On December 21, 2015, the U.S. Food and Drug Administration (FDA) announced the establishment of the Office of Dietary Supplement Programs (ODSP). Until now, dietary supplement programs were a division under the Office of Nutrition Labeling and Dietary Supplements (which will now be known as the Office of Nutrition and Food Labeling).
Why create a new office?
The dietary supplement industry has grown abundantly over the past 20 years, making its way from a $6 billion to a $35 billion dollar industry. Such an industry growth calls for an increased focus on compliance.
“Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.” – FDA
What does this mean for industry?
The creation of the ODSP means an increased focus on the regulation of dietary supplements. Therefore, industry should take additional steps to ensure compliance with FDA regulations to avoid disciplinary action. Dietary supplement manufacturers should ensure they are registered with FDA and avoid using inappropriate claims on supplement labeling that could cause the supplement to be regulated as a drug. For additional important steps, take a look at these 10 things to know before exporting dietary supplements to the United States.
Registrar Corp is an FDA consulting firm and can assist dietary supplement manufacturers to comply with U.S. FDA regulations. We can register your facility with FDA, review your supplement labeling for FDA compliance, conduct mock facility inspections to ensure compliance with dietary supplement good manufacturing practices, and more.
For questions or assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.