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FDA Journal

Here is the applicable law.

Sec. 190.6 Requirement for premarket notification.

  • (a) At least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of Special Nutritionals (HFS-450), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, information including any citation to published articles that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. An original and two copies of this notification shall be submitted.
  • (b) The notification required by paragraph (a) of this section shall include:
    • (1) The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient;
    • (2) The name of the new dietary ingredient that is the subject of the premarket notification, including the Latin binomial name (including the author) of any herb or other botanical;
    • (3) A description of the dietary supplement or dietary supplements that contain the new dietary ingredient including:
      • (i) The level of the new dietary ingredient in the dietary supplement; and
      • (ii) The conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement;
    • (4) The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which the distributor or manufacturer of the dietary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will reasonably be expected to be safe. Any reference to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and
    • (5) The signature of the person designated by the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient.
  • (c) FDA will acknowledge its receipt of a notification made under section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and will notify the submitter of the date of receipt of such a notification. The date that the agency receives the notification submitted under paragraph (a) of this section is the filing date for the notification. For 75 days after the filing date, the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient shall not introduce, or deliver for introduction, into interstate commerce the dietary supplement that contains the new dietary ingredient.
  • (d) If the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient, provides additional information in support of the new dietary ingredient notification, the agency will review all submissions pertaining to that notification, including responses made to inquiries from the agency, to determine whether they are substantive and whether they require that the 75-day period be reset. If the agency determines that the new submission is a substantive amendment, FDA will assign a new filing date. FDA will acknowledge receipt of the additional information and, when applicable, notify the manufacturer of the new filing date, which is the date of receipt by FDA of the information that constitutes the substantive amendment.
  • (e) FDA will not disclose the existence of, or the information contained in, the new dietary ingredient notification for 90 days after the filing date of the notification. After the 90th day, all information in the notification will be placed on public display, except for any information that is trade secret or otherwise confidential commercial information.
  • (f) Failure of the agency to respond to a notification does not constitute a finding by the agency that the new dietary ingredient or the dietary supplement that contains the new dietary ingredient is safe or is not adulterated under section 402 of the act.

Friday, July 7, 2017

Dr. Aardsma mailed the NDI notification to FDA via Express mail today. It should arrive Monday, July 9, making Friday, September 22, 2017 the 75 day deadline for hearing from FDA. (Dr. Aardsma's NDI notification may be viewed here.)

Thursday, July 13, 2017

The entire mail package was returned, marked "Forwarding Order Expired". It turns out that the FDA has moved and has not maintained a forwarding address with the USPS. As a result, the mail-to address supplied in Section 190.6(a) above is no longer valid. Dr. Aardsma mailed the package out again this afternoon. Each mailing cost $45.70. Efforts to get a refund for the first mailing were unsuccessful.

Wednesday, August 2, 2017

FDA e-mailed saying today is the official filing date.

Attention: Gerald E. Aardsma

Your notification NDIN#2017001046, dated August 2, 2017, concerning "Methylphosphonic acid (MePA) " which you identify as a new dietary ingredient, was received and filed by FDA on August 2, 2017. FDA intends to mail a response to the address provided in your notification within 75 days of the filing date of August 2, 2017. FDA will email or fax a courtesy copy of the letter to you on the day it is mailed.

Your notification will be kept confidential for 90 days after the filing date. After the 90-day date, the notification will be placed on public display at FDA's Division of Docket Management at www.regulations.gov. Prior to that date, you may wish to identify in writing specifically what information you believe is proprietary, trade secret or otherwise confidential for FDA's consideration.

Fred Hines
Consumer Safety Officer

This delays the FDA 75 day deadline until Monday, October 16, 2017.

Thursday, August 3, 2017

Dr. Aardsma replied to the above email, requesting correction of the filing date.

Dear Fred Hines,

I am requesting that the filing date for this notification be corrected to either July 10, 2017 or, at the latest, July 14, 2017.

The reason for this request is humanitarian, not punctiliousness. MePA is a newly discovered vitamin. The present state of our knowledge of this vitamin indicates that every day of delay in bringing it to the public results in the loss of some 6000 American lives. A delay of 23 days (July 10 to August 2) implies needless loss of 138,000 American lives.

Sec. 190.6 (C) specifies, "The date that the agency receives the notification submitted under paragraph (a) of this section is the filing date for the notification."

The notification was Express mailed (Tracking Number: EK179081434US) to the address specified by Sec. 190.6 (a) on Friday, July 7, 2017. Under normal circumstances, this would have been received at FDA no later than the following workday, Monday, July 10, 2017. This is the basis for my request that the filing date be corrected to July 10, 2017.

This mailing was returned to me by the USPS on Thursday, July 13, 2017 with the notice that the forwarding order for FDA had expired. I Express mailed (Tracking Number: EL071373181US) the notification a second time that same day to the new FDA address. The online tracking information shows that it was hand delivered the following workday, Friday, July 14, 2017 at 10:57 a.m. This is the basis for my request that the filing date be corrected to July 14, 2017 at the latest.

Thanks for your kind attention to this matter.

Gerald E. Aardsma

Fred Hines replied as follows:

Gerald,

Unfortunately in this day and time, any package received at our facility has to go to a central facility that determines whether the package may or may not contain terrorist material. It then is mailed back to us. Our secretary received and filed in his software program that your NDIN was filed on July 28 (which is the real filing date). I had to scan and enter the scan into our electronic portal system and that is what I did upon my return from leave on August 2. I should have corrected that filing date from the date the eportal system designated upon my data entry on August 2. The official filing date is July 28, 2017. I apologize for the error.

