UltraInflamX

[bluesharp]

I want to start a conversation over the product UltraInflamX by Metagenics. It is a scientifically tested medical food. I am trying it right now as advised by my doctor. He says it should help heal the gut and potentially cure Crohn's Disease. What are your thoughts on this product? Have you used it? If so did it help, and how long were you on it for?

 

[Judith]

I want to start a conversation over the product UltraInflamX by Metagenics. It is a scientifically tested medical food. I am trying it right now as advised by my doctor. He says it should help heal the gut and potentially cure Crohn's Disease. What are your thoughts on this product? Have you used it? If so did it help, and how long were you on it for?

It does not meet the standards for a "Scientifically Tested Medical Food". The company received a Warning Letter from the FDA for Violation of the "Federal Food, Drug, and Cosmetic Act"

Here is the letter to Metagenics, Inc. 01-Oct-03

Public Health Service
Food and Drug Administration

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900




CERTIFIED MAIL
Return Receipt Requested

October 1, 2003

WARNING LETTER

W/L 53-03

Jeffrey J. Catch, CEO
Metagenics, Inc.
100 Avenida La Pata
San Clemente, California 92673

Dear Mr. Katke:


Investigators from the U.S. Food and Drug Administration (FDA) performed an inspection of your facility from May 6, 2003, to May 19,2003. During the inspection, the investigators collected labels from your products UltraClear®, UltraMeal®, UltraInflamX™, and UltraGlycemX™. FDA reviewed the labels for these products and found that the labels cause the products to violate the Federal Food, Drug, and Cosmetic Act (the Act) in several respects.

The products are labeled as “medical foods,” and are represented on the labels as intended for use with a variety of medical conditions. The products do not meet the definition of a medical food in 21 USC 360ee(b)(3), which defines a medical food as a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. The regulations further define a medical food as one that is intended for the dietary management of a patient who has special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the diet alone [21 CFR 101.9(j)(8)(ii)]. Your products UltraClear®, UltraMeal®, UltraInflamX™, and UltraGlycemX™ are not medical foods because the diseases and conditions described in the product labels do not have distinct nutritional requirements and because the products do not have any unique impact on the dietary management of those diseases and conditions beyond that which could be achieved by modification of the normal diet alone.

Because UltraClear®, UltraMeal®, UltraInflamX™, and UltraGlycemX™ do not meet the definition of a medical food, they are not subject to the exemption from nutrition labeling afforded medical foods. Therefore, your products are misbranded within the meaning of Section 403(q)(1) of the Act because the labels do not bear nutrition labeling in the appropriate format, as prescribed in 21 CFR 101.9. In addition, your products bear label claims suggesting that they are useful in the treatment of various diseases. These claims include:

UltraClear’ is formulated to nutritionally support overall liver detoxification activity and the removal of potentially harmful toxins associated with health conditions such as food allergies, chronic fatigue syndrome, . . . and migraine headaches.

“UltraMeal® is . . .designed to nutritionally support the management of conditions associated with altered body composition, including . . . hypertension . . . .”
“UltraInflamX™ NUTRITIONAL SUPPORT FOR INFLAMMATION” and “UltraInflamX™ is designed to nutritionally support patients with chronic inflammatory conditions, such as osteoarthritis, rheumatoid arthritis, psoriasis and eczema, as well as other conditions associated with excessive inflammation.”
“Designed to provide nutritional support for those with insulin resistance, or type 2 diabetes, UItraGIycemX™ promotes a healthy insulin and glucose response.”
The presence of the above referenced claims indicates that the products are intended to treat, cure, or mitigate diseases. Such claims are evidence that the products are intended for use as drugs within the meaning of Section 201(g)(1)(B) of the Act. The products are new drugs under section 201(p) of the Act because there is no evidence that these products are generally recognized as safe and effective for their intended uses.

Therefore, they may not be legally marketed in the United States without approved New Drug Applications (Section 505 of the Act). These products are also misbranded within the meaning of Section 502(f)(1) of the Act because the labeling fails to bear adequate directions for use. The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.


Your response should be directed to Mr. Larry Stevens, Compliance Officer, U.S. Food and Drug Administration, 19900 MacArthur Blvd., Suite 300, Irvine, CA 92612.

Sincerely,
/s/

Alonza E. Cruse

Director, Los Angeles District

Source: Public Health Service Food and Drug Administration (FDA) http://www.fda.gov/ICECI/Enforcemen...m=website&utm_term=UltraInflamX&utm_content=1

I hope this clarifies your question about the product.

