New Dietary Ingredients (NDIs) | Alliance for Natural Health USA - Protecting Natural Health

Is the New Attack on Brain Health Supplements Putting Thousands of Other Supplements at Risk?

Tue, 27 Oct 2015 19:29:24 +0000

There are plenty of reason to wonder. Action Alerts!
As we revealed in our related story, the attack on picamilon (a safe supplement combining the natural substances GABA and vitamin B3) spearheaded by the attorney general of Oregon, with the assistance of Sen. Claire McCaskill (D-MO), has likely been orchestrated by the US Food and Drug Administration. Since the FDA has full power to move against any supplement, what is going on here?
To get to the bottom of this, you have to know about the agency’s recent treatment of new dietary ingredients (NDIs) —or, in other words, new supplements. You can read our previous coverage for context, but this pertains to a section of the Dietary Supplement Health and Education Act (DSHEA) that deals with how the FDA is to treat NDIs. In DSHEA, “new” means a supplement or ingredient that appeared on the market after 1994.
A few years ago, the FDA released a very bad draft guidance that, if enacted, would have eliminated thousands of supplements from the market in the blink of an eye. Essentially, the agency wrote an extremely restrictive definition of what would be considered a “new” supplement, and created an onerous set of regulations—including something akin to a pre-approval system—for “new” supplements to be allowed.
Remember, too, that drug companies can gain market exclusivity on dietary ingredients by filing investigational new drug (IND) applications before an NDI is filed. A parallel FDA guidance will accelerate this process, making a bad situation even worse and eliminating consumer access to affordable nutrients. This has happened before, most recently in the case of the pyridoxamine form of vitamin B6.
The FDA agreed to revise this bad NDI draft guidance in 2012 after substantial pushback from ANH-USA members and others, and the agency has been working on a revised guidance ever since. This means that supplement companies are in the dark about how to comply properly with DSHEA’s NDI provision.
This is part of what makes the Oregon AG’s lawsuit so troubling—thousands of “new supplements” (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal “drugs” or “unlawful dietary ingredients” despite the fact that the FDA won’t say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products—products that consumers rely on—vulnerable to similar assaults.
Action Alerts! If you haven’t taken action already, click the button below to tell the Oregon AG, the FDA, and Sen. McCaskill that this lawsuit sets a very dangerous precedent.

The post Is the New Attack on Brain Health Supplements Putting Thousands of Other Supplements at Risk? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Congressional Committee to FDA: Listen to ANH-USA and the Supplement Community!

Tue, 18 Jun 2013 19:00:07 +0000

The committee that controls FDA’s purse strings is now turning up the pressure. Will we see change at last? Action Alert!

The House Agriculture Appropriations Committee has released a report that, among other things, chastises the FDA for stalling on the second draft of their New Dietary Ingredient (NDI) guidance. The committee directed the FDA to end this “regulatory uncertainty,” issue a timeline for the NDI guidance, and include stakeholders in the process.

Specifically, the committee told FDA to report back by September 1 on how the agency plans to “develop new methods of communicating with its stakeholders on future actions…including estimated timeframes for when regulations, advisories, and guidances are planned for release.” (NDI is included as an example of “guidances.”) The agency was also told to report back within sixty days of enactment of the Agriculture Appropriations bill with “a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.”

This is a tremendously important development. It was ANH-USA’s work with the committee that got them to compel a second draft of the guidance, and it was our lobbyists who helped include the important language in this new report. This would not have been possible without your support and activism! THANK YOU!

You would think that because the House Ag Appropriations Committee controls the FDA’s purse strings, the agency would have to listen to them. However, this same committee directed them to act before, and FDA did very little. Now, because the committee is turning up the volume, it pressures FDA to take action. FDA has now been specifically asked to provide a timeline, which would be hard for them to circumvent. We think it’s likely FDA will recognize that the committee is serious about all of this, and we hope that FDA will stick to the timeframe they provide.

The committee’s mention of an “uncertain regulatory environment” refers to the FDA dragging its feet on the NDI draft guidance. It has been close to two years since FDA submitted its initial draft guidance, and the agency has been promising to work with the supplement community on a second draft since October 2012—eight months ago!