Fred.

This made Wednesday, October 11, 2017 to be the 75 day deadline for response from FDA. This was the earliest date that Dr. Aardsma's Vitamin MePA Dietary Supplement could begin to ship, unless FDA responded with a "no objections" letter at an earlier date. If FDA responded with objections, shipping could be delayed even further.

Tuesday, September 26, 2017

Attention: Gerald E. Aardsma

Attached is a courtesy copy of the FDA's response letter to your NDI notification for "Methylphenolic acid (MePA)". You will be receiving a hard copy of it by mail. Let me know if you have any questions.

Fred A. Hines DVM, HFS-810
Consumer Safety Officer

FDA's response letter may be viewed here.

Thursday, September 28, 2017

Hello Fred,

Thank you for emailing the copy of FDA's response letter. (Note that MePA is short for methylphosphonic acid, not methylphenolic acid.) I have spent a day and a half digesting the response letter, and I do have some questions.

The response letter says, in a nutshell, that FDA has not commented on the safety of Dr. Aardsma's Vitamin MePA Dietary Supplement because they reject the claim that MePA is a vitamin. Though not explicitly stated in the response letter, this would kick MePA out of the dietary supplement category and, by default, into the drug category. This would be quite unsatisfactory since MePA is, in fact, a vitamin and thus, according to DSHEA, it is not a drug.

My main question is what action should I take next in an effort to get FDA most quickly to come to understand that MePA most certainly is a vitamin? Is dialog still possible in regard to the present response letter, falling within the present 75 day deadline, or should the present response letter be appealed (if such a thing is possible), or do I need to start again from scratch with a new application (and a new 75 day deadline for response), or is there some other, quicker route?

I am concerned to get this resolved as expeditiously as possible because, as I have previously communicated, delay in bringing this vitamin to market results in the unnecessary loss of some 6000 American lives per day.

My remaining question regards how the conclusion was reached that my notification provides insufficient basis to establish that MePA is a vitamin. (The response letter actually winds up saying that my notification "indicates that "MePA" is not a dietary ingredient," but this seems to be a sentence structure problem, because my notification certainly indicates no such thing. My notification states explicitly that MePA is a vitamin, and hence it follows that it is a dietary ingredient.) The response letter kindly spells out the FDA definition of a vitamin. I feel my notification provided all the background which was necessary for an FDA examiner to see that MePA satisfies this definition.

Here's how this goes, broken down, using the FDA definition.

A vitamin is:

  • an organic substance — MePA [Linear Formula CH3P(O)(OH)2] is an organic substance
  • that is a minor component of foods, — MePA was naturally present in micrograms per liter (that's minor!) in drinking water
  • is essential for normal physiological functions (e.g., maintenance, growth, development), — MePA is essential to maintenance
  • is normally not produced within the body in amounts adequate to meet normal physiological needs, — MePA is not produced in the body at all
  • and which causes, by its absence or underutilization, a clinically defined deficiency syndrome. — absence or underutilization of MePA produces the clinically defined deficiency syndrome called "aging"
What does FDA feel is missing?

Sincerely,
Gerald E. Aardsma

Thursday, October 12, 2017

Hello Fred,

It has been two weeks and I have not yet received a response to my September 28 email. When should I expect a response?

Thanks for your help with this.

Gerald

Tuesday, October 17, 2017

Mr. Aardsma:

According to a research article by Munro et al., methylphosphonic acid is an degradation product of (O-ethyl S-[2-(diisopropylamino)ethyl] methylphosphonothioate (VX) which is a nerve agent used in chemical warfare[1]. Kumbachka et al. published a paper on chromatographic techniques to detect degradation products such as methylphosphonic acid in food[2].

Methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act (the Act); i.e., it is not food and is certainly not a vitamin.

References

[1] N.B. Munro, S.S. Talmage, G.D. Griffin, L.C. Waters, A.P. Watson, J.F. King, V. Hauschild, The sources, fate, and toxicity of chemical warfare agent degradation products, Environmental health perspectives, 107 (1999) 933.

[2] K.M. Kubachka, D.D. Richardson, D.T. Heitkemper, J.A. Caruso, Detection of chemical warfare agent degradation products in foods using liquid chromatography coupled to inductively coupled plasma mass spectrometry and electrospray ionization mass spectrometry, Journal of Chromatography A, 1202 (2008) 124-131.

Fred Hines
Consumer Safety Officer

Wednesday, October 18, 2017

Hello Fred,

Kumbachka et al. studied how to detect methylphosphonic acid (MePA) in food, not because MePA is bad (i.e., harmful to humans), but because it is a decomposition product of things which are bad. If MePA were found in some food, it would mean that somebody had put one or more bad things in that food (which had subsequently decomposed, leaving harmless MePA behind). Kumbachka et al. explained: "The analysis was focused on detecting CWADPs [chemical warfare agent degradation products] in food matrices, as they [i.e., food matrices] present possible vehicles for terrorist contamination."

Being a decomposition product of a bad thing does not make a compound bad. Hydrogen peroxide is bad. Its permissible exposure limit is just 1 ppm. Its decomposition products—water and oxygen—are not only not bad, they are essential.

