What is a dietary supplement? By definition, it is a substance taken by mouth in whatever form (gel, capsule, tablet, powder and more), but is not a food.
It can contain a vitamin, mineral, herb, amino acid, hormone, plant extract or practically anything. It is called a supplement because it is supposed to provide something your diet does not supply in sufficient quantity. The range of ingredients and formulations is enormous.
You can buy supplements almost anywhere, and you don’t need a prescription. There are some legal limits to the claims that can be made on labels of dietary supplements, but in their advertising and especially on the Internet, many products go beyond them and claim medicinal and therapeutic effects.
Polls and surveys show that most consumers have little idea what the rules of the game are. Here are some myths most people believe:
- Supplements are regulated like drugs, and the claims made in ads and on labels are held to a standard of truth and accountability.
- If the label says a supplement contains certain amounts of various ingredients, you can trust it.
- If it is on the drugstore shelf, that means the U.S. Food and Drug Administration (FDA) has approved it.
- The government requires supplements to carry warning labels about potential side effects, and like prescription drugs, supplements can be quickly taken off the market if they cause serious adverse effects.
- The word “natural” on a label means the product is safe.
- When it comes to vitamins, minerals, herbs and other supplements, if a little is good, more will be better.
Unfortunately, all these statements are false.
Pharmaceutical drugs, both prescription and nonprescription, are strictly regulated by the FDA. Drugs must be tested for efficacy and safety before they are sold; potentially harmful side effects must be plainly stated. Drugs must contain what the label says they contain. Generics must meet the same strict equivalency standards as brand-name drugs. Inspections enforce these rules. Yet even all these safeguards don’t prevent some dangerous drugs from getting to market. Pharmaceutical companies have long been required to keep track of and report “adverse events” to the FDA so drugs can be withdrawn quickly from the market, if necessary.
In contrast, supplement manufacturers do not have to prove safety and efficacy of products they want to market; they simply send the FDA a copy of the labels they plan to use. It remains the responsibility of the government (using taxpayers’ money) to demonstrate harm and remove dangerous supplements from the market. Predictably, this has proved hard to do. The task is formidable, and the FDA’s supplements division is underfunded and understaffed. Some members of Congress have been hostile to any proposal to increase the regulation of supplements. Powerful lobbies support the supplements industry.
Building a case against a dangerous supplement can take years. For instance, it took a decade for the FDA to ban the herb ephedra, the active ingredient in many weight-loss products as well as in supplements claiming to enhance athletic performance. In 2003, a 23-year-old baseball player, Steve Bechler, died after taking ephedra. It turned out that one manufacturer, Metabolife, had received more than 14,000 complaints of adverse events from ephedra, but had not reported them to the FDA. In 2004, having concluded that ephedra users are at risk for heart attack, stroke and sudden death, the FDA announced a ban. However, a number of stimulant compounds (such as bitter orange extract) that took the place of ephedra may cause some of the same problems.
Only since 2007 have supplement manufacturers been required to inform the FDA about serious adverse events. Apparently, a relatively small number of problems have been reported, and it’s not clear how well this system is working.