A bill sponsored by Senators Durbin (D-IL) and Braun (R-IN) — S. 4090, the Dietary Supplement Listing Act — mandates a federal registry of all food supplements, citing safety, while the Senate HELP Committee also seeks mandatory product registration in must-pass prescription drug user fee legislation S. 4348 (FDASLA).
These concerns are overblown, the proposed solutions draconian. Why treat an overwhelmingly safe food category as inherently dangerous? Multivitamins, vitamin C, calcium, fish oil and common nutrients are nontoxic, with few safety concerns. Sen. Durbin uses Adverse Event Reports (AERs) as justification; though he knows they are defined as associative, not proof of a causal relationship, with supplements among the safest food categories.
If there’s a safety issue, FDA already has authority to ban products, but now seeks to duplicate NIH’s huge dietary supplement label database in a wasteful agency rivalry.
S. 4090 imposes large fines — and jail — for lacking advance bureaucratic permission to market any supplement, even vitamin C; adding red tape and inflationary costs.
Since the stated concern is FDA’s lack of enforcement actions, how does a duplicative but expansive new mandate solve that persistent agency problem? Think: would new laws lowering the speed limit and requiring drivers to keep unvetted mileage logs stop speeders, or is enforcement the real answer for lawbreakers?
The dietary supplement industry supported laws giving FDA authority over ingredients, labels, Good Manufacturing Practices, food safety, facility registration, AERs, steroids and allergen labeling. But we oppose universal pre-market approval.
Why are dietary supplements targeted for onerous new regulation, strangling innovation and consumer needs? If safety is the issue, why shouldn’t far riskier food categories — allergens and food poisoning — also need pre-market approval, with their employees targeted for prosecution? Please oppose these punitive bills targeting an overwhelmingly safe product category for no justifiable reason.
Neil Edward Levin
Bloomingdale
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