Lets talk about GRAS NotificationBXI already has GRAS Certfication (BXI's website :
https://www.bioexx.com/index.php?option=com_content&view=article&id=224:bioexx-updates-product-certification-status&catid=43:news&Itemid=83
"BioExx requires, and has obtained, Self-Affirmed GRAS (Generally Regarded as Safe) status in accordance with the regulations of the US Food and Drug Administration
(see November 18, 2009 news release). The self-affirmed GRAS status was obtained as a result of a detailed process that required a thorough review of both the manufacturing process and the resulting chemical profile of each product by independent and qualified experts in the fields of toxicology and allergenicity. The GRAS review was completed by Keller and Heckman LLP based in Washington D.C., whose comprehensive food and drug practice is one of the largest in the world, having represented companies in front of the FDA in matters such as this for more than 40 years. Self-Affirmed GRAS is all that is required for BioExx to sell its protein products into most human food applications"
Again for those who think GRAS might take forever...lets do a little DD and research (the internet is a wonderful thing)
FDA's website regarding GRAS
https://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/ucm083022.htm)
FDA Response.
Within 30 days of receiving a notice FDA will inform the notifier in writing of the date on which the notice was received. FDA then evaluates whether the submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice, or otherwise available to FDA, raises issues that lead the agency to question whether use of the substance is GRAS. On occasion, FDA will consult with other agencies; for example, when the notice includes use in meat and poultry products, FDA consults with the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Following this evaluation FDA responds to the notifier with one of three types of letters. The first type of letter states that FDA does not question the basis for the notifier's GRAS determination. This type of letter may also note, among other things, potentially pertinent issues related to labeling, the substance's use in certain foods, and requirements for a color additive.[4] In the second type of letter, the agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information, or because the available data and information raise questions about the safety of the notified substance). The third type of letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.
As part of the 1997 GRAS proposal, FDA also announced its intention to maintain an inventory of GRAS notices and the agency's response to those notices. In accordance with this, the Office of Food Additive Safety has created and maintains a web page titled 'Summary of All GRAS Notices.'[5] The page lists all GRAS notices that FDA has received, describes FDA's responses, and provides hyperlinks to FDA's response letters and additional correspondence. The page is organized by year, and within the summary table for each year, there is a link to a table that provides more details about the GRAS notices received in that year, including: the name of the person who made the GRAS determination (notifier); the substance that is the subject the notice; a description of the intended use of the substance; the basis for the GRAS determination; and FDA's response to the notice.
FDA encourages individuals contemplating filing a GRAS notice or who are just interested in knowing more about GRAS substances to review
Further Reading:
CFSAN's GRAS Notification Program web page at
www.cfsan.fda.gov/~dms/opa-noti.htmland the 'Frequently Asked Questions About GRAS' document on that page.
Information on other programs under the purview of CFSAN's Office of Food Additive Safety can be found at www.cfsan.fda.gov/~lrd/foodadd.html.