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Indirect Additive or GRAS Ingredient?

The case of Monsanto v. Kennedy forever established the fact that food contact materials (such as packaging ingredients) obey the Second Law of Thermodynamics, i.e., “the entropy or an isolated system not in equilibrium will tend to increase over time, approaching a maximum value at equilibrium” – sometimes called the “diffusion principle.”  In the circumstance of a food and its wrapper, the Second Law of Thermodynamics dictates that components of the wrapper become part of food, albeit “indirectly.”  However, this becoming a part of food satisfies one of the criteria for identification as a food additive, as according to the Federal Food Drug and Cosmetic Act (FFDCA)(§201(s))

The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in …packing, …packaging, or holding food…

Once the issue of the status of the substance was resolved, energies were refocused on (1) how much of the migrating substance constitutes an insignificant or de minimus amount and (2) because food additive petitions had become so burdensome, was not there a way to expedite the process?

In the first regard, while the courts avoided identifying a de minimus threshold, the packaging industry initially embraced a threshold of 50 parts per billion (ppb), below which, a food additive petition would not be required (provided no heavy metals, carcinogens or substances of known toxicity were present).  This has since been replaced by the concept of Threshold of Regulation (21 CFR 170.39), which embodies the principle that substances in the diet at less than 0.5 ppb are not subject to regulation.  The Threshold of Regulation may also be applied to already approved food additives, whose presence as a packaging ingredient in the diet does not exceed 1 percent of the acceptable daily intake for the substances direct addition to food.  Lastly, the 0.5 ppb exemption applies to substances whose carcinogenic constituents or impurities with a TD50 of less than 6.25 mg/kg body weight per day.

In response to the complaint of a too burdensome food additive process ((1) because of resource limitations of the agency, a food additive petition could take two to four years and (2) the possibility of performing many costly toxicology studies à la the Redbook criteria), Congress provided some relief with the Food and Drug Administration Modernization Act of 1997 (FDAMA), allowing the initiation of a Food Contact Notification (FCN) program (FFDCA§409(h)). Now in place, the FCN program describes administrative, chemical, toxicological and environmental requirements for an FCN; even the forms to be used for the FCN submission are available online.  Once the appropriate steps have been taken and the requirements satisfied, FDA has 120 days to respond to a submission.  In the approximately 10 years since its authorization, nearly 500 FCNs have been approved.

While the FCN program has been of great benefit to an over-burdened agency, provided relief for the manufacturer and protected the safety of the consumer, the program will be discontinued by October of this year as the result of budget constraints.  While the loss of this program is regrettable, manufacturers looking for renewed relief might consider the other criteria for defining a food additive; that is, a food additive is something that is “not generally recognized as safe” (GRAS).  While GRAS determinations for food contact substances have not been the most popular method for meeting compliance requirements, it is likely this process would have a higher degree of appeal to manufacturers.  Further, it would seem that convincing evidence of eligibility for a determination of GRAS by an Expert Panel, would be embodied in a demonstration that the substance meets the same criteria laid out in the FCN program.  Although it is unlikely many GRAS Notifications may be carried out, the increase in non-notified GRASes will likely be on the increase in the near future for packaging ingredients.

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