An uncertain regulatory environment is, of course, not good for business. Companies don’t know what they can sell (and invest in) and what they can’t. Manufacturers will be less likely to submit NDIs for new supplements if they are unclear on what the requirements are. This will stifle innovation. And once again, consumers will be the losers.

Also, despite their explicit promises to the contrary, FDA continues to enforce the controversial provisions of the draft guidance by sending out warning letters. For example, it issued letters to ten different companies for, in part, selling supplements that contained synthetic botanicals. The draft guidance says that synthetic botanicals are not considered to be a dietary ingredient at all (much less a new dietary ingredient), and therefore cannot be sold as an ingredient in dietary supplements.

As written, the draft guidance puts a number of synthetic botanicals—all of which have important health benefits—in regulatory limbo, such as the following:

Epigallocatechin gallate (EGCg): EGCg is a potent antioxidant that is abundant in green tea and that may have therapeutic applications. EGCg is synthesized and commonly used in many supplements for its antioxidative qualities. It can protect the DNA in human cells from ultraviolet and visible radiation-induced damage.
Allicin: A sulfur compound obtained from garlic. Allicin is generated by the oxidation of diallyl disulfide for use in supplements and could be considered a synthetic botanical. In pure form it has been shown to have antibacterial activity, including multidrug-resistant enterotoxicogenic strains of E. coli; antifungal activity, particularly against Candida albicans; antiparasitic activity, including some major human intestinal protozoan parasites such as entamoeba and giardia; and antiviral activity.
Lycopene: While this phytochemical occurs abundantly in tomatoes, supplemental lycopene is usually synthesized from enzymes found in algae. Some studies show that lycopene lowers the risk of certain types of cancer and has a strong antioxidative effect.
L-theanine: This amino acid is found naturally in green tea, but in supplements is derived from fermentation of a tree leaf. In action, the result is chemically and, presumably, biologically identical. However, technically, it is both chemically altered and a synthetic botanical. L-theanine has numerous benefits, including helping to balance brain chemistry, reduce the risk of strokes, and reverse liver damage.

FDA has a history of enforcing its draft guidances via warning letters, even before they are finalized. For example, FDA has not completed its guidance distinguishing between dietary ingredients and beverages, yet the agency has cited the draft guidance in warning letters to supplement companies. And FDA has not issued final guidance on whether a dietary supplement is considered a food (in the context of determining when a food becomes a drug), yet has issued a warning letter to a supplement company on this issue.

Don’t forget what is at stake in all this: FDA’s draft guidance threatens access to 29,000 supplements, and while FDA agreed to reconsider concerns and work with us and the supplement community, we still haven’t seen anything concrete. Our original concerns remain:

It’s unclear whether multiple NDI notifications will be required for the same ingredient if only the formulation has changed. Companies don’t know when and how they should submit NDI notifications.
The agency’s NDI draft guidance, as written, is a perversion of congressional intent. When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was written, Congress envisioned a simple notification system that would ensure the safety of supplements, but FDA is trying to turn it into a de facto pre-approval system.
Additionally, the definition of “grandfathered dietary ingredients” is still unclear. FDA is supposedly working on a list of grandfathered ingredients, but the agency still has not released anything. Supplement companies don’t know whether popular products like resveratrol and P5P will be considered grandfathered and therefore protected—or subject to the endless red tape of NDI submissions.

ANH-USA will continue to actively participate in the process to ensure we receive the best guidance possible from FDA—one that protects the needs of the entire natural health community—in a timely manner.

Action Alert! Please write to House Agriculture Appropriations Committee members, and thank them—in particular, the committee chair, Rep. Robert Aderholt (R-AL), and its ranking member, Rep. Sam Farr (D-CA), for their leadership—for including this important charge to FDA in their report. (Because this Action Alert is being sent only to the committee members, rather than the whole House, you will see a message if you don’t live in one of the committee members’ states.)

The post Congressional Committee to FDA: Listen to ANH-USA and the Supplement Community! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The World Didn’t End, but Access to Some Supplements Might. Act Now!

