Emerging ingredients that address health issues are often a combined effort of research into new uses of a commodity compound along with clinical studies.

They show up at trade expositions and in trade magazines. They garner your attention through word of mouth from vendors or R&D and marketing coworkers—or perhaps in competitors' products. Whichever way a new ingredient is marketed, its path to commercialization is paved with research, intellectual property (IP) and regulatory challenges.

An overworked adage has it that new products are the lifeblood of a company. For recently launched dietary supplements, beverages and other functional foods, their newness often is based on a medicinal or nutritional component. Identifying and turning an emerging ingredient into a strategic business advantage is a challenge in itself. Insights into the origins of such key ingredients provide clues into how a manufacturer of consumer products can achieve this goal.

It is very rare to have a completely new ingredient, such as grape seed extract that was introduced to the U.S. market several decades ago.

Just a Twinkle in Someone's Eye

"Most developments in functional ingredients happen at the academic level," says Matt Hietala, MH Consulting (Old Greenwich, Conn.). Companies rarely have the resources to commit to the long-term process of identifying, testing and developing a compound and/or processing technology.

To support his point, Hietala notes that a university with a reputation for research in a particular area tends to be located close to the relevant raw material source. For example, universities strong in grain research are located in the Midwest. Funds for research are derived not only from government, to aid rural development, but also from agricultural groups, such as grain producers, in hopes that collaborative efforts will result in value-added products. In the value-chain, ingredient vendors normally are first to take advantage of the opportunity.

"When it comes to identifying an ingredient with potential, consumer product companies usually depend on suppliers to develop a novel ingredient or a new use for a current one,"? says Anthony Almada, IMAGINutrition (Laguna Niguel, Calif.). That is why the industry for both traditional and “exotic� ingredients is so robust; innovation occurs at the supplier level, which then must provide ingredients to manufacturers at a tolerable price.

Almada gives examples of where consumer product companies with cutting-edge reputations first obtained a high-profile, novel ingredient. Red Bull (Salzburg, Austria), for example, uses an ingredient (the amino acid taurine) long popular in Japan. Kellogg's USA (Battle Creek, Mich.) patented and utilized the dietary fiber psyllium, an ingredient used in dietary supplements for years. The food industry developed and promoted the health benefits of beta-glucan in oats, but that was “heritage,� charges Almada. That is, the component was already present in food, although true research was required to validate its health benefits.

“I also would argue that it's the same thing in the dietary supplement world,� says Almada. A Solgar or NBTY will wait for a German or East Indian supplier to bring a new ingredient that is safe and effective in humans and that has regulatory approval. Something completely new in the market is very rare. An example would be grape seed extract some 20 years ago when it was first introduced to the U.S. by a wine company, although it was sold in Europe before that, he says.

Milking Genomics

Inspiration for new ingredients goes beyond searching adjacent industries—whether food, pharmaceuticals or dietary supplements—or from other countries. Joseph O'Donnell, Ph.D., executive director with the California Dairy Research Foundation (Davis, Calif.) offers an approach based on genomics that looks to mine the potential of a basic commodity.

“Milk is the only substance designed by nature specifically for the purpose of providing nutrition and health to humans,� says O'Donnell. Other foods are processed (e.g., cooked) to remove toxins and anti-nutritional factors or to provide more optimal nutrition.

“Through milk, nature figured out how to provide us with what we need. It is our challenge to figure out what nature did,� he adds. Bruce German, Ph.D., a University of California-Davis professor, is looking at the human genome and the genome system responsible for milk, with the goal of developing milk-derived dietary components that can influence human physiology, notes O'Donnell. “We are learning which genes 'light up' for specific metabolites. Milk consumption may turn on or create certain metabolites.�

Respondents to the 2003 Prepared Foods R&D Investment Survey indicated that (of the options given) trade publications and trade shows were where they would most likely look for information on new ingredients. (Editor’s Note: No, we did not make that up!)

As milk is digested, its constituents—bioactive components from proteins, for example—are activated in different parts of the GI system and impact physiological functions. Some of these components are multifunctional. For example, lactoferrin carries iron and is also bacteriostatic. “Milk has the most complex triglyceride profile of any fat. What role do they serve?� asks O'Donnell.

Companies now separate protein factions from milk and/or enriching fractions with desirable components. “Product developers will take what we discover and formulate those into foods to provide specific benefits such as peptides to reduce blood pressure, to provide bacteriostatic properties or to influence the immune system.� The human genome is non-proprietary. Much of the nutritional information will not be patented, but published in scientific journals. However, the application of that information, how ingredients can be used in products, will be IP (intellectual property), “ says O'Donnell.

