Mislabeling has caused hundreds of recalls since the Food Labeling and Consumer Protection Act (FLCPA) became law in 2004.  Will Genetically Modified Organisms (GMOs) be the cause of hundreds of new recalls because of mislabeling? Knowing industry requirements and having reliable labeling processes in place will help you avoid a costly recall.

Industry Requirements

Not all countries require the same labeling for products containing GMOs. Thresholds for GMO ingredients range from a total ban, to threshold amounts, to no limits at all.  Strong advocates on all sides of the labeling issue are beginning to see action.  The USDA implemented labeling requirements as of January 1, 2020.  The FDA has issued guidance, but not yet entered the formal rulemaking process. Most countries have requirements in place, ranging from minimal to comprehensive, while a few ban genetically engineered foods entirely. Global Food Safety Resource provides an overview of requirements by country or you can view the information in map format provided by the Center for Food Safety.

Understanding labeling requirements is important. Although there is no FDA requirement to disclose GMO ingredients, their guidelines for manufacturers wishing to provide voluntary GMO labeling state that the “main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading.”[1] According to the Guidance for Industry, examples of accurate labeling include “Not genetically engineered” and “Not genetically modified through the use of modern biotechnology;” or conversely, “Genetically engineered” and “This product contains cornmeal from corn that was produced using modern biotechnology.”[2] In other words, manufacturers should use language that clearly communicates the presence or lack of genetically modified ingredients.

The USDA has more specific labeling requirements in place, with the recent implementation of the final rule in January 2020. According to the rule, bioengineered foods must be disclosed on labeling, with the exception of a list of refined products that may be excluded from the requirements. Food Dive provides a helpful overview, while the final rule can be viewed in full at the Federal Register.

Process Controls

Having process controls in place so products are accurately labeled, communicates clearly with the public, and prevents the need to recall products. Process control points for labeling integrity start at package design and end with finished goods review.  Consider this checklist:

• Label design and review against current regulations
• Review and approval of package prototypes
• Review and approval of package before use
• Review and approval of package at beginning, middle, and end of production runs
• Review and approval of package after any change, including:
• Change in ingredient supplier
• Change in production process
• Refilling of packaging during production runs
• Final review and approval upon completion of production, pre-shipping

Each of these checkpoints allow errors to be discovered and corrected before the product enters commerce. What a relief to correct an error and avoid a product recall.

These control points are part of a bigger system for managing product quality and safety.  An annual review of these points and the system adds a level of insurance to the plan making it more than in a folder on a desktop, and actually results in actions to protect your brand and your customers.  Along with a plan review, correcting deficiencies, and implementing those corrective actions plays a lasting role in protecting your business.

Avoiding Mislabels

Correcting mislabeled product once it’s in the supply chain requires quick action.  Even though there may be no direct legal infringement, the effects of mislabeled product are widespread. Having a clear plan in place to identify mislabeling and perform the necessary recall is vital. Recalling product efficiently will minimize impact to the brand and business.

Staying educated about industry requirements and having process controls in place will not guarantee a perfect label, but good systems and processes with regular review will go a long way to keeping your company recall free.

__

[1] U.S. Food and Drug Administration: “Guidance: Voluntary Labeling Food from Genetically Engineered Plants,” U.S. Food and Drug Administration, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-voluntary-labeling-indicating-whether-foods-have-or-have-not-been-derived (retrieved February 25, 2020).

[2] FDA: “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants: Guidance for Industry,” U.S. Food and Drug Administration, https://www.fda.gov/media/120958/download (retrieved February 25, 2020).

‍