HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human Services (HHS) is exploring pathways to enhance FDA oversight of the US food supply, including by closing the asserted “GRAS loophole” that allows ingredient manufacturers to self-affirm that a substance is GRAS and thereby bypass premarket review.

GRAS reform would most directly affect food ingredient developers deciding whether to submit a GRAS notice to FDA to ensure FDA has no questions—and potentially risk a decision that a food additive petition is necessary—or instead to bypass the informal review process via the GRAS self-affirmation pathway. But the broader push to reassess and rein in novel ingredients and chemicals added to food would affect companies at every level of the food and dietary supplement supply chain. Although the scope and mechanism of the reform are yet to be announced, food manufacturers should prepare now to assess their potential exposure and avoid operational and commercial disruption.

INGREDIENT DEVELOPERS

Pick a Pathway

Deciding whether to use the voluntary GRAS notification process (GRAS Notification) or instead proceed to marketing via self-affirmation (Self-Affirmation) has implications for public data availability, commercial and legal interactions with downstream manufacturers, and enforcement efforts from federal and state regulators.

GRAS Self-Affirmation

Self-affirmations are the most likely to be targeted by FDA, as they provide FDA with no notification or safety data about the food ingredient. This pathway does not require automatic public disclosure of any data, and going to market via this pathway does not prevent a developer from later submitting a subsequent notification or providing information on the self-affirmation if requested by FDA.

GRAS Notification

Although FDA’s GRAS Notification Program has been formalized and notifications have been standardized, the positive outcome of the voluntary notification process is a “No Questions Letter” that does not preclude FDA from later inquiry or withdrawal. Notifications provide FDA with visibility to an ingredient’s proposed use, safety data, and scientific expert analysis of the ingredient’s safety, but FDA’s review of a GRAS notification can take months to over a year and is cataloged in the GRAS Notice Inventory, which may provide a basis for later action by third parties contesting the status.

Food Additive Petition

Ingredient developers whose basis for a GRAS determination is not robust and potentially at risk of FDA disagreement may opt for a food additive petition to ensure the highest degree of certainty with respect to legal status and dealings with downstream manufacturers. Food Additive Petitions also allow for reliance by any manufacturer on the approval, assuming conformity with the specifications of the regulations that result from a successful petition. However, food manufacturers should anticipate slowdowns in the food additive review process due to restructuring efforts within the Human Foods Program by FDA.

Confirm GRAS Determination

Ingredient developers relying on GRAS self-affirmation must ensure that documentation is readily available if requested and can withstand FDA scrutiny.

Verify Product Status

GRAS determinations (either notified or self-affirmed) only apply to the intended use of a substance. Ingredient developers may have modified a particular ingredient through manufacturing or specification changes or changed its intended use via marketing, such that the ingredient as marketed no longer falls within the GRAS determination. Any changes should be closely reviewed to ensure continued coverage of the GRAS status.

Food manufacturers may seek to confirm the status of their products by requesting copies of GRAS dossiers or other documentation supporting a GRAS determination. Ingredient suppliers will need to consider how much of the dossier to share in view of the trade secret and discoverability risks of disclosing information.

Prepare for Inquiry

Ingredient developers should consider legal options if FDA requests copies of GRAS self-affirmations and keep the following in mind:

• FDA may initiate review of GRAS self-affirmations by asking all manufacturers to notify FDA of the existence of such affirmations and then requesting supporting documentation for more novel ingredients or otherwise in accordance with its priorities
• Companies should be prepared for such a request and consider how to construct a dossier that can be provided to FDA without revealing trade secrets or confidential information
• Companies with GRAS self-affirmations should also be aware of any commercial notice obligations with customers that may be triggered if an affirmation is challenged or revoked

DOWNSTREAM USERS OF GRAS INGREDIENTS

To ensure continued regulatory compliance and marketing status, food manufacturers should take the following steps when using GRAS substances sourced from suppliers:

• Get Organized: Food manufacturers should conduct a detailed review of every ingredient in their marketed products, confirm the regulatory status of each ingredient, and review the documentation they have available to independently verify the status of each GRAS substance.
• Review Sourcing Agreements: Food manufacturers may want to review supply agreements with ingredient manufacturers to determine references to the ingredient’s GRAS status and identify any language providing product guaranties concerning adulterated and misbranded products.
• Assess Alternatives: If documents are not made available that would permit a manufacturer to confidently defend an ingredient’s status as GRAS, manufacturers should request additional testing or documentation from the ingredient supplier, begin to assess alternative suppliers for a particular ingredient, or, when necessary, explore reformulation