The new webpage, called Supplement Your Knowledge, includes informational sheets advising the public about what to consider when purchasing or prescribing supplements, warnings about safe usage, and information about how FDA regulates supplements.
A new page on FDA’s website aims to educate consumers, educators, and healthcare practitioners about what to consider when purchasing or prescribing supplements, including warnings about safe usage and information about how FDA regulates supplements. The new page, called “Supplement Your Knowledge,” launched yesterday.
Of note, the information sheets downloadable from the webpage include one titled “Dietary Supplements: How FDA Helps Keep You Safe.” In this, FDA states that the Dietary Supplement Health and Education Act of 1994 created regulations for supplements. It also states, “FDA does not have the authority to approve dietary supplements for safety and effectiveness or their labeling before they are sold in stores or online…Dietary supplement companies can introduce new dietary supplements to the market without receiving approval from FDA. In fact, they often can introduce dietary supplements to the market without even notifying FDA.”
It continues: “Even though FDA does not approve dietary supplements, there are product manufacturing and labeling requirements in place that supplement companies are required to follow. FDA oversees the dietary supplement marketplace by: Periodically inspecting dietary supplement manufacturing facilities to verify that companies are meeting all manufacturing and labeling requirements, [and] monitoring adverse event reports and complaints received from industry, healthcare professionals, and consumers.” It then notes that FDA can act against unsafe or noncompliant products by requiring voluntary recalls or removing a product from the market.
Other materials on the new FDA resource page advise consumers about the risks (such as risks of drug-supplement contraindications) and tell consumers how they can report serious adverse events. They also encourage patients to discuss supplement usage with their healthcare providers.
The resources also point out the benefits of dietary supplements, noting: “Dietary supplements can help you improve or maintain your overall health, and some supplements can also help you meet your daily requirements of essential nutrients.” But, FDA notes, supplements should not substitute a healthy diet.
In an FDA press release announcing the new initiative, Douglas Stearn, deputy director for regulatory affairs in FDA’s Center for Food Safety and Applied Nutrition, stated: “Dietary supplements can be valuable to your health but taking some supplements can also involve health risks. It’s important for consumers to have a comprehensive understanding about dietary supplements as well as the ability to identify and safely use supplements that are beneficial to their health. These Supplement Your Knowledge resources will help provide consumers and healthcare professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”