A brief overview of dietary supplement ingredient regulation in the United States

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In 1994 the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA, Public law 103-417, October 25, 1994, 103rd Congress). This law modified the Food, Drug, and Cosmetic Act and expanded the definition of dietary supplements to include botanical ingredients, hormones, and a diverse array of related products in addition to vitamins and minerals. The DSHEA also specified the role of the United States Food and Drug Administration (FDA) in regulating dietary supplements, mandated the creation of a Presidential Commission on Dietary Supplement Labeling, and authorized the establishment of the Office of Dietary Supplements at the National Institutes of Health (NIH). The main elements of the definition of dietary supplements from the DSHEA are listed in Box 1.1.

For products that are regulated by the FDA, the 'intended use' of a product or ingredient is the turnkey that determines whether an item is broadly classified as a food or a drug. Dietary supplements, no matter how they are presented, if intended to be used to supplement the diet, are reviewed by the Office of Special Nutritionals and related offices in the Center for Food Safety and Applied Nutrition (CFSAN) at FDA. The DSHEA included a number of provisions that apply to dietary supplements alone. As a result of the DSHEA the pre-market safety evaluations that are required for new food ingredients or new uses of approved food ingredients do not apply to dietary supplements. The DSHEA authorized the FDA to establish good manufacturing practice (GMP) guidelines for dietary supplements and dietary supplement ingredients and the DSHEA provided guidelines for the display of literature used to market dietary supplement products (Box 1.1).

When a manufacturer wishes to market a dietary supplement or dietary supplement ingredient, they must submit information attesting to the safety of the new ingredient to the FDA 75 days prior to the product's availability. This petition must indicate that the ingredient does not present a significant risk of illness or injury based on the conditions of use specified on the product label. This DSHEA-based process for dietary supplements differs from the requirements for food additives and new food products, ingredients, or uses for food ingredients. These products must be reviewed through FDA's pre-market approval process, which includes the submission to FDA of the results from a specified array of safety studies. Once a dietary supplement is on the shelf, for the FDA to take action it must demonstrate that the product or its ingredients are unsafe. Since the passage of the DSHEA, there have been a number of instances in which the FDA has taken direct public action regarding ingredients that

A dietary supplement can be:

• a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

— a vitamin, mineral, amino acid, herb or other botanical; OR

— a dietary substance for use to supplement the diet by increasing the total dietary intake; OR

— a concentrate, metabolite, constituent, extract or combination of any ingredient described above;

• intended for ingestion in the form of a capsule, powder, softgel or gelcap; and not represented as a conventional food or as a sole item of a meal or the diet.

Box 1.1 Key elements of the definition of a dietary supplement from the DSHEA

are marketed as dietary supplements. One early example occurred in 1997 when the FDA requested manufacturers to limit the amount of ephedrine alkaloids in dietary supplements as a result of reports of adverse events including cases of reported heart attacks, strokes, seizures, and death. Also in 1997, the presence of the harmful herb Digitalis lanata as a contaminant in selected batches of a herbal product containing plantain, resulted in the industry and FDA joining forces to identify and remove the contaminated products from stores nationwide (Slifman et al., 1998).

Both manufacturers and the FDA have been moving forward to assure the safety of dietary supplements. While the FDA has made progress to fulfil the mandates of the DSHEA regarding guidance, labelling, and GMPs, most companies have begun to self-regulate their products and adopt the same good manufacturing practises used for foods. To aid this effort, the American Herbal Products Association (AHPA), a trade association composed of growers, processors, manufacturers and marketers of herbal products, developed a reference book that pulls together in one place the published safety information on over 600 herbs commercially available in the United States (AHPA, 1997).

Of particular concern to the consumer is that botanical supplements and supplement ingredients are derived from plant materials that may be grown throughout the world and shipped to the United States for capsulation and packaging. Collection and processing of natural plant materials introduces additional concerns that need to be addressed for good consumer information on the quality of the products. There are plant variables such as identification of the plant species, the plant part (young leaf versus mature leaf, stem, etc.), the presence of potentially toxic pesticide residues, and purity concerns such as the potential for contamination with bacteria, fungal growths, etc. There are manufacturing variables, including the processing of the plant material, extraction procedures, product formulation, and product packaging (exposure to light). Also to be considered are post-manufacturing variables, including appropriate shipping and product stability during storage or on the shelf. A shelf-life designation is not required for dietary supplements.

The Presidential Commission on Dietary Supplement Labeling issued its report in 1997 and the resulting labelling requirements for dietary supplements went into effect on 23 March 1999. The label is modelled after the label on food products and includes a 'Supplement Facts' box of specified size that must include information about the serving size, amount of primary ingredient, other ingredients in descending order and the name and contact information of the supplier. The identity of the product, net quantity and any structure—function claims for the product are elsewhere on the label. If the manufacturer chooses to include a structure—function claim, there must also then be the disclaimer: 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.'

A structure—function claim on a dietary supplement is a statement about how the product may affect the structure or function of the body. A structure—function claim that is used as an example by the FDA is 'Calcium builds strong bones'. Another that might be used related to the functioning of the body is 'Amino acids are essential for normal brain functioning'. Structure—function claims do not have to be approved by the FDA.

In contrast, health claims on products must be authorized by the FDA. Health claims link the product or ingredients in the product, whether food or supplements, to a disease or health condition. The FDA has authorized a number of health claims for foods, several of which may be used for dietary supplements if the product meets the minimum content requirements. At present, health claims can be found on supplements if they include a sufficient quantity of calcium, folic acid, oat bran and Psyllium seed husk. These claims may associate calcium with the reduction in risk of osteoporosis, folic acid with reduction in risk of neural tube defects, oat bran with reduction in cholesterol levels, and Psyllium husk fibre with reduction in risk of heart disease.

While the steps for handling the regulatory process for supplements are evolving, there have been product classes introduced into the market that further confuse the picture. Standard snack foods such as potato chips have been marketed with added botanical ingredients such as ginseng, kava kava, etc. Beverages, performanceenhancement food bars, and teas also boast the addition of botanical ingredients with structure—function claims on the products. According to the DSHEA definition of dietary supplement, most of these products are foods with non-regulated food additives incorporated into them. However, most are being marketed as dietary supplements.

As an example, on 26 October 1999 the FDA authorized the use of health claims for soy protein in reducing the risk of coronary heart disease (CHD) through cholesterol lowering. To qualify for the health claim the food item must include 6.25 grams of soy protein per serving. This amount is based on the assumption of four servings per day and because 25 grams per day have been shown to significantly lower cholesterol. This health claim is an example of one in which the amount of soy protein in the product may result in health claims for dietary supplement food products such as snack bars, beverages, etc. How the FDA will continue to regulate these types of products as well as the growing market of functional foods remains to be seen. It appears, however, that the approach of 'intended use' may no longer be a clear turnkey for distinguishing among the ever-evolving array of products that are blurring the distinctions between food, drug and dietary supplements.

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