MePA is also essential. Without it, humans grow "old" and die, generally several decades before they have reached even their hundredth birthday. In contrast, humans can live in excess of 900 years when MePA is included in their diets.

MePA is an organic compound, needed by our bodies in tiny amounts, without which the ultimately fatal deficiency disease we call "aging" develops. Our bodies are unable to synthesize MePA, so it must be supplied in the diet. These properties of MePA define it to be a vitamin.

The Act explicitly includes vitamins within its definition of "dietary supplement" (see 201(ff)(1)(A)). Thus, Dr. Aardsma's Vitamin MePA Dietary Supplement is unavoidably subject to the Act as a dietary supplement.

For this reason, I have submitted an NDI notification for Dr. Aardsma's Vitamin MePA Dietary Supplement to the FDA as required by law. I am urgently requesting a green light from FDA to introduce Dr. Aardsma's Vitamin MePA Dietary Supplement into interstate commerce so informed Americans can begin to incorporate this anti-aging vitamin into their diets to save themselves from the morbidity and early mortality which the "aging" deficiency disease presently exacts.

I know this is a tough NDI to handle. The golden years of vitamin discovery ended in the mid-twentieth century, making the presentation of a new vitamin to the FDA at this time a novelty with no clear precedent to follow. But surely FDA foresaw the possibility that a new vitamin might yet be identified, and FDA surely intended for such a vitamin to be able to be moved rapidly into the marketplace for the benefit of the American consumer and the American economy. The fact that FDA uses a functional definition of "vitamin," rather than merely listing the thirteen traditional vitamins, shows that FDA has allowed for the possibility of discovery of new vitamins. The use of a functional definition (wisely) makes inclusion of any substance into the "vitamin" category to be purely a technical matter as far as FDA is concerned: if it satisfies FDA's definition of the word "vitamin," then it is, for FDA's purposes, a vitamin. This means, for example, that FDA does not need to wait on scholarly consensus to come around to the view that the newly discovered vitamin is indeed a vitamin, for FDA to take appropriate action. This shows that FDA intends that the claim that a substance is a newly discovered vitamin be given the benefit of the doubt. This is as it must be. If the FDA obstructs commercial distribution of a substance which meets the FDA definition of a vitamin, and the claim that it is a vitamin is ultimately borne out by scholarly consensus, then FDA makes itself liable for health injury to the US citizenry, whose health FDA has been charged by Congress to protect. If, on the other hand, contrary to FDA's definition, scholarly consensus should ultimately reject the "vitamin" classification of the substance, and the substance was not obstructed by FDA because the substance was reasonably expected to be safe, FDA will still have fulfilled its mandate to protect the health of the US citizenry.

Gerald

Friday, February 9, 2018

by Gerald Aardsma

It has now been the better part of four months since I last heard from the FDA.

Winston Churchill said, "We can always count on the Americans to do the right thing, after they have exhausted all the other possibilities."

The right thing to do, in the present instance, is for America to begin immediately to make all-out war on aging.

This is the right thing to do because victory is now certain. Victory became certain with the discovery of the true nature of human aging—that aging is nothing more than a deficiency disease. This discovery became certain when it was demonstrated that the biblical longevity data could be successfully mathematically modeled working from the hypothesis that aging is a deficiency disease. (A link to my book giving details of the model [Aging: Cause & Cure, chapter 10] can be found in the banner at the top of this page.)

Where now is scurvy, the deficiency disease which was once the dread of every mariner? Where now is pellagra, the deficiency disease which was the scourge of the American South but a century ago? Deficiency diseases have been vanquished in every instance that institutions responsible for public health have made the defeat of these diseases a priority.

The only thing standing between us and victory is delay.

How long will Americans tolerate delay in this instance? Over half a million Americans have died of aging since I last heard from our FDA, and nearly every remaining American has been swept another four months closer to an untimely death by this fatal disease.

To save as many lives as possible, it seems necessary to alert President Trump about this matter. As President Roosevelt made the defeat of the polio virus a national priority, and as President George W. Bush made defeat of the HIV/AIDS pandemic a national priority, I am asking President Trump, in the following open letter, to make defeat of aging a national priority.

Perhaps, in this instance, we Americans will be able to prove Winston Churchill wrong.

Mr. President,

The present matter needs to come to your attention for two reasons:

  1. It is a matter of life and death to 2 million Americans per year.
  2. It is a matter worth trillions of dollars per year to the U.S. economy.

The matter, in a nutshell, is this. I have recently discovered the cause of human aging. To minimize unnecessary suffering and loss of life due to aging, it seems that exploitation and implementation of this discovery should be taken up at this time by the federal government. I have patent pending on the cure, but recent experience has taught me that millions of Americans will die of aging unnecessarily unless the task of bringing the cure for aging to the world is shouldered by the federal government itself. Hence, I am asking that the federal government buy me out at this time.

I am an independent research scientist (Ph.D. in nuclear physics from U. of Toronto, 1984). For two decades, my research focused on harmonizing biblical and secular chronologies of the ancient past using physical dating methods such as radiocarbon. I found that the ancient biblical narrative, including that which is found in Genesis, while frequently regarded as mythological today, is, in fact, reliably historical when chronological issues have been resolved.

Genesis records that people once lived in excess of 900 years. I began, in the year 2000, to research full time how such a thing might be possible. This research culminated in discovery of the cause and the cure of aging. The kernel of the discovery is that aging is a vitamin deficiency disease. This kernel I regard as incontrovertible. A prolonged search for the (previously unknown) vitamin responsible for this deficiency disease succeeded in identifying it as methylphosphonic acid (MePA). (Please see "Aging: Cause & Cure," available as a free download from my website, www.biblicalchronologist.org, for more details.)

Since the discovery of MePA, I have been trying to save as many lives with it as possible while working night and day in the lab at the same time to learn yet more about the vitamin. I had hoped to introduce this new vitamin into interstate commerce rapidly, so that those individuals who became aware of the discovery early on (especially any who were elderly) could immediately avail themselves of it. Unfortunately, the FDA has effectively blocked this effort. (You can read our full correspondence on my website.) They have blocked the vitamin, not over any concerns of toxicity (MePA has no known toxicity in the micrograms per day dose range of interest) but via the assertion that it is a drug, not a vitamin. Ordinarily, I would accept philosophically the need to go the three or thirteen rounds required to convince the FDA bureaucracy that MePA is indeed a vitamin. But I cannot philosophically accept 6,000 Americans needlessly lost each day while we dicker over definitions irrelevant to their fate.

Delay in making vitamin MePA widely available at this point is, by normal standards of decency, morally intolerable. Your recent State of the Union address has encouraged me to believe that you will feel about this as I do. Specifically, you stated, "We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives." Aging is now known to be nothing more than a vitamin deficiency disease. This disease, left untreated, is 100% terminal. It now appears that simple, inexpensive, dietary supplementation with MePA could potentially save hundreds of millions of American lives. President Trump, it appears that I have completed my leg of this race to defeat aging. If you are willing, I would like to pass the baton on to you.

Sincerely,
Gerald Aardsma

P.S. I have published this communication as an open letter on my website. My reason for doing so is to clear my own name with posterity in the event the letter's mission should fail.

Tuesday, March 6, 2018

by Gerald Aardsma

I received a prompt autoresponder to my open letter to President Trump (above) when I emailed it to the Whitehouse. There has been nothing since.

I went on line to try to learn how long responses take from the Whitehouse. I quickly learned that there is a substantial staff of gatekeepers, and that personal responses are rare, but learning how long a response might take, should your communication be favored with one, was not so easy.

Eventually, I found one response by President Obama which was dated February 11, 2015, more than a year after the date of the letter he was responding to, which was dated December 23, 2013. Further hunting turned up a second example. This was for a woman writing to President Trump. She got a response in six months.

In six months, roughly one million one hundred thousand Americans will have died of vitamin MePA deficiency disease.

I am desperate to end this now unnecessary disease. But how does a lone individual, with critical, inside information, get the proper authorities even to listen to what he is trying to say?

I am not the first to have grappled with this question, of course. The nation has just been through a tragic school shooting which cost 17 lives. Much has been made about the failure of the FBI to respond to a tip which might easily have prevented the tragedy. There appears to be little an individual with inside information can do other than to keep trying.

So I keep trying, in every way I can think of.

This past week, I decided I should try to obtain professional help with the problem of how to get our message to the President as rapidly as possible. I considered several well-known politicians. Eventually, I settled on Mike Huckabee. His knowledge of and respect for the Bible singled him out as the most likely prospect to actually listen, understand, and help.

I went to Mike's website to figure out how I might get in contact with him, and was confronted with a hintingly small text field in which to type my message. I opted at that point for metaphor. Not only is metaphor a succinct way to say a lot, but the possibility presented itself that it might, out of sheer novelty, get past whatever gatekeeper(s) stood between me and Mike. On the negative side, it was clear that it might look like brash nuttiness. Well, one can only try.

I sent the following message on March 1st:

I have a righteous cause which is badly in need of a mentor able to navigate the shark invested and otherwise treacherous waters of the Politic Ocean. I am offering you the job. The position affords no other guaranteed compensation than the chance to save some 6000 American lives per day. You may learn all about the cause beginning here: http://www.biblicalchronologist.org/products/Aging_book.php. If you would do me the dignity of replying to this message in a bottle at your earliest convenience, my fears that it had come to grief on Handlers' Reef would be assuaged.

I have had no reply so far.

I will keep trying to get through to President Trump in whatever ways I can.

Meanwhile, spread the word to those around you that the cause of aging has now been found. A cure for the deadly aging disease is now available. All they need to do is supplement their diets with vitamin MePA, freely available here.

Thursday, March 22, 2018

by Gerald Aardsma

I sent the following letter this morning to Dr. Scott Gottlieb, appointed by President Trump as FDA Commissioner in May, 2017.

Dear Commissioner Gottlieb,

I am a Ph.D. scientist who has spent decades researching the cause of aging. I have discovered that what we call human "aging" is nothing other than a vitamin deficiency disease. I have found that the previously unknown vitamin whose (presently global) dietary deficiency results in aging is methylphosphonic acid (MePA). I have submitted an NDI notification to FDA for vitamin MePA, and I have received the response that MePA is a drug, not a vitamin. I have responded showing that MePA satisfies the FDA definition of a vitamin, and I have asked how I should proceed with my NDI notification to resolve this matter and bring MePA to market as quickly as possible. I have had no response to this question in five months. Because each day of delay in bringing MePA to market costs another 6000 American lives, it seems best to go directly to the top and bring this matter to your attention at this time.

I mean no harm to anyone's career at FDA; Fred Hines, with whom I have corresponded, strikes me as both professional and considerate. I feel that, because the nature of this NDI is unprecedented, it has been misunderstood and, consequently, it is being mishandled, with tragic, irreversible consequences. If what I have discovered about aging is true—and it is true, regardless of how absurdly impossible this may seem—then aging is a preventable/curable disease, like scurvy or pellagra, and each day of delay in bringing MePA to market needlessly fates another 6000 Americans to death by vitamin MePA deficiency disease (aka "aging"). It seems impossible that FDA could want to be responsible for perpetuating such an outcome.

I am all too aware that my research must seem nutty to many. So did Galileo's and so did Einstein's. Breakthroughs resulting from paradigm shifts take decades to penetrate the mainstream. Unfortunately, the luxury of waiting decades does not exist in this particular instance. The cost of waiting, in terms of real human suffering and unnecessary loss of life, is simply too large.

Meanwhile, there is no good reason to wait. Besides satisfying the FDA definition of "vitamin," MePA has behaved in predictable vitamin-like fashion in limited trials with volunteers. It displays multiple physiological roles, a characteristic of other members of the traditional vitamin set, with no negative side effects. In common with many of the other water-soluble vitamins, toxic effects have not been observed, even at clearly excessive doses. In short, there is no good reason why FDA should be stalling commercialization of this vitamin that I am aware of, and there is at least one very good reason why it most certainly should not be doing so.

I have recently written to President Trump asking him to initiate a federal government program to eradicate this now unnecessary disease. Given the innate inertia of government, this seems likely to take many months to get rolling. I am writing to you asking that the FDA stop blocking my efforts to make vitamin MePA commercially available, to save as many American lives as possible while waiting on the federal government to get proactively involved.

Waiting on your reply,
Gerald Aardsma

Wednesday, May 30, 2018

by Gerald Aardsma

I have had no response from the FDA Commissioner, Dr. Scott Gottlieb.

An ombudsman, according to wikipedia, is "an official who is charged with representing the interests of the public by investigating and addressing complaints of maladministration or a violation of rights." Today, I sent the following email to the FDA ombudsman in an effort to get this stalled train moving once again. The subject of the email was "Help needed."

Dear Ombudsman,

THE PROBLEM:
FDA is hindering efforts to save some 6000 Americans per day from needlessly dying.

BACKGROUND:
See my "FDA Journal" blog: http://www.biblicalchronologist.org/products/FDA_Journal.php

OBJECTIVE:
Get a green light from FDA for introduction of Dr. Aardsma's Vitamin MePA Dietary Supplement into interstate commerce as expeditiously as possible.

Can you help with this?

Sincerely,
Gerald Aardsma

Thursday, May 31, 2018

Dear Mr. Aardsma:

Thank you for your March 22nd inquiry regarding your proposed new dietary ingredient (NDI) methylphosphonic acid. As explained in our response to your New Dietary Ingredient Notification (NDIN), dated September 26, 2017, and again in an email we sent to you on October 17, 2017, methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act (the Act). The Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. As noted in our prior communications with you on this matter, your notification, as well as information from peer reviewed literature, fails to demonstrate that methylphosphonic acid is a substance that meets the statutory definition of a dietary ingredient.

FDA regulates dietary supplements under the authority of the Federal Food, Drug, and Cosmetic Act (Act). FDA's role in regulating dietary supplements includes inspecting manufacturing establishments for product quality, labeling and claims as well as monitoring adverse event reports from firms, consumers, and health care providers to identify products that may be unsafe. However, FDA does not approve dietary supplements or product labeling because the Act places dietary supplements under the general umbrella of foods. The manufacturer is responsible for ensuring dietary supplements are safe and comply with applicable requirements in the Act and Title 21 of the Code of Federal Regulations (21 CFR), which you can access at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart.

If you contact FDA, specifically, Fred Hines, from the Evaluation and Research Staff within the Office of Dietary Supplement Programs, he can provide you with general guidance on pre- and post-notification meetings. Dr. Hines can be reached at fred.hines@fda.hhs.gov. For more information pertaining to new dietary ingredient notifications, please see the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.

We hope this information is helpful.

Sincerely,
Robert J. Durkin, Esq., M.S., R.Ph.
Deputy Director.
Office of Dietary Supplement Programs
Center for Food Safety and Applied Nutrition

Monday, June 4, 2018

Dear Mr. Durkin,

No, the information in your email was not very helpful. In point of fact, it was, if anything, frustrating on several levels.

Here is level 1: It was frustrating because it failed to provide necessary context. I was left confused about who I was communicating with, and I was left confused about why you, specifically, have emailed me at this specific time.

I emailed Fred Hines October 18, 2017, and I am still waiting on a response from him. I emailed Commissioner Gottlieb March 22, 2018, and I have had no response from him. I emailed the FDA ombudsman office May 30, 2018, and I have so far not heard back from them. You are Robert J. Durkin, whom I have never emailed, but whom I recognize as the signatory on the FDA response to my NDIN.

You specify that you are responding to my March 22 email. That email was to Commissioner Gottlieb. Why is the response from you? Are you responding in place of Commissioner Gottlieb, acting as his agent, or are you responding together with Commissioner Gottlieb (your email says "we"), or do you mean by "we" that you are representing the FDA, or does "we" mean you and Fred Hines, or...?

Regarding the timing of your email: Are you responding because of my email to the ombudsman a day earlier, or is your response the day following my email to the ombudsman purely coincidental? Should I expect a separate response from the ombudsman?

In composing this reply to your email, I have guessed at the answers to the preceding questions as follows. Guess 1: My email to the ombudsman is the reason you are responding at this time. Guess 2: Commissioner Gottlieb has referred the matter back to you and Fred Hines to deal with.

Here is level 2: It was frustrating because it implied that I am the problem—that I have been given an adequate answer, articulated on two occasions, and that the ball is in my court, all I need to do is contact Fred Hines about a meeting.

In actual fact, I have not been given an adequate answer. Fred Hines and I were engaged in a cordial email exchange in 2017, trying to get to an adequate answer. I bounced the ball back to Fred October 18, 2017 ... and I am still waiting for it to be bounced back to me. The ball is definitely in your court, not mine.

In addition, your procedural advice at this stage is frustratingly anachronistic. I explicitly asked Fred, over eight months ago, on September 28, 2017, how to expedite this vitamin issue through FDA:

"My main question is what action should I take next in an effort to get FDA most quickly to come to understand that MePA most certainly is a vitamin?"
Fred did not explicitly answer this question, but he implicitly answered it by personally tackling the vitamin question in an email to me on October 17, 2017. Thus, we are already in a procedure—a procedure which seems, with no explanation, to have stalled, which is why, after some months had transpired, I first tried to contact Commissioner Gottlieb, and then, when that had apparently failed, I contacted the ombudsman.

Here is level 3: It was frustrating because it seems to start over again at the beginning, ignoring time consuming progress, in an absolutely time-critical environment.

You say: "As explained in our response ... methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act (the Act)."

(Before I can proceed to discuss this sentence, I must first correct it. The word "explained" here is inaccurate and should be changed to "asserted." Your sentence should read, "As asserted in our response... methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act (the Act)." There has been no explanation of this assertion to the present time. In point of fact, your inability to provide a rational explanation of this assertion is why Fred and I have been in correspondence in regard to it.)

I grant that it has been repeatedly asserted that "methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act," but the assertion is false and logically indefensible—as I think had been demonstrated at the point that the ball failed to be returned from your side of the net.

The logic here is not difficult. I asserted in my NDIN that methylphosphonic acid (MePA) is a newly discovered vitamin. I gave evidential support for my assertion, referencing the book on the discovery of the vitamin, Aging: Cause and Cure. Now either MePA is a vitamin or it is not a vitamin—there are only these two possibilities. If it is a vitamin, then, in direct contradiction to your assertion, it absolutely fits under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act since the Act explicitly defines a dietary supplement as "a product (other than tobacco) intended to supplement the diet that bears or contains a vitamin, ...". So, for your assertion that MePA does not fit the Act to be valid, it is necessary for you to have first proven the other of the two logical possibilities: that it is not a vitamin. You have not done this.

Fred, in his email of October 17, 2017, attempted to do this. He argued that MePA may be found as a degradation product in foods adulterated with certain nerve agents. He concluded:

"Methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act (the Act); i.e., it is not food and is certainly not a vitamin."
If MePA were toxic, like a nerve agent, then it would not be a vitamin. Vitamins are not toxic (when taken in appropriate doses), they are essential to health. But just because a parent compound is toxic does not mean that its degradation products are toxic. I refuted Fred's argument by explaining that essential compounds can be degradation products of toxic parent compounds, giving as an example the degradation of hydrogen peroxide into water and oxygen.

It is frustrating to see your unproven assertion that "methylphosphonic acid does not fit under section 201(ff)(1)(A-F) of the Federal Food, Drug, and Cosmetic Act" repeated in the present context, as if it is somehow the definitive final word when, in fact, it has already been the subject of subsequent discussion which was tellingly against it.

Here is level 4: It was frustrating because it attempts, once again, to shift the burden of proof over to me, where it does not belong.

You have repeatedly tried to shift the burden of proof which is yours, to show that MePA is not a vitamin, over to me, to prove to your satisfaction that MePA is a vitamin. You do this again in this latest email:

"As noted in our prior communications with you on this matter, your notification, as well as information from peer reviewed literature, fails to demonstrate that methylphosphonic acid is a substance that meets the statutory definition of a dietary ingredient."
This is unfair. If the assertion is made that an NDI is a vitamin, as I have done, and FDA disagrees, surely the burden of proof must rest with FDA to show that the NDI is not a vitamin. The Act certainly nowhere specifies that it is the manufacturer's responsibility to prove to FDA's satisfaction that a claimed vitamin is in fact a vitamin. The Act instead provides a definition of "vitamin," presumably to be used by the manufacturer and the FDA to determine whether a claimed vitamin really is a vitamin as far as FDA is concerned. You recited this definition in your response to my NDIN. I explicitly showed that MePA satisfies this definition in my email to Fred on September 28, 2017.

My remaining question regards how the conclusion was reached that my notification provides insufficient basis to establish that MePA is a vitamin. (The response letter actually winds up saying that my notification "indicates that "MePA" is not a dietary ingredient," but this seems to be a sentence structure problem, because my notification certainly indicates no such thing. My notification states explicitly that MePA is a vitamin, and hence it follows that it is a dietary ingredient.) The response letter kindly spells out the FDA definition of a vitamin. I feel my notification provided all the background which was necessary for an FDA examiner to see that MePA satisfies this definition.

Here's how this goes, broken down, using the FDA definition.

