FDA has blocked sale of E. coli Nissle to the USA

This link is from Kiwi44's post in another thread this morning:
journals.lww.com/jcge/Fulltext/2010/04000/Probiotic_Therapy_for_Ulcerative_Colitis.7.aspx

The most effective probiotics used were E. coli Nissle strain and VSL#3

I had been sporadically ordering E. coli Nissle (brand name Mutaflor) from Canada for well over a year. This morning when I tried to reorder I was told that the FDA has blocked sale to USA.

We'll be in Vancouver in August should I pick you up some and mail it?
Seriously, depending on where one lives why couldn't you walk/drive/fly it across the border. Why have they banned it?

I bought 3 months worth(180 capsules) in 2010 when it started being sold in the US. I thought it helped but when I took the last 60 capsules over 2 months then stopped I noticed no change.

Unlike other probiotics, Mutaflor can reproduce and permanently colonize the gut and is not a lactic acid bacteria(yogurt culture). So maybe I still have that strain of bacteria in residence.

From Mutaflors web site:

Somebody said...
Why can’t I buy Mutaflor in the US anymore?

Mutaflor is currently discontinued from the U.S. market respecting the FDA’s decision on the classification of the product as a“biologic” instead of it’s former status as a “medical food”

Please note that the discontinuation of the product is solely attributed to the FDA’s classification of the product and a final decision is still pending.

We will do our best to bring Mutaflor back to the US market as soon as possible while respecting the FDA.
Is There Anything I Can Do?

If you would like to provide a testimonial of your use of Mutaflor, please email it to info @ medfutures.com

Unlike VSL#3 you can't culture yogurt out of mutaflor which is why I went with vsl#3 instead

E. coli nissle was discovered in soldiers that managed to avoid the rampant dysentery in WWI. Not everyone has the strain and not everyone can host it permanently I believe. That is why they have you taking it every day. I should probably explained why I said "can"

Somebody posted about the new research into gut microbe types recently. It might be that only one type can host e.coli nissle or it could be that it can only help one type.

I can't understand the T-cell business but mesalimine, lactic acid bacterias, and mutaflor regulate them somehow.

I got some bad vibes dealing with the selling company but it could be that they were just new at it. Hopefully it will get back on the market as a medical food.

what dose do you take of Mutaflor, 2 caps/day or 1?

I don't pay much attention to dosages. I assume no probiotics are colonizing in my colon so I try to take at least one capsule morning and evening but most of the time I eat probiotics like candy. As far as I am concerned you cannot have too many probiotics. I have tried as many different varieties as I could find and discovered that VSL#3DS, E. Coli Nissle, Culturelle, and S. Boulardii seemed most compatible with me.

The research for E. Coli Nissle is overwhelming so I had to try it. It probably does not hurt to have more than just lactic acid probiotics. I like taking pills with the fewest additives and fillers. Culturelle is very clean and VSL3DS powder only adds a little maltose and silicon which is pretty good considering that it contains 900 billion cells.

I can assure you that Mutaflor was not taken off the US market because of any "bad side effects" The same product has been used around the world for over 50 years and is one of the most clinically studied probiotics.

In fact, there is so much data, it may have been a reason why the FDA would want it registered as a "biologic" to be able to make claims.

We are currently working with the FDA and hope to have a resolution sooner rather then later.

A big thank you to everyone on this board who wrote in with their success stories and praise for Mutaflor.

Actually goat's milk has done wonders for my intestins. But be sure to get the raw one, otherwise it is of not much use.

Thanks to Mother Nature Herself.    

Hmm, i had high hopes for mutaflor but it actually seemed to flare me up. However it reads well in the literature and jn any case I think that its outrageous that the FDA bans it... Probably some thickheaded clerk in a government office saw the word "e.coli" and freaked... Leading to a hundred boxes to have to be ticked off on forms. i say Send those cleRks out to inspect factory farms and feedlots and get off the back of obstructing goos harmless therapies.

therearemiracles, this might have changed but medical futures had the sole distribution rights to this in North America and they were selling it directly so I'm not sure how the health food store got it? Was it refrigerated?

It was sent with a cold pack on Monday, got it yesterday and the cold pack was still a little cool to the touch. It went right in the frig. Today I'm been pooping my head off! Not a whole lot of blood, but definely on the rise! ALTHOUGH I got up at 6 30 and felt great!!!! Went to the gym for just a bit, still pooping all the way, but I feel great!

I should take away from meds right, although it doesn't say I have to.

Ok I will call them. No today it didn't slow down and I had blood :( which I didn't have this morning. But it's early yet in the game. I still love the clay!!!

Thanks lookforcure, I will keep trying it. Yes I'm experiencing some more gas, but heck, what haven't I experienced? LOL I'm glad to be trying it.

My nails tips are so white and strong and they haven't been this nice and white in years! It must be the clay, that's all I've done except the colozal, which maybe healing the gut at the same time. It makes me feel good knowing I'm absobing some good stuff in my gut to produce my  nail to be nice and strong!