The FDA has drafted a proposal to regulate what it calls New Dietary Ingredients. If this proposal is implemented, some of the most effective nutrients you take will be pulled from the market.
If passed, this New Dietary Ingredient guideline can define ALMOST ANYTHING as a “new” dietary ingredient. For example:
If a supplement includes more of an ingredient than was used 17 years ago–even if it is the same ingredient–it’s” new”.
If an ingredient uses a different extraction process–it’s” new”.
If a supplement uses an ingredient at a different “life state” such as using ripe rather than non-ripe apples–it’s “new”.
If a supplement duplicates an ingredient in a laboratory rather than extracting it from food–even though it’s chemically identical–it’s “new”.
If a probiotic formula includes a strain of bacteria that wasn’t found in yogurt 17 years ago, it’s “new”.
So what would happen to all these “new” ingredient? The manufacturers would have to take them off the market until they could PROVE the ingredients are safe–even if those ingredients have been safely used for 17 years!
WHY IT’S NEARLY IMPOSSIBLE TO COMPLY
What kind of proof is the FDA demanding in these new guidelines? They want animal conducted studies using a dosage that’s 1,000 times the typical dose for a full year. If a company uses the same ingredient as another company, it doesn’t matter, both companies must perform the same test studies. An average study costs between $100,00-$200.00 to perform per ingredient. Multiply that by several ingredients in several products and you get an idea of the entire burden of cost the FDA is demanding.
Few supplement companies will be able to afford these studies so many companies will be put out of business. Those companies that do survive will be at the mercy of the FDA’s whims. Interestingly there are NO REQUIREMENTS for the FDA to approve anything. They can approve or reject anything they want and historically they have rejected the majority of ingredients submitted to them.
What this means is that MOST OF THE NUTRIENTS YOU BUY TODAY WILL BE PULLED FROM THE MARKET and never return. Those that do return will be a lot more expensive or only offered as a prescription drug.
This is a blatant abuse of power and the freedom of choice! Current law states that the FDA has to PROVE a dietary supplement is unsafe before it can be taken off of the market. These new guidelines are an end-run around existing law and should be stopped.
December 1, 2011 is the deadline for public comment on this law. The only way it can be defeated is to TALK and WRITE to the people you have elected to represent you–your congressman and your U.S. Senators. They have the power to reign in the FDA and have done it in the past when enough voters have complained.
Go to: www.usa.gov/Contact/Elected.shtml. This web address is case sensitive. Type it exactly as it appears. On the web site look up the phone numbers of your U.S. Senators and your Representative (congressman) and their addresses. Then give them a call and follow up with a letter.
Don’t be shy with your opinions or feelings. The job of the staffers who answer is to listen politely and to relay what you say to their boss. PLEASE CALL, BE POLITE, AND TAKE ACTION AND DON’T FORGET TO ALSO WRITE!!
Then send the same letter you have written to your senators and congressman to President Obama. His address is at the same web site www.usa.gov/Contact/Elected.shtml. Please don’t make the mistake thinking the FDA won’t take away your supplements. Similar regulations have been passed in other countries and the results are disastrous. In some cases it decimated the entire supplement industry in some countries.
Consider the following points when writing and talking to your representatives:
1. I request Congress direct the FDA to review their draft guidance. If they do not amend the guidance to reflect my concerns, I request Congress call hearings at the end of the review process. I also call on Congress to write legislation that would “grandfather” all supplements currently on the market.
2. The FDA already has ample regulatory authority to take action against a product if it’s unsafe. They don’t need to have this pre-approval power too.
3. Supplements have an unrivaled safety record. Statistics show they’re safer than drugs, safer than medical devices, safer than cosmetics, and even safer than food in some cases.
4. The FDA wants to wipe out 17 years’ worth of innovation and 17 years’ worth of benefits to the consumer after doing nothing about new dietary ingredients for the past 17 years. Why now?
5. The FDA cannot define New Dietary Ingredients so broadly as defined in the new guidelines. These new guidelines put almost everything as a New Dietary Ingredient which will strangle innovation and deprive consumers of the supplements they depend on for their health.
6. When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients. The FDA is turning this into a pre-approval scheme, which goes against the intent of the law.
7. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care. This could be disastrous to public health.
8. The cost of complying with these new guidelines will put many companies out of business. The economy is already hurting and we have high unemployment. Experts estimate that this could cost the economy tens of billions of dollars and result in the loss of tens of thousands of jobs.
9. The government’s resources are already stretched. We have record budget deficits and record debt. Why enact more regulations when there are NO safety issues here?
Please, please take action now. There is only a small window of opportunity to make your voice heard. Get started by going to www.usa.gov/Contact/Elected.shtml.
Dr. Janeel Henderson