Understanding the Properties of Common Dietary Supplements: Clinical Implications for Healthcare Practitioners (Part 1)

Background

- Dietary supplement industry reached >$25 billion in year 2010.

- In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed into law in the United States to establish standards with respect to dietary supplements

- Regulation of the DSHEA is enforced by the Center for Food Safety and Applied Nutrition (CFSAN) under the FDA.

Definition

- According to DSHEA, dietary supplement is defined as a product that is:

1) a concentrate, metabolite, constituent, or extract of a vitamin (ie, vitamin E), mineral (ie, calcium), herb (ie, ginseng), botanical (ie, kava), or amino acid (ie, tryptophan);

2) intended to supplement the diet;

3) intended to be taken by mouth as a pill, powder, capsule, tablet, or liquid; and

4) labelled as a “dietary supplement”

Labeling

(1) A dietary supplement label can make only 1 of 3 claims:

• Nutrient content claims – describe the amount of nutrient contained in a dietary supplement.

• Health claims - describe a relationship between an ingredient of a dietary supplement and reduced risk of disease

• Structure/function claims - describe how components of the dietary supplement affect the structure or function of different parts of the body without mentioning any specific disease (Eg: “calcium helps to build strong bones” is allowed, whereas “calcium reduces the risk of osteoporosis” is not allowed because it mention the role of the nutrient in disease prevention)

(2) Dietary supplement label must also contain the following: “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.”

(3) “Supplement facts” is required:

a) Indicate the name of the product and that the product is intended for use as a supplement.

b) All ingredients must be listed by common name, in descending order by weight.

c) State the appropriate serving size, amount of nutrient per serving size, and percentage of daily value (%DV)

d) Direction of use

(4) Registered business name, and the place of business of the manufacturer, packer or distributor

(5) If the active ingredients is a botanical, the scientific name of the plant or the plant part

used in the preparation must be listed

(6) If the upplement contains a proprietary blend (a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend must be listed by weight in descending order of predominance

Regulation

- Any dietary supplement ingredients sold in the United States prior to 1994 are presumed to be safe based on their historical use and are not regulated by the FDA.

- Dietary supplement after 1994 are required to notify the FDA and provide information on how the product works and how they can determine its safety and efficacy à FDA then decides on whether to allow the product to come to market. Results of scientific studies and trials are not required.

- Once a product is available to consumers, the FDA can only decide to remove the product from the market if it can prove that the product is not safe

- Manufacturers need to adopt current good manufacturing practices (CGMPs) for dietary supplements - to ensure that dietary supplements are processed in a consistent manner as to identity, purity, strength, and composition of products to meet quality standards

Trends in the United States

- Prevalence of dietary supplement use increased from 28-38% in the early 1970s to more than 50% in year 2003

- Use of herbal product (non-vitamin or mineral) rose from 2.5% in 1990 to 1.1% in 1997, an increase of 480%.

- The 10 most common natural products used by adults (in descending order): Fish Oil/Omega 3, Glucosamine, Echinacea, Flaxseed, Ginseng, Combination Herb Pills, Ginkgo Biloba, Chondroitin, Garlic, Coenzyme Q-10

 Complementary and Alternative Medicine (CAM)

- In 2007, approximately 4 in 10 adults reported using some form of CAM therapy

- The National Center for Complementary and Alternative Medicine (NCCAM) defines CAM as

 “a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine.”

a) Complementary medicine refers to “use of CAM together with conventional medicine,”

b) Alternative medicine refers to “use of CAM in place of conventional medicine.”

- CAM modalities are commonly grouped into 2 broad categories:

i) Natural products, defined as “nonvitamin, non-mineral products such as herbs and other products from plants,”

ii) Mind and body medicine, which include meditation, yoga, and other manipulative and body-based practices

- Common Diseases/Conditions for which CAM modalities are used: Pain (back, neck, joint, arthritis), Anxiety, High cholesterol, Prevent/treat colds and infections, Headache & migraine, Insomnia, Improve memory, Improve energy, Promotion good health, Prevent/treat other diseases and illnesses

- CAM use was most prevalent among women, adults aged 50, adults with higher levels of education, and adults with higher annual incomes

Zelig & Radler. Nutr Clin Pract 2012; 27(6): 767-776