Navigating FDA compliance – article

Food Contact Notifications (FCNs) are an expedited way to obtain formal authorization from the Food & Drug Administration (FDA) for food packaging materials and other substances used in contact with food (such as components of food processing equipment). Think of them as a faster, better alternative to the older Food Additive Petitions (FAP). Instead of waiting several years for the FDA to issue a food additive regulation, an FCN can become effective in just 120 days from the time it is filed, barring any FDA safety concerns.

It's important to note, however, that FCNs are not the only route to establishing FDA compliance for substances that touch food. Here are a variety of options for establishment of FDA compliance through various self-determination methods.

Understanding the legal landscape—key terms to know

Understanding the legal definitions of key terms is pivotal to being able to navigate this terrain effectively.

Under the Federal Food, Drug and Cosmetic Act (FDCA), a food additive is: any substance whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component of, or otherwise affecting the characteristic of, any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use), if such substance is not Generally Recognized as Safe (GRAS), or approved by FDA or the US Department of Agriculture prior to 1958 (Prior Sanctioned), or otherwise excluded from the definition of food additive.

On the other hand, a food-contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use of the substance is not intended to have any technical effect in such food.

Comparing these definitions, the takeaway is that a food-contact substance may or may not be a food additive and, therefore, may or may not require an FCN to establish FDA compliance.

When is FDA authorization necessary for food-contact substances?

While FCN authorization is available for all food-contact substances, it is required only for food-contact substances that also are food additives.

If the food-contact substance is covered by an exception to the food additive definition, it does not require FDA authorization.

Companies are allowed make this judgment on their own without involving the FDA. This approach can be used alone or alongside an FCN application to get a product on the market while the FCN is being reviewed.

Two common approaches to self-determination of FDA compliance

There are two primary exemptions from the food additive definition that allow for self-determination of FDA compliance and do not involve FCNs: No Migration and GRAS.

No Migration. This exemption derives from the element of the definition of a food additive that it is reasonably to become a component of the food it touches. If there is no detectable migration of the substance to food, the substance is not reasonably expected to become a component of food and does not require FDA authorization through an FCN. The potential for migration may be determined by calculation (100% migration or based on diffusion theory) or by testing. 

Establishing zero migration is not possible as a matter of science. Traditionally, FDA has taken, and to some extent still espouses, the position that any contact of a substance with food necessarily results in some migration. The United States Court of Appeals for the District of Columbia Circuit, however, rejected the assumption of migration based on contact with food. The court held that, in order for FDA to require authorization of a food-contact substance as a food additive, FDA must be able to show migration at more than an insignificant level.  Monsanto v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979).

The question then becomes what constitutes an “insignificant level” of potential migration.  Reliance on the “no migration” exemption requires a showing of no detectable migration at an appropriate level of analytical sensitivity.  The level of sensitivity is based on the toxicology of the food-contact substance.  In other words, what is a reasonable estimate of the safe level of human exposure to the food-contact substance?

For many years, industry used a “no migration” detection level of 50 parts per billion (ppb).  This was based on a proposal by an FDA official, Dr. Lessel Ramsey, for a level of migration of a food-contact substance that could reasonably be considered to be safe in the absence of special toxicology concerns.  Although the proposal was not adopted formally by FDA, it was used for many years by industry for determination of “no migration” status. FDA has never challenged a “no migration” determination using this standard.

A more recent benchmark for a “no migration” determination is FDA’s Threshold of Regulation (TOR) rule.  This standard is 0.5 ppb dietary exposure. The dietary exposure is the level of potential migration multiplied by the appropriate consumption factor—the percentage of the diet estimated to be contacted by the food-contact substance. While only FDA can formally issue a TOR exemption, the level of exposure in the rule can be a useful consideration in setting a detection level for a “no migration” determination.

More recent scientific analysis has established estimates of exposure to substances without specific toxicology data that may reasonably be considered to be safe based on the chemical structures of the substances. This work is known as the Threshold of Toxicological Concern and is the subject of published scientific literature.

Note that the “no” in “no migration” must be taken literally. If your testing or calculation using the appropriate level of analytical sensitivity shows potential migration, the “no migration” exemption is not available. That is not necessarily the end of options for a self-determination of compliance for a food-contact substance, however. GRAS status may be an option.

Generally Recognized as Safe (GRAS). If you can demonstrate that your substance is generally recognized as safe by compiling scientific evidence supporting your GRAS determination, you won't need to submit an FCN. GRAS substances are exempted from the food additive definition in the FDCA. The basic scientific evidence supporting the GRAS conclusion must be published in the peer-reviewed scientific literature and can be supported by unpublished data. Note that the GRAS publication requirements are more stringent than those of FCNs, which may be based entirely on unpublished data.

As with “no migration,” GRAS status is a company self-determination that does not require FDA confirmation.  FDA has a GRAS Notification Program in which FDA will review a company’s determination of GRAS status, but that program is only available for direct food ingredients.

Exploring Additional Pathways for Self-Determination of FDA Compliance

There are some additional options to establish FDA compliance for substances that touch food without going through the FCN process.

Prior Sanctioned. This involves seeking out pre-1958 FDA authorization or USDA acceptance for food-contact substances, which are also exempted from the FDCA food additive definition. If the FDA or USDA had already approved your substance prior to 1958, when amendments to the U.S. Food, Drugs and Cosmetic Act of 1938 were enacted, you may be in the clear. Some prior sanctions have been codified by FDA. Prior to 1958, however, both FDA and USDA issued clearances for the use of food-contact substances by letter. If a company can find such a letter in its files or elsewhere, it may be the basis for a prior sanction. Prior sanctions are limited to the uses specified in the FDA or USDA letter.

Housewares Exemption. If your substance is used in products like containers sold empty (without food in them) for home or food-service use, it might not require an FCN.  FDA has denied the existence of this exemption, but the Agency also has made public statements acknowledging it. Realistically, this “exemption” may be useful as a defense to an allegation of not having valid FDA compliance for a food-contact substance. This approach is not commonly used as an affirmative compliance strategy.

Basic Resin Doctrine. Also known as the Catalyst Doctrine, this pertains to modifications made in the production of food-contact substances. More specifically, if your company changes the way it makes a substance, such as using a different manufacturing method or catalyst, and it doesn't affect safety, it may be able to do so without FDA approval. This principle allows companies to change manufacturing processes for food-contact substances authorized by FDA under a food additive regulation or an FCN without petitioning FDA for a revised authorization.

Navigating FDA compliance for food-contact substances is a multifaceted endeavor, demanding careful consideration of legal definitions, exploration of alternative pathways and the application of rigorous scientific evidence. Understanding the FCN route and knowing its useful alternatives can help you confidently ensure FDA compliance in your products, while upholding the highest standards of food safety and quality.