FDA regulation of drugs versus dietary supplements

All prescription and non-prescription drugs are regulated in the United States by the Food and Drug Administration (FDA). But dietary supplements are treated more like special foods.

Because supplements aren’t considered drugs, they aren’t put through the same strict safety and effectiveness requirements that drugs are. So all the drugs you can buy, even without a prescription, must be proven safe and effective – but supplements do not.

Drugs are considered unsafe until proven safe

In general, the FDA considers new drugs to be unsafe until they are proven safe by clinical trials. And the FDA must approve any new drug before it can be legally sold in the United States. Clinical trials are studies done under well-controlled conditions on human volunteers. These tests must be done even on all drugs – even those that are sold over the counter (without a prescription). The FDA approval process requires that the drug be proven in a series of clinical trials. These studies must show “substantial evidence” that the drug is both safe and effective for each of its intended uses.

Once the FDA approves the drug, it must be manufactured under carefully monitored conditions and packaged with complete information on the best dose, route, and schedule. The package information must also include:

Once the general public is using a new drug, the FDA follows up on any ill effects patients and their doctors report (see the section, “How to report adverse reactions”). The drug company is required to file information they get about side effects as well. This data helps ensure that any side effects not seen in the clinical trials will eventually be found and tracked for the safety of other people.

Dietary supplements are considered safe until proven unsafe

In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise. The DSHEA says that dietary supplements cannot contain anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with normal use if there are no directions on the label.

A dietary supplement is considered “new” if it contains an ingredient not recognized as a food substance, unless it was sold as a supplement before October 1994. The manufacturer must provide the FDA with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public.

But manufacturers are not required to test new ingredients or supplements in clinical trials, which would help find risks and potential interactions with drugs or other substances. The DSHEA gives the FDA permission to stop a company from making a dietary supplement, but only when the FDA proves that the product poses a significant risk to the health of Americans. They are found unsafe only after they cause harm. This approach is the reverse of the way prescription and non-prescription drugs are treated.

Dietary supplements are usually self-prescribed, so there is no controlled system for reporting bad reactions and side effects. Doctors and patients can report problems, but are not required to do so. If a supplement has unknown side effects or interactions with other drugs, foods, or supplements, they are not likely to be discovered as quickly as those of new drugs on the market.

What kinds of problems have there been with supplements and herbs?

Many dietary supplements have clean safety histories. For instance, millions of people take multi-vitamins safely and have no ill effects. Many manufacturers are very careful with their claims, labeling, and the ingredients they use in their products.

But since they became widely available in 1994, the FDA has found problems with some dietary supplements. Products like herbs were sometimes tainted with germs, pesticides, or toxic heavy metals. Other supplements did not contain what was listed on the label. Still others contained more or less than the amount listed on the label.

A more recent trend is extra ingredients in supplements. Some “herbal” supplements have been found to contain prescription drugs or other compounds that are not listed on their labels. For example, some supplement ads are targeted to men as “enhancers” or muscle builders. Certain of these so-called “supplements” have been found to contain substances much like Viagra^® or Cialis^®, and have been recalled. “Prostate health” supplements have been found to contain terazosin, a prescription drug used to treat the symptoms of an enlarged prostate. Other ads target women and tout the supplement as an aid to weight loss. Some of these “weight loss supplements” contained the weight loss drug sibutramine, which was banned in the United States because of the risk of heart attack and stroke. The supplement makers recall these only after they have been found to have these illegal additives. The FDA can also seize these drugs and prosecute the companies who make them.

These kinds of extras can cause serious health issues for people who take the supplement. There are also risks of mystery drug interactions because the person doesn’t know that he or she is taking a drug.

Despite all these issues, the FDA is not legally responsible for the safety of dietary supplements; the manufacturers are. The manufacturers are also responsible for what is in them, and being sure the contents are the same from one pill or package to another. The FDA only looks into problems or safety hazards. To find out more about what is in a supplement, the manufacturer is your first contact.

To avoid tainted supplements, don’t buy any of these: