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What’s old is new again? The FDA takes aim at modern science and innovation

By James Gormley, Senior Policy Advisor, Citizens for Health

On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.

What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ? herbal extracts and nutrients ? that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.

NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.

Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.

The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.

“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.

As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIseven though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”

The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”

In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”

What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

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45 Responses to “What’s old is new again? The FDA takes aim at modern science and innovation”

By Anita - 23 August 2011 Reply

Please construct a petition for people to sign to send to the FDA.

By lenoris coen - 23 August 2011 Reply

please dont do this.its .dont you all care you are undemining us .the people.make sure the saftey standards stay in place.thank you

By Truman berst - 23 August 2011 Reply

The FDA is, and always has been a hindrance to consumers, sellers, and manufacturers of health food. They operate as protectors of drugs industry that harms and kills people. They are the bullying drug police thugs who intimidate the natural health industry, and prevent the truth about health food. The FDA should be disbanded, and all jailed for there egregious, and illegal crimes against the citizens they are so supposed to protect. After that burning in Hell for eternity would be appropriate.

By CajunDoc - 23 August 2011 Reply

The Pharma industry is HEAVILY invested in broadening their bottom line by entering the nutraceutical realm, and they are increasingly using chemical modifications of natural product molecules to ‘enhance’ absorption or utilization. While this process may indeed be advantageous to the patient/ consumer looking to optimize results, such biochemical manipulations may well indeed make profound differences in function of natural products. For example, consider if a company were to patent a water-soluble form of a unique fat-soluble flavonoid with a multitude of well-researched effects in vitro and in vivo and in human studies. This chemical manipulation profoundly changes the cellular compartment of function (from lipophilic to hydrophilic). Do we call this the same thing? Does the company have to show that the water-soluble form is equivalent to the natural lipid-soluble form? I don’t think that is unreasonable. When natural products are significantly modified, they can legitimately be called ‘drugs’ and the burden of proof should indeed rest on the manufacturer.IF we do not address this reality, then the Pharma companies who tweak the natural products will become the purveyors of ‘natural’ products which are distinctly un-natural and have effects way different than the simple, extracted components of medicinal plants or foods. The chemically-modified products can be controlled and marketed as drugs and placed under the control of the Pharma industry, with an attendant increase in cost of 1000% or more, and the truly ‘natural’ products will be lost… awash in a sea of adulterated miracle nutraceuticals. Let us distinguish between natural products (and leave them alone via DSHEA) and chemically-modified nutraceuticals and nano-products!

By k - 23 August 2011 Reply

I believe this is just an attempt by the FDA to allow the pharmaceutical companies to increase their profits. This new regulations will give many people no other choice than to choose pharmaceutical drugs.

I am so sickened by the power this agency has. I created a petition on change .org. My goal is to inform as many people as possible about the blatant abuse of power by the FDA.

I am hoping you can help me spread the word by including my link in one of your future articles about the Durbin bill and NDI regulations. What I am doing is on a small scale compare to your website but I think if we work together on spreading the word about the FDA perhaps we can have a bigger impact.

To read more about what I’m trying to do and to sign my petition, click here:
http://www.change.org/petitions/it-is-time-americans-take-back-the-constitutional-rights-that-our-founding-fathers-work-so-hard-for?share_id=MJAwrtgcWb&pe=d2e

karen stoute

By dolores tippett - 23 August 2011 Reply

Our tax money should be spent more wisely than this.

By doug purcell - 23 August 2011 Reply

We already have too many UNELECTED officals runing things.

By Chip - 23 August 2011 Reply

Its time to let America decide own its own what is best for their health.
Read the Constitution of the United States of America if you do not believe me.
Re-educate yourself regarding republicanism.

The founding fathers never wanted government to dictate the health of America.

FDA WITHDRAW THIS NOTIFICATION NOW!!!!!!!!!!!

By Wayne Blake - 23 August 2011 Reply

FDA, I am appalled that in this day of expensive health care that you could be such an impediment to us who are desiring to improve our health. Yes, I suppose it is your drug connection showing. Shame on you.

By Conway Redding - 23 August 2011 Reply

I simply want to go on record as opposing the implementation of the Food Safety Modernization Act, on the grounds that the old adage, “If it ain’t broke, don’t fix it,” needs to be rigorously applied here. The FSMA seems to me to have the potential of depriving me of nutritional supplements that I have come to rely on to maintain my health and to fend off, or at least delay, if possible, the degenerative physical changes associated with the aging process. Please,FDA, leave my supplements alone! As far as I am concerned, the only legitimate role of the FDA should be informational and advisory, making public any problems it has found with pharmaceutical and nutriceutical products. Armed with that information, we members of the informed public can then make up our own minds about whether we wish to expose ourselves to those products. In my opinion, for the FDA to be able to ban ANYTHING outright is over-reach, and borderline un-Constitutional.

By Susan Gallegos - 23 August 2011 Reply

New testing requirements for foods, herbs and supplements under the Food Safety Modernization Act are unnecessary to determine the safety of these products. We ask to have these stricken from the law as attempts to disallow safe food, et al. and only allow us to have unhealthy if not deadly genetically modified foods. GMO plants are now found to be sickly and subject to diseases not affecting non-GMO plants. Animals that eat GMO food are more sickly and have a excessive rate of still-born babies. We believe we have to right to healthy food, not what is being promoted by this law.

By Herb Hill - 23 August 2011 Reply

Stop the FDA and USDA from their power grabs for the purpose of protecting the pharmaceutical, big food manufacturing and big chemical companies instead of the American people.

By Jim Illick - 23 August 2011 Reply

James,

Your article makes it simple to understand how NDI’s work. Thank you for making this available to us, so that we can take action by writing our own messages to the FDA regarding NDI’s. I hope that thousands of people respond.

Jim Illick

By barb - 23 August 2011 Reply

The new law for supplements is insane and needs to be removed

By Kathi - 23 August 2011 Reply

The FDA is a branch of our existing government. Many people do understand what exactly that does entail in today’s world.

Big Pharma, GMO’s, the Vaccine industry, Big Ag, and Big Fuel conglomerates lobby the American government and openly share important funds which make this country stay afloat during these times of excess spending in the US government.

Now enter the world of herbs, plants, essential oils etc.. None of these are large profit makers for anyone, therefore no one has the capability of flashing money around as the aforementioned groups do.

Nature has given us the miracle of healing many conditions of poor health just by utilizing the substances already supplied by the earth itself. But who in this country has the capability of saying I own every poppy plant, every foxglove plant and each willow bark etc.. No, it is not possible for any company, or individual, to use this statement. Nature’s plants are shared by everyone. The promise of a profit is almost extinct.

But what this list that nature offers can do is offer major competition to an industry which survives, and thrives, on chemical and artificially based ingredients. From the perspective of some people, competition is great. From the perspective of an industry giant, it is one great big headache. It is a constant drain on their possible escalating bottom line, the amounts of possible profits and the capability of supplying a product which does not cure, it performs a means of relief. Relief is great until the next time you get the same condition again. Then who is available to relieve that condition again? This is one great big monopoly on maintaining a system of recurring customers.

I for one firmly believe that complementary therapies and its remedies is a stumbling block in the USA for a large corporate interest which wishes to squash the whole thing like a bug. The FDA unfortunately is caught in the middle of being partially dependent on that large corporate interest and then also their presence is extremely visible to large interest groups which are not swayed by corporate America.

Since, at present, most of the appointees to this department are offered the positions, not as independents but just assigned by their backgrounds and availability. Therefore some of the board members themselves have ties to corporate America. Has anyone ever actually heard of a majority board in the FDA where all of these members have ties to just Nature itself. I think not.

With current government, it has become abundantly clear, the wishes of the people are inconvenient and unimportant. The desires and wishes of corporate America seem to be placated at every turn and crossroad as much as is possible.

Every once in a while in the last few months, a government agency actually has had the decency to initiate a program that may border on the desires of the people themselves. But, don’t get too happy about it because it won’t be too long until that possible small victory gets over-ridden by something else.

Government in this country right now is not of the people, for the people. Somehow the people of this once great country have become one great big nuisance to the powers that be. It’s sad, but oh so true.

By bams - 23 August 2011 Reply

The FDA is sounding more like a little group that got starting in Germany about 1933.
Remember, Only what they said was true, only what they said was law. Question it and you went to jail. The FDA is doing that to nutritional companies that make safe and natural products that are good for us.

The FDA says something is bad. They are right, if your premiss is to keep Americans chronically ill and keep Big pharma in the money.
I wonder if all of us in America donated one or two dollars, into an “FDA fund” would it be more than big brother and could we influence their thinking with the same green stuff.
How much worse will it get? How much more corruption will we have to tolerate?
One wonders. Can our laws continue to protect us??

By Kathryn Walker - 23 August 2011 Reply

Mr. Gormley,

It is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. We you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward. The government has allowed corporations to devitalize our food for profit, and then wants to forbid us from supplementing our health with vitamins and minerals. You think citizens don’t realize the FDA actually needs to help keep people sick from food borne illness in order to justify its existence and support the sick-care industry (Big Pharma, hospitals, doctors, etc.)

By Ted - 23 August 2011 Reply

It’s just away to drive up food prices and hurt the consumers
so the government can GAIN MORE CONTROL over the people of the USA!!!!

By Oliveira - 23 August 2011 Reply

The FDA mustwithdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. I will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

By Sandra Goodman - 23 August 2011 Reply

I am totally aganist FDA regulations reguarding what dietary supplements that I know are good for my health. This is unacceptable and outrageous. This is my freedom to choose what I believe is best for me.

By h ozeran - 23 August 2011 Reply

hi, keep your biased hands OFF our vits and minerals, you are so blind to the true facts!!!!!!!!! and biased towards the money grabbing drug companies, their drugs kill or hurt more people than they save not to mention the horrific side affects.

By Harold & Darlene Todd - 23 August 2011 Reply

This is an outrage and an unacceptable approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. WE will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years to harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward. Leave dietary supplements alone. They do NOT kill millions of people like the pharmacutical drugs do.

By Charlotte Pierce - 23 August 2011 Reply

The FDA is really overstepping the lines here. This notification should be taken away immediately.

I think the FDA should clean its house first before it goes after the dietary supplement industry.

I for one will do everything in my power and through whatever channels available to me to fight this wanton display of government power run amok.

It’s time for us ciitizens to start standing up to the corruptness that has developed in this agency.

By Jane Smythe - 24 August 2011 Reply

I can’t stand this repetitive issue! What a power play! FDA only supports drugs that hurt people, Why can’t they let us decide what we want for our bodies? Don’t we own them? Or don’t we?

By Paul A. Shafer - 24 August 2011 Reply

James Gormley makes excellent comments and analysis of a complex piece of legislation. Clearly a manufacturing improvement with more natural and less synthetic or caustic ingredients augmenting an already well established combination of herbal phytosterols is not a “New Drug Ingredient”.

By richard kimbrough - 24 August 2011 Reply

What is it that the FSA does NOT understand the legal connotation of “Grandfathered?” Get the stinking conniving FDA nose back out from under the tent and leave the old tried-and-true, good healthy ingredients alone. Your actions and campaign against DSHEA is intolerable.

By Garcia - 24 August 2011 Reply

Thank you for the information!

By Michael Mac - 24 August 2011 Reply

This is good information and something that consumers should be more aware of. Unfortunately we are living in the “tea party” time, where all things governmental and protection are seen as hampering our lifestyles and stealing our money. http://michaelmaczesty.blogspot.com/2011/07/diet-remedies-are-proven-to-work-right.html

By Joe Mac__ Bates Jr - 24 August 2011 Reply

Its about time YOU GUYS get into this fray! I and others have been fighting tooth & nail against this type of Bureaucratic, Regulatory Over Reaching (Bull) since pre-2010 Elections, this little guy, along with The Endowment for Medical Research: Inc. http://www.endowmentmed.org , Natural Solutions Foundation: http://www.healthfreedomusa.org/?p=5715 , Robin O’Brian: http://www.robynobrien.com/ and My Associated Company, Manna Tech: http://www.mannapages.com/joemacbates/Country.aspx, Inc. This is the DIRECT RESULT of Eletist Bureaucrats working to INCREASE & PRESERVE their jobs.
Let’s STOP THEM NOW.
Joe Mac Bates, Jr.
Irmo, S. C.
803-920-8053
joemacbates@earthlink.net

By Frank Herd - 24 August 2011 Reply

We are indeed in “this fray”! As noted in our email alert, we will be sending our own action alert very soon to generate comments from our supporters. So many groups jumped right into this when it was announced, and so many of the groups like us out there share “supporter” overlap – belonging to multiple organizations in the same issue area – that we felt we’d have a bigger impact with our alert, and generate more comments, if we waited until the energy from other alerts died down a bit.
We’ll be sending one soon, I assure you – and thank you for your commitment and your participation!

By FDA Screwing Things Up Again! - 24 August 2011 Reply

[…] Screwing Things Up Again! http://www.citizens.org/?p=2543 Great article……. __________________ May you always have..Love to Share, Health to […]

By Marianne Egan - 24 August 2011 Reply

I deplore this attempt to roll back the clock on innovation.

Marianne Egan
Tempe AZ

By Gail cashman - 24 August 2011 Reply

This indeed is outrageous! I rely on and have for years natural products that have enhanced my quality of life. The FDA needs to focus on safe drugs for those who need and choose them and stop interfering with unrelated subjects.

By Honz Zondorgh - 24 August 2011 Reply

I agree with this statement: “We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market…”. This is an unacceptable reclassification that rolls back the clock on innovation. This notification needs to be withdrawn.

By Dolores Cunha - 24 August 2011 Reply

To whom it may concern…

We the people! Do these words ring any bells with you? We the people want you to butt out of our right to make decisions for ourselves! We do NOT need you making decisions regarding supplements, vitamins, or any healthful ingredient WE, WE, chose to use! You, the FDA, need to butt out/back off/leave the Health Food Industry ALONE!! WE are adults and very well versed in what supplements we need…we do NOT need YOU making these draconian, arbitrary, decisions on what supplements we can and can’t have! WE DON’T WANT OR NEED YOUR INTERFERENCE! The government is now telling us what we can and can’t eat..revamped school menus….on and on with your interference…get OUT…LEAVE US ALONE…stop destroying industries in the United States….LEAVE THE HEALTH FOOD INDUSTRY ALONE….we do not want your biased, uninformed, self centered, proclamations!

D.C.
California

By Ted JS - 24 August 2011 Reply

Essentially Big Pharma gives the FDA its marching orders and for years have used the uneducated media to spread falsehoods about natural substances… prescription drugs are our problem, just listen to any ad about a prescription drug on TV… the list of side effects is longer than the benefits and in many cases natural alternatives are available… this is what Big Pharma needs to surpress and the FDA is their lacky to try and make it happen! remember the FDA is not here to protect us… just look how long it takes them to pull a prescription drug with a long history of serious issues off the market or require “black box” labeling!
Thanks for providing a voice to keep their feet to the fire!

By Natasha Turaki - 24 August 2011 Reply

I feel HELPLESS… Europe is done deal, no more easily accessible herbs… now US. Corporate greed is too strong , they will buy everyone out and make a buck – they are unstoppable. When the law gets corrupt… then freedom becomes an unreachable illusion. My heart is crying out for our grandchildren, they will hate us for many reasons, but I think mainly because we stripped them of the right to be close to a natural way of living.

God please help those who have clarity and wisdom to make a difference

By Mike Dennison - 24 August 2011 Reply

Once again, government policing our lives where we don’t need them. I prefer natural, safe alternatives on the market today to any prescription drugs. Just this year I have come off my blood pressure and cholesterol meds after 15 years. I immediately began experiencing a higher quality of life without these drugs. Natural, safe alternatives are being discovered and understood more everyday. Don’t get in the way of these discoveries and their developments.

By Beth - 24 August 2011 Reply

This is just ridiculous. Those natural remedies should be available to all. The FDA will make it unaffordable for us to take care of ourselves. Isn’t bad enough that well over half of the US can not afford and does not have health insurance. In this economy people are forgoing treatment and medications in order to feed their families. Many of us also use these natural products for our pets. We kept my daughters dog alive for well over a year after a dx of 30 days with a natural remedy. Shame on corporate and political greed! We the people are going to get fed up.

By Joel Marchus - 24 August 2011 Reply

This president really needs to be reviewed and rewritten in lue of this common sense information.

By Melodie Chrislock - 25 August 2011 Reply

As a consumer of nutritional supplements for over 40 years, I think the NDI guidance will limit my health choices and my freedom to purchase products which are not produced by large pharmaceutical companies. This was not Congress’s intent with the DSHEA. The FDA is asking the supplements industry to meet an impossible requirement.

I can appreciate the FDA’s intent to make nutritional supplements safe, but really with 80,000 dangerous and untested chemicals in our environment and a flood of drugs, they are focusing on an insignificant problem here. I want my tax dollars to be better used!

By Jack Bershtel - 25 August 2011 Reply

As a large co-packer for the functional food as well as supplement and nutrition business, I am amazed at the lack of thought that goes into some of these regulations. Even though we know that many prescription drugs only work on certain people as a percentage of the group that takes them, they statistically say it is in the best interest of the well being of the public good.What could possibly be different between vitamins and prescription drugs?

By Ralph Watson - 29 August 2011 Reply

I agree with Anita ,if this is going to go very far, a petition needs to be constructed to send to FDA.

By rondi terracino - 31 August 2011 Reply

I will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

Stop FSMA now!!! Leave DSHEA alone!!! Your efforts are outrageous and unacceptable to me and many other American citizens. Dietary supplements are far safer than your drugs as we all know. You need to admit it also.

By James J. Gormley - 15 September 2011 Reply

Dear Fellow Citizens for Health,
I greatly appreciate all of your comments of support. You will have a number of tactical opportunities for effective action through Citizens for Health’s website starting next week as we roll out our multi-pronged approach to tackle the FDA on this.
Many thanks!
James
Senior Policy Advisor, http://www.citizens.org

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