The FDA on Monday announced the creation of the Office of Dietary Supplement Programs (ODSP), a development that will greatly improve its ability to police the dietary supplements industry. Prior to this, the regulation of dietary supplements was run through a division of a larger office (which is now becoming the Office of Nutrition and Food labeling). As a division of a larger office, it did not have independent leadership, and competed with other divisions within that office for the funds and manpower needed to regulate dietary supplements under Federal regulations 21 CFR Part 111.
I have been calling for this move for years now. Congress did an excellent job signing into law FDA 21 CFR Part 111 regulation for manufacturing, packaging, labeling and holding of dietary supplements back in 2008. The laws are strong and effective and will protect consumers if they can be enforced. The only problem was that the division in charge of these regulations was given inadequate funding to enforce them. In other words, the FDA had the bark but not the bite.
As the new Office of Dietary Supplements, it will now have its own leadership focusing solely on Dietary Supplement Regulation along with its own budget directed from Congress. This is great news for you as consumers because it means much more enforcement of the regulations that are meant to protect you is coming.
I applaud this move by the FDA. I’ll be telling you more about this soon. - Mark G.
