What is a Dietary Supplement?

  • Defined in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
  • Key parts of the definition
    • Taken by mouth
    • Contains ingredients meant to supplement diet
    • Includes vitamins, minerals, amino acids, herbs, enzymes, organ tissues, metabolites, extracts, and concentrates
    • Many forms (pills, powders, liquids, etc.)
    • Label “d.s.” considered “food” not “drug”

Sales in Billions ($)
The dietary supplement industry is growing at an exponential rate. Dietary supplements aren’t just popular in the United States, but worldwide. In 1990 the industry made just over 3 billion dollars in sales. In 1993 the industry made 4 billion dollars in sales. In 1994 the industry made 8 billion dollars in sales. In 1997 there was 12 billion dollars in sales. By the year 2000 dietary supplements reached 16 billion dollars in sales. This is old data of course as I do not have more recent years, but it’s not hard to see the growth of the industry within the last decade.

How is Dietary Supplements Regulated?
The Food and Drug Administration (FDA) oversees things such as safety, manufacturing procedures, labeling, and packaging inserts. The Federal Trade Commission (FTC) oversees advertising such as infomercials, print advertisements, and much more.

FDA Regulations: Key Protections and Key Limitations
Consumer Protection #1: Supplement businesses must have evidence that there is “no significant risk of illness or injury.”
Limitation: No FDA review of safety data unless a problem arises with the product. (FDA has to then prove that it’s unsafe).

Consumer Protection #2: Must have an ingredient label (“Supplement Facts” label).
Limitation: No rules limit the potency of supplements and the FDA lacks resources to analyze the composition of products.

Consumer Protection #3: Businesses must have scientific evidence to demonstrate that described functions of the supplement are true.
Limitation: Structure-Function statements permitted without prior review by FDA.

Consumer Protection #4: Businesses may not make statements that their product cures, treats, or prevents disease, unless based on explicitly approved FDA health claim (as for foods).
Limitation: Sometimes it is unclear what a “disease” is, there are limited resources for enforcement, and more and more “qualified” health claims are being allowed.

Consumer Protection #5: If a business makes a structure-function claim, it must include a disclaimer on the product label. For example, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Structure-Function (vs. Disease Prevention Statements)

  • Calcium builds strong bones (NOT calcium prevents bone fracture).
  • Vitamin E, an antioxidant, helps maintain cell integrity (NOT vitamin E helps prevent heart attack).
  • XYZ helps promote urinary tract health (NOT protects against urinary tract infections).
  • XYZ helps maintain cholesterol levels already in the normal range (NOT lowers blood cholesterol).
  • XYZ gives you energy and focus throughout your busy day (NOT alleviates depression and attention-deficit disorders).
  • XYZ helps maintain healthy joint function (NOT helps build cartilage and relive the pain of arthritis).

Vitamin and Mineral Supplements
Nutritionists agree that pills are not a substitute for a lousy diet, but…
Pros:

  • Might decrease risk of chronic disease
  • Generally appropriate for:
    • Women of childbearing age (folic acid)
    • Pregnant women
    • Dieters or others with low kcal intakes
    • Vegans
    • People with a poor or monotonous diet
    • People with diagnosed deficiencies
    • People with medical conditions which increase risk of primary or secondary deficiencies

Cons:

  • Potential Toxicities
  • Expensive and may be a waste of money
  • Unknown factors in foods that can’t put in pills
  • Mega doses usually unproven
  • Lack of safety data

Evaluating Supplements
When choosing supplements, beware of many “red flags” that seem untrue or too good to be true. Be sure to look for the “USP” (U.S. Pharmacopeia) on the label of the product as well as the guidelines for strength and purity, which can only be found on a few herbal supplements right now. Remember, when choosing supplements keep in mind that there are no guarantees. Also, make sure you choose something you think will work and try it out. If it doesn’t work, you can also stop taking it and try something else.

Check Out Key Resources

  1. FDA at http://www.cfsan.fda.gov/~dms/supplmnt.html#about
  2. Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/
  3. USP info at http://www.usp.org/
  4. NIH National Center for Complementary and Alternative Medicine http://nccam.nih.gov/
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