Wednesday, April 9, 2014

Who Really Decides What Is Safe In your Food (and Nutritional Supplements)?

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
Obvious fact:  nutritional supplements are considered "food" by the Food and Drug Administration (FDA).

Not so obvious fact: what ends up in the nutritional supplements are often UNregulated
by the FDA, because companies can simply declare some ingredient to be "generally regarded as safe" (GRAS) based on some internal studies, and include them without telling the FDA.

Some ingredients are submitted to FDA with full studies and gains full FDA approval, but most ingredients are not approved by the FDA, and are merely declared to be GRAS by internal studies. A third way, where the GRAS study was submitted to FDA for approval, are often withdrawn, and the ingredient used any way.

GRAS was meant to be used for common ingredients like vegetable oil, vinegar, and so on. But the law, enjoying its 56th birthday recently, is now an anachronism and a loophole for companies to punch through ingredients without formal review by the FDA.

National Resource Defense Council has published a paper where it tracked 56 companies involved in 250+ chemicals declared as GRAS, as reported by Consumerist. Some of which are... troubling. And you need to be aware if you are drinking or taking any weight-loss or energy formulas.


 Quoting from the report (PDF file, some italics added by me for emphasis):
Epigallocatechin-3-gallate (EGcG): 
A Japanese company declared this chemical to be GRAS for
use in beverages including teas, sport drinks, and juices,
despite evidence it may cause leukemia in fetuses based on 
studies using newborn and adult human cells grown on a 
dish.31 Moreover, the company did not address a short-term 
study on rats showing it affected the thyroid, testis, spleen, 
pituitary, liver, and gastrointestinal tract. The notice did
not explain potentially dangerous interactions with sodium 
nitrite, a common preservative, or with acetaminophen 
(the active ingredient in Tylenol® and many other over the 
counter pain-killers).32 The company withdrew the notice,
resubmitted it, but withdrew that one as well.33 In response to
our inquiries, the company assured us it was not marketing
the product in the United States. However, two other
companies, DSM and Kemin, appear to market chemicals
high in EGCG in the United States pursuant to undisclosed
GRAS determinations (Table 1). We identified more than 25 
food products with EGCG as a named ingredient.
EGCG has a reputation of being a powerful antioxidant is is often found in various energy drinks, esp. those advertised to be healthy.  Here it is in Vemma Bod-e, as per Vemma's own literature:
Each serving of Bod•─ô Burn contains 445 mg of a unique proprietary weight loss blend that includes natural caffeine plus EGCG, L-theanine, conjugated linoleic acid (CLA) and resveratrol to support your weight management success by supporting your energy levels and overall health.*
Basically, if you drink anything that has "green tea concentrate" or "natural caffeine", it may have EGCG too, as EGCG is basically extracted from green tea.

So whether having ultra-concentrated (and thus, unnatural) form of an alleged antioxidant is good for you, and if the good is supposed to outweigh the potential harm... Well, that's up to you to decide.

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