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"...the exclusion of selected data is both uncalled for and inappropriate,
if not unethical..."

July 21, 1994

BY FAX (301) 571-1876
Kenneth D. Fisher, Ph.D.
Life Sciences Research Office
9650 Rockville Pike
Bethesda, MD  20814

FDA Docket No. 92N-0391
Dockets Management Branch  (HFA-305)
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, MD  20857

RE: Analysis of Adverse Reactions to Monosodium Glutamate (MSG); FDA Docket No. 92N-0391
Dear Dr. Fisher:

It is our understanding that the final report on the Analysis of Adverse Reactions to Monosodium Glutamate (MSG) will exclude consideration of 60 pages of tables that focus on animal studies in which MSG was administered parenterally.  We further understand that the stated basis for excluding these studies is that they are beyond the scope of work assigned by the FDA.

If our understanding is correct, FASEB will exclude much of the data that demonstrate that ingestion of MSG places humans at risk; and, therefore, will come to conclusions that, at least in part, fail to recognize the magnitude of the MSG problem.

We feel, that for the following reasons, the exclusion of selected data is both uncalled for and inappropriate, if not unethical:

1. The Scope of Work defined in FASEB's contract with the FDA did not limit review of the literature to feeding trials, only.

On May 8, 1992, Adrienne Samuels, Ph.D. wrote to Thomas H. Vargo, Contracting Officer, DHHS/PHS/FDA, Division of Contracts and Grant Management, stating, in part that "The proposal for a literature review is both 1) unnecessary, and 2) constructed to serve the end of the food industry.  The questions asked which might serve the needs of consumers if answered are, for the most part, presently unanswerable ...because little or no data presently exist which address them...[and] no reference has been made to reviewing the literature on the relation of neurodegenerative disease to brain glutamate levels; no mention has been made of evaluating studies based on whether they are industry sponsored or independently conducted; and there is no mention that a qualified neuroscientist be part of the review team."
The response from Mr. Vargo was by phone, not mail.  Over the phone, Mr. Vargo assured Dr. Samuels that the 18 questions found in Appendix A of the Request for Proposal (RFP), were to serve as guidelines only, and that FASEB would be encouraged to search out all data pertaining to the safety/toxicity of MSG.  (The underlining is ours.)

The following statements are found in the RFP:

"The objectives of this task order are to:....determine whether MSG as used in the American food supply...has the potential to contribute to brain lesions in neonatal or adult nonhuman primates and any risk to humans ingesting dietary MSG."  (The emphasis is ours.)  (Attachment 1, page 1)

"The contractor shall perform a comprehensive review and analyses of reports from scientific and clinical studies that may be pertinent to biological effects resulting from ingestion of monosodium glutamate (MSG)."  (The emphasis is ours.)  (Attachment 1, page 2, number 3-1)

"In the review and analyses of the studies cited above, the contractor shall include consideration of the role of MSG and hydrolyzed protein products in: ...c) development of lesions of the arcuate nucleus of the anterior hypothalamus (or circumventricular complex of the brain); and d) release of certain hormones such as prolactin and luteinizing hormone of the pituitary of subhuman primates."

Data pertaining to the previous paragraph, regarding the arcuate nucleus and release of certain hormones, will be found only in parenteral studies.  Furthermore, given that the blood-brain barrier is pervious to MSG, any study that demonstrates that endogenous glutamate causes brain damage, would have to be within the scope of work specified by the FDA.
2. FASEB collected data on the effects of parenteral administration of MSG.  It is our understanding that 60 pages of summary data were accumulated before it was decided to eliminate them from consideration.

3. There is no question that MSG is toxic.  There is no question that the blood-brain barrier is pervious to MSG.  And the data supporting these facts are not to be found in food studies, but rather, are found in parenteral studies.

4. Elimination of parenteral studies will serve to eliminate consideration of the role that MSG plays in neurodegenerative disease, such as ALS, Alzheimer's disease, Parkinson's disease, and Huntington's chorea.

5. Three neuroscientists gave testimony at the FASEB Open Hearing on April 7-8, 1993, expressing their concerns about the use of MSG in food.  The elimination of parenteral studies from consideration, effectively eliminates their testimony and the supporting data that their published studies would offer.

6. In focusing on feeding studies, FASEB is focusing on studies underwritten by the glutamate industry; and in eliminating parenteral studies from consideration, FASEB is eliminating virtually all of the studies done independently.

7. While the vast majority of parenteral studies are not glutamate-industry sponsored, the vast majority of feeding studies are funded, at least in part, by the glutamate industry.  Most of the glutamate industry sponsored studies are methodologically flawed.  Some of them are flawed to the point of being fraudulent.

Questionable methodology includes repeated study of variables that have no relevance to human adverse reactions, using subjects who are not know to be sensitive to MSG, concluding that because non-sensitive subjects do not respond to irrelevant variables, "no one" is sensitive to MSG.

A number of feeding studies have been conducted at the University of Iowa by Lewis D. Stegink, Ph.D., and others.  Among the factors that invalidate the conclusions that few, if any people are sensitive to MSG, are the facts that these studies evaluate the effects of variables that have no relevance to human adverse reactions, and use subjects who are not known to be sensitive to MSG.

We previously pointed out to both FASEB and the FDA that at least four members of the Expert Panel had conflicts of interest.  We also pointed out that FASEB's February, 1993 Tentative Report focused on results of industry sponsored studies and industry inspired submissions, paying little attention to independent research.  Now, it would appear that FASEB will claim to have thoroughly reviewed the literature on the safety/toxicity of MSG, while failing to do so.

To exclude the parenteral studies from full and complete consideration, will serve to invalidate any conclusion that FASEB might come to, short of the conclusion that MSG is a toxic substance and should be removed from the GRAS list.

Sincerely yours,

Jack L. Samuels

Adrienne Samuels, Ph.D.
850 DeWitt Place
 Suite 20B
Chicago, IL  60611

cc: David Kessler, M.D.
     John W. Olney, M.D.
     Richard C. Henneberry, Ph.D.
     Jeffery D. Rothstein, M.D., Ph.D.

850 DeWitt Place, Suite 20B, Chicago, IL  60611
adandjack@aol.com 858/481-9333 http://www.truthinlabeling.org

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