According to one survey, more than half of the American population has heard of omega 3 fatty acids. Most associate it with a health benefit. Formulators are consistently improving taste profiles and solving reflux issues. The science behind it continues to grow. And a health claim has been filed with FDA. In terms of nutraceuticals, this certainly looks like one for the books in terms of what you want to do.

But looks can be deceiving. While the taste of fish oil products has gotten better, a totally deodorized product may or may not exist. And while consumer awareness is high, there is still no recommended daily intake amount in the U.S. And even though the supply/demand situation is in control, fish contamination and purity considerations still must be taken into account. So what's the real story?

The Real Story
The real story is actually a very positive one in the nutraceuticals spectrum. There are few products that have as much strong science behind it as omega 3 fatty acids. According to Charles Hillyer, Vice President of Arista, Wilton, CT, the science behind omega 3's is stellar. "The concern had been if these products do what they're supposed to do. There is so much science now backing up the claims," he said.

Indeed, more than 1000 clinical studies have been completed to date and research continues. The most researched area has been omega 3's and cardiovascular health, with brain and cognitive function close behind. A primary association with omega 3's is the reduction of triglycerides, a risk factor for heart disease, say suppliers. Yet the connection between the two needs to be officially made. According to Paul Paslaski, Senior Marketing Manager, Roche Vitamins, Parsippany, NJ. "Everyone knows that omega 3's reduce triglycerides. We need to have a major organization say this is a risk factor for heart disease. When you go to the doctor, he tells you your triglyceride level and gives recommendations for how to reduce it, but no major health organization has made the formal connection between triglycerides and heart disease."

While cardiovascular health may be the main target, omega 3's are also beneficial in a variety of other areas and the science is growing about these indications as well. A recent Good Morning America segment talked about omega 3 fatty acids as one of the top five factors for aiding brain development. Olaf Sandnes, President of Marine Nutriceutical, Mt. Bethel, PA, commented, "The major indication now is cardiovascular health, but we think 'brain power' and inflammatory conditions represent better long term opportunities. The brain area in particular has developed primarily in the last two years," he said, "but there's more room for growth. In the future I believe we'll see specific fatty acids targeting specific diseases."

In other areas, a study completed recently on bipolar disease is raising awareness in that area. According to Bjorn Rene, Sales and Marketing Director, Pronova, Lysaker, Norway, a few studies about the anti-arrhythmic effect of omega 3 have also been published. "In addition," he said, "in many European countries people suffer from rheumatoid arthritis, which is a big user group since they can easily feel the effect of omega 3's by less morning stiffness and fewer tender joints."

Also commenting was Mark Braman, President and Chief Executive Officer of OmegaTech, Boulder, CO, who said, "While cardiovascular health may be the biggest indication right now, it's moving towards brain and eye health. There's also a larger understanding of the immune benefits."

Attention deficit disorder (ADD) was a condition mentioned by Claire Mullins, Manager-Consumer Relations and Advertising , Martek, Columbia, MD, which sources its DHA from algae rather than from fish sources. "There is a recent book written by Marcia Zimmerman called The ADD Nutrition Solution, which recommends changing the diet and also supplementing with fatty acids," she said. "This makes sense. The brain is 60% fat and the predominant fat is DHA. If there's not enough DHA, it follows that there won't be optimal signal transmissions and thought processes."

Finally, a recent article in the New Jersey Bergen Record (10/11/99) talked about DHA as a therapy for cystic fibrosis. The research, which is being conducted at the Beth Israel Deaconess Medical Center, has only been done on rats to date and involves a purified form of DHA. Human trials could begin early next year, according to the paper.

What Do All The People Know?
As science into omega 3's continues, so does an increase in consumer awareness. Two recent consumer studies conducted by Sloan Trends and Solutions and Gallup (see accompanying sidebar) rate omega 3 awareness and the consensus is that momentum is building. "Omega 3's are becoming very mainstream," said Ms. Mullins. "The average person is becoming more aware of the cardiovascular and cognitive function indications for omega 3's."

Michaela Knupfer, Product Manager, Human Nutrition, BASF Corporation, Mount Olive, NJ, concurred. "There has been an increase in awareness about omega 3's and people associate it with a positive health benefit. You can see this positive development because omega 3's are always in the 'top 10' among hot products in the industry."

Also agreeing was Arista's Mr. Hillyer, who said, "Consumers hear a blurb on TV, then they read something in a newspaper and they start to think, 'maybe I should be taking this.'"

