Fabricant on NDI draft guidance: Thanks for your 146,000 pages of comments. We’ll get back to you…

By Elaine Watson

- Last updated on GMT

Related tags Draft guidance Food and drug administration Dietary supplement

Fabricant: DSHEA is ‘pretty explicit’ that NDI submissions are for supplements, not ingredients
Fabricant: DSHEA is ‘pretty explicit’ that NDI submissions are for supplements, not ingredients
Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.

During a webinar hosted by the United Natural Products Alliance (UNPA), Dr Fabricant thanked stakeholders for their comments – all 146,000 pages of them – but continued to defend the document's most controveral points.

He acknowledged that many commentators wanted him to tear up the document and start again, but implied this was firmly off the table: “Withdrawal is certainly somewhat unique, especially when it is a draft guidance and the purpose of a draft is for receiving comment.”

Given the large number of comments submitted (7,000 unique entries), the FDA could not yet give a timeline for what happened next, he added. "The timeline is really up in the air."

DSHEA is ‘pretty explicit’ that NDI submissions are for supplements

On the contentious issue of whether NDI notifications should be for ingredients or supplements, he said that the Dietary Supplement Health and Education Act (DSHEA) was “pretty explicit​” on this point.

The “plain reading​” of DSHEA is that NDI notifications must show reasonable evidence of the safety of dietary supplements containing NDIs, and not just the NDI itself, he insisted.

However, an ingredients supplier could submit this information about finished supplements, he said. “Maybe the burden is met by the supplier. Maybe they submitted for a broad range of use with other ingredients and other amounts of that ingredient?

“There are examples in the docket where ingredients suppliers have submitted for a broad range of use with that ingredient and also uses of that ingredient with other ingredients across a broad range of use ​[in end products].”

Guidance vs law

He repeatedly stressed that the draft guidance did “not establish legally enforceable rights and responsibilities​” (although UNPA president Loren Israelsen did note that it had already been cited in civil litigation this week over the use of DMMA in supplements​).

With this in mind, the agency was “more than willing to discuss alternative approaches​ [to meeting the requirements laid out in the statute]" he said.

The numbers don't add up

Interestingly, few respondents commenting on the draft guidance addressed what Fabricant said was the elephant in the room on this issue.

“If you look at the numbers​ [NDI submissions vs the number of supplements introduced to the market since 1994], it would appear there is a significant lag in compliance.

“I think this is critical and ​[yet] it wasn’t really an underlying theme in the comments.”

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Posted by Suzanne Shelton,

We're still in "wait and see mode" after the comment period ended. This headline says it all, for now, but it's pretty clear the FDA has a fight on its hands with the radical steps they are proposing in the draft guidance.

What makes the headline perfect is how beautifully it captured the undercurrent of the conversation.

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I have sued the FDA andDOJ and you should too!

Posted by Rev. Truman Berst,

Americans for FDA reform
FDA and DOJ Complaint #11-6338-HO has been filed in Federal Court October 26th 2011

December 21th , 2011
By Rev. Truman Berst
Founder/President/Master Herbalist - Good Shepherd Ministries/ALTERNATIVE Health & Herbs REMEDIES, a nonprofit. Founder/President of Americans for FDA Reform a nonprofit.
The Food and Drug Administration, FDA, refuses to accept medicine, as large as its benefit and strong as its healing power may be, that is not man-made and synthetic, but will gladly support producers of harmful and addicting prescription drugs. Unless the product brings in vast revenue for the pharmaceutical industry, it is unacceptable to the FDA, and what is unacceptable to the FDA is unacceptable FOR the entire population – no matter the case, no exceptions. Since natural medicine, such as herbs and vitamins, is unacceptable to the FDA, they want the producers – WE herbalists, naturopaths, and health food store owners – to stop encouraging the use of such substances and to shut down our businesses, despite all of the people that we help on a daily basis. This is unfair and unconstitutional. We should have the freedom to dispense what is naturally grown in a garden, such as herbs, or synthesized by the human body, such as vitamins and enzymes, or not, such as minerals and amino acids. We do not intend to harm, only to help, yet the FDA labels us criminals.
This is where I come in – my name is Truman Berst. I have been a master herbalist for over 50 years, and am the founder of ALTERNATIVE Health & Herbs REMEDIES, a Christian nonprofit, small, family-run herbal manufacturer in Albany, Oregon. For 35 years I have actively fought with the FDA to educate people about natural remedies, and manufacturer herbal products. Now, in 2011, I have decided to take this fight to a different setting – the courtroom. I am suing the FDA and DOJ for every Americans right to Medical Freedom, Religious freedom, and to not have to live under Repressive Food and Drug Laws.

