Background: In 1999, an estimated $5 billion was spent on herbal products, dietary supplements and literature about these products. This is an enormous jump from the $467 million spent in 1990. Since the Dietary Supplement Health and Education Act (DHSEA) of 1994 was passed, there has been an explosion of herbal and dietary supplements added to the market. It has been estimated that 50% of the population in the United States uses supplements daily (FDA Consumer 1998;32(6)).
Dietary Supplement Health and Education Act of 1994: The DSHEA supplies the legal framework for regulating dietary supplements. Before 1994, supplements were considered food and regulated to ensure safety and wholesomeness. This also guaranteed that food labeling was truthful and not misleading. Under the DSHEA, herbal products can be sold as dietary supplements as long as health or therapeutic claims are not stated on their labels. Prescription and OTC medications must undergo clinical studies to determine efficacy and safety prior to marketing; however the Food and Drug Administration (FDA) does not authorize or test dietary supplements.
Definition: A dietary supplement is a product intended to supplement the diet that contains “vitamins, minerals, herbs or other botanicals, amino acids, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.”
Labeling Requirements: Manufacturers are required to include the words “dietary supplement” on product labels and all of the following:
· Statement of identity (e.g., "St.
John’s Wort")
· Net quantity of contents (e.g.,
"60 capsules")
· Structure-function claim (e.g.,
“Helps improve mood”)
· 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."
· Directions for use (e.g., "Take
one capsule daily.")
· Supplement Facts panel (lists
serving size, amount, and active ingredient)
· Other ingredients in descending
order of amount, by common name or proprietary blend
· Name and place of business of
manufacturer, packer or distributor
Efficacy and “Structure-Function” Claims:
A primary difference between the labeling and advertising of dietary supplements
compared to drugs is the claims that dietary supplements are allowed to
make. Supplements cannot be advertised as a treatment or
cure for a specific disease or condition. The following are examples
of disease claims and are not legal for supplement advertising because
claims are directly linked to a recognizable disease state:
"Protective against the development of
cancer."
"Reduces the pain and stiffness associated
with arthritis.”
Supplements are allowed to make reference
to the product’s effect on the body’s structure or function, including
its overall effect on a person’s well being. Examples of permitted
structure/function claims:
"Reduces stress and frustration."
"Improves absentmindedness."
Safety of Supplements: The FDA requires manufacturers to show a supplement is “generally recognized as safe” before marketing to the public. Once a product is marketed, the FDA is responsible for showing that a supplement is unsafe before any action can be taken to restrict it’s use. The fact that a supplement is known to be toxic does not ensure removal from the market. When the FDA concludes that a supplement is dangerous, it will often issue a warning rather than a ban. An example of attempted restrictions is a proposed action to limit the amount of ephedrine alkaloids (a.k.a. Ma huang, ephedra) in supplements and provide warnings to consumers about the risks of these products (FDA Consumer 1998;32(6)).
Manufacturing Quality Concerns: The FDA is also responsible for regulating the manufacturing practices of supplements. Requirements for manufacturing supplements are currently the same as for packaging food items, but are very different from manufacturing prescription and OTC medications. Manufacturers of supplements who register with the FDA must follow current good manufacturing practices, but registration is not mandatory and many supplement manufacturers are not registered. Herbal supplements are also unique because growing, harvesting, storage and extraction processes can cause great variability between batches of the end product. Identifying the “active” ingredient in a supplement can also lead to inconsistency. The root of a particular plant may be the ingredient that has a pharmaceutical action, but the end product may include all parts of the plant. Adulterants have also been identified in some supplements, including pesticides, arsenic, steroids and digoxin (Pharm Lett Detail 141101, 1998). The United States Pharmacopeia (USP) is a non-profit, private group that sets the legally recognized standards for identity, strength, quality, purity, packaging and labeling of drugs and supplements. The best reassurance of quality and guaranteed ingredients in a supplement are the letters "USP" on the label. (Press release. The United States Pharmacopeial Convention, Inc. 1999.)
Cautions and Possible Fraud Indicators Patients and providers should be on the lookout for fraudulent products. These are supplements that do not do what they claim or do not contain the ingredients listed on the label. These supplements can range from a waste of money to causing harm to the patient (Barrett S. http://www.quackwatch.com, Tyler VE. The Honest Herbal. 4th Edition. 1999). Be aware of the following possible fraud indicators:
· Products that claim to “cure”
a wide range of unrelated diseases.
· Products that claim to be backed
by scientific studies, but have no list of references or references that
are inadequate.
· Accusations that the government,
pharmaceutical companies and the medical profession are suppressing the
truth about a particular treatment.
· Products that are a “miracle
cure”, “breakthrough” or “new discovery”.
If the product were actually a cure for a serious disease it would be used by health care providers and widely reported by the media.
Reporting Adverse Reactions with Supplements The FDA’s Medwatch program has a database of adverse reactions linked to herbs. Healthcare providers can report possible reactions to herbal and dietary supplements to the FDA at 1-800-FDA-1088 or online at http://vm.cfsan.fda.gov/~dms/aems.html.
Rational Dietary and Herbal Supplement Choices Patients should consider the following before using herbal products or dietary supplements:
· Always inform health care providers
of any supplements being taken. Drug interactions are possible
with any supplements and should be evaluated before starting any new product.
· Remember that “natural” doesn’t
guarantee safety.
· Consider the manufacturer or
distributor. A nationally known food and drug company is more likely
to have tight quality controls in place.
· Be aware that it takes approximately
three months to determine if any change in a person’s condition is due
to the “placebo effect” or the supplement’s actual effects.
Conclusions More people are using herbal and dietary supplements. Please advise your physician of any and all supplements you are takiing as there may be potential interactions with prescription medications. Please choose the sources of your supplements carefully to ensure the presence and quality of the ingredients of the supplement. Please consider product claims with “a grain of salt” to avoid being defrauded.