| FDA Ready To Make Scores Of Supplements Illegal To Purchase In The U.S.
1. On Your Mark - The FDA Is At It Again!
2. Get Set - To Act
3. Go - Contact Your Congress Persons!
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 It's the FDA's "New Dietary Ingredient (NDI) Draft Guidance".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 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! We, the public, have until Friday, December 2nd, 2011!!!! |