A vitamin is:

  • an organic substance — MePA [Linear Formula CH3P(O)(OH)2] is an organic substance
  • that is a minor component of foods, — MePA was naturally present in micrograms per liter (that's minor!) in drinking water
  • is essential for normal physiological functions (e.g., maintenance, growth, development), — MePA is essential to maintenance
  • is normally not produced within the body in amounts adequate to meet normal physiological needs, — MePA is not produced in the body at all
  • and which causes, by its absence or underutilization, a clinically defined deficiency syndrome. — absence or underutilization of MePA produces the clinically defined deficiency syndrome called "aging"
What does FDA feel is missing?

From there, the burden rests with you, if you disagree with me, to show that MePA is not a vitamin. The burden of proof has to be yours because all the power within the scientific method rests with falsification, not with proof (see Karl Popper, "The Logic of Scientific Discovery"). In this instance, only FDA possesses the potential for falsification. Fred has tacitly agreed with all of this by attempting to falsify the vitamin status of MePA in his October 17, 2017 email.

If the claim that MePA is a vitamin is false, then it should be very easy for FDA to show this. The definition of "vitamin" is rather strict. Up until my discovery of MePA, only 13 substances, out of the myriads of known compounds, had been found to fit this definition. Obviously, one can't successfully claim that just any old compound one chooses is a vitamin. The definition simply won't allow it. I suggest that it is a fairly trivial exercise to falsify an erroneous claim that a substance is a vitamin. And I would go on to suggest that the reason you have been unable to falsify the claim that MePA is a vitamin is because it is, in fact, a vitamin.

It is frustrating to find you once again attempting to shift your responsibility in this matter onto my shoulders.

Here is level 5: It was frustrating because of its apparent oblivion of the moral dimension which the handling of this matter cannot possibly evade, even though I have repeatedly stressed this moral dimension and the urgency which it dictates.

Let me show you what I am seeing by use of a simple analogy.

I am standing on the shore of the Niagara River a few miles above the falls. A boatload of 6000 Americans is drifting helplessly down the river. I have a rope coiled in my hand, tied at one end around the base of a tree, ready to throw out to these people as they drift by. To fasten this rope to their boat is these folk's only hope of survival. Meanwhile, a government agent stands by the river, tasked with keeping people from throwing garbage in the water. He draws his gun and threatens to shoot if I throw the rope into the water. I desperately try to explain that a lifeline is not garbage. He ignores my plea—as the boat drifts hopelessly out of reach.

No analogy is ever perfect, and this one is no exception. Its major defect lies in its understatement of the moral dimension it attempts to illustrate. To correct that defect, we need to allow the same drama to repeat itself with a new boatload of 6000 Americans each and every day. (Which also explains why I don't simply throw the rope to the first boatload and get myself blown away.)

Your apparent moral oblivion in this present situation no doubt seems to you suitably and perhaps even necessarily professional. From my perspective, it is not only frustrating but also outrageous and inexcusable. You have another option. You have the option to agree (even tentatively, if need be) that MePA does seem to fit the FDA definition of "vitamin" and to move on to the safety question. I spelled this option out to Fred in my October 18, 2017 email:

"I know this is a tough NDI to handle. The golden years of vitamin discovery ended in the mid-twentieth century, making the presentation of a new vitamin to the FDA at this time a novelty with no clear precedent to follow. But surely FDA foresaw the possibility that a new vitamin might yet be identified, and FDA surely intended for such a vitamin to be able to be moved rapidly into the marketplace for the benefit of the American consumer and the American economy. The fact that FDA uses a functional definition of "vitamin," rather than merely listing the thirteen traditional vitamins, shows that FDA has allowed for the possibility of discovery of new vitamins. The use of a functional definition (wisely) makes inclusion of any substance into the "vitamin" category to be purely a technical matter as far as FDA is concerned: if it satisfies FDA's definition of the word "vitamin," then it is, for FDA's purposes, a vitamin. This means, for example, that FDA does not need to wait on scholarly consensus to come around to the view that the newly discovered vitamin is indeed a vitamin, for FDA to take appropriate action. This shows that FDA intends that the claim that a substance is a newly discovered vitamin be given the benefit of the doubt. This is as it must be. If the FDA obstructs commercial distribution of a substance which meets the FDA definition of a vitamin, and the claim that it is a vitamin is ultimately borne out by scholarly consensus, then FDA makes itself liable for health injury to the US citizenry, whose health FDA has been charged by Congress to protect. If, on the other hand, contrary to FDA's definition, scholarly consensus should ultimately reject the "vitamin" classification of the substance, and the substance was not obstructed by FDA because the substance was reasonably expected to be safe, FDA will still have fulfilled its mandate to protect the health of the US citizenry."

Please note very carefully that the fundamental, unavoidable ethical issue intrinsic to this NDIN cares not at all whether the claim that MePA is a new vitamin is credible. The ethical issue cares only about whether the claim may be true. If you cannot prove that the claim is false, then you must grant that it may be true. And in that case, you must grant that your prevarications may be sending boatloads of Americans over the falls. What sort of morality is it that permits any government agent or any government agency to take such an unnecessary gamble with the lives of 6000 American citizens per day, and for month after month?

I have never asked you (or Fred) to close your eyes and wave this NDIN through the system, and I am not asking you to do so now. I have only ever asked, on behalf of 6000 Americans dying per day, that this NDIN be dealt with expeditiously. Is that really so much to have asked that it has deserved to have been ignored?


Can we please resume discussion toward a rational closure on the vitamin question at this time?