The comment brings up a major frustration of scientists and businessmen alike…how to reap the rewards from well-invested research?

A License to Steal

“We define intellectual property as being in five forms: patents, trademarks, trade secrets, copyrights and ingredient- or product-specific research on a complex composition,� says Almada. IP enables one to exclude competitors from having the ability to compete with the same technology. The stronger the IP is, the stronger the ability to deny use of that technology to others.

“A patent is like a deed to a house,� offers Norm Singer, Ideas Workshop Inc. (Northbrook, Ill.), a researcher who holds some 145 patents or “foreign equivalents.� A patent only gives a company the right to defend its property; it does not actually do so on its own. A strong patent, with a suitable defense, gives a company a period of time in which it is the only game in a marketplace segment.

Hietala agrees and says, “IP protection is important in that, without it, nobody would be willing to invest in research, development and clinical studies.� Its advantage is that it gives the owner time to obtain a return on investment. It is not specifically difficult to obtain a patent; the greater challenge is to bring a product successfully to market before a competing product with parallel benefits is invented.

Patents do not have teeth unless aggressively enforced, says Almada, who also offers advice. Before going to market, have a plan. For example, develop a radar screen to look for IP infringement and decide what to do if someone does so. Relatively inexpensive ways to enforce exist, but they take planning. Examples of preemptive strikes include patent insurance and drafting form letters to send those appearing to infringe on an IP. “You don't have call a lawyer every time,� says Almada. “Publicly scourge those that are infringing. You may be accused of bad-mouthing, but think of the time and money that you have invested.�

Almada suggests other ways to protect IP. For example, Baxter Healthcare (Deerfield, Ill.) could theoretically use a copyright to protect its Pulse brand nutrient-fortified water. “Baxter could do a study on Pulse, but rather than patent the product, they could post the data on their website. “If other companies want to use the same data for a similar product that sells for 35% less, they would be infringing on a copyright,� says Almada. (It would be crucial to put the copyright symbol on the website and register the data with the U.S. copyright office in order to provide maximum teeth in defense of the IP.)

Good analytical chemistry can also help defend a claim for an ingredient or a finished product. For example, if a company shows its dairy protein-, tea- or grape seed-containing health bar—with a clearly defined chemical profile—to have a specific benefit, then others that make a claim that their product (of a different profile) can do the same thing, they have stolen the IP. “Some call this borrowed science, but it really is data piracy since nothing is returned,� says Almada. The company can be taken to court or pursued through the National Advertising Division of the Better Business Bureau, although it is rarely done.

Increased Speed, Decreased Cost

The Regulatory Thing
Food Additive Requirements
New Dietary Ingredient Requirements
Chemical identity and composition including its physical, chemical and biological properties, other impurities, and analytical controls, stability data.
Description of ingredient.
Amount of food additive proposed for use. Level of new dietary ingredient in dietary supplements.
Amount of food additive proposed for use and purposes for what it is proposed, directions regarding proposed use.
Conditions of use recommended on labeling.
Data establishing the food additive will have the intended physical or other technical effect on the characteristics of food.
No requirement.
Description of methods to determine the amount of the food additive in raw, processed or finished food.
No requirement.
Full reports of investigations made with respect to the safety of food additive— reports include detailed data from animal and other biological tests.
History of use or other evidence of safety, including citations to published articles.
Proposed tolerances for food additive, if required to ensure safety.
No requirement.
Ingredient subject to FDA food additive regulation is safe as a matter of law.
Successful new dietary ingredient submission establishes DSHEA compliance—no FDA affirmation ingredient is safe for intended use.
Source: W. Patrick Noonan, www.wpnpc.com

Speed to market while working within monetary constraints is par for the course in developing any new product.

A strategy for more efficient use of funds is to partner with others in the earliest stages of development, when only preliminary data exists. “At that point, you have greater input in the shaping of the maturation and future direction of the product,� says Almada. “It doesn't cost that much to put an ingredient through a 'filter' to show if it potentially is effective and safe at that point.�

In an ingredient's market development, Hietala suggests that an advantage can be made of the fact that regulatory issues differ in various countries. Global markets should be considered in order to gain further evidence of ingredient functionality and experience in consumer markets. “This early learning with a new ingredient is crucial for further development and adaptation,� he says. “Choose markets of first entries that have the best chance of success. The regulatory environment and consumer perception are just two things to consider.�

Of all challenges to be overcome in a novel ingredient's development, one should not lose sight of the customer. “Listen to your consumer target group very closely. Define clearly what you offer and how you will reach them in marketing communication and distribution,� says Hietala. Or, as Singer simply says, “Focus on serving the needs of the consumer.�

On the Web: Ingredient Development