Vitamin A capsule expiry
vitamin A capsule expiry Michael Golden 19.03.2000
Re: vitamin A capsule expiry Rafah Aziz 20.03.2000
re: vitamin A capsule expiry Venkatesh Mannar 21.03.2000
RE: vitamin A capsule expiry Ibrahim Parvanta 22.03.2000
vitamin A capsule expiry Phil Harvey 22.03.2000
Re: vitamin A capsule expiry Ian Darnton-Hill 29.03.2000


Date: Sun, 19 Mar 2000 15:15:24 +0000

From: Michael Golden <m.goldenatabdn.ac.uk>

Subject: vitamin A capsule expiry

 

Dear NGONUTS,

A member has asked about the expiration of vitamin A capsules.

There is a National Immunisation Day scheduled to May, but some of the Vitamin A capsules expire in April.

What is the "leeway"?

The member states "I know that we have 6 months after this date, but I want to confirm it"

This brings up a wider issue of products that go marginally "out-of-date", particularly when logistically the products are needed and cannot be replaced in time or when they are so expensive that to replace them would mean that services would need to be otherwise truncated.

The expiration date is normally the time when the manufacturers will no longer guarantee the product - this is always very conservative because, if the product is found to be ineffective before date they are liable. It is nonsense to assume that the day before the expiry date the product is 100% and the day after it is defective. And yet strict adherence to the "rules" can lead to tremendous waste and even to people going without drugs, such as vitamin A, that they really need and are available in a perfectly safe and active form, albeit past the expiry date. The difference being that the manufactures will no longer stand by the quality of the product.

If the product does not degrade to form toxic compounds and the degradation is slow then even 6 months after the expiry date there may be 90% of the stated amount in the capsule: the required doses that we use clinically are simply not that accurate and normally also have a built in wide margin of "safety" to make sure that they work. There is a difference between guaranteeing the actual dose in a capsule and giving a drug that is almost always going to be clinically effective.

For a product such as vitamin A it would be good if there was guidance over the "leeway" and consequences of using out-of-date stock, perhaps the International Agencies could,during this time, take over responsibility from the manufactures for an adverse event - They would not guarantee the amount of active ingredient in the preparation, but rather to state that it will do no harm (no toxic degradation products) and that the amount of the ingredient remaining is within the range of clinically effective doses (if you have been given the drug it will be protective)..

Of course the manufacture's guarantee is only effective if the product has been stored according to instructions. Storage conditions during transport and in the developing world frequently depart from specifications, and I am sure that the manufactures could successfully defend themselves against an action based upon analysis on these grounds. The expiry date is thus not a guarantee that the product is still within specification just its passage does not mean that the product is now useless and must be destroyed.

It is noteworthy that the US government has traditionally given no dates (either of manufacture or expiry) on manufactured food products such as CSB. This is to avoid the problem of refusal of perfectly good food because it is a few days beyond expiry - so food that is years out-of-date can be distributed without anyone being aware that the micronutrients are all gone. This is the other side of the coin. Clearly, a middle ground is required. I would like to see a change from "expiry date" to something such as "composition guaranteed until....", and also a second date "product likely to be ineffective after..." - or some such use of words that is acceptable to the lawyers and yet is much more informative of the likely actual situation with the product.

Mike Golden

 

Prof. Michael H.N.Golden

Dept of Medicine and Therapeutics

Univ of Aberdeen, Foresterhill, AB9 2ZD. Scotland, (UK)

Tel +44 (1224) 681 818 ext 52793/53014, Tel(direct) +44 (1224) 663 123 527 93, Fax +44 (1224) 699 884

INTERNET m.goldenatabdn.ac.uk


Date: Mon, 20 Mar 2000 10:06:13 +0000

From: razizatunicef.org (Rafah Aziz)

Subject: Re: vitamin A capsule expiry

 

Hi Mike,

This is a real life dilemma, people now are more aware of expiry (dates), we know that we can continue to use certain items beyond the expiry dates, BUT if any thing goes wrong who to blame? How can we be sure that there are no toxic effects? Toxic bi-products after a certain time? validity of the product becomes questionable..... As you mentioned, storage conditions affect very much contents and reduce shelf life , it is risky to say yes you can use the item beyond the expiry date.

Some times agencies providing humanitarian aid are accused of trying to market items that are close to expiry (or even expired) and sending it to the needy less fortunate population, one has to be realy carefull.

I would add my voice to yours and others in requesting a way of getting info on safety margins for commonly used commodities (including vit A) All the best

Rafah

 

Rafah S. Aziz, Chief Health & Nutrition Section

Khartoum - Sudan P.O. Box 1358

Fax : (249 11) 471126 Tel.: (249 11) 471835 - 37- 38 Mobile : 012309412

e-mail : razizatunicef.org


Date: Tue, 21 Mar 2000 14:58:51 +0000

From: <vmannaratidrc.ca> (Venkatesh Mannar)

Subject: re: vitamin A capsule expiry

 

We are surprised that expired Vitamin A capsules are still floating in the system. Since the middle of 1998 the Micronutrient Initative with assistance from CIDA has provided through UNICEF a significant quantity of capsules from Canada (nearly 1 billion so far) to boost their global availability wherever needed. The capsules have a shelf life of 3 years which means that even the first capsule that we supplied should still be OK.(All capsules supplied by us are marked "A gift from the Micronutrient Initiative with an indication of expiry date which is 3 years from the Mfg date) The MI is providing additional quantities of capsules to UNICEF to build up a buffer stock so as to be able to respond quickly to urgent needs.

Therefore I would say that no government should have to accept expired capsules and should be able to contact the local UNICEF office to arrange for supplies.

 

M.G. Venkatesh Mannar, Executive Director

Micronutrient Initiative

Tel: 613-236-6163 ext. 2210, Fax: 613-236-9579

Email: vmannaratidrc.ca


From : Ibrahim (Abe) Parvanta, IParvantaatcdc.gov

Date: 22.03.2000

Subject: re: vitamin A capsule expiry

 

Please see below regarding regulations in the United States.

Regards,

 

Ibrahim (Abe) Parvanta, Chief, International Activities

Maternal and Child Nutrition Branch, Division of Nutrition and Physical Activity

CDC, Atlanta, GA

tel: 770-488-5865

e-mail: IParvantaatcdc.gov

 

> From: Yetley, Elizabeth A [SMTP:Elizabeth.Yetleyatcfsan.fda.gov]

> Subject: RE: Ngonut: vitamin A capsule expiry

Abe --

In the U.S., the potency of a marketed product must be maintained throughout the shelf life of the product. To achieve this, most manufacturers add overages, sometimes quite significant overages. Moreover, most products, even at a labeled expiration date, are still at or above label declaration. If they fall below label value, it's generally minor (e.g., 10%). Label expiration dates are not required by FDA. They may be done voluntarily by manufacturers. There are, therefore, no regulations to guide them. However, as I indicated, the manufacturer must have at least 100% label potency throughout the marketed shelf-life of a product, regardless of what the expiration date says.


Date: Wed, 22 Mar 2000 13:52:34 -0500

From: "Phil Harvey" <pharveyatistiinc.com>

Subject: vitamin A capsule expiry

 

NGONUTs

I asked a colleague working with a large manufacturer of vitamin A to respond to the specific question asked regarding expiry. I caught him between planes but he was kind enough to give a quick response. He will follow up with a more authoritative and informed opinion when he has a chance to check with others.

The quick response, in general terms, was that the manufacturers of the raw product (vitamin A) guarantee that the product will have the declared activity at least until the expressed date. This does not mean the day after that there will be no vitamin or that toxic compounds will have evolved overnight.

He described vitamin A as "pretty stable in the capsule environment, as long as it is kept cool, dark and dry". Since the conditions of storage are unknown, it is clearly difficult to estimate the loss of activity. His guess was that in ideal conditions, one might expect a drop in activity not larger than 10% in the next 6 month. Again, he stressed that this was a top of mind response and that and he hoped to follow up with a more definitive answer after conferring with others in the organization. I will post this response when it is available.

 

Phil Harvey, Nutrition Advisor

MOST - The USAID Micronutrient Program, 1820 N. Fort Myer Drive - Suite 600

Arlington VA 22209, USA

Tel: (703) 807 0236 (General), (703) 248 3311 (Direct), Fax: (703) 807 0278

E-mail: pharveyatistiinc.com


Date: Wed, 29 Mar 2000 18:28:32 -0500

From: "Ian Darnton-Hill" <IDarnton-HillatHKI.Org>

Subject: Re: vitamin A capsule expiry

 

Mike:

I agree this is a very interesting problem with both practical and ethical dimensions (not least those of waste) and there is not a simple answer (in my opinion) that can be applied worldwide- for one thing the needs are so different. I hope it gets further discussion, and hope it gets identified as an important issue at the MN WG at SCN.

cheers,

Ian