A New Approach to the Chronology of Biblical History from Abraham to Samuel.  112 pages. $29.95. Click for details. The Exodus Happened 2450 B.C.  94 pages. $29.95. Click for details. Noah Aging: Cause and Cure.  143 pages. Free download. Click for details. Click for a quick introduction to vitamin MePA. Click to purchase vitamin MePA. Click to give a gift of support.
 
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Purchase Vitamin MePA

Your ancestors, before Noah's Flood, got vitamin MePA in their drinking water. Dr. Aardsma's Vitamin MePA dietary supplement is sold as a liquid in a convenient dropper bottle. Each day, simply add one drop to a glass, fill the glass with water, and drink it. You will then be getting vitamin MePA the way your long-ago ancestors did.

Sale of Vitamin MePA is Waiting on FDA

The Biblical Chronologist is ready to sell Vitamin MePA to you as a patent-pending dietary supplement. However, the law requires that the U.S. Food and Drug Administration (FDA) be notified 75 days in advance of any introduction of a new dietary supplement into interstate commerce. The journal below is designed to keep you informed and up to date on this process so you can understand what the holdup is, and so you can best estimate when Dr. Aardsma's Vitamin MePA dietary supplement will be commercially available. We will notify the New Content e-mail list (see link at left) as soon as we are able to ship.

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.

Journal

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.

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 from Paxton post office. 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 makes Wednesday, October 11, 2017 to be the 75 day deadline for response from FDA. This is presently the earliest date that Dr. Aardsma's Vitamin MePA could begin to ship, unless FDA responds with a "no objections" letter at an earlier date. If FDA responds with objections, shipping could be delayed even further.

 
 
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