Nutraceuticals and the Elderly
(10/29/00)- Many of the biggest companies in the chemical industry have begun to plan for entry into a market that affects the elderly. They are building up sizable businesses in an untraditional market called nutraceuticals. Nutraceuticals involve health-enhancing or disease-preventing products that are not as strictly regulated as the bulk pharmaceutical industry. Have you noticed the amount of products that are now "vitamin enriched" and/or other health related items that are now on the market?
When you go to your neighborhood health food store and buy vitamins, supplements and other nutritional products, you are probably buying products composed of long-chain polyunsaturated fatty acids (PUFAs), or a product that takes advantage of some combination of chemical knowledge and biotechnology expertise. The companies that make the active raw ingredients for these nutraceuticals are also involved in chemical, margarine, grain and plant-derived products. They have always been aware of the potential of the health-product market, but only now are starting to go into it in a big way. Sales indicate that the elderly are the largest users of health care products. Witness all the advertisements targeted to this group. Secondly, the largest growing age category of the population is the elderly. Combining profits with health is very attractive to these chemical companies, especially when they are under attack from environmental groups and could righteously proclaim they are engaged in health- enhancing activity.
Omega -3 and omega –6 fatty acids, less commonly known as docosalhexaenoicacid (DHA) and arachidonic acid (AA), are marketed, long-chain polyunsaturated fatty acids (PUFAs), one of the most common nutraceuticals. DHA can be produced in one of two ways: microbal fermentation and extraction from the oil of fatty fish such as tuna. It is also found in breast milk and is the predominant structural fatty acid in brain gray matter. This opens its use in the infant formula supplementation market as well as in individuals experiencing cognitive decline. One company, Martek, is reported to have signed a nonexclusive PUFA technology licensing agreement with all the major infant formula manufacturers except Nestle. They await approval from the FDA to include this product into the US term infant formula. This would bring the infant formula closer to natural breast milk, a requirement for federal approval.
Two small companies market DHA-rich oils produced by advanced fermentation techniques, while the large firms use fish-oil-based products combined with their knowledge of microencapsulation of the fatty oil along with encapsulated powders. The small companies usually have agreements to get the unrefined product, which they then refine, for consumer distribution. One of these companies makes DHA by fermenting algae, similar to what the fish does naturally. This company linked itself to a division of a very large chemical company, Montsano (since acquired by Pharmacia), that had a large facility to ferment the algae. Part of the agreement allowed the chemical company to market a DHA containing dietary supplement through General Nutrition Company (GNC) stores.
You can expect to see omega fatty oils, not only in infant formula and dietary supplements but also in "functional foods" and beverages stressing that these products provide a health benefit beyond basic nutrition, just like the claims for vitamins. There is a claim before the FDA that these omega fatty oils can provide cardiovascular health. The FDA has yet to rule on this subject.
Another nutritional supplement is lecithin-derived phospholipids, suggested as a way to improve memory. The worldwide leader in lecithin products, Lucas Meyer Group, was bought out by the international chemical industry firm SKW and folded into its bioactives unit. Other nutritional products in this unit include gamma linolenic acid, creatine, pyruvates and phytosterols and some new amino acids. It has been predicted that this product will do $200 million in sales by the year 2003.
Another company, BASF, came out with a nutraceutical blockbuster in 1999 called SAMe (adenosylmethionine), and is one of the country’s best-selling nutritional supplement. It is made via fermentation in Switzerland and then tablets in Italy and then sold directly to the consumer under the label of stores such as GNC and Nature Made.
BASF is searching for a new blockbuster and it thinks it may have it in the product 5-MTHF (5 methyltetrahydrofolate), an ingredient considered to be the biologically active form of the B vitamin folic acid. It is also pursuing new antioxidants and a complement to vitamins C and E and beta-carotene called lycopene. This compound has been shown to reduce the risk of prostate cancer. Roche, the number one vitamin producer, launched its own lycopene in the US in the third quarter of 1999.
Raisio, a Finnish company involved in chemicals, margarine and grain combined with McNeil Consumer Healthcare, to market plant derived stanol esters, extracted from vegetable oils and tall oils, a product of paper pulping. A recent study showed that stanols have a cholesterol-lowering effect and there is a way to combine the otherwise insoluble stanols with vegetable fat to produce an edible product. They are using the Benecol labeling for their products. The FDA has allowed them to state that the product has been proven to lower cholesterol and may lower the risk of heart disease. This is only the 12th ever approval by the FDA to a product to make this claim. The public will have 75 days to make comments and then the claim will start appearing on product labels.
All these products could prove healthier for the individual, but we would hope that there would be effective monitoring of these products so that the consumer gets what is on the label. We have reported in another article on this web site of the varying amounts of the active ingredients found in St John’s Wort. We were recently informed that ConsumerLab.com, an independent testing firm in White Plains, NY, found only six out of 13 retail SAMe products contained the level of the active ingredient indicated on the label.
We would also be concerned about the potential for the "functional food" enhancers to interact with the medications being taken by the elderly and result in synergistic effects not previously seen or reported in the literature. It is imperative for all manufacturers to maintain the highest product quality, and also to be aware of allpotential side effects with medications. The elderly are particularly vulnerable to adverse effects from medications. Nutraceuticals are a new frontier needing continuing excellent science and high standards if they are to take their place in the health armentarium. They will need to monitor the intermediate users of their products in order to protect the consumer.
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, ABD, CRC, Guest Lecturer
posted October 29, 2000
To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com