Marketing dietary supplements

As manufacturers are not required to submit safety information before marketing dietary supplements, the FDA must rely on adverse event reports, product sampling. 

Research methodologies must be developed that allow for studying systems as a whole (e.g., using systems theory or multidimensional outcome measures) to determine whether component parts are truly synergisticJ A small step in the right direction has been the creation of four botanical centers by ODS These centers are charged with studying the effects of marketed dietary supplements currently purchased and used by the public, rather than the reductionistic search for a solitary active principle. 

DSHEA) of 1994 defined a dietary supplement as a product taken that contains a dietary ingredient intended to supplement the diet and the dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites. Dietary supplements do not have to be approved by the US Food and Drug Administration (FDA) before marketing. Dietary supplements are not intended to treat or cure disease [9] whereas nutraceuticals more emphasize the expected results of these products, such as prevention or treatment of diseases [10],... 

Most of the thiamine sold worldwide is used for dietary supplements. Primary market areas include the following appHcations addition to feed formulations, eg, poultry, pigs, catde, and fish (see Feeds and feed additives) fortification of refined foods, eg, flours, rice, and cereal products and incorporation into multivitamins. Small amounts are used in medicine to treat deficiency diseases and other conditions, in agriculture as an additive to ferti1i2ers (qv), and in foods as flavorings. Generally for dry formulations, the less soluble, nonhygroscopic nitrate is preferred. Only the hydrochloride can be used for intravenous purposes. Coated thiamine is used where flavor is a factor. 

SRB contains high-quality protein, oil, dietary fiber, polysaccharides, fat-soluble phytochemicals (plant derived bioactive compounds) and other bran nutrients. Rice bran and germ are the richest natural sources of B complex vitamins as well as E vitamins, polyphenols, several antioxidants and minerals. It is now available in the commercial food ingredient market as a safe and effective functional food and dietary supplement. 

Natural and herbal diet pills available in the United States today are considered dietary supplements and are not subject to FDA review prior to being sold. Although these agents may have drug-like activity in the body, they do not need to be proven safe or effective like conventional drugs do. Unlike conventional drugs, natural and herbal diet pills can only be withdrawn from the market when they are proven to be dangerous. As a result, many herbal products reach the market without any scientific evidence that they are safe or effective. These products are discussed in more detail in Chapter 6. 

In February 2004, the FDA withdrew ephedra, one of the most popular dietary supplements, from the market because it finally had enough information to prove that ephedra presented an unreasonable risk of illness or injury under the conditions of use recommended on the product labeling. This withdrawal did not happen until many people suffered from the terrible potential side effects of this supplement (see Chapter 4). 

Thousands of dietary supplements are marketed for the purpose of weight loss. It would be impossible to cover each of these individual products in this chapter. Instead, this chapter will familiarize you with common ingredients found in many dietary supplements. You are encouraged to review ingredients in common dietary supplements for weight loss to understand the potential positive and negative effects of these products. 

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

In contrast to vitamin and mineral products, which are chemically well-defined, the biopharmaceutical quality and behavior of botanical dosage forms marketed as dietary supplements are often not well documented. In most cases,... 

Government agencies have never had sufficient resources to cope with the enormous amount of deception in the marketing of herbs, dietary supplements, and homeopathic products. Dietary Supplement Health and Education Act made the problem worse. Without an adequate law, the FDA cannot curb the deceptive marketing of what DSHEA calls dietary supplements. Regulators have the power to ban homeopathic remedies but have shown no interest in doing so. 

Other dietary supplements and herbal remedies should be held to regulatory standards that are at least as stringent as those for OTC drug products. At the very least, active ingredients should be required to meet standards for purity, content, safety, and some level of effectiveness before they can be marketed. 

Rhoades, R.A., Global corner dietary supplement GMPs and the global market. Update, 6, 41-42, 2001. 

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