In the months which have transpired since I first mailed my NDIN to FDA, substantial additional experience with MePA has accumulated. Numerous volunteers, myself included, have taken Dr. Aardsma's Vitamin MePA Dietary Supplement in various doses. You can read reports on these individuals at http://www.biblicalchronologist.org/products/vitamin_MePA_testimonials.php. These reports constitute pilot study data, not controlled trial data. Nonetheless, they exhibit reproducible regularities, even at this early stage, which appear to show aging in the process of being cured. This is most easily seen by comparison to some traditional vitamin deficiency disease. Consider the cure of pellagra via dietary supplementation with nicotinic acid, for example.

Clinically advanced pellagra is rare in the U.S. today, but before the discovery of nicotinic acid in the later half of the 1930s, pellagra was common in the southern states where corn was a major dietary stable. Following is a description from back at that time [Physicians' Vitamin Reference Book, third edition (New York: E.R. Squibb & Sons, January 1940), 46--47.] of the effects on pellagra patients of treatment with nicotinic acid.

A comprehensive report has been made by Spies, Bean, and Ashe, based on observations at the Cincinnati General Hospital, and the Hillman Hospital, Birmingham, Alabama, on the nicotinic acid treatment of hundreds of cases of classic pellagra. It is stated that:
"The administration of adequate amounts of nicotinic acid or one of its compounds is followed by the disappearance of many symptoms of the disease. Within 24 to 72 hours [1 to 3 days], the fiery redness and swelling of the tongue, gums, mouth, throat, and vagina subside, and the associated Vincent's infection disappears. Within 24 to 72 hours, nausea and vomiting cease, the increased salivation decreases, and bowel movements become normal. Abdominal distention, pain and discomfort disappear and, in most cases, the desire for food returns. The acute, fiery red erythematous [reddening of the skin, usually in patches] dermal lesions, in which the epithelium [thin tissue forming the outer layer of a body's surface] is intact, blanch within 48 hours after the administration of nicotinic acid, but where the continuity of the skin is broken and the lesions are moist, ulcerated, dry or pigmented, there seems to be no specific benefit. Perhaps the most dramatic response of the pellagrin to nicotinic acid therapy is the disappearance of the acute mental symptoms. These symptoms, varying from slight confusion to delirium and mania, disappear rapidly, often over night. The maniacal patients become calm and the confused patients, mentally clear. After therapy they become readjusted, and often have excellent insight and memory of their actions, ideas and surroundings during the psychotic period. Apathy and lassitude give way to interest."
Notice the relief of diverse symptoms with no hint of any negative side-effects due to the treatment. This is the signature of a water-soluble vitamin at work curing a deficiency disease.

A major difference in the analogy between pellagra and aging is that pellagra develops relatively quickly on a deficient diet and resolves relatively quickly on a diet appropriately supplemented with nicotinic acid, while aging develops relatively slowly on a deficient diet and resolves relatively slowly on a diet appropriately supplemented with methylphosphonic acid. Fortunately, however, some of the symptoms of aging begin to resolve rapidly, and because of this, the experience gained to date with volunteers is able to provide further evidence that MePA is indeed the anti-aging vitamin it claims to be.

Here is my summary of this experience, deliberately imitating the report on the nicotinic acid treatment of pellagra cases quoted above, to show the analogy.

The administration of adequate amounts of methylphosphonic acid is followed by the disappearance of many symptoms of the disease of aging. Within a few weeks to a few months, the sleep disorders characteristic of aging subside: there is less trouble getting to sleep (i.e., reduced insomnia), sleep is deeper and more refreshing, and less sleep is needed. Associated fatigue is reduced or disappears. The rate of wound healing is remarkably increased, and accompanying inflammation and pain is decreased. The incidence of headaches and migraines is reduced. Within a few weeks to a few months, diseases which have taken hold because of agedness, such as heart failure, cancers, and autoimmune disease, may begin to be slowed, reversed, or cured. Numerous skin disorders disappear: skin becomes more moist and supple; chronic skin infections begin to clear up within a month after the administration of methylphosphonic acid; aging spots begin slowly to fade. Perhaps the most dramatic response of the elderly to methylphosphonic acid therapy is the disappearance of chronic mental symptoms. These symptoms, varying from ``brain fog'' to depression and anxiety, disappear rapidly, sometimes within the first week. The depressed become more happy, the anxious, more calm, and the ``brain fogged,'' mentally clear. Apathy and lassitude give way to interest and creativity.

In short, experience gained to date with MePA demonstrates the relief of diverse symptoms with no hint of any negative side effects which is characteristic of the cure for a water-soluble vitamin deficiency disease. If MePA is not a vitamin, why then is it behaving this way?

Gerald

Friday, June 8, 2018

by Gerald Aardsma

Yesterday, I sent the following email to my representative in Washington, D.C., Congressman Adam Kinzinger, using the form provided for that purpose on his website. The subject of the email was "new discovery."

My situation is somewhat similar to the one portrayed in the 1961 Disney film, "The Absent-Minded Professor." I am a Ph.D. scientist who has made a discovery which I believe needs to come to the attention of President Trump at this time, but I seem unable to get through to him. Can you help me with this?

Today, Congressman Kinzinger's office phoned and left a message for me to return the call. I have difficulty hearing phone conversation clearly, so I prefer to use email as much as possible. My wife, Helen, returned the call and explained this. Staff assistant Will Schuneman said he would email me.


 
 
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