September 20, 2011
FOR IMMEDIATE RELEASE
Contact: James J. Gormley, VP and Senior Policy Advisor, Citizens for Health
Phone: 202.695.2027; email: jamesgormley01@gmail.com
Washington, D.C. – Citizens for Health (CFH) today launched an action campaign to join with our 100,000 supporters and the rest of the health freedom movement in opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. The agency issued the guidance, mandated by the food “safety” law passed earlier this year, in July, purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.
However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present.
James Gormley, Vice President and Senior Policy Advisor for CFH, notes:
“Quite simply, the FDA is ignoring Section 413 [21 USC §350b] of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which says an NDI submission is not required if ‘there is a history of use or other evidence of safety’ supporting its inclusion, use and marketing prior to 1994. Essentially, the FDA is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of DSHEA.”
Gormley adds:
“In addition, the FDA’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and is in violation of the law on the basis of this alone.”
While much has been written regarding the FDA’s guidance since its introduction, CFH made a strategic decision to “let the dust settle” and do a thorough analysis before adding its voice to the clamor for its withdrawal, given the massive impact to the dietary supplement industry implicit in the guidance. CFH is also calling for the comment period to be extended to July, 2012 so that more industry and policy experts, as well as the public, can be sufficiently heard on the issue. (Industry leaders have succeeded in pressuring the FDA to extend the comment period once already, until December of this year).
Click here to send a letter urging Congress to put pressure on the FDA to withdraw the guidance.
In the coming days and weeks CFH will offer further analysis and talking points on the guidance, as well as opportunities to take action. In fact, CFH will be conferring with consumer advocates and health-food industry leaders this Friday at the Natural Products Expo East trade show in a meeting sponsored by Jarrow Formulas, Inc.
CFH asks you to join them, industry leaders, the health freedom community and concerned Americans everywhere in the campaign to get the guidance withdrawn. Furthermore, ask Congress to rebuke the FDA and demand that the agency state, for the record, that they will no longer attempt to deviate from the plain and intended meaning of DSHEA.
As a health care professional I have witnessed death and severe adverse reactions from medications but NEVER from supplements. The FDA should concentrate on where the huge problem lies and leave supplements alone because they have no education or background to judge them properly. Big pharma comes with lots of money in hand to influence the FDA so they can control supplements which is definitely not in Americans interest. Those at the FDA should be ashamed of the sad cases of those who have suffered from drugs they have approved and mind their business of protecting people from dangerous drugs and not in controlling harmless supplements.
It is ridiculous that anyone of legal age can purchase and consume as much liquor and as many cigarettes as they choose, and yet there is now a war to remove health supplements from the available market.
This is NOT the American I was born into.
Dean M
Just a suggestion. Try to express the problem in simple terms as many folks will not understand what the NDI Guidance entails nor its impact.
We did make the effort to communicate the details of the guidance and its significance for the health freedom community as simply and succinctly as possible, but offered Mr. Gormley’s more detailed summary and analysis for those who wished to dig deeper.
Unfortunately, one of the advantages the folks enshrined at the FDA have over the average American is that they are under no obligation to issue guidance or policy in plain language – so we all have to work to unravel their jargon to understand the potential consequences. This, of course, favors the status quo. (Congress enjoys this same advantage).
We will continue to do our best to present issues and their impacts as clearly and plainly as possible, but there is only so much one can do to simplify the way some policies are communicated.
James Gormley- what is your email address and cell number? Please let me know how that meeting goes with Jarrow Formulas as I won’t be attending Expo East but wish I could be at that meeting. Prior to Friday, I will have sent the following blurb to every vitamin company that will be attending Expo East:
The FDA’s NDI Guidance Document threatens to remove between 20,000 and 42,000 dietary supplements from the market and to put more than 100,000 people out of work. Please file attorney Jonathan Emord’s comments with FDA as your own, and put FDA on notice that if they fail to withdraw the NDI Guidance document, you will back Emord’s lawsuit against them. Learn more and see how to file your comments at http://ymlp.com/zKHqHq
James is already at the Expo, but I forwarded your comment to him via email.
He left the following auto-reply:
Greetings!
I am at the Expo East trade show in Baltimore. Please feel free to call my Google Voice number, which is 202-695-2027.
I am staying at the Holiday Inn Inner Harbor and messages can be left for me there or on my cell.
If you are not at Expo, or are e-mailing in response to the CFH release or the Jarrow-sponsored Industry Leadership Meeting, pls.
provide your e-mail, cell and deadine.
Many thanks!
James J. Gormley
Do not restrict our ability to choose supplements. Votes have consequences for the endorsing members who try to restrict our choices.
It is very important that the drug companies not have a monopoly on the health of Americans.
Please vote to keep the FDA out of Nutritional Supplements.
Freedom of choice,, is our right.. The FDA, has stepped over the line.. Dietary supplements have been around for decades and provide a good way to help impove the health of a great many people.. The FDA is funding by our tax dollars,, if they are going to work for the drug companies, then they should be removed from the tax payers payrole…….
MORE PEOPLE DIE EACH AND EVERY YEAR FROM DRUGS AND THERE SIDE AFFECTS. THE ONLY WAY THE GOVERNMENT CAN GET RID OF MORE PEOPLE IS TO TAKE AWAY HEALTHY CHOICES. CHECK THE BILDERBERG GROUP, HOW MANY HEADS OF COUNTRIES ARE INVOLVED, HAVE BEEN FOR A VERY LONG TIME AND ALSO WHAT THERE PLANS ARE FOR THE POPULATION.