Mandatory product registration for supplements may sound innocuous, but it isn’t.
For starters, the National Institutes of Health already has a supplement label database, so mandatory product registration would be a duplicative waste of millions of taxpayer dollars. But the main threat is the way that mandatory product registration would interplay with other FDA regulations, particularly the “new supplement” regulations that have not yet been completed.
Mandatory product registration would give the FDA an easy way to seek out supplements that are not in compliance with the very problematic “new supplement” guidance and remove those products from the market. This guidance is a power grab by the FDA because it creates a drug-like pre-approval system for “new” supplements when the law simply called for a notification system for these products. According to an economic analysis, this could mean more than 41,000 supplements are threatened.
Why are more supplement regulations such a priority for these federal authorities? Supplements are overwhelmingly safe.
According to the FDA, in 2021, the agency received 2,400 adverse event reports related to dietary supplements. To put this in context, according to the FDA’s adverse event database, in 2021 FDA received a total of 2,333,453 adverse event reports. That means that dietary supplements make up 0.1% of the adverse event reports to the FDA. National reports consistently show zero deaths from dietary supplements; according to the FDA’s database, in 2021 alone drugs killed 187,750 Americans. That supplements are the products getting federal attention speaks to the power of the drug industry lobby and the willingness of elected officials and FDA officials to do their bidding.
There is no time
to lose.
We must reach out to Congress and tell them to oppose this policy!
Action Alert!
Write to Congress and tell them to oppose “mandatory filing” for supplements.
Please send your message here immediately.