Re: GRAS - Geoff
in response to
by
posted on
Nov 29, 2006 06:42PM
Geoff,
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I certainly am not an expert on the FDA and GRAS designation, but I sure know a lot more now than I did two months ago. There was a lot of confusion created when I posted Bioagra’s website headline here, stating that Agrastim had, in essence, been declared GRAS compliant by the FDA. Since that time, I have been able to clear up some of my own misconceptions, and believe, based on further reading and conversations with people I consider to be very reliable sources, that what I am about to say is much closer to reality than the mental picture I conjured up just one month ago.
I do not expect to see Argastim ever listed on the FDA website that you and I have been watching for the listing of GRAS notifications. Since beta-glucan and beta-glycan have already received FDA designation as GRAS when used in the manner Agrastim is to be used, there seems to be no need to be involved in the “notification” process. I don’t think it is a matter of the FDA having set up a “procedure for companies to follow if they want to get an official response, but the company apparently hasn’t followed it.” I think it is more a matter of that procedure not applying to Agrastim’s set of circumstances.
Bioagra can manufacture Agrastim under the GRAS guidelines that are published in the Code of Federal Regulations (CFR) for both FDA and Center for Veterinary Medicine (CVM/FDA). This means that as long as Bioagra manufactures product that complies with the FDA regulations, whether for human or animal use, Bioagra can manufacture and certify that their product(s) meet the FDA regulations (of which there are several).
I originally misunderstood FDA GRAS designation, thinking that GRAS is a program that certifies a manufacturer’s product or brand name. GRAS is, more specifically, a compliance program under which a manufacturer has to maintain certain procedures including a Quality Assurance program, FDA “Good Manufacturing Practices” (GMP), and other programs associated with the manufacturing processes.
I do not believe that “somebody at Bioagra talked to somebody at the FDA and was told something along the lines of, ‘Yeah, sounds okay to me.’” I believe that Agrastim was subjected to multiple independent lab analyses to demonstrate to the FDA that Agrastim had a high enough level of purity (with only insignificant amounts of other substances or compounds) to legitimately claim to be GRAS compliant under the already established FDA CFR regulations for Bakers Yeast Glycan (172.898) and Curdlan 172.809). Bioagra’s manufacturing process also had to comply with the regulations that govern the product class that applies. Each run of product continues to be tested and certified to be GRAS compliant.
Your hunch is probably right, that we will never see an image of any FDA correspondence on the Bioagra website. Communications between US Government agencies and a manufacturer are usually considered confidential, just as if the manufacturer had an FDA 510K. It really isn’t advisable to publish any information, including the FDA listing number, because of rampant fraud and abuse of information. I would suspect that any shareholder of a public company would have to jump through giant hoops, including BOD approval, to get a look-see at confidential company documents. I think that the closest we will get to this, is the peek we got at the Lowenkamp R&D Labs certification document that was posted on the Bioagra website, but which has since been removed.
My impression, from what I know of Bioagra, is that they view their website as a means of communicating information about Agrastim with their customers as well as potential customers….. customers who need no tutoring about FDA procedures. When Bioagra posted the headline stating that the FDA had declared Agrastim to be GRAS compliant, I doubt they ever anticipated the scrutiny it would received. But, sometime around November first, the “headline” statement was modified to the more accurate wording that the “FDA accepts Bioagra’s certification that all components of Agrastim are GRAS, according to FDA Regs.” I see nothing sinister here, but attribute it to the learning curve that can easily occur when a private company and a public company (a la zealous shareholders) engage in a joint venture.
Though it stimulates some entertaining chat room conversation, I don’t give much credibility to the assertion that the “Certified GRAS Compliant Analysis” provided by Lowenkamp R&D Labs on October 17, 2006, was the result of a couple of Good Ole Boys chatting on the phone and deciding it “sounds okay to me”. Bioagra must substantiate its product to the buyer, who then accepts the responsibility of controlling the application of that product, and the end result. Most buyers will insist on doing their own testing and analysis before taking on the product and the responsibility of introducing it into the human food chain. The results can’t be faked. Bioagra provides a Certificate of GRAS Compliance with each delivery of product, insuring that the manufacturing process, the QA, the FDA/GMP and all other FDA GRAS requirements have been met up to the point that the product is delivered.
Best regards,
-zties