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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

 
 
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