Flexible Food Packaging: Navigating FDA Compliance

Microwaveable retort pouches. Stand up zip bags. Single serving stickpacks. These represent just a few examples of flexible packaging uses found in the U.S. market today. As demand for flexible packaging continues its momentum in the food sector, it is imperative that manufacturers have a fundamental understanding of the way in which flexible food packaging is regulated in the U.S.

Agencies & Acts

A discussion of the U.S. regulatory framework for flexible food packaging must first begin with an understanding of the government agency with jurisdiction over food packaging materials, in this case the Food and Drug Administration (FDA). Under the Federal Food, Drug and Cosmetic Act, food packaging, including flexible food packaging, is prohibited from adulterating food. Adulteration of food can occur if the packaging renders the packaged food to be unsafe or unfit for consumption, or if the packaging contains a "food additive" that is not cleared for the intended use by FDA.

Significantly, not all substances used in food packaging are properly considered food additives. A food additive is defined in the Act as:

"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 . . .[1]

The Act excludes from regulation substances that are Generally Recognized as Safe (GRAS) or those that are subject to a prior sanction, discussed later on. By virtue of its definition, the term "food additive" also excludes from regulation any substance that, when used as intended, is not reasonably expected to become a component of food.

The first step in evaluating the FDA status of a flexible packaging material is to determine if it is already authorized by a food additive regulation or Food Contact Notification (FCN), or subject of a "Threshold of Regulation" (TOR) exemption letter. In terms of clearances under the food additive regulations, these can be found in Title 21 of the Code of Federal Regulations (CFR), § 175-186. Since food additive clearances are generic, anyone may rely on them. However, the clearances can have limitations, so it is important to confirm whether the regulation imposes any restrictions with respect to use levels, foods to be contacted, temperature conditions of use and the like.

The FCN program was implemented in 2000 and has become the primary vehicle for obtaining a formal clearance for new food contact substances. The program has largely replaced the food additive petition process, where it could take an average of two to four years for FDA to promulgate a food additive regulation for new substances. Under the FCN program, the Agency is required by law to clear the substance in 120 days unless FDA objects to the notification. Unlike food additive regulations, FCNs are propriety; therefore, only the manufacturer and its customers can rely on the notification.

Exceptions to the Rules

As for the TOR exemption, FDA can exempt a food contact substance from regulation as a food additive regulation based on de minimis dietary exposure to the compound. The TOR exemption can be relied upon in two scenarios:

• The intended use of the substance results in dietary exposures of less than 0.5 ppb
• The substance is cleared as a direct food additive and the dietary exposure of the compound from food-contact uses is less than 1% of the Acceptable Daily Intake.[2]

The exemption is valid so long as the food contact substance does not contain any carcinogenic constituents or impurities.

If the intended use of the substance is not subject of one of FDA's formal regulatory vehicles we've discussed, certain exemptions from FDA premarket clearance may be available. Under the Act, a company is entitled to determine independently whether the use of a substance in a particular food contact application poses a food additive situation. As mentioned above, substances that are not reasonably anticipated to become components of food are not food additives under the Act and, as a result, are not subject to FDA premarket clearance. This exemption, known as the "no migration" exemption, is supported by case law and has been used by industry for many years to substantiate the FDA status of various food contact materials.

As already discussed, the Act also exempts "prior sanctioned" substances from the definition of food additive. Whether a substance is prior sanctioned is a matter of fact, and refers to substances that are subject of letters issued by FDA or the U.S. Department of Agriculture prior to 1958. Some, but not all, of these prior sanctions are listed in 21 CFR § 181.

Substances that are properly considered GRAS also are excluded from the definition of "food additive" and thus exempt from FDA premarket clearance. The Act defines a GRAS substance as one that, when used as intended, is generally recognized as safe by scientific experts qualified to evaluate its safety. Where a compound was used in food prior to 1958, the GRAS status of a substance is established through either scientific procedures or experience based on common use in food.[3]

While a number of GRAS substances are listed in 21 CFR § 182, 184 and 186, the food additive regulations acknowledge that the list of GRAS substances is not exhaustive.[4] Thus, manufacturers are free to determine on their own whether a substance is GRAS, without authorization or notice by FDA.

It is important to keep in mind that, even if your flexible packaging is subject of a relevant regulatory clearance or exemption, the package also must comply with FDA's good manufacturing practice (GMP) regulation. The regulation is found at 21 C.F.R. § 174.5 and requires a food contact material to be of a "purity suitable for its intended use." This means that food contact materials may not impart a taste or odor to food, so as to render the food unfit for consumption or contain impurities at levels so high as to result in the adulteration of food. Suitable purity may be particularly relevant to the flexible packaging sector where issues like set off may be of potential concern.

There are myriad materials that can be used in flexible packaging for food. Manufacturers along the supply chain will best maximize their opportunities in this growing market by ensuring that their materials comply with FDA's food-contact materials regulatory scheme.

The following article appeared in FLEXO® Magazine's August 2014 issue.

[1] Federal Food, Drug and Cosmetic Act, § 201(s), 21 U.S.C. § 321(s).

[2] The ADI is the amount of a substance that can be ingested on a daily basis over a lifetime without an appreciable health risk.

[3] See supra note 1.

[4] 21 C.F.R. 182.1.