterize the relationship | | | | that may sound, it may be true. Thus, even with |
| between a substance and a reduction in the risk | | | | patent and health claims intact, consumers may |
| of a health condition or disease, and can be | | | | be more difficult to convince than the patent |
| expressed or implied by the product branding or | | | | office or the FDA. |
| packaging. | | | | |