While awareness has increased, the next step is making the connection between omega 3's and a health benefit. According to Jacques Boudreau, Sales and Marketing Manager, Ocean Nutrition, Bedford, Nova Scotia, Canada. "Consumer awareness is increasing significantly, but right now they know that omega 3's are good, but they don't necessarily know why."

And alot may depend on the words you use. According to Mr. Paslaski of Roche-which sponsored the Gallup consumer research study- "there are different perceptions according to the words you choose. If you say fish oil, people associate that more with cognitive function, while omega 3's are associated with cardiovascular health."

"Consumer awareness about benefits over the long haul must be raised," said Ron Lowry, Vice President, Sales and Marketing, SeaTech Bioproducts, Shrewsbury, MA. "This is not a quick panacea for a short term problem. As the next generation grows up, they will be more in tune with this and more open to taking these ingredients as part of the normal regimen."

Globally, the U.S. is behind other world markets, according to BASF's Ms. Knupfer. "The primary most developed market for omega 3's is Asia. They understand the health significance and therefore have omega 3's in everything from yogurt and milk to noodles. After that Europe is next, with the U.S. lagging behind. Even Mexico is getting involved," she said, explaining that Nestle has just introduced an omega 3-enriched milk product. While awareness is increasing, she said, there is still growth to be had. "It's a little difficult because we need to educate the consumer that omega 3's are for long term disease prevention and do not have an immediate effect. It's not like an energy drink that you drink and feel great afterwards. A lot of work still needs to be done to further educate the consumers."

Mr. Paslaski summed up the awareness situation. "This is an emerging business and we've spent years building it before we could work on selling. Roche saw this with beta-carotene and with antioxidants; you have to invest the time and effort. We've been working on the taste and the awareness levels. Now the market is primed and ready."

But What Will The Government Say?
One development that would help in terms of both awareness and education would be the establishment of a dietary reference intake (DRI) for omega 3's. Work is ongoing in this area and currently the Food and Nutrition Board is considering the science. A consensus study sponsored by the International Society of the Study of Fatty Acids and Lipids (ISSFAL) at NIH was held this spring to examine the essentiality of recommended dietary intakes (RDI) for omega 6 and omega 3 fatty acids.

According to Mary Van Elswyk, Director of Scientific Affairs at OmegaTech, speaking at this summer's Nutracon conference, "The study examined the role of essential fatty acids in infant nutrition, cardiovascular disease and mental health. Results of the study stressed the importance of reducing omega 6 fatty acids but determined that there was not enough scientific evidence to establish an estimated average requirement (EAR). Upper limits were established and the addition of principal long chain polyunsaturates AA and DHA to all infant formulas was endorsed. EPA was not recommended for infant formulas."

Ms. Van Elyswick recently provided an update on DRI status. "The results were forwarded to the committee on Lipids, Food and Nutrition Board, which is in the process of forming a committee for DRI evaluation. A chair was selected and this will be included as part of the Committee on Macronutrients. It should be discussed in the spring of 2000."

Obviously the establishment of DRI's would raise the level of credibility of the nutrient in the eyes of the public. While strong science is fine, the American consumer trusts the government to tell it what to eat. "Public exposure with the stamp of a government agency would go a long way toward raising awareness," said Mr. Lowry. "It will then slowly be incorporated into purchasing decisions."

Another area that continues to appear on the omega 3 radar screen is the elusive infant formula market in the U.S. Pronova's Mr. Rene pointed out, "Infant formulas with omega 3's are already available in many countries in Europe and Pacific Rim countries. It's still quite an issue in the U.S. however." Opinions are heated on the infant formula issue. One industry leader commented that the whole situation is a travesty and that the government simply does not want to admit that there is such strong science behind the ingredient that it should have been added years ago, while another suggested that the reason DHA is not being used in U.S. infant formula is political; it has been used successfully in 60 countries with no safety concerns. It remains to be seen what the final decision will be.

Also on the regulatory front for omega 3's is the proposed health claim submitted earlier this year and one of the subjects of the Pearson vs. Shalala decision. Now that the court mandated that FDA must consider this claim, the agency in September issued its official call for science backing the claim linking omega 3 fatty acids and coronary heart disease. The comment period is open until November 22.

Ian Newton, Director-Business Development and Regulatory Affairs at Roche spoke on the proposed health claim at October's CRN conference. According to Mr. Newton, the claim may be approved as either a qualified health claim or a health claim with a disclaimer, "with the former having the best chance of success." Roche has done initial work on potential wording of such claims, said Mr. Newton. For a qualified health claim, he offered, "Diets rich in long chain omega 3 fatty acids reduce serum triglycerides, which may be one factor associated with risk of heart disease," while for a health claim with a disclaimer, Mr. Newton suggested, "While many factors affect heart disease, diets rich in long chain omega 3 fatty acids reduce serum triglycerides, which may be associated with the risk of this disease. The association between LC omega 3 fatty acids and heart disease has yet to be proven conclusively."

