No. If you are correct in concluding that a substance is GRAS under the conditions of its
intended use, there is no requirement under section 409 of the FD&C Act for FDA review and
approval for that use of the substance. Your decision to submit a GRAS notice to CFSAN or
CVM is voluntary, and the response to a GRAS notice from CFSAN or CVM is not an approval.
You may market a substance that is GRAS under the conditions of its intended use without
informing CFSAN or CVM or, if CFSAN or CVM is so informed, while the applicable Center is
evaluating your GRAS notice. (See Response 114, 81 Fed. Reg. 54960 at 55022). We
recognize, however, that some firms prefer to know that the applicable FDA Center has
evaluated a submitted GRAS notice, without raising safety or legal issues, before marketing.
