One major difference between OTC drugs and dietary supplements is how they’re regulated and tested.
In general, the FDA considers new drugs to be unsafe until they are proven safe. Any new drug must be approved by the FDA before it can be legally sold in the US. They are subjected to several clinical trials. Clinical trials are studies done under well-controlled conditions on human volunteers. These tests must be done on all drugs – including those that are sold over the counter, or “OTC” (without a prescription). The studies must show “substantial evidence” that the drug is safe and effective for all of its intended uses. Once the drug is approved by the FDA, it must be manufactured under very carefully monitored conditions. It must also be packaged with complete information on the best dose, route, and schedule, and include all of the information below:
- Known side effects
- Unsafe interactions with other drugs
- Conditions the drug has been proven to treat
- Contraindications (special conditions for which the drug should not be used because it may cause harm)
Dietary supplements, however, are not regulated by the FDA. This is because back in 1994 dietary supplements were defined as a food category by the Dietary Supplement Health and Education Act (DSHEA). A dietary supplement is considered “new” if it contains any ingredients that are not recognized as a food substance (unless it was sold as a supplement before October 1994). If a supplement is new, the manufacturer must provide the FDA with reasonable evidence that the new ingredient is safe before the supplement can be marketed to the public. The DSHEA states 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 aren’t any directions on the label). Another difference between supplements and drugs, is that 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 if they are able to prove that the product poses a significant risk to the health of Americans.
Overall, dietary supplements and OTC drugs are different in many ways, and each have their own intended uses. If you’re looking to add dietary supplements to your brand today, contact Sawgrass Nutra Labs to learn more.