BY FDA REGULATIONS: According to Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act and FDA regulations 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS (generally recognized as safe) either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
In short, to be designated FDA GRAS an ingredient must be tested for safety using scientific procedures (with the same evidence as required for food additive approval), unless it is known to be safe through common use in food prior to January 1958.
FACT: Neither the monosodium glutamate in use prior to 1957 (MSG-1) nor the monosodium glutamate in use today (MSG-2) has ever been tested for safety.
FACT: The monosodium glutamate in use today (MSG-2) is not the same monosodium glutamate that was grandfathered GRAS in 1958 (MSG-1), yet the FDA seems not to have noticed.
FACT: Glutamic acid is an excitotoxic amino acid. When ingested in controlled quantities, glutamic acid is essential to normal function of the body. But when ingested in excess, it causes brain damage, leading to a variety of abnormalities. Prior to 1957, when MSG-1 was the source of monosodium glutamate, there was not enough manufactured free glutamate added to food to cause glutamate to become excitotoxic. That changed with the introduction of MSG-2.
FACT: MSG-2, the monosodium glutamate in use today, could not have been grandfathered GRAS in 1958 because it didn’t exist.
CONCLUSION: To be designated FDA GRAS, an ingredient has to be tested for safety using scientific procedures – unless it was known to be safe through experience based on common use in food prior to January 1958. MSG-2, the monosodium glutamate in use today was neither.
For more details, and to read the FDA rules as they appear in the Federal Register and the Code of Federal Regulations go here.
Adrienne Samuels, Ph.D.