Formula recall and deaths

iVillage Member
Registered: 03-26-2003
Formula recall and deaths
14
Sun, 11-09-2003 - 3:14pm
http://www.haaretz.com/hasen/spages/358387.html

No, this is not in North America...but it is news from this week, to do with formula made in Germany for export to Israel.

Fio.

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iVillage Member
Registered: 09-24-2003
Mon, 11-10-2003 - 8:08am
That is horrible.

Thank God formula in the USA is so heavily regulated.

iVillage Member
Registered: 03-26-2003
Mon, 11-10-2003 - 8:51pm
from my local newscast..this formula is available here. so, much for all that "heavy" regulation...

Health Alert: Kosher Baby Formula Recalled



By Jeff Rossen

(Williamsburg-WABC, November 10, 2003) — A popular baby formula that may be linked to the deaths of three children is being yanked from store shelves.



Jeff Rossen reports from Williamsburg with details.

The formula is called Remedia, and the problem is that while the label says it contains vitamin B1, thiamin, it doesn't. Somehow the vitamin never made it into the formula. But B1 is essential to a baby's central nervous system. Remedia is manufactured by a German company, and all production has been halted.

It is a soy-based kosher formula that's also very popular in Israel, which is where the warning comes from. But the warning extends across this country as well because it is popular across the country, but especially in Jewish neighborhoods here in New York City.

Three children in Israel have already died, and others are sick and hospitalized.

"All my friends here say that they were panicked."

Dr. Tommy Schenfeld, Schneider Children's Medical Ctr.: "There is increasing interest from other Jewish populations around the world, especially from New York. We heard that since the Jews in New York keep kosher, they give to their children this formula, the Remedia formula ... And we'll get information from the New York community today or tomorrow."

iVillage Member
Registered: 03-26-2003
Mon, 11-10-2003 - 9:26pm
Are you so sure it is? What do you consider "regulated"?

Fio.

iVillage Member
Registered: 09-24-2003
Mon, 11-10-2003 - 9:50pm
<>>



The kosher formula is made for Remedia by the German company Humana Milchunion.

Why the sarcasm? I get the feeling you almost *wish* it was made here. The formula was not manufactured in this country. It was therfore not subject to the testing by the FDA under the Infant Formula Act. It IS sold in this country and while I would never buy foreign made infant formula apparantly some Orthodox Jews use it here. Like I said, it is horrible.

RE: Formula manufactured in this country:

<>

More detailed info:

<

Section 412 specifies that an infant formula is adulterated:

if it fails to provide nutrients as required

if it fails to meet the nutrient quality factors required by regulation

if the processing is not in compliance with the appropriate GMP and quality control procedures or record retention requirements as prescribed by regulation

if it otherwise fails to comply with Section 402 of the Federal Food, Drug, and Cosmetic Act.

Section 412 also requires manufacturers of infant formulas to notify FDA 90 days before any charitable or commercial distribution of any new infant formula or any infant formula that has had a major change in its formulation or processing.

Under authority of the Federal Food, Drug, and Cosmetic Act, FDA has established regulations (21 CFR 106) which specify quality control procedures for assuring nutrient content of infant formula. Similarly, regulations have been established for infant formula on the following: (21 CFR 107) the labeling of infant formula; the terms and conditions under which certain infant formulas may be exempt from some of the Federal Food, Drug, and Cosmetic Act's requirements; nutrient specifications for infant formula; infant formula recalls; and record retention. The FDA is also developing additional regulations in response to amendments to the Infant Formula Act, including regulations on good manufacturing practices.>>





iVillage Member
Registered: 03-26-2003
Tue, 11-11-2003 - 7:29am
not sure what you perceived as sarcasm...not intended.

as for "wishing" it was made here -- are you serious? that's a pretty sick thing to say. honestly, the idea put forth in your original post that it's not safe for children in other countries to consume formula is interesting to say the least.

otherwise, i'm sure you know, formula recalls have occured in this country.

ALL the regulation in the world cannot prevent human errors in the manufacturing process.

iVillage Member
Registered: 03-26-2003
Tue, 11-11-2003 - 7:57am
Might I point you to this post?

It talks about FDA regulations too and seem to counter what you're saying...

http://messageboards.ivillage.com/iv-psbfvbottle/?msg=832.1

Also this: http://www.infactcanada.ca/marketing_fats_to_fatten_profits.htm

Oneproudmama, you said: "Section 412 also extends FDA's factory inspection authority to permit access to complaint files and other manufacturers' records, quality control records, and test results necessary to determine compliance with the Act. "

Yeah, but do they ever really take the time to do this?