Fri, 21 Dec 2012 21:59:16 +0000

Special interests and huge international
corporations are making the FDA and Codex
work for them—but together, you and
ANH-USA can stop them. Donate now!

Recently, we asked for your help to raise $30,000. We told you about the disastrous New Dietary Ingredients draft guidance, how it threatens 29,000 supplements currently on the market, and how we need funds for educational costs and legal fees to fight it. Hundreds have already responded generously—but we still need your help!

We also shared how ANH-USA proudly represented you at the recent Codex meeting in Germany. Codex Alimentarius is a collection of internationally adopted food standards and guidelines that “supporters” (read: Big Business and Pharma) hope will “facilitate international trade” (read: make it easier to make more money with less consumer choice).

So, how do the NDI guidance & Codex threaten your access to quality supplements? Think of it as a domino effect:

The EU has adopted absurd limits on supplements—either banning them or allowing for sale only dosage strengths so low as to be completely ineffective. Codex could easily follow suit, potentially impacting 185 countries.
The FDA tends to follow the EU. In fact, the current NDI draft guidance mirrors the EU’s Novel Food Regulation.
The FDA’s NDI guidance could restrict access to your favorite supplements. Even the thousands of supplements marketed prior to 1994 are in danger, as the FDA requires an unreasonable amount of evidence to prove an ingredient isn’t “new” (marketed after 1994).

In our increasingly interconnected world, the fight to protect supplements is going global. What happens abroad today could affect your access to supplements tomorrow. That’s why we can’t take a single day off—please act now, before it’s too late.

Any size gift makes a huge difference—$5, $50, $500,
or more! Your donation will be 100% tax deductible—
every single penny goes straight to the Natural Health
Alliance Foundation, the charity that supports ANH-
USA’s legal and educational projects.

With your donation comes our promise: all of us at ANH-USA will do everything we can to protect your access to natural health in 2013. Happy holidays!

The post The World Didn’t End, but Access to Some Supplements Might. Act Now! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Carly and I Need Your Help!

Wed, 19 Dec 2012 14:04:50 +0000

Thousands of nutritional supplements
could be taken off the market—
but you can fight back.
Make your tax-deductible donation today!

I’d like to introduce you to a friend of mine—she’s my personal inspiration to protect our dietary supplements from the FDA’s New Dietary Ingredient(NDI) guidance.

Carly Lockman is a Chicagoan, a mother-to-be, and works in the holistic nutrition field. For years, she suffered not only from hyperthyroidism, but from the endless doctor’s bills and pills that were supposed to cure her. Finally, after a punishing radiation “treatment,” Carly turned to natural health solutions: a diet of whole, organic foods; a toxin-free lifestyle; regular exercise; and nutritional supplements.

Carly is now disease-free and living life to the fullest, and is excited to share the benefits of a holistic lifestyle with her clients, her loved ones, and soon, her daughter.

But the way of life that you, Carly, and I value so highly is under attack: thousands of our nutritional supplements may soon disappear because of the FDA’s NDI guidance.

In June, the FDA revoked the first draft of its NDI guidance. This was a huge victory, and was only possible because you stood up to them with ANH-USA. Thank you! But that was one battle in what will be a long war. We now have a seat at FDA’s table representing consumers as the agency begins the revision process—though we fear the next draft could be even worse.

Your donation today, no matter how small,
will allow us to continue the fight against
the FDA’s anti-supplement bias.

ANH-USA works hard every day to protect your supplements from threats like these. We are the only consumer advocacy group in talks with the FDA over the next draft of the NDI guidance, because we are one of the few organizations that work on behalf of everyday people like you and Carly. Not Big Business, Big Pharma, or other special interests.

And we’re ready to take the fight to anyone, anywhere! As you read this, my boss and ANH-USA’s executive director, Gretchen DuBeau, is representing you in Germany at the meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). She’s there to protect the right of American consumers to truly wholesome foods and high-quality supplements.

