drmichaelroth@juno.com
214-707-3878
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Welcome Friends!
Ever since I was in chiropractic school, there have been reports about the government's and FDA's efforts to control the supplement industry and reduce your freedom to make your own nutrition choices. While part of their effort is to safeguard the public from fraud and/or contamination of unsafe manufacturing processes, lately a couple more motives come to mind: control and greed.
Without delving into those darker areas of regulation, I wanted to share with you the latest measure to try and regulate (i.e., control) what you choose to consume for your health. This particular draft guidance is certainly making the rounds online, but it's important for you to be aware of exactly what is going on and what you can and should do to protect your freedom of choice.
Below are the highlights, including some links so you can easily contact your state reps to voice your opinion.
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Highlights
- The FDA's new Draft Guidance on New Dietary Ingredients threatens to remove some of the most commonly used supplements from the market.
- Supplement companies will be forced to conduct expensive safety studies with unusually high ingredient doses, forcing many out of business and decreasing the competition against pharmaceutical companies.
- The FDA guidelines for supplements are similar to those for food additives which is in direct violation of DSHEA, which classifies dietary supplements as foods, not additives.
- Defend your right to continue using supplements by taking action now!
15 years ago, people were so upset with the FDA's meddling that they became very proactive resulting in Congress passing a law prohibiting the FDA from banning popular nutrients. However a loophole in the 1994 law allowed the FDA to regulate "new" ingredients introduced after October 15, 1994. So after 17 years, the FDA has just issued proposals as to how it intends to regulate what it now calls "new dietary ingredients". If implemented, some of the most effective nutrients you are taking will be removed from the market. Here is the actual FDA Draft Guidance on New Dietary Ingredients (NDI's): FDA Draft Guidance In order to receive approval, the FDA will require manufacturers to conduct very expensive studies using very high doses of new dietary supplements. According to the new guidelines, the FDA believes that "new dietary supplements" must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives - in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives. This limitation would lower the amounts of beneficial and safe dietary supplements, such as fish oil for example, to useless levels. |
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Pharmaceutical Industry Profit Threatened
By Low Cost Supplements
The FDA claim basically is requesting unreasonable and expensive testing to "protect consumers" from unsafe supplements. These safety thresholds are in excess of even those required by dangerous pharmaceutical drugs!
According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6% were pharmaceutical drugs. This compares to only 0.8% for all dietary supplements combined!
There is, of course, a massive financial benefit for the drug industry if the proposed guidelines are enforced by the FDA. They will force the price of many supplements to soar, while removing many effective ones altogether. This will result in more reliance on side-effect-laden prescription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.
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What can we do?
Since this could effect us all, it's important to take measures to defend our right to continue using supplements that our very lives depend on, and to gain access to new, safe, natural ingredients. I ask each one of you contact your representatives by following this link: Contact Your Representatives Before you click on the "Log a Call" links on the above page, you'll see a link at the bottom where you can e mail the senators in addition to or instead of calling. It reads: "Click here to email your legislators!" The email letter is already formatted and ready to go. I've already sent mine in and if you value your freedom to choose your own supplements, you should too. If you decide to make a call also, make sure that you: - Give your name.
- Express your concern about the new FDA draft guidance on dietary supplements and ingredients.
- Request that Congress hold hearings and take action to review the FDA's draft guidance and stop their overreach of power.
- Thank them for their time.
Remember, there's power in numbers. They are counting on us to stand by and do nothing. Let's prove them wrong. The good news is that I've heard back from Ga. State Senator Johnny Isakson who informed me that the law still needs funding before it can be fully implemented and he is doing what he can to block funding for the provisions of the bill.
And rest assured that we at Drucker Labs will continue to lead the fight to keep bringing you the best carbon-bond supplements in the world!
I thank you once again for your time, for your friendship and for your devotion to good health! May God protect our freedoms! Yours in good health, Dr. Mike drmichaelroth@juno.com 214-707-3878 www.SomaHealth.Net |
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