Q: If Animal Feed Ingredient Company A obtains GRAS for Ingredient X from a consultant and does not publicize it, would Animal Feed Ingredient Company B need to obtain its own GRAS for the very same Ingredient X? I’m wondering if FDA would really bother Company B about an ingredient that it already knows has GRAS from Company A. Or does FDA treat every company’s ingredients separately, even if one company already has GRAS for that ingredient?
– Mr. Michael Crane, writer for Nutritional Outlook
A: Yours is not an uncommon question (in one form or another).
If Company A obtains a self-GRAS for Ingredient X and does not notify CVM, no one is going to know Ingredient X is GRAS until Company A tries to sell it. Once Company A tries to sell Ingredient X, potential customers might want to see evidence of X’s GRAS status. In response, Company A may furnish the potential customer a statement by the GRAS panel indicating ingredient X is GRAS – sometimes this is as little as a short paragraph or it may be the entire dossier. Once it becomes obvious (through media advertising, etc.) that Company A is selling Ingredient X as GRAS, CVM has the right to request documentation of the GRAS and again, Company A will respond with a short paragraph or the entire dossier. CVM will file this information in its archives, but will likely not publicize the finding. The only way another company can find out what happened with the interaction between CVM and Company A is to file an FOI request to which CVM may or may not respond in a likely manner.
Now, regardless of a CVM interaction, if Company B sees Company A advertising Ingredient X as being GRAS, can Company B also sell Ingredient X as GRAS? Technically, the answer is “no” for at least two reasons: (1) it is the use of a substance that is GRAS – if Ingredient X was originally GRASed by Company A as a preservative, Company B could not sell it for another use (such as a flavor or buffering agent) or for another application, such as use for cats instead of dogs – GRAS determinations are very specific. (2) Ingredient X is more specific than the name alone and includes product specifications, manufacturing technique, etc., Ingredient X must be substantially equivalent (i.e., close to identical) to the substance originally GRASed (specifications may be different or even a manufacturing change could produce something that is toxic in the Company B product as opposed to the Company A product). Without access to the original GRAS documents from Company A, it would be very difficult for Company B to claim it’s Ingredient X is without harm and functions the same way as the Company A product.
The bottom line – Company B would be better off conducting its own GRAS (including safety testing, etc.) – that would be the only fool-proof way to demonstrate the Company B product is safe.
Q: How would you explain the effects of FSMA with regards to the consumer and the mindset of the FDA?
A: In a nutshell, probably the best way to characterize FSMA is as a first step in top down federally regulation mandating food safety instead of relying on a patchwork of bottom up regulations involving regulations promulgated by state and federal agencies. FSMA amends the Food Drug and Cosmetic Act and directs the Commissioner to among other things: (1) implement preventive controls for entities involved in the food production chain, (2) issue guidance documents, (3) establish minimum standards for safe production and harvesting of food, (4) inspect food facilities, (5) establish a product tracing system and (5) gives the Commissioner greater control over the import of foreign foods. Importantly, it gives the Commissioner the power to order a recall of a food article, a power the Agency did not have before.
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