But protecting access to supplements is expensive. In 2013, ANH-USA will meet with the FDA to monitor its revision of the NDI guidance and will alert you when the second draft guidance is issued (so you can tell the FDA exactly what you think). We will also submit formal comments on behalf of the public and commission an independent legal analysis—but this will easily cost tens of thousands of dollars.

This is why we need your help:

Our goal is to raise $30,000 by December 31 for
research, education, and action on the next NDI draft guidance.
Will you make a tax-deductible gift today?
Every dollar makes a difference.

Thank you so much for your support! Our work would not be possible without it.

P.S.: As an extra bonus, through December 31, your qualifying donation earns you a reusable tote bag, BPA-free water bottle, picnic blanket, or yoga mat that lets you proudly show off your support for ANH-USA. Please make your gift today!

The post Carly and I Need Your Help! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

ANH-USA and Trade Groups Meet with FDA on New Supplement Guidance

Tue, 07 Aug 2012 21:00:34 +0000

Agency begins its promised rewrite after a massive grassroots letter-writing campaign.

Last week ANH-USA, together with a number of supplement industry trade associations, met with the US Food and Drug Administration to discuss their promised revision of the FDA’s draft guidance for New Dietary Ingredients (NDIs) which, in ordinary English, means dietary supplements developed since 1994.
As you know, the guidance was originally released in July of 2011, and immediately faced a firestorm of criticism from consumers, natural health advocates, the supplement industry, and Congress. FDA took what was supposed to be a notification process for new supplements and turned it into a de facto pre-market approval system with so many absurd restrictions and arbitrary rules that it would have forced a large number of products off the market, denying you access. It would also have resulted in over $1 billion of lost industry revenue, and cost over 100,000 Americans their jobs now—and far more jobs in the future.
In June, after a massive grassroots letter-writing campaign, congressional leaders persuaded FDA to withdraw the guidance and start over—a startling reversal from the agency’s previous intransigence on the subject. Last Tuesday’s meeting was constructive—and significant in that it was the first time a group representing natural health and consumer activists had been invited to be at the table.
One main focus of the meeting was how the FDA would distinguish between old dietary ingredients (ODIs) and new ones. At issue is whether the FDA will agree with the supplement industry and the natural health community that many of the supplements used by consumers today should be considered ODIs and thus not subject to the new onerous regulations (currently being re-written) that threaten access to supplements.
This is a concern for consumers for many reasons. To take just one example, when a supplement is considered an NDI, drug companies, under some circumstances, are able to develop synthetic version of natural ingredients and then petition the FDA to remove the nutritional supplement versions of the ingredient from the market. This is what happened with pyridoxamine, one of the most bioavailable and best natural forms of vitamin B6—the supplement industry thought it was a grandfathered ODI and didn’t file an NDI notification, but the FDA ruled that it was an NDI. Now the natural supplement form of pyridoxamine is no longer available.
A second issue discussed was the creation of an official list of grandfathered ingredients, which currently does not exist. Should such a list be created? The concern is that FDA may determine that the list is static and any ingredient not on the list is by default an NDI. We don’t want the list to be used as a hammer by the FDA to go after industry and ultimately deny consumers access to safe supplements.
Then there’s the “chemically altered” question. Supplements that have been chemically altered, even if they were originally marketed before DSHEA was passed, become NDIs. But FDA’s definition of “chemically altered” is very broad. It may include a change in the manufacturing process—and there have been many such changes in the past eighteen years!
Many of these manufacturing processes do not chemically alter a supplement, just make it safer and better by taking advantage of new technologies. Since the purpose of the NDI notification process is to ensure safety, FDA shouldn’t freeze-frame the technology to 1994, but should instead allow for improvements—all the more so since the FDA is issuing guidance eighteen years after it was required by Congress.
Our meeting did not decide any of these issues. But as the consumer representative at the meeting, we were able to represent you and express these points strongly. With your help and that of Congress, especially the appropriations committee that controls FDA’s purse strings, we will finally win this battle, no matter how long it takes.

The post ANH-USA and Trade Groups Meet with FDA on New Supplement Guidance first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Breaking News: We Win Major Concession on New Supplement Guidance

Wed, 20 Jun 2012 21:13:08 +0000

FDA reverses itself—for now.

