I wanted to share this with my readers since every time a dangerous anti-supplement bill is introduced I want my readers to have the tools to fight it with all they have. This means writing your representatives and telling them how you feel, and that you want them to vote down this dangerous proposal so you can enjoy any supplement you want, unencumbered with high costs and limited availability that surely would occur if supplements were limited by senseless acts of bureaucracy.
Senator Durbin has just reintroduced S. 1425, the Dietary Supplement Labeling Act. As your constituent, I ask you to oppose this very dangerous legislation.
The bill requires that the FDA, together with the Institute of Medicine, compile a list of dietary ingredients ( supplements) that could possibly lead to adverse events or are otherwise deemed risky in some way — based on completely arbitrary or nonexistent standards. Moreover, once an ingredient or supplement is on the list, there is no clear process to challenge the FDA and IOM determination, not even if new or contradictory evidence comes to light.
Sen. Durbin has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.” If that’s the case, the senator should be pleased to know that each of those things is already against the law! In fact, almost all of the bill’s provisions are already covered by existing law, and the few that aren’t covered are so vague that they could mean whatever the FDA wants them to mean.
DSHEA, the Nutrition Labeling and Education Act, GMP standards, and the Fair Packaging and Labeling Act all ensure the safety of nutritional supplements and provide guidelines for clear and comprehensive labeling. This bill uses vague language to create extraneous red tape, paperwork, and burdensome labeling requirements, when everything the bill mandates other than its new and entirely arbitrary disapproval process is already being accomplished under current law! What is needed is enforcement, not new legislation.
This bill may also have far-reaching consequences. For example, if the FDA and IOM draw up their arbitrary list of “safe” supplements and amounts — such as no vitamin D in amounts greater than 4000 IU — as provided for in this bill, more therapeutic supplement doses or preparations would never meet the new hurdle set by the FDA’s guidance on New Dietary Ingredients, if that is allowed to go forward.
The Dietary Supplement Labeling Act gives government agencies the right to say no to safe and healthful nutritional supplements on unknown and completely arbitrary grounds. It’s a naked FDA power grab, an attempt to move us one step closer to a full FDA pre-approval system for supplements. This could all have a profoundly negative impact on our nation’s health and our healthcare costs.
For one thing, it would make supplements insanely expensive, like drugs — if you could get them at all. The cost of pre-approval for supplements would be so prohibitive for producers that most supplements would simply disappear from the shelf. Let’s not forget that the average cost for drug pre-approval has reached $1 billion and that supplements, unlike drugs, have no patent protection.
Please oppose the Dietary Supplement Labeling Act!