The year 1994 was a big year for vitamins. That year, Congress passed a law commonly known as DSHEA. This law lets vitamins be vitamins…not drugs. It means that vitamins don’t need FDA approval before entering the marketplace.
The law also protects your rights as a consumer. Specifically, the law says:
- The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
- dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.
The years since DSHEA have been filled with innovation and research. We know so much more today about nutrients like vitamins D, vitamin E, and resveratrol than I ever thought possible!
And best of all, today more than 53 percent of Americans take vitamins. And that number only seems to grow with each passing decade.
But the FDA wants to overthrow the DSHEA (or at least strangle it) with a complex set of new guidelines.
And they’re sneaky about it too. The “guidelines” don’t change the law at all. (Any changes to the law would require Congressional approval. And they know they won’t get that!)
No, instead, they go in through the backdoor. They issue “guidelines” to change how business is done in the vitamin world. And if you don’t comply…watch out…they’ll put you out of business in a heartbeat.
Plus, trust me. I’ve read the new guidelines. You need a legal background to understand what they mean.
In the end, I firmly believe the changes — if adopted — will end up hurting you and your family. Innovation will end and it will be much harder (and more costly) to find the vitamins you want.
How the New “Guidelines” Will Strangle the Vitamin Industry
Under current DSHEA law, vitamin companies must submit a letter to the FDA the very FIRST time a new ingredient is used in a supplement. (FDA calls these new ingredients NDIs or “new dietary ingredients.”)
But from there on out…any company in the U.S. that uses the ingredient is in the clear. They can ride on the coattails of the first NDI submitted to the FDA.
But under the new guidelines, the FDA says vitamin companies will need a new NDI disclosure any time and every time they use an ingredient that wasn’t on the market before 1994.
Take resveratrol for example. It entered the market after 1994. And today, you can find it just about everywhere. It’s a very common supplement.
Well, under the new guidelines, every time a company wants to put resveratrol into their formula, they will have to submit another NDI disclosure letter to the FDA.
Plus, these NDI disclosure letters will need to prove that resveratrol is safe for human consumption. According to some legal experts, this means that vitamin companies will need to conduct human safety trials to get a new product past the FDA.
This throws vitamins into the same league as drugs. And let’s not forget it takes 10 years, on average, and $359 million dollars in safety testing to bring a new drug to market.
The Institute of Medicine says approximately 1,000 new dietary supplements enter the market place each year in the United States. But if the new guidelines take effect, this free market enterprise will grind to a halt.
Vitamin makers simply cannot afford to spend millions of dollars to test something they will sell over-the-counter for six bucks a bottle.
And that’s not the only problem…
The FDA plans to expand the definition of an NDI. Under the new regulations, if a company combines two pre-1994 ingredients in a new way, that qualifies as a NDI. Or, if a vitamin is even slightly altered from its 1994 form, that also qualifies as an NDI. So say a supplement company adds just a little more DHA to their formula…BAM…it needs a new NDI disclosure.
On the other hand…
The new guidelines say that synthetic forms of supplements are not NDIs. So if they’re not NDIs, what are they?
The FDA says they will be classified as drugs…and sold ONLY as drugs. According to the Alliance for Natural Health, this could knock out a number of “important supplements currently sold” on the market.
If the FDA adopts these new “guidelines”, I guarantee that many, many supplements will virtually disappear from the shelves. Supplements like CoQ10, curcumin, and resveratrol. That’s because natural supplement companies cannot afford to pay for massive safety testing to sell their products. Nor can they compete with Big Pharma.
Experts say these regulations will cost the American economy between $20 and $30 billion dollars a year in lost revenue!
So Here’s What You Can Do — TODAY!
Earlier this month, one vitamin maker filed a Freedom of Information Act with the FDA to get to the bottom of the agency’s “about-face” on dietary supplements.
Why do we need a sudden overhaul of a good law that protects consumers and vitamin makers? Are we missing something?
Has the largest vitamin maker in the United States been plagued with recalls? (No, that would be Johnson & Johnson scrambling to get millions of OTC meds off the shelves.) Did a popular vitamin start to cause liver failure in men and women who took too much of it? (Nope. That would be acetaminophen.)
I wouldn’t be surprised at all if the investigation turns up lots of dirty laundry.
In any case, I urge you to take action. Tell the FDA to leave your vitamins alone! Here are a few things you can do today:
1. Visit the Alliance for National Health’s website at anh-usa.org. The website will give you more information about how the FDA’s new interpretation of these regulations could destroy the supplement industry. You’ll also find phone numbers, email addresses, and sample letters for contacting your DC representatives about these harmful policies.
2. Write, call, or email you Congressional representatives opposing the new draft guidance.
3. Leave a comment for the FDA opposing the new guidelines at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0079. You have until December 2 to leave a comment.
Dr. Allan Spreen
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