Vitamins, Nutraceutical Manufacturing and Dietary Supplements
Nutraceutical, a portmanteau of the words “nutrition” and “pharmaceutical”, is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. Health Canada defines the term as “a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical is demonstrated to have a physiological benefit or provide protection against chronic disease.”Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. With recent developments in cellular-level nutraceutical agents, researchers, and medical practitioners are developing templates for integrating and assessing information from clinical studies on complementary and alternative therapies into responsible medical practice. The term nutraceutical was originally defined by Dr. Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine (FIM), Crawford, New Jersey.Since the term was coined by Dr. DeFelice, its meaning has been modified by Health Canada which defines nutraceutical as: a product isolated or purified from foods, and generally sold in medicinal forms not usually associated with food and demonstrated to have a physiological benefit or provide protection against chronic disease. Examples are beta-carotene and lycopene.The definition of nutraceutical that appears in the latest edition of the Merriam-Webster Dictionary is as follows: A food stuff (as a fortified food or a dietary supplement) that provides health benefits. Nutraceutical foods are not subject to the same testing and regulations as pharmaceutical drugs. The American Nutraceutical Association works with the Food & Drug Administration in consumer education, developing industry and scientific standards for products and manufacturers, and other related consumer protection roles.
Nutraceuticals is a broad umbrella term used to describe any product derived from food sources that provides extra health benefits in addition to the basic nutritional value found in foods. Products typically claim to prevent chronic diseases, improve health, delay the aging process, and increase life expectancy.
There is minimal regulation over which products are allowed to display the nutraceutical term on their labels. Because of this, the term is often used to market products with varying uses and effectiveness. The definition of nutraceuticals and related products often depend on the source. Members of the medical community desire that the nutraceutical term be more clearly established in order to distinguish between the wide varieties of products out there.There are multiple different types of products that may fall under the category of nutraceuticals.
A dietary supplement is a product that contains nutrients derived from food products that are concentrated in liquid or capsule form. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined generally what constitutes a dietary supplement. “A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”
Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing. Although supplements claim to provide health benefits, products usually include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Functional foods are designed to allow consumers to eat enriched foods close to their natural state, rather than by taking dietary supplements manufactured in liquid or capsule form. Functional foods have been either enriched or fortified, a process called nutrification. This practice restores the nutrient content in a food back to similar levels from before the food was processed. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.
Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.”In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally-occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.
Medical foods aren’t available as an over-the-counter product to consumers. The FDA considers medical foods to be “formulated to be consumed or administered internally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, on the basis of recognized scientific principles, are established by medical evaluation.” Nutraceuticals and supplements do not meet these requirements and are not classified as Medical Foods.
Medical foods can be ingested through the mouth or through tube feeding. Medical foods are always designed to meet certain nutritional requirements for people diagnosed with specific illnesses. Medical foods are regulated by the FDA and will be prescribed/monitored by medical supervision.
The following is an incomplete list of foods with reported medicinal value:
* Antioxidants: resveratrol from red grape products; flavonoids inside citrus, tea, wine, and dark chocolate foods; anthocyanins found in berries, Vitamin C
* Reducing hypercholesterolemia:soluble dietary fiber products, such as psyllium seed husk
* Cancer prevention: broccoli (sulforaphane) fiddleheads (Matteuccia Struthiopteus)
* Improved arterial health: soy or clover (isoflavonoids)
* Lowered risk of cardiovascular disease: alpha-linolenic acid from flax or chia seeds, Omega 3 fatty acids in fish oil.
In addition, many botanical and herbal extracts such as ginseng, garlic oil, etc. have been developed as nutraceuticals. Nutraceuticals are often used in nutrient premixes or nutrient systems in the food and pharmaceutical industries.