At first blush, there's something sinister sounding about companies making cookies for diabetics, salt for people with high blood pressure and gooey pastries aimed at those with cholesterol problems.
Yet these products, some available now and some on the drawing board, are part of a potentially huge market in "nutriceuticals," what the U.S. Food and Drug Administration classifies as "medical foods."
Intended to manage, not cure, specific medical conditions, nutriceuticals are attractively packaged, bite-size portions of medicine that can help control everything from arthritis to heart disease.
For consumers, the new products can be a pleasant way to take required dosages of medicine. Companies manufacturing the nutriceuticals like them because as yet they don't require the rigorous regulatory evaluation given new drugs, meaning the companies can get their products to market much quicker.
One of the first to hit the shelves is NiteBite, made by Medical Foods Inc., of Cambridge, Mass. NiteBite looks like a candy bar with cookie dough texture. The 100-calorie bar contains three sources of glucose -- sucrose, protein and uncooked starch -- and is aimed at the estimated 2.7 million Americans with diabetes who require insulin. It is generally ingested in the evening to prevent nocturnal hypoglycemia, a low blood sugar condition that leads to a rapid pulse, cold clammy skin and can cause neurological damage and diabetic coma.
Dr. R. Armour Forse along with dietitian Stacey J. Bell and immunologist Sambasiva Chavali, who are affiliated with the Beth Israel Deaconess surgical metabolism laboratory, founded Medical Foods and are the brains behind NiteBite, the company's first product.
NiteBite sales have been rising as the company expands its distribution. First sold last year, sales have been climbing monthly from $20,000 in January to $50,000 in March and expectations of $60,000 in April.
"Five years ago we could not have created this company, because the science was not as robust, managed care was just emerging and baby boomers were just starting to take control of their own health," said Bob Jones, Medical Foods executive vice president responsible for marketing, sales and manufacturing.
With just 13 employees, the company is essentially a virtual company, with research at Beth Israel/Deaconess Hospital in Boston and production of its first product by a California food company.
"We want to stay on the small side, by developing partnerships with food and pharmaceutical firms and maintaining our core strength in research and development," said Franklin Loew, Medical Foods' president since January, who spent 13 years as dean of the Tufts School of Veterinary Medicine in Grafton, Mass., and holds a doctorate in both veterinary medicine and nutrition.
Medical Foods has raised $3 million in private placement and expects to close on an additional $3 million in venture capital by the end of this month with plans to add $2 million more by this summer, noted Loew.
"No one really knows the size of the medical food market but it's growing very quickly, in part because baby boomers are getting older and they are looking for innovative ways to control their health plus the boom in alternative medicine and nutritional products," said Thomas D. Aarts, editor and publisher of Nutritional Business Journal.
Big food and drug companies such as Nestle Foods and Bristol-Myers Squibb are reportedly developing food products that function like medicine to treat a variety of conditions.
Medical Foods is among a group of smaller companies trying to get a jump on the giants. Another is AMBI Inc., based in Tarrytown, N.Y., which developed Cardia Salt Alternative for people with high blood pressure. AMBI's $1.3 million in sales in the first three months of this year exceeded management's expectations. Last year the salt was still being tested.
Unlike drugs, which must pass a gantlet of tests by the Food and Drug Administration, nutriceuticals can get to the market relatively quickly. There are no FDA-mandated human clinical trials, although most medical food makers do their own human testing before releasing their products.
And while the FDA does regulate health claims on food labels to ensure that they are accurate and not misleading to consumers, medical foods must meet more specific criteria. For starters, a medical food helps control a disease that cannot be treated through dietary management. Secondly, it must be recommended by a physician even though the products can be put on open drug store shelves.
"What people eat has a great impact on prevention and treatment of disease," said Dr. Isadore Rosenfeld, who has written several books about nutrition and alternative medicine as well as a monthly health column for Vogue. "There are a lot of nutriceuticals, some of which are fine, like NiteBite, but you worry about the gimmicky ones."
Later this year, Medical Foods plans to develop a product containing beta glucan, the key ingredient in nutritional foods for reducing artery-damaging choles- terol.
Beta-glucan is found in oatmeal but in very small quantities -- 0.75 gram in a single serving. Scientific studies published in the Journal of the American Medical Association maintain it takes four times that amount or three grams of beta-glucan per day to reduce cholesterol levels.
Medical Foods is acquiring a concentrated form of beta glucan derived from yeast containing 90 percent of the daily recommended amount for lower cholesterol and hopes to package it in yogurt, ice cream and pastries as well as liquids.
Other areas of research involve a combination of Indian herbs and spices that might be used in a snack bar to reduce painful flare-ups of rheumatoid arthritis.
NiteBite's explosive sales has come from people with diabetes who responded to print advertisements that included a toll-free phone number readers used to call for a free sample or to order the bars at $1 each. Armed with a 10,000-person database of people with diabetes and their addresses, the company then called on pharmacies, both independents and chains, to get them to carry NiteBite.
Several weeks ago, Eckerd Drug agreed to carry NiteBite products at its 1,814 retail pharmacy stores.
Medical Foods' Jones estimates the company will achieve revenues of $5 million this year, in part from growing NiteBite sales and from new products and expected partnerships with large food and pharmaceutical companies.
Pub Date: 4/29/97