Here's a bit more:

http://www.cfsan.fda.gov/~dms/qa-inf22.html

"The law does not require that FDA approve infant formulas but instead requires companies to provide certain information to FDA before they market new infant formulas. Manufacturers must provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. If such assurances are not provided, FDA will object to the manufacturer's marketing of the formula; however, the manufacturer may market the new infant formula over FDA's objection."

So...even if the FDA scrutinizes the formula heavily (which doesn't seem the case...mfg's just have to provide assurances, whatever that means...doesn't say the FDA actually tests anything), if they don't approve of the formula, the mfg. can still market it. How screwy is that???

http://www.cfsan.fda.gov/~dms/inf-exmp.html

"An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems (21 CFR 107.3). Prior to any company or person manufacturing and marketing a new exempt infant formula or any infant formula, certain practices, procedures and processes must be followed (Section 412 of the Federal Food, Drug, and Cosmetic Act). For exempt infant formulas, there are specific terms and conditions that must also be met (21 CFR 107.50). The following list provides all of the products classified as exempt infant formulas that FDA believes are currently available (to date) on the U.S. retail market. The products are grouped by the company that manufactures and/or distributes them as well as grouped by type of product (if applicable). "

RIIIIIGHT. So the kids who are the most fragile are the ones who are the least protected if I understand correctly???

And about DHA/ARA:

http://vm.cfsan.fda.gov/~rdb/opa-g007.html

ARASCO is derived from a soil fungus--crude oil--Mortierella alpina and

DHASCO is derived from a microalgal species Crypthecodinium cohinii. Now on

page 3(if you print this document out) it says, " we are particularly

concerned about toxicological effects that could derive from constitutuents

of the source microorganisms, which have no prior use as a source of food

ingredients...Some of these sterols may be novel sterols that are not present

in commonly consumed vegetable oils."

Hmm, NO PRIOR USE AS A SOURCE OF FOOD INGREDIENTS...interesting. Sure, we have to start somewhere, but this on GMO's, sounds rather fishy to me...pun intended. Sounds more like unethical testing on human subjects than anything else.

I hardly consider infant formulas a "heavily regulated" substance.

Fio.

iVillage Member
Registered: 03-26-2003
Tue, 11-11-2003 - 8:03am
"honestly, the idea put forth in your original post that it's not safe for children in other countries to consume formula is interesting to say the least. "

This makes me think of a subject...but otherwise, excellent post Waiting...

Fio.

iVillage Member
Registered: 09-24-2003
Tue, 11-11-2003 - 8:08am
You're right my comment was uncalled for, I'm sorry. In retrospect, the feeling I was trying to convey was not that you wished it was made here but that I got the feeling you were using this recent tragedy with Remedia formula to further your argument re the debate of the risks of contamination in formula. My point being, this formula was not made here, not subject to FDA inspection and not relevant to that argument.

Yes I know recalls occur here. That has been discussed at length here within the last month. In this country, the only recalls have been on powdered formulas and usually it's precautionary. I don't believe any babies have been harmed by infant formula in this country since the Infant Formula act was passed in 1980. Bottom line, you are 100% right, all the regulation in world can't prevent human error. But the fact remains that formula here is overwhelmingly safe and is regulated more heavily than other processed foods and products which we also give to our children.

iVillage Member
Registered: 03-26-2003
Tue, 11-11-2003 - 8:20am
"But the fact remains that formula here is overwhelmingly safe and is regulated more heavily than other processed foods and products which we also give to our children."

I think the major difference here is that other processed foods that we give our children are supposed to be only a small PART of a regular balanced diet...not the sole source of nutrition from day one. Even if they're more heavily regulated than those other processed foods, I think that wholefoods (and only breastmilk for infants really counts as such) are always much MUCH superior and should be used wherever and whenever possible.

It's a bit like the soy debate too...yes, soy formulae can be dangerous, b/c that's the sole source of nutrition for a baby...but that doesn't lead me to imagine that a bit of tofu once every couple of months, or using SOME soy oil to cook with, or having some soymilk here and there, less than 3x a week, is dangerous for someone with an otherwise balanced diet.

Fio.

iVillage Member
Registered: 03-26-2003
Tue, 11-11-2003 - 8:43am
to further your argument re the debate of the risks of contamination in formula. My point being, this formula was not made here, not subject to FDA inspection and not relevant to that argument. >>>>

so, does this mean that the fact that infant formula may not be safe in other countries is not "fair game," on this debate board?

otherwise, personally i don't have anywhere near as much faith in the fda as you seem to. but, then again, i don't have to. i've not used an fda approved product as "sole nutrition" for either of my children when they were under 6 mos.

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