 

[David]

A quick look at the ingredient list and I deplore the high vitamin A content which I feel people with IBD need to be very careful of, especially considering its reaction with vitamin D.

http://www.ncbi.nlm.nih.gov/pubmed/11585356
http://www.vitamindcouncil.org/news-archive/2010/vitamin-d-vitamin-a-and-cancer/

I'm not impressed with the vitamin and mineral quantities at all. 100iu of vitamin D? 3mcg of B12? And this is formulated for people with Crohn's Disease and other IBD?

 

[nogutsnoglory]

I just saw a segment on a TV show called Healing Quest about "Medical Foods" which are supposed to be FDA approved and by prescription only. I wonder where one can find a list of medical foods. Are there any for IBD? Anyone with any experience?

 

[Mountaingem]

I tend to be leery of anything or anyone that claims to "cure" Crohn's. It just strikes me as trying to take advantage, we have all been desperate and willing to try anything to get better. Just my two cents.

 

[nogutsnoglory]

Also looked up who in my area is authorized to prescribe metagenics and they aren't doctors. They are life coaches, chiropractors, and some nutritionists. Very wary of the list which seem to be mostly "quack" docs.

 

[LaLaNapa]

Just an additional post regarding this product - Metagenics has a "new formulation" which now contains carageenan as an ingredient. Carageenan is a substance used in lab tests to induce inflammation. I didn't realize it's connection with inflammation until my naturopathic doctor told me to avoid foods with it. So I started doing research on it and was startled how many studies have made this connection. No wonder it's an illegal ingredient on the SCD list.

 

[kiny]

Can't believe that ingredient list, that's insane, if anything will destroy your liver, that should be it.

The herbs in that list are nice, but you can get tumeric and ginger without having to take the 101 other ingredients too really.

And I don't like glutamine in capsules or pills, I did a test once and took glutamine out of capsules and then did the same thing with powdered glutamine, the powdered glutamine mixes way better than whatever they put in glutamine capsules (it's powder but they add stuff to it for whatever reason). When I mixed a few capsules, there was some icky residue left on the top of the water and no mater how much I mixed it didn't budge (acids might break it down, but it was sticky and clogged as hell), if you're going to take glutamine you might as well use powder. (there is one brand of glutamine capsule with enteric coating I know of, but all other glutamine capsules are not enteric coated, so they won't reach the small intestine without breaking open, so I don't see the benefit of taking glutamine caps or pills, unless you feel it's convenient or something, idk)

 

[Caldotis]

I have used it. It did not work for me. It was recommended by my chiropractor (I don't really think chiropractic is 'quackery') and by someone who gives hydrotherapy colonics (now, that's a whole different story )

 

[nogutsnoglory]

I have used it. It did not work for me. It was recommended by my chiropractor (I don't really think chiropractic is 'quackery') and by someone who gives hydrotherapy colonics (now, that's a whole different story )

I don't think a chiropractor has any business treating your crohns. It's kind of quackish.

 

[helpingmama]

Ultra Inflam-x has helped my daughter beyond words. She was finally able to gain weight and energy. It is definitely our go-to nutritional aid.

 

[momofzach]

I took Ultrainflamx 360 every morning instead of breakfast for almost a year. It really helped me, and was suggested by my OB/GYN, who also is very interested in holistic care. I was careful not to over-do the other supplements I take, specifically the vitamin A. Now I am seeing an integrative care MD, he put me on some other supplements and I stopped the ultrainflamx.

 

[gentry4jc]

My son has been using the Ultra InflamX Plus 360 for almost 2 weeks and loves it! Our acupuncturist prescribed this once per day (to start his day) he's so thin and is in obvious need of nutrition... It's very soothing, it tastes great and it's also supposed to be very healing to the mucosal lining from esophagus to rectum (sorry so literal). He likes it with fresh strawberries and banana. He's still tapering off the prednisone so we don't know yet how he's "really" doing? But we are hopeful! His ND has 30 yrs experience in acupuncture and specializes in Chinese medicine along with diet/nutrition, and supplements. He also has done a lot of testing to find out what foods are hurting him. Gluten and cow dairy are huge problems! He is also VERY firm on drink and eat warm! So no "smoothies"! Best to stick with Soups, broths, room temp drinks, and foods that are easy to digest. He really can eat pretty much anything... I buy almost all organic so the whole family has been "sojourning" this path We are learning... It's been a rough 8 mo's and I'm sure we are only scratching the surface Blessings to you!

 

[Helping Evan]

does anyone recommend Jill Patel Thompson's Absorb Plus?? We're on scd diet and not sure what to use for a weight gaining, vitamin drink.....