You must be aware the recent tactic of the FDA and DOJ is to send 17 pages (more or less) of threats against any herbalist or health food reseller that calls herbs food, despite historical, traditional, and scientific evidence that herbs and supplements are foods and they are GOOD FOR YOUR HEALTH. FDA and DOJ say(s) “herbs and supplements are drugs if they are good for your health” and if herbalists, health food stores, or anyone they want to target, WILL NOT SIGN AN ADMISSION OF GUILT, they will bring the full force of a federal law suit against them, closing them immediately from manufacturing health food products or selling them, and LATER if the store or herbalist does everything they demand, and spends countless hours making every change that refers to the actual value of the herb or supplement and, they must have at least $100,000.00 to defend themselves from the FDA and DOJ. Also, if I was stupid or intimidated enough to sign a false admission of guilt, then, I get to pay the mafia style FDA agents $25 per hour, per agent, to harass me and cause business disruptions until I am out of business. No business can operate under such government tyranny and that is their goal. THE LAW OF THE LAND IS HARMING ITS OWN PEOPLE FOR GREEDY DRUG MANUFACTURERS. The scales of justice are weighted down with greed and graft.

I have filed a complaint in United States District Court with Summons to Josh Burke, U.S. Food & Drug Administration, and U.S. Department of Justice, with certified notice to Eric H. Holder, Jr., U.S. Attorney General. The American people must be alerted that the FDA and DOJ have declared war on health foods, and me personally. I will respond with radio and TV media interviews, USP, and internet mailings to health food stores and others, and an internet blog, , as well as any other avenues available to alert the American people of this gross misuse of government power and travesty of justice.

CLICK HERE TO VIEW THE CASE AND OUR LEGAL STRATEGY: https://www.healthherbs.com/my-complaint-against-fda-doj.html


The DOJ is truly the Department of Injustice.
The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun
September 13, 2011
By James J. Gormley,
Vice President and Senior Policy Advisor, Citizens for Health

According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.
U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.
I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone — calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) — could reduce healthcare costs by over $24 billion.
These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements — such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on —- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.
Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.
It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.
Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.
Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.
The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.
Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.
In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:
• Citizens for Health (http://www.citizens.org);
• Alliance for Natural Health (http://www.anh-usa.org);
• Your Voice for Health (http://www.yvfh.org/about);
• Operation Pushback (http://www.operationpushback.com); and others.
I invite all of you to join with and support the critical work being done and about to be rolled out over the coming weeks.
While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.
While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.
Our defining health-freedom battle of the first century of this new millennium has begun.
CLICK HERE TO VIEW THE CASE AND OUR LEGAL STRATEGY: https://www.healthherbs.com/my-complaint-against-fda-doj.html


May the Grace of our Lord Jesus Christ, the love of God, and the sweet
fellowship of the Holy Spirit be with you now and forever more, Amen.

Merry Christmas, Happy Holidays and Happy New Year!

Rev.Truman Berst
Master Herbalist for over 50 years
Corporation Sole

a nonprofit of Good Shepherd Ministries
an Evangelical Christian Ministry
425 Jackson Street SE
Albany, OR 97321

1-541-791-8401 fax

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FDA is out of touch with reality

Posted by Tim,

The reason why the industry has not filed the ten's of thousands of NDIN's that Fabricant expects is because they only considered filing for NEW DIETARY INGREDIENTS, NOT NEW DIETARY SUPPLEMENTS. Fabricant fails to consider this, yet is it THE primary reason why there are so few NDIN's to date.

If they would just listen to the people that they've asked to comment, they'd easily see that. It seems to me like they asked for comments just so that they could ignore them (particularly the most important and oft repeated ones) and tell us how smart and important they are.

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