We have pointed out for months that the FDA’s NDI (new supplement) guidance threatens our access to supplements and indeed could destroy the industry, leaving drugs with a total monopoly.
After adamantly digging in its heels and refusing to reconsider, FDA has now at last agreed that the draft NDI guidance requires substantial revision. This follows a meeting between FDA Commissioner Margaret Hamburg and Mike Taylor, Deputy Commissioner of Foods, with Senators Harkin and Hatch, longtime champions of natural health.
According to our sources, the FDA stated in the meeting that the guidance would be revised to account for the numerous comments and concerns, and released in draft form once again, which will then be open for public comment. This is exactly what we asked for!
The FDA’s decision is a dramatic reversal of the position taken in an earlier meeting with the Senators’ representatives, in which they adamantly refused this very same request. While we may never know how or why the FDA changed their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.
ANH-USA has also been working closely with the Appropriations Committee that controls the FDA’s purse strings. We recently helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.” This appears to be another reason the FDA is finally listening.
While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (ie. supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.
Although an authoritative list of “grandfathered” dietary ingredients could be useful to the supplement industry, we fear that the FDA will use this as an opportunity to knock out supplements that were indeed on the market before 1994 but may not meet the FDA’s idea of proof. This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.
ANH-USA will participate in this process to try to ensure that the list of “grandfathered” dietary ingredients is inclusive in order to maintain your access to as many supplements as possible. We will also try to prevent the FDA from using the list as an excuse to delay indefinitely their promise to revise the draft guidance.
Our readers have sent hundreds of thousands of messages to the FDA regarding the NDI draft guidance issue. We have just won an important preliminary victory and it wouldn’t have happened without you! Now on to the next phase of the struggle. If we are patient and persistent, we will win.

The post Breaking News: We Win Major Concession on New Supplement Guidance first appeared on Alliance for Natural Health USA - Protecting Natural Health.

FDA Breaks Promise on Proposed New Supplement Rules

Tue, 01 May 2012 20:00:32 +0000

FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.

The specific provision that FDA has decided to enforce is the one that says synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs. Last Friday, FDA issued a press release and sent warning letters to ten companies who sell supplements containing DMAA (dimethylamylamine), which is advertised to increase energy, concentration, and metabolism. The manufacturer says DMAA is derived from the Asian geranium—specifically, geranium oil.
In their warning letters, FDA said the supplements are technically classed as “adulterated” for two reasons: (1) DMAA has not gone through the NDI notification process, and (2) it is a synthetically produced botanical which, by definition, is not an NDI.
However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.
For years drug companies have studied plants for medicinal uses. As we noted recently, if they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance—a new molecule that can be patented and then taken through the FDA as a new drug. With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only patented substances can afford to be brought through the hugely expensive FDA approval process.
The worst part is that FDA is now treating the guidance as if it has been finalized—something they promised not to do. In February, FDA held a meeting with the Natural Products Association (NPA), and explicitly told the group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance. Now they’ve gone back on their word.
In addition, we would point out that FDA has still not addressed the many formal comments that were submitted on the synthetic botanicals question. We, and many others, said that FDA’s claim that synthetic constituents of botanicals are not NDIs while synthetic constituents of any other substance are NDIs is a completely arbitrary distinction. Taking action when they haven’t reviewed any of the thousands of pages in public comments makes a complete sham of the formal comment period. Moreover, FDA shouldn’t be enforcing a guidance when it is still in the draft stages anyway—that’s the point of it being a draft.
Worse, by going outside the bounds of DSHEA, the NDI guidance is basically creating new law, which the FDA is not allowed to do. Instead of issuing proper regulations and going through the formal rulemaking process (as is required when creating a new law), the FDA sidestepped everything by issuing a guidance. Technically, a guidance is not legally binding—which makes lawsuits difficult—but as feared, the FDA is enforcing the guidance as if it were.
DMAA is not without some controversy. Last year, two soldiers died after having heart attacks during fitness exercises, and both happened to be taking supplements that contained DMAA, though as of this writing, DMAA has not been conclusively linked to the deaths. A spokesperson for the manufacturer said that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed. Just to be safe, the US Army is investigating, and the Defense Department has removed all products containing DMAA from stores on military bases until the safety review is complete.
If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is a New Dietary Ingredient, then by all means it should go through the NDI notification process as outlined by DSHEA. But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical—that is not a requirement of DSHEA. That requirement comes only from FDA, and it is not supported by law.
Here’s the crux of the matter: If FDA fully enforces this guidance as drafted, we will likely lose up to 29,000 nutritional supplements from the market, at an economic loss of between $5.6 billion and $10.5 billion; the nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and between 55,720 and 104,475 jobs in the supplement industry could be lost.
Let’s be clear: this is not about DMAA. This is the FDA setting in motion its draft guidance, which threatens our access to more than half of the supplements we all need to stay and get healthy.

