FDA Regulation of Drugs vs. Dietary Supplements

by Christine Hronec

According to the Food and Drug Administration, all prescription and non-prescription drugs are regulated in the United, where dietary supplements are regulated like special foods. Since supplements are not considered drugs, they aren’t put through the same strict safety and efficacy testing as drugs are. Regardless of whether or not you need a prescription to purchase a specific drug, that drug must be proven safe and effective before clearance for pre-market approval whereas supplements do not.

Drugs are considered unsafe until proven safe

The FDA considers new drugs to be unsafe until they are proven safe by clinical trials. In addition, any new drug must be FDA approved before it can be legally sold in the United States. The approval process required by the FDA consists of a series of clinical trials (controlled studies performed on human volunteers). The purpose of these studies is to gather substantial evidence that the drug is both safe and effective for each of its intended uses. Once the drug receives FDA clearance, manufacturers of the drug must pass a rigid set of regulations and compliance protocols to ensure that the product is made under carefully monitored conditions. In addition, the FDA requires that the packaging includes the following information:

  • Dosage
  • Route of Administration
  • Recommended Schedule
  • Conditions the drug has been proven to treat
  • Known Side Effects
  • Contraindications (special conditions under which using the drug should not be used because it would cause too much risk)
  • Unsafe interactions with other drugs

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. This means that 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. Manufacturers are not required to test new ingredients or supplements in clinical trials. 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.

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