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Save Our Supplements Occupy The FDA
FDA Ready To Make Scores Of Supplements
Illegal To Purchase In The U.S.
In July, the FDA lost its collective mind. Let’s trust that we can stop them before real damage is done: done to us, the supplement-purchasing public; done to the natural products industry; and done to the possibility of good health for everybody.
What Is It?
It’s the FDA’s “New Dietary Ingredient (NDI) Draft Guidance”. More clearly, it’s proposed guidelines for the natural products industry to follow in bringing new dietary ingredients onto the market. (Of course, there are already guidelines. They have been followed diligently for the last 17 years.)
What Does It Do?
It changes the requirements for bringing new supplements to market. In 1994, due to tremendous public pressure, Congress passed the Dietary Suuplement Health and Education Act. Commonly referred to as “DSHEA” [d’shay], that law has protected supplements from the FDA unless the feds can prove the supplement isn’t safe. The FDA is taking advantage of a loophole in DSHEA, allowing it to regulate new ingredients introduced after October 15, 1994.
What’s The Big Deal?
 Here it is. The FDA is changing the definition of the word “new”. In addition, they are reversing the burden of proof onto the manufacturers. The proposed new means:
• When a supplement includes more of an ingredient than was used 17 years ago, it becomes “new” 1…
• When an ingredient is produced using a different extraction process than previously…
• When a supplement contains an ingredient at a different “life stage”, say a ripe rather than unripe fruit…
• When a supplement contains an ingredient that has been duplicated in a lab rather than extracting it from food – even though it’s chemically identical…
• Last, if a probiotic formula contains a strain of bacteria that wasn’t found in yogurt 17 years ago, it becomes a new ingredient and subject to testing.
Ingredients which actually are new are covered also. This includes ingredients like resveratrol, ubiquinol, curcuminoids, vitamin E factors, and the jillion phtyo nutrients.
What Kind Of Proof Is The FDA Demanding?
Manufacturers are mandated to:
 1) go back to the lab for a year AND
2) conduct animal studies using a dosage that’s 1,000 times the typical dose!!! Not kidding, folks. In a recent example, a fish oil manufacturer would have to conduct a one-year study, force-feeding animals the human equivalent of 240,000 mg of fish oil daily. It doesn’t take a PhD to realize that these amounts are bound to harm the animals, resulting in an excuse for the FDA to pull the product from the market.
If the study happened to pass, other manufacturers could not ride the victory. Rather, they are each required to run their own studies on their particular products. Further, the studies are expensive, running from $100,000 to $200,000 per ingredient. If a company has 6 products with 6 “new” ingredients in each, that company is looking at a bill of at least $3.6 million. Some larger companies could be looking at testing more than 50 products, each of them containing other new ingredients. Yikes!
It’s obvious that this is a blatant abuse of power by the FDA. The agency is making an end run around existing law.
What Can We Do?
 SPEAK UP!!! We can win this! Sign A Petition! We, the public, have until Friday, December 2, to comment on this proposal. (Put a move on it BUT don’t sweat the deadline. If enough of us continue to clamber to our Congress persons, notice will be taken.) In an unhappy country, a non-partisan issue against health choice is not a stand Congress is going to make. But the individual congress people need to be aware of how we feel.
Contact Your Congress Persons! Go to www.usa.gov/Contact/Elected.shtml. (Case sensitive.) Look up your Senators and Representative, and give them a call. Some polite staffer will take the call and relate your concerns to your elected officials.
Here is a possible script and talking points:
• My name is _________. I am a constituent of _________.
• I am concerned about the FDA’s NDI draft guidance on dietary supplements.
• Mention that the draft guidance (referred to as “The Proposal”) allows the FDA to remove scores of useful supplements from the shelves unless the manufacturers spend millions to avoid this happening.
• Note that these are supplements that have been used safely over the last 17 years. (In fact, in the last four years there has been only one supplement-related death, while Vioxx alone is known to have killed 26,000 people.)
• We already have DSHEA which has worked fine for 17 years.
• A major concern is that The Proposal allows the FDA to limit access to preventive health care.
• Lastly, if accepted, the FDA will also be delivering an economic blow to an already beaten down economy.
Joanna Shepherd Bailey, PhD, an expert in assessing the impact of regulation, has written that The Proposal would cause “approximately 50 percent of dietary supplements currently on the market to be unlawful to sell. [Further, it] could cause more than 100,000 people in the industry to lose their jobs, and revenue losses would be in the billions.”
Let’s get on it, folks. Playing the “Is It Healthy?” Game sometimes looks like being an advocate for your own health. We don’t need a big hit to our personal health care programs. Nor do we need more injustice and even greater loss of freedom of choice. Being Healthy Works!!!!
Siri Khalsa,
Editor in Chief, Nutrition News
1 Thus, if one of your favorite formulas increased the amount of vitamin C say from 30 to 60 mg, vitamin C becomes “new”. 
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