Mr. Newton also commented that while the FDA process is one path to a claim, the industry should also be looking for an authoritative statement to be able to then submit a petition under FDAMA. "There are several tracks that could be followed," he commented, "including structure function claims. However," he said, "for a food health claim, FDA needs to issue an approving 'nutrient content' claim."

Food Vs. Supplement
As with any nutraceutical ingredient, the debate about whether it is better in food or supplement form rages on. Here, though, there is much more activity in the functional food area compared to other nutraceutical ingredients. According to BASF's Ms. Knupfer, "I think you'll see omega 3's more in the food area than ever before. There is a trend toward functional foods, mainly in the area of nutrient bars and beverages and I think you're going to see more category-specific products-for the elderly, for athletes, for women and for men."

Several suppliers commented on making omega 3's part of 'center of the plate' nutrition. OmegaTech is perhaps farther along with this concept; the company sells Gold Circle Farms DHA-enriched eggs and is working on several other mainstream food applications for the ingredient, which is actually manufactured from a vegetable (algae) rather than animal source of DHA. "The core strategy with our DHA product line is to restore DHA naturally back into the diet," explained Mr. Braman. "For more than 100 years DHA was found in animals from what they ate; with the domestication of animals it was weaned out of their diet and levels are down considerably. We've found a way to restore levels to the diets of animals and provide healthier products."

In addition to the egg products, said Mr. Braman, "we have also been doing research in Europe for over two years on how to feed cows our algae to enrich milk naturally. We can now produce DHA-enriched milk, cheese, yogurt, butter, etc." The company is just starting to work with producers now for product introductions in early 2000. OmegaTech is also working in the meat category. "We have a number of patents for milk, chicken, beef and pork," he added.

"We believe it will be more accepted by consumers and more easily consumed if it's 'center of the plate' nutrition. We're concentrating on dairy primarily because it's the second largest grocery category, it's a trusted product area and it plays well through the natural enrichment of dairy and eggs. We know once customers understand, they'll continue to buy. We have significant repeat business; it's a convincing story."

Roche's Mr. Paslaski agreed. "Particularly in terms of heart health, people are more apt to believe an ingredient for this indication should be in a meal rather than a snack. They are looking at a more serious product, one that they can build into their lifestyle."

Richard Schoenfeld, Vice President-Oil Marketing, Omega Protein, Barrington, IL-which concentrates on the food segment-commented on the challenges in the food industry. "The biggest issue right now is product stability," he said, "with the biggest complaint continuing to be burping fish flavor. We have worked very hard to improve our refining process and as of January 1999, we believe we've developed a top quality product.

"I think the move into food right now will be a big one," he went on. "We are going to have customers in the retail food market-from salad dressings to beverages-by the end of the first quarter of 2000."

Ms. Mullins of Martek added, "I think in the future we'll see more omega 3's in both foods and supplement form. The functional food market is really great and there's a real trend towards food that is extremely beneficial. You will see omega 3's being added to margarines and drink mixes, for example."

Yet taste and processability concerns remain. "The problem," said Arista's Mr. Hillyer, "is that the oils must be protected from oxygen and handled properly or they will begin to break down. There is a great opportunity in food products but the delivery system needs to be able to protect the product during the shelf life."

"It's a very young marketplace," said SeaTech's Mr. Lowry. "People are concerned about taste and odor and cost is prohibitive for food; there's either not enough in the food form or the food formulation itself makes it cost prohibitive."

Several companies believed that supplements would remain the delivery system of the future. "The main market is supplements," said Marine Nutriceutical's Mr. Sandnes. "Oil tends to go rancid and give off a pungent taste, so it's easier to work with supplements."

Mr. Rene of Pronova concurred. "I think supplements will remain the primary delivery system for omega-3 fatty acids for a long time. It is a big challenge to keep these highly unsaturated fatty acid flavorless and odorless in food products."

Whether in supplement or food form, purity will always be a concern. Yet suppliers report that so far, this has not been a major obstacle. "Contamination can play a role in consumer choices but actually, fish oils are a refined product," said Ocean Nutrition's Mr. Boudreau. "They are cleaner than most of the fish you eat as a meal."

Mr. Paslaski concurred. "This is purified fish oil we're talking about. Actually, purified fish oil is probably cleaner and safer than simply eating fish."