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The post FDA Breaks Promise on Proposed New Supplement Rules first appeared on Alliance for Natural Health USA - Protecting Natural Health.

More Congressional Voices Protesting the NDI Draft Guidance

Tue, 03 Apr 2012 16:00:39 +0000

Our campaign is catching fire, and Congress is continuing to drive the message home to the FDA. Action Alert!

This week fourteen members of Congress—all of them members of the House Energy and Commerce Committee—wrote to the FDA, raising their concerns about the NDI guidance which threatens our access to supplements. They highlighted many of our major concerns about the guidance:

It doesn’t allow innovation: “We believe that regulations should provide useful clarity to the regulated industry [and] allow innovation and market forces to prevail,” they write. “The draft guidance on new dietary ingredients falls short on these criteria.”
It is contrary to the intent of Congress: “Above all, [the guidance should] remain grounded in the statutory authority provided by Congress to the regulators….The draft guidance released by FDA in July of 2011 appears to undermine DSHEA in a number of critical respects….Congress expects and the industry needs FDA to develop a reasonable guidance document on this matter….that is consistent with the DSHEA.”
It is a de facto pre-market approval process that is more appropriate to a food additive market: “FDA may in effect be establishing a pre-market review process for dietary supplements and impos[ing] standards that were deemed suitable for food additives.”
It will cost jobs and harm the economy: “Imposing these regulatory requirements on products that have a long history of safe use will increase costs on manufacturers at a time when we should be encouraging, rather than hindering, their efforts.”
It is redundant: “It appears that this guidance will require multiple filings for the same ingredient…which is at odds with the statute.”
It is beyond FDA’s resources: “Given the FDA’s current workload, it does not seem prudent to follow this course of action.”
It needs to be rewritten, with input from stakeholders: “We respectfully request FDA to reexamine and significantly rework this guidance so it does not undermine consumer access to safe, affordable dietary supplement products….It is our hope that the FDA will engage in meaningful dialogue with the relevant stakeholders in industry.”

It is clear that Congress is now seeing the huge regulatory burden of NDI guidance, not to mention its cost to the economy and the loss of jobs. We also expect more individual Congress members to write to the FDA.
In October of last year, the committee announced it would start investigating legislation that is redundant and threatens jobs and the economy. The NDI draft guidance is a perfect example of this, as we pointed out in our economic analysis, and it is heartening to see that Congress recognizes it too.
As you know, the NDI comment period is now closed, and FDA is in the review period. It could take months or years before FDA issues final guidance (if ever—the agency can try to stall), but the more pressure Congress can put on the FDA, the better.
Please write to the House Energy and Commerce Committee, thank them for writing the letter, and ask them to encourage their colleagues to raise their voices in agreement. Please take action immediately!

The post More Congressional Voices Protesting the NDI Draft Guidance first appeared on Alliance for Natural Health USA - Protecting Natural Health.

FDA Isn’t Listening—Time to Turn Up the Heat!

Tue, 14 Feb 2012 19:50:47 +0000

A champion of supplements in the House sends a warning to FDA. Persuade others in Congress to join him with our Action Alert!

