|FDA Questions "It-Won't-Hurt" Philosophy|
What is considered a dietary
According to the FDA:
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. 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. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement."
Sales of dietary supplements have soared in
recent years, growing from $2 billion in 1982 to an astounding $15.4 billion in
1999. Because conflicting information abounds, and many people tend to think,
"Even if a product may not help me, it at least won't hurt me," the FDA (Food
and Drug Administration) has set up a collection of tips and resources to help
dietary supplement consumers become "savvy supplement users."
Before taking supplements, consider:
- Dietary supplements are not meant to replace the balance of a healthy diet. You can get too much of some nutrients, so it is important to consider your diet as a whole.
- Always check with your doctor and/or pharmacist before taking supplements. The active ingredients in many supplements have strong biological effects, and may not be safe for all users. In fact, some supplements can put you at risk if you have certain medical conditions or are taking certain medications. Remember, supplements are actually drugs as drugs are strictly defined.
- Some supplements may interact with prescription and over-the-counter medications. The combination may render either the medications ineffective. The combination can also, in some cases, produce dangerous side effects.
- Be especially careful to talk to your doctor about supplements well before having any kind of surgery. Many surgeons recommend discontinuing some supplements two to three weeks prior to surgery.
- Does it sound "too good to be true?" If it does, be skeptical until you have verifiable information.
- Beware of the latest headlines. Remember, that a single study tells us little. A larger body of evidence is needed. There is seldom any such thing as a "quick fix."
Question typical assumptions:
- "Natural is safe." Keep in mind that the term "natural" is not well defined, and it's use does not necessarily mean a product is safe.
- "It might not help, but it can't hurt." This is far from true. All chemicals, including nutrients, plants, and other biologically active ingredients can be harmful in combination with other products, in certain health conditions, if taken for too long, or taken to quantities too large.
- "A product recall ensures that all similar harmful products will be recalled." Recalls of dietary supplements are voluntary. One cannot assume that a single recall will result in the recall of all such products.
"If there are no warnings on the label,
the product is safe." Dietary supplements are not regulated as drugs are.
Manufacturer may not necessarily print warnings of adverse effects on the
labels. If you have questions, contact the manufacturer directly. The FDA
recommends asking these questions:
- What information does the firm have to substantiate the claims made for the product? Be aware that sometimes firms supply so-called "proof" of their claims by citing undocumented reports from satisfied consumers, or "internal" graphs and charts that could be mistaken for evidence-based research.
- Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?
- Does the firm have a quality control system in place to determine if the product actually contains what is stated on the label and is free of contaminants?
- Has the firm received any adverse events reports from consumers using their products?
1 U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition, "Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information." January, 2002.