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DP...Optimum letter

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Posted by: ZECH

took me a while but I found it.
Guys, think the FDA is not serious. Think again........
http://www.fda.gov/foi/warning_letters/g3288d.htm



Posted by: w8lifter

Damn...they're picky



Posted by: ZECH

Probably will get worse too! They have all but declared war on supp companies.



Posted by: LILFLEX

FDA .......Stands for.......FAT DOG ASSES



Posted by: Dr. Pain

Thank you, but what a shot storm!

The stevia thing is mind boggling.......and the some of the letter was knit-picky and the concerns will be alleviated with a disclaimer

Quote:
Stevia is considered a food additive when used as an ingredient in a conventional food. There is no regulation in effect that provides for the safe use of stevia, nor is there a suffcient basis to conclude that stevia is generally recognize as safe (GRAS) among qualified experts for its intended use in food. Therefore, stevia is an unapproved food additive that is unsafe under Section 409 of the Act. The presence of stevia in your products Natural Opti-Soy 50, Natural PRO COMPLEX, and Natural 100% Egg Protein renders these products adulterated under Section 402(a)(2)(C) of the Act.

This is bad, very bad for the industry

We have also noted that the label for your Natural Opti-Soy 50, a soy protein product, states that soy protein ". . . may play a significant inhibitory role in certain cancers and atherosclerosis development." Your promotional literature for your soy product links soy use to slowing the development of atherosclerosis and heart disease. Since a health claim for the relationship between soy and diseases other than coronary heart disease has not been authorized by regulation or the Act, your Natural Opti-Soy 50 is misbranded under Section 403 (r)(1)(B) of the Act. It is misbranded since the claims that this product makes for inhibiting cancer and atherosclerosis are unauthorized health claims.

This was a partial mistake on the FDA's part.......it has been mandated and re-inforced with litigation that if a product has as little as 6.25 grams of soy...it may be labeled "Heart Healthy" and obviously Optimum took it too far..........but it opens the door for approved claims
It just went downhill form there...Thanks again!

DP



Posted by: 1Fast400

This has been out for a long time, why does it surprise everybody?



Posted by: ZECH

Quote:
Originally posted by 1Fast400
This has been out for a long time, why does it surprise everybody?
Because you didn't tell us!! You need to do a better job in keeping us informed. j/k



Posted by: 1Fast400

If I told you all that you would know way to many industry secrets



Posted by: ZECH

Yeah, yeah! Chicken!!! That's ok! I have ways of finding out!!



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DP...Optimum letter


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