As we reported last week, FDA has flatly refused to listen to the Senate, rejecting the call of Sens. Tom Harkin (D-IA) and Orrin Hatch (R-UT) to withdraw its disastrous New Dietary Ingredient draft guidance and start over. You may recall that Harkin and Hatch are the original drafters of DSHEA, the law that requires supplement manufacturers to submit notifications whenever an NDI is introduced into the marketplace. FDA’s job was to articulate how those notifications are to be submitted, but they ignored the original intent of Congress and created a de facto approval system for any supplement or ingredient created or changed over the past eighteen years.

Now Rep. Jason Chaffetz (R-UT) has composed a letter to FDA expressing regret over FDA’s dismissal of Senators Hatch and Harkin’s request and reiterating that Congress did not intend to give FDA pre-market review of new dietary ingredients, nor did it intend to permit the agency to treat dietary ingredients in the same manner as food additives.

The letter goes on to articulate the legal problems with FDA’s proposal, and strongly urges FDA to withdraw its guidance and instead design a fair and workable NDI notification system. It also requests that FDA refrain from taking any enforcement action that is based solely on positions articulated in the draft guidance that are not unequivocally grounded in the law.

Rep. Chaffetz’s letter to FDA ends with a warning that, in the unfortunate event that FDA does not withdraw this guidance as requested, legislation to clarify current statute will be considered. Let’s show FDA that the House means business—that there is support from Democrats and Republicans alike to withdraw the draft guidance altogether, so that consumers won’t lose access to thousands of supplements.

Please write to your congressional representative and ask that he or she sign onto Rep. Chaffetz’s letter to FDA. Reiterate the serious concerns with NDI guidance—how it severely threatens access to thousands of supplements, even though supplements have a proven safety record (unlike FDA-approved drugs!)

And if you haven’t yet asked your representative to make a one-minute floor speech on this subject, please do that as well.

Please take action today!

We’d love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by ANH-USA readers, not members of Congress or the President. Click the button above to send your message to the Congress and the President!

Please note that because members of US Congress only accepts messages from residents of the districts they represent, this alert is restricted to US residents.

The post FDA Isn’t Listening—Time to Turn Up the Heat! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

FDA Says No to the Senators Who Drafted DSHEA

Tue, 07 Feb 2012 22:09:01 +0000

According to our sources, the rogue agency is digging in its heels on the NDI draft guidance that threatens so many supplements, refusing to listen to Congress or follow the intent of the law.

Senators Orrin Hatch and Tom Harkin met with Dr. Daniel Fabricant of the FDA on January 26 to request that the FDA withdraw its NDI draft guidance altogether—a meeting that ANH-USA, together with some trade groups, helped set up. They were following up on their recent letter to FDA Commissioner Margaret Hamburg asking the FDA to stop the process altogether, withdraw the guidance, and start again after meeting with interested parties to address the list of significant concerns expressed by consumers and industry.
You may recall that the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) required that guidelines be established for supplement manufacturers to notify FDA when a new dietary ingredient was introduced into the marketplace. The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.
Unfortunately, the FDA’s proposed regulations are in fact completely contrary to the intent of Congress when DSHEA was passed, and Sens. Harkin and Hatch wanted to make that clear to FDA. They should know—they were the two principal authors of the legislation!
According to our sources, FDA has turned down the senators’ request. FDA in effect said that it is refusing to reconsider its interpretation of what the NDI section of DSHEA means, regardless of what Sens. Hatch and Harkin say they meant when they wrote the law.
Does this mean FDA intends to use the NDI process as a de facto pre-market approval system—something which regulatory observers believe was specifically excluded by DSHEA? In a word, yes. We have been told that FDA claims the NDI process is the only “preventive control” for dietary supplements in federal law. Whatever “preventive control” means, it is completely untrue that supplements are uncontrolled under federal law or that the FDA lacks the power presently to regulate them.
In refusing to follow the intent of the law as clearly stated by the law’s authors, the FDA is acting as a rogue agency. If you haven’t done so already, please ask your legislators to make a one-minute floor speech opposing the FDA’s guidance document. FDA’s plan would sweep many supplements off the shelf and make the ones that survive much more expensive.

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