Food Components to Enhance Performance An Evaluation of Potential Performance-Enhancing Food Components for Operational Rations (1994) / Chapter Skim
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23. Regulatoin of Amino Acids and Other Dietary Components Associated with Enhanced Physical Performance
23. Regulatoin of Amino Acids and Other Dietary Components Associated with Enhanced Physical Performance
Pages 461-474
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From page 461... ...
The question also has a profound impact on how the safety of the substance is addressed and what claim can be made for the substance in relation to disease. The answer to the question depends on answers to a number of other questions, including what the substance is and what it contains, how it is used, ~ The views expressed in this chapter reflect the policy ofthe Food and Drug Administration at the time of the CMNR Workshop in November, 1992.
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From page 462... ...
The FD&C Act defines the term drug as articles recognized in the official United States Pharmacopeia, the official Homeopathic Pharmacopeia of the United States, the official National Form ulary, or supplements to any of them; (United States Code §321ta]
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From page 463... ...
The Nutrition Labeling and Education Act of 1990 (NLEA) provided the FDA with the authority to publish regulations that would allow manufactures to provide specific health claims on food labels to describe a nutrient-disease relationship but they would not be required to call the product a drug (United States Congress, 1990~.
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From page 464... ...
New food ingredients that do not fit in any of the GRAS categories are food additives (United States Code §321 Isis. Approval to market a food additive is gained by submitting a petition to the FDA with sufficient data to demonstrate reasonable certainty of no harm at the intended levels of use.
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From page 465... ...
It is important, however, that this category of food has been afforded special status relative to claims for one year under the Dietary Supplement Act of 1992 (United States Congress, 1992) , and the agency is required to propose new rules for regulating these substances.
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From page 466... ...
A food additive regulation was proposed, setting out the conditions under which amino acids used as food additives may be safely added to intact, protein-containing foods that were considered significant sources of dietary protein. The proposal stated that this action did not include amino acids in foods that did not contain intact protein in their original form.
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From page 467... ...
The report of that task force will soon be released for public comment as part of the agency's process of reviewing current policy for regulating these products (Food and Drug Administration, 1992~. The situation is perhaps different for other nutrients that are on the GRAS list as nutrient supplements, dietary supplements, or other functions.
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From page 468... ...
. United States Code §321(g)
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From page 469... ...
If you are going to do research in this area, you may want to be in the IND category. Let me just say that you are taking a risk, by saying that applesauce with tyrosine was going to maintain performance without new safety data, you take the risk of the FDA determining that this was an unapproved use for tyrosine, and that should be made abundantly clear.
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From page 470... ...
We can use some natural ingredient that converts to those amino acids. There are many amino acids in soy protein and hydrolyzed vegetable protein.
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From page 471... ...
JOHN VANDERVEEN: Caffeine is an approved food additive. It was obviously used in soft drink beverages.
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From page 472... ...
As a result, the FDA got a letter from Richard Truly, the NASA administrator saying, wouldn't you approve the use of the irradiated food for use on board the shuttle, and we said "sure," and that took care of it. DAVID SCHNAKENBERG: A related thing could come down the road: We could have a product intended for use just for military populations on the Meal Ready-to-Eat (MRE)
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From page 473... ...
So that I think we need to think very carefully about whether we want to be ahead of the mainstream on this one. Even if it is legal, we may want to think about possible public relations disasters from pushing the envelope.
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