A rare win for consumers as the FDA gets a public scolding

Got to love it!

I have some good news. This is apparently a victorious moment for everyone who takes dietary supplements.

I say “apparently” because I’m also talking about the FDA and Congress. You can never really be sure what’s going on with these two nests of snakes.

But we do have reason for optimism. And you’re a big part of that.

Thanks to you, me, and many others, Congress rebuffed an FDA attempt to impose harsh new controls over dietary supplements. And the frosting on the cake: the FDA also got a public scolding.

You’ve got to love THAT!

Imprudent course of action

Last November, I told you about the FDA revised guidelines for new dietary ingredients (NDI). These proposed guidelines would put severe new restraints on dietary supplement makers. Many supplements would vanish from the market. New supplements would be much harder to bring to market.

In the end, the FDA action would chill the supplement industry. Supplies would dwindle. Supplement makers would need to charge higher prices to meet FDA demands. Many companies would simply go out of business.

In short, the guidelines read like a drug industry wish list. If you’re a drug maker, what better way to sideline competition, right? Get your cronies at the FDA to impose harsh new rules and regs.

That’s why I asked you to join me in writing to the FDA and our representatives in Congress. And it now appears that all our efforts were successful. At least for the moment.

After Congress heard from us, FDA officials heard from Congress.

Just a few days ago, several members of the House Energy & Commerce Committee sent a letter to the FDA. The letter calls for a “significant reworking” of the NDI guidance, because it “appears to undermine” DSHEA “in a number of critical respects.”

DSHEA is the Dietary Supplement Health and Education Act of 1994. DSHEA put regulations in place to keep the FDA from overstepping its bounds. So the committee’s letter basically said, “We already took care of this. This is our turf. Back off.”

But the committee wasn’t quite finished.

Here’s another quote from the letter… “Imposing these regulatory requirements on products that have a long history of safe use will increase costs on manufacturers at a time when we should be encouraging, rather than hindering their efforts.”

That’s just stunning! And the subtext is clear: “This is ridiculous. Are you out of your minds?”

And here’s the slammer… “Given the FDA’s current workload, it does not seem prudent to follow this course of action.”

Hysterical! Allow me to translate one more time… “You have MORE than enough to do, FDA. Get back to work and regulate something that actually NEEDS regulating.”

This is a little bit hard to process. I’m actually experiencing a warm feeling about Congress.

Okay — back to reality.

No doubt, this letter is a solid win for our side. But notice that the committee members didn’t tell the FDA to drop this topic forever. They asked for a “significant reworking.”

That means it’s still alive. And it means the FDA will regroup and develop another strategy. They’ve been trying to put the screws to dietary supplements for decades. One letter from Congress isn’t going to bring that to a halt.

But it is empowering to know that we played a part in this victory. We raised our voices. Congress heard us and took action.

Best of all, the next time this comes up, there will be no question about how powerful we can be when we all work together.

Sources: 
“House Energy & Commerce Committee Members Call on FDA to ‘Re-examine’ NDI Draft Guidance” Stephen Daniells, NutraIngredients-USA, 3/30/12, nutraingredients-usa.com