Red Patent

Functional Food Patents

The United States functional foods market is relatively immature compared to that of nutraceuticals. From an intellectual property standpoint, this may be because functional food technology develops from within the food industry, while nutraceuticals may come as the result of convergence between the food industry and industries with greater IP acumen.

Historically, food technology is not an area of frequent patenting relative to other technologies such as formulation science that impacts the nutraceutical and functional food markets. While patenting of food technologies has risen in recent years, most of the filings are classified more like medicines and usually cover processes such as extraction or purification rather than bare end product-and that results in the FDA treating the products as drugs. Interestingly, the FDA regulates nutraceuticals less stringently than foods in terms of what health claims can be made.

Functional foods impart health benefits above and beyond those naturally found in foods. The functionality comes from adding ingredients such as antioxidants and cholesterol-reducing ingredients, or from the elimination of undesirable components such as sodium or saturated fat. Substances that the FDA classifies generally recognized as safe (GRAS) are highly utilized because they do not require separate FDA approval.

Marketing Health Benefits

From a regulatory standpoint, the only way to market the benefits of a product to consumers is by using the product label to promote those benefits, which is more difficult with functional foods than nutraceuticals. Thus, while patented technologies may be employed to create improved functional foods, their makers may be unable to create the level of consumer benefit awareness required for successful marketing. Moreover, many U.S. consumers would rather supplement their diets with nutraceuticals than change the way they eat. That is, they’d rather swallow a pill than eat and drink their way to health.

The FDA position on food labeling is that food content or health claims must be supported by data, and the results of randomized, double-blind clinical studies are the best supporting data. However, the FDA may consider a substance a drug if it has been the subject of published clinical trials. In fact, the FDA will block foods containing approved drugs or biologics from the food market. Thus, while tests must be conducted to support health claims, if those tests are in clinical trials, they may cause the ingredients to be categorized as drugs and subject to more onerous safety regulations.

The Four Food Label Claims

The FDA defines the four basic classifications of food label claims as nutrient content, health, qualified health, and structure/function claims. Nutrient content claims may describe reductions or increases of quantities of specific substances from the list of allowed substances, or compare a product to a reference food. Health claims are statements that characterize the relationship between a substance and a reduction in the risk of a health condition or disease, and can be expressed or implied by the product branding or packaging.

Health claims are limited to statements of a reduction in the risk of a disease and cannot claim that the product is a treatment for it, lest it be considered a drug. However, the distinction becomes blurred as the physiological benefits of various botanical substances are determined. Qualified health claims must contain a statement such as this: “Although the evidence is not conclusive, eating [a specific substance] may reduce the risk of [a specific disease].” In structure/function claims, the wording of the claim is important in determining whether the substance is considered a food or a dietary supplement as opposed to a drug. The claim must discuss the effect of the substance on a structure or function of the body rather than claiming a benefit with respect to a disease.

Legal Requirements

Legally, health claims must meet the Significant Scientific Agreement (SSA) standard, which imposes a burden of showing to the FDA’s satisfaction that the claims are supported by published studies and opinions from qualified professionals. Exceptions are made for a few qualified health claims or for claims based on an authoritative statement by a U.S. scientific body as defined by Congress.

However, most health claims necessary to distinguish functional foods from their counterparts on the grocery store shelves require the manufacturer to generate supportive data. Moreover, manufacturers are required to generate supportive data without having the studies deemed clinical trials, which would thrust its functional food into classification as a drug and require the costly submission of a New Drug Application for market approval. This can create a difficult dilemma for getting functional foods to the market.

The Lines Are Blurring

As we become more knowledgeable about the mechanisms of action of botanical substances and exploit their properties by using them in functional foods or supplements, the division between food ingredients and drugs is increasingly blurred. Food crops have always been bred for more desirable traits. Now genetic modification is improving this process, producing foods with increased nutritional value.

Moreover, ingredient extraction technologies have enabled product manufacturers to add functional ingredients from one food into another. In the event that a producer is successful at developing-and preferably patenting-sound functional food technology, the ultimate challenge remains to sell enough of the product to make it profitable.

One may intuit that with patents granted and health claims approved for labeling, functional foods should succeed if the prices are reasonable. Not quite. Although ingredients may be available in functional foods at only a modest cost increase, many people may rather get them from a capsule than pay extra for functional food products, even if the end cost of using functional foods in lieu of nutraceuticals is less. As illogical as that may sound, it may be true. Thus, even with patent and health claims intact, consumers may be more difficult to convince than the patent office or the FDA.