The supermarkets of tomorrow may feature one aisle dedicated to food and beverage products associated with heart health while another aisle may feature products associated with bone health, said Rodger M. Jonas, national business development manager for P.L. Thomas, Morristown, N.J. An aisle dedicated to items that help prevent diabetes is another possibility.
"I can see it," Mr. Jonas said. "It’s already started."
He pointed to memory bars and energy bars as examples.
If these supermarket aisles of tomorrow are to come about, nutraceuticals may need to play pivotal roles. The term nutraceutical draws its name from blending the word "nutrient" and the word "pharmaceutical" and is used properly to describe something from the food supply that has medicinal properties, said Scott Lloyd, a registered patent attorney and lead project analyst with Nerac, Inc., a research and advisory firm based in Tolland, Conn. The U.S. government offers no definition for nutraceutical, he added.
"The most common examples currently of health benefits conferred upon food products by nutraceuticals are antioxidant effects, cholesterol reduction and reduction in the risk of heart disease," Mr. Lloyd said.
Nutraceuticals might be better known in the dietary supplement industry, but they are finding their way into foods and beverages, too. Probiotics, superfruits, coenzyme Q10 and phosphatidylserine all have been classified as nutraceuticals.
Mr. Jonas said food and beverage companies wanting to use nutraceuticals in products should ask three questions: Does it have the science to prove a health benefit? Is the required use level affordable? In what products will it work?
All nutraceuticals should have the science to prove they are GRAS (Generally Recognized as Safe), Mr. Jonas said.
"The big guys won’t use it otherwise," he said in reference to larger food and beverage companies.
Colleen M. Zammer, director of sales for FutureCeuticals, Momence, Ill., said, "Self-affirmed GRAS is generally not acceptable. F.D.A. GRAS is required. To get this, significant research and testing must be completed to prove safety in given applications."
The risk tolerance of a company generally dictates the level of testing required, she said.
"Some less risk-tolerant companies may require large double-blind, placebo-controlled studies to prove that a product is significantly efficacious," Ms. Zammer said.
Manufacturers may consider nutrient/content claims, health claims, qualified health claims and structure/function claims in accordance with Food and Drug Administration guidelines when promoting foods and beverages enhanced with nutraceuticals, Mr. Lloyd said. An example of a structure/function claim might be "vitamin D promotes bone resorption," he said and added manufacturers must be most cautious with these structure/function claims.
"Note that these types of claims are most akin to drug claims," he said. "So wording is important."
Mr. Jonas said manufacturers should walk a fine line and make certain they are not claiming a food or beverage may treat a disease.
"The majority of mainstream food and beverage manufacturers do a good job of promoting benefits rather than treatment and sounding like drugs," Ms. Zammer said. "The reason for this is most of them are extremely conservative and are reluctant to want to draw attention from F.D.A. It is expensive to have to withdraw a product from the market, and mass market companies do not want to lose credibility with fickle consumers."
She said positive examples of company promotions include Tropicana products with calcium, fiber and omega-3 fatty acids; Dannon’s Activia for digestive health benefits; and Quaker Oats cereals and other cereals for the health benefits of fiber and oats.
For question No. 2 from Mr. Jonas, the affordability of nutraceuticals may vary. Some may be used at small levels, such as in milligrams, Mr. Jonas said.
For question No. 3, a small use level also may mean the nutraceutical will have little effect on taste, color or odor of the final product, meaning they may work in more products. Solubility, temperature, pH and interactions with other ingredients are some issues to consider when deciding whether to incorporate a nutraceutical into a specific product, Mr. Jonas said.
Examples of nutraceuticals
Listed below are a few ingredients being promoted as nutraceuticals for use in foods and beverages:
Israel-based Enzymotec offers phosphatidylserine under the Sharp PS brand for use in functional foods and dietary supplements. The company promotes the soy-derived nutraceutical as a "brain energizer."
The U.S. Food and Drug Administration last December said it had no questions about Enzymotec’s view through scientific studies that phosphatidylserine is Generally Recognized As Safe (GRAS) for use as an ingredient in flavored milk, milk drinks, milk substitutes such as soy milk, milk-based meal replacements, yogurt, breakfast bars, and fruit-flavored drinks at levels of 100 mg per serving; and in breakfast cereals and milk at levels of 50 mg per serving.
Superfruits may play a role in the development of nutraceuticals for use in foods and beverages because of their antioxidant properties, said Colleen M. Zammer, director of sales for FutureCeuticals, Momence, Ill. Found in the colors and hues in the superfruits, the antioxidants fight off damage done by free radicals.
"Free radicals are generated by actions as simple as breathing and metabolism, but for those of us that also encounter environmental pollutants (smog, smoke, allergens) or mental/emotional stress from working or raising a family, we may need additional protection from oxidative stress," Ms. Zammer said. "Superfruits are a fun and tasty way to defend ourselves against these villains."
Superfruit phytonutrients generally are most stable at low pH levels and in environments with minimal exposure to heat and light, she said.
FutureCeuticals now offers AnthoComplete, a blend of fruits, vegetables and legumes that are in the blue/purple/black end of the color spectrum and contain a range of phytonutrients called anthocyanins associated with health benefits such as heart health, mental acuity and vision support.
Coenzyme Q10, a fat-soluble, vitamin-like substance, is a power plant of the body and found in most cells, with high concentration in the heart, according to Kaneka Nutrients L.P., Pasadena, Texas. CoQ10 prevents the generation of free radicals and oxidative damage to the body’s cells, including proteins, lipids and DNA.
CoQ10 in its pure state is odorless and flavorless and naturally orange in color, said Rodger M. Jonas, national business development manager for P.L. Thomas, Morristown, N.J. It may be used in baked foods and dairy products. Since it is now available in water-soluble form, CoQ10 also may be used in dry mixes and beverages.
"It’s GRAS now," Mr. Jonas said. "It’s kosher now. It’s all those lovely things now."
Omega-3 association seeks exclusion from Section 912
A congressional mandate that may restrict the marketing of foods with added biological ingredients should not apply to certain omega-3 fatty acids, according to the Global Organization for EPA and DHA Omega-3s (GOED).
The mandate, Section 912 of the Food and Drug Administration Amendments Act of 2007, amends Section 301 of the Federal Food, Drug and Cosmetic Act. It prohibits the interstate shipment of certain foods that have had an approved drug or a licensed biological product added to them. It also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public.
The GOED provided comments to the F.D.A. in a Nov. 25 letter and said companies should be able to continue to market docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in various forms as ingredients in foods, infant formulas, medical foods and dietary supplements.
"Section 301(II) does not apply to DHA and EPA because these omega-3 fatty acids were marketed in food prior to the F.D.A. approval of any new drug application or the initiation of substantial clinical investigations that have been made public," the letter said. "F.D.A. should recognize a substance has been ‘marketed in food’ when it is found naturally in foods such as the DHA and EPA in fish and other foods."
The GOED letter added the F.D.A. must interpret section 301(II) in a manner that allows companies to conduct research on new ingredients prior to their marketing in food.
"In evaluating the published clinical studies, F.D.A. must look beyond the existence of such studies and the endpoints evaluated in the study and determine whether the study has been conducted for purposes of obtaining F.D.A. approval of a new drug or as part of the scientific evaluation of the role that a new food or dietary ingredient may have on health and nutrition," the letter said.
The GOED is an association of nearly 60 manufacturers and marketers of products containing EPA and DHA omega-3 fatty acids.
This article can also be found in the digital edition of Food Business News, December 9, 2